louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04674501: Radiotherapy for Thoracic and Breast Cancer and the Related Cardiotoxicity Following Treatment (RACCOON)
Official title: A Prospective Cohort Study of Patients Receiving Radiotherapy for Thoracic and Breast Cancer and the Related Cardiotoxicity Following Treatment (RACCOON)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Patients Who Receive Thoracic Irradiation
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2020-12-19
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with solid tumors who receive thoracic irradiation

Brief summary: The purpose of this study is to investigate the risk factors and mechanisms of cardiotoxicity following thoracic radiotherapy and to provide insights in preventing radiation-related cardiotoxicity.

-Condition or disease : Thoracic irradiation -Intervention/treatment : Cardiac evaluation, Blood sampling

Detailed description: Cancer patients who undergo thoracic irradiation receive a certain amount of dose to the heart. Cardiotoxicity may occur in some patients several years after radiotherapy due to the late effect of radiation. Considering that cardiotoxicity is often lethal, screening and preventing radiation-induced cardiotoxicity is crucial in patients receiving thoracic irradiation.

Patients in this cohort will undergo cardiac evaluation before and after thoracic irradiation. The dose-volume parameters for each cardiac substructures will be estimated using artificial intelligence-based auto-segmentation of the heart in CT images. Dose-volume parameters that predict cardiotoxicity will be analyzed. Among the patients who developed cardiotoxicity, blood sampling will be performed to establish cardiomyocytes derived from induced pluripotent stem cells, which will be used for identifying the mechanisms of radiation-induced cardiotoxicity and therapeutic targets.

Eligibility criteria: Inclusion Criteria:

1. Patients with solid cancer who are subject to thoracic irradiation.
2. Patients who are 20 years old or older
3. Eastern Cooperative Oncology Group Performance Status Scale 0-2
4. Patients with cognitive abilities to receive virtual reality information

Exclusion Criteria:

1. Patients with a history of previous thoracic irradiation
2. Patients who refused consent
3. Patients with a history of heart failure before radiotherapy

Primary outcomes:
measure: Cardiotoxicity rate
timeFrame: 2 years
Secondary outcomes:
measure: Overall survival
timeFrame: 2 years
measure: Cancer-specific survival
timeFrame: 2 years
measure: Progression-free survival
timeFrame: 2 years
measure: Other toxicity rates
timeFrame: 2 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei Cancer Center, Yonsei University College of Medicine, Yonsei University Health System
Study officials:
affiliation: Severance Hospital
name: Hong In Yoon
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00005101: Study of Low Bone Mass in Premenopausal or Perimenopausal Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoporosis
Keywords: disease-related problem/condition
osteoporosis
rare disease
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
Collaborators: name: Columbia University
First posted: 2000-04-07
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 54
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no

Brief summary: OBJECTIVES:

I. Determine the possible causes of bone loss in premenopausal or perimenopausal women.

Detailed description: PROTOCOL OUTLINE: Patients undergo physical examination and complete history with emphasis on risk factors for osteoporosis and screening for occult secondary causes of osteoporosis through blood serum and 24 hour urine collection.

Patients with more than 6 months since prior bone mineral density measurements or who did not receive measurements at participating center, undergo dual energy x-ray absorptiometry over 30 minutes for bone mineral density measurements.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Low bone mass (T score less than -2.0) with no secondary cause on routine exam
* Premenopausal

OR

* Perimenopausal

--Prior/Concurrent Therapy--

* Chemotherapy: No prior or concurrent chemotherapeutic agents
* Endocrine therapy: No prior or concurrent glucocorticoids or suppressive doses of thyroid hormone
* Other: No prior or concurrent anticonvulsants

--Patient Characteristics--

* Hematopoietic: No multiple myeloma
* Other: No hyperparathyroidism No thyrotoxicosis No anorexia nervosa No Paget's disease of bone No rheumatoid arthritis No Cushing's syndrome No malabsorption syndrome No type I diabetes mellitus

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University College of Physicians and Surgeons
state: New York
Study officials:
affiliation: Columbia University
name: Elizabeth Shane
role: STUDY_CHAIR
References:
Clinical trial NCT04348201: Foot Reflexology on Premenstrual Syndrome
Official title: Foot Reflexology Combined With Dietary Modification on Premenstrual Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Reflexology
Dietary Modification
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-04-16
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Fifty volunteer, single females with premenstrual syndrome (PMS) were selected randomly from outpatient clinic of obstetrics and gynecology at Kasr El Ainy University Hospital, Faculty of Medicine, Cairo University to share in this study, their age ranged from 18 to 25 years old and their body mass index (BMI) did not exceed 30kg/m2, the participants were assigned into two groups of equal numbers. The group (A) received therapeutic foot reflexology with dietary modification 3 times/week for8 weeks, while the group (B) received dietary modifications only for 8 weeks
Primary purpose: TREATMENT

