louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03902509: A Study About Safety and Efficacy of Pirfenidone to Treat Grade 2 or Grade3 Radiation-induced Lung Injury.
Official title: A Randomized, Controlled, Multi-site Study About Safety and Efficacy of Pirfenidone to Treat Grade 2 or Grade3 Radiation-induced Lung Injury.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Radiation-induced Lung Injury
Keywords: pirfenidone
Lead sponsor: Beijing Continent Pharmaceutical Co, Ltd.
Sponsor class: INDUSTRY
First posted: 2019-04-04
Enrollment: 126
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: Using Pirfenidone to treat Grade 2 or Grade3 radiation-induced lung injury, and observe the efficacy and safety of the drug.

Detailed description: The study is a randomized, controlled, multi-site clinical trial.

Eligibility criteria: Inclusion Criteria:

1. 18-75 years old (including 18 and 75 years);
2. clinically diagnosed grade 2 or 3 radiation-induced lung injury;
3. the course of radiation-induced lung injury is less than 2 months;
4. ECOG 