Brief summary: : Premenstrual Syndrome (PMS) is a set of physical, emotional and behavioral symptom that start during the week preceding menstruation and are alleviated when the menstrual flow begins. Reflexology is one of the most popular complementary therapies

Detailed description: This study was aimed to determine the effect of foot reflexology in the treatment of premenstrual syndrome. Subjects and methods: Fifty volunteer, single females with premenstrual syndrome (PMS) were selected randomly from outpatient clinic of obstetrics and gynecology at Kasr El Ainy University Hospital, Faculty of Medicine, Cairo University to share in this study, their age ranged from 18 to 25 years old and their body mass index (BMI) did not exceed 30kg/m2, the participants were assigned into two groups of equal numbers. The group (A) received therapeutic foot reflexology with dietary modification 3 times/week for8 weeks, while the group (B) received dietary modifications only for 8 weeks. All subjects in both groups were assessed through the visual analogue scale (VAS) for pain and Premenstrual Daily Symptoms Questionnaire for (PMS) related symptoms. Results: The results of the present study revealed that there was statistically significant improvement in both pain and premenstrual related symptoms in group (A) than in group (B).

Eligibility criteria: Inclusion Criteria:

* their age ranged from 18 to 25 years old
* their body mass index (BMI) did not exceed 30kg/m2

Exclusion Criteria:

* Rheumatoid arthritis
* Bronchial asthma
* depression
* anxiety

Primary outcomes:
measure: Visual analogue scale
timeFrame: 8 weeks
Secondary outcomes:
measure: Premenstrual daily symptoms questionnaire
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01295801: Vitamin B6 on Relieving Linezolid-associated Cytopenias
Official title: The Effects and Mechanism of Vitamin B6 on Relieving Linezolid-associated Cytopenias
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cytopenias
Erythropenia (Diagnosis)
Keywords: Linezolid
Vitamin B6
Linezolid-associated cytopenias
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2011-02-15
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Use of linezolid

Brief summary: Linezolid is the first approved synthetic oxazolidinone that is active against multidrug-resistant Gram-positive pathogens. Because of its significant efficacy, linezolid is widely used in clinical treatment. However, the side effects of linezolid commonly lead to anemia and thrombocytopenia. This hematological toxic effects limit its prolonged used. The investigators have found that Vitamin B6 application, as a preventive, auxiliary therapy, can relieve anemia and thrombocytopenia. The present study was designed to verify the effects of Vitamin B6 in the prevention of linezolid-associated cytopenias and investigate its mechanism.

Detailed description: Infected patients receiving linezolid therapy are divided into two groups, i.e. the linezolid group and the linezolid + vitamin B6 group, the line of division being whether vitamin B6 is to be applied or not in the course of treatment. The purpose is to evaluate the role that vitamin B6 plays, during the process of linezolid therapy, in the relief of erythropenia and cytopenias.

Eligibility criteria: Inclusion Criteria:

* Use of linezolid is not less than 3 days

Exclusion Criteria:

* Serious adverse reactions

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
affiliation: Pneumology Department of chinese PLA General Hospital
name: Xie Lixin, Doctor
role: STUDY_DIRECTOR
References:
citation: Deng J, Su LX, Liang ZX, Liang LL, Yan P, Jia YH, Zhang XG, Feng D, Xie LX. Effects of vitamin b6 therapy for sepsis patients with linezolid-associated cytopenias: a retrospective study. Curr Ther Res Clin Exp. 2013 Jun;74:26-32. doi: 10.1016/j.curtheres.2012.12.002.
Clinical trial NCT02138201: Representation of the Bladder Innervation Using Diffusion Tensor Imaging Fiber Tracking With MRI - a Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Cord Injury
Neurogenic Lower Urinary Tract Dysfunction
Keywords: diffusion tensor imaging fiber tracking
magnetic resonance Imaging
spinal cord injury
neurogenic lower urinary tract dysfunction
Lead sponsor: Swiss Paraplegic Research, Nottwil
Sponsor class: NETWORK
First posted: 2014-05-14
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: individuals with and without neurogenic lower urinary trat dysfunction

Brief summary: The exact innervation of the bladder and the changes after a spinal cord injury have been not yet been illustrated.

Diffusion tensor imaging with magnetic resonance imaging is a new technique which can be used to visualize single nerve fibers, and thus represent the neural supply of a region in vivo. There are studies in which both the sacral plexus and the lumbar nerve roots have been represented using diffusion tensor imaging. However, there is no study concerning the innervation of the bladder.

The investigators are therefore using diffusion tensor imaging with magnetic resonance imaging to represent the bladder innervation of individuals with neurogenic lower urinary tract dysfunction and individuals with normal bladder function.


Eligibility criteria: Inclusion Criteria:

* neurogenic lower urinary trat dysfunction
* normal bladder function

Exclusion Criteria:

* no signed informed consent
* contraindications for MRI (pace maker, implanted metal, claustrophobia)
* upper or lower urinary tract surgeries
* pregnancy (anamnestic)

Primary outcomes:
measure: bladder innervation quality
timeFrame: day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Nottwil
country: Switzerland
facility: Swiss Paraplegic Centre
state: LU
Study officials:
References:
Clinical trial NCT02159001: Electroconvulsive Therapy in Clozapine-resistant Schizophrenia
Official title: Efficacy and Cognitive Effects of Electroconvulsive Therapy in Clozapine-Resistant Schizophrenia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Schizophrenia
Schizoaffective Disorder
Keywords: clozapine
ECT
PANSS
schizoaffective disorder
schizophrenia
treatment
Lead sponsor: Niuvanniemi Hospital
Sponsor class: OTHER
First posted: 2014-06-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Electroconvulsive therapy (ECT) is one of the oldest neuromodulation treatments still used in psychiatry. Only case reports and open label non-randomized studies have been published of ECT in clozapine-resistant schizophrenia patients. The purpose of this trial is to study the efficacy and cognitive effects of add-on ECT treatment (10-course) in schizophrenia patients taking clozapine.


Eligibility criteria: Inclusion Criteria:

* diagnosis of schizophrenia or schizoaffective disorder
* treatment-resistant to clozapine
* age 18 - 64 years
* capacity and willingness to give informed consent

Exclusion Criteria:

* serious somatic illness
* progressive neurological illness, recent brain damage or sequela of serious brain damage
* ECT less than 3 months prior to this trial

Primary outcomes:
measure: Positive and Negative Symptom Scale
timeFrame: 2 days
Secondary outcomes:
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: Niuvanniemi Hospital
Study officials:
References:
Clinical trial NCT00513201: Lyspro Insulin vs Regular Insulin in Cirrhotic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus
Cirrhosis
Keywords: lyspro
regular insulin
cirrhotic patients
Lead sponsor: University of Campania Luigi Vanvitelli
Sponsor class: OTHER
First posted: 2007-08-08
Sex: ALL
Minimum age (years): 48
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: OBJECTIVE: To compare lispro insulin and regular insulin in the glycemic control of patients with liver cirrhosis and type 2 diabetes subjects. METHODS: 108 patients with liver cirrhosis and type 2 diabetes were randomly treated with regular insulin or lispro. After 122 weeks a cross-over was carried out and patients followed-up for 122 weeks. Then, all patients received a standard breakfast of 145 kcal following 12 U.I. of regular insulin or lispro, and C-peptide and insulin serum levels were determined over 300 minutes.


Eligibility criteria: Inclusion Criteria:

* Insulin-treated diabetes mellitus and liver cirrhosis

Exclusion Criteria:

* Oral hypoglycemic agents treated diabetes mellitus
* Liver cancer

Primary outcomes:
measure: Glycemic control in lyspro vs regular insulin treated patients
measure: Glycemic control in lyspro vs regular insulin in cirrhotic patients
Secondary outcomes:
measure: Tolerance to treatment and reduced postprandial hypoglycemia episodes
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Department of Medicine
Study officials:
affiliation: University of Campania Luigi Vanvitelli
name: Roberto Torella, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00420901: Effect of Chronic PDE5-Inhibition on Endothelial Function in Diabetics
Official title: Effect of Chronic Administration of Sildenafil on Endothelial Function in Men With Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes
Keywords: function
inhibition
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2007-01-11
Enrollment: 30
Sex: MALE
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: chronic PDE5-Inhibition improves endothelial function in diabetics

Detailed description: Evaluation of endothelial function at baseline and after chronic administration of sildenafil in male subjects with diabetes

Eligibility criteria: Inclusion Criteria:

* type 2 diabetes
* males

Exclusion Criteria:

* females, nitrate use, PDE5-Inhibitors intolerance

Primary outcomes:
measure: Endothelial function responders - Improvement in endothelial function
Secondary outcomes:
measure: Changes in vascular inflammatory markers
Other outcomes:
Locations:
city: Roma
country: Italy
facility: San Raffaele EUR
Study officials:
affiliation: San Raffaele EUR
name: giuseppe rosano, md
role: STUDY_DIRECTOR
References:
Clinical trial NCT02835001: Hyperinflation Assessment After Treatment by Lung Volume Reduction Coil
Official title: Impact of Reduction Lung Volume Reduction by Coil on Hyperinflation in Severe Emphysema
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Emphysema
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2016-07-15
Enrollment: 20
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Hyperinflation Assessment After Treatment by Lung Volume Reduction Coil (HEAT-LVRC) on Hyperinflation in Severe Emphysema

Detailed description: Two sequences (around 30 minutes) are necessary by patient. Under general anesthesia, two lobs treatment ( 10 Coil by lob) successively introduced by a bronchoscope.

Eligibility criteria: Inclusion Criteria:

* Severe emphysema (recent CT-scan (\< 6 mois) )
* Age \> 35 ans
* Modified Medical Research Council Scale (mMRC) \> 2
* Forced expiratory volume in one second (FEV1) post-bronchodilatator \< 45%
* Residual volume \> 175%
* Total Pulmonary capacity \> 100%

Exclusion Criteria:

* Forced expiratory volume in one second (FEV1) variability \> 20% after bronchodilatator
* Carbon Monoxide Diffusing Capacity (TLCO) \< 20%
* Recurrent respiratory infection Infections with clinics symptoms
* Pulmonary arterial hypertension (PAH) with Pulmonary Arterial Systolic Pressure (PAPS) estimated with echography \> 50 mm Hg
* Impossibility to walk more that 140 meter (6 min test)
* Surgery history of volume reduction or pulmonary transplantation
* Broncho-dilatation with clinic symptoms

Primary outcomes:
measure: Hyperinflation Assessment After Treatment
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Larrey Hospital
Study officials:
affiliation: University Hospital, Toulouse
name: Nicolas Guibert, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03794401: Alternations of Intestinal Microbiota and Health Impact in CKD
Official title: Alternations of Intestinal Microbiota and Health Impact in Chronic Kidney Disease (AIM-HI CKD): A Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Kidney Disease
Keywords: body composition
chronic kidney disease
dietary pattern
gut microbiot
Lead sponsor: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Sponsor class: OTHER
First posted: 2019-01-07
Enrollment: 750
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Regional Hospital

Brief summary: This study is aimed to evaluate the impact of dietary pattern, gut microbiota and their interactions on clinical outcomes among patient with CKD stage 3-5.


Eligibility criteria: Inclusion Criteria:

* Patients with CKD stage 3-5 defined as eGFR \<60 ml/min/1.73 m2 calculated with the use of the four-variable Modification of Diet in Renal Disease formula who have not yet on dialysis therapy.

Exclusion Criteria:

* Patients with active cancer
* Patients with liver cirrhosis
* Patients have taken antibiotics within three months before screening for inclusion.
* Patients with a cardiac pacemaker or metallic implants,
* Patients are amputees
* Pregnant women
* Patients with inherited renal diseases

Primary outcomes:
measure: renal outcome
timeFrame: 3-year follow-up
measure: cardiovascular outcome
timeFrame: 3-year follow-up
Secondary outcomes:
measure: all-cause mortality
timeFrame: 3-year follow-up
measure: neurological outcome
timeFrame: 3-year follow-up
Other outcomes:
measure: change of lean body mass, measured by bioimpedance spectroscopy every 3 months for 2 years
timeFrame: 2-year
Locations:
city: New Taipei City
country: Taiwan
facility: Taipei Tzu Chi Hospital
Study officials:
affiliation: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
name: SZU-CHUNG HUNG
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04094467: Comparison Between Two Different Protocols in Polycystic Ovary Symdrome Women Undergoing Intra-cytoplasmic Injection
Official title: CLASSICAL ANTAGONIST PROTOCOL IN COMPARISON WITH AGONIST STOP PROTOCOL IN Polycystic Ovary Symdrome WOMEN UNDERGOING Intra-cytoplasmic Injection TRIAL: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Polycystic Ovary Syndrome
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-09-19
Enrollment: 150
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Stein and Leventhal were the first to recognize an association between the presence of polycystic ovaries and signs of hirsutism and amenorrhea (eg,oligomenorrhea, obesity), After women diagnosed with Stein-Leventhal syndrome underwent successful wedge resection of the ovaries, their menstrual cycles became regular, and they were able to conceive. As a consequence, a primary ovarian defect was thought to be the main culprit, and the disorder came to be known as polycystic ovarian disease.


Eligibility criteria: Inclusion Criteria:

1. Women under 35 years with polycystic ovary syndrome criteria
2. Normal male semen parameters
3. Normal tubes either by hysterosalpingography \&/or laparoscopy
4. Free from other endocrine abnormalities

Exclusion Criteria:

1. NON polycystic ovary syndrome Criteria
2. More than 35 years
3. Abnormal semen parameters
4. Pathological tube\& pelvic factor
5. Other endocrine disorders

Primary outcomes:
measure: The difference in clinical pregnancy rate in both groups
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Ahmed Abbas
state: Cairo
Study officials:
References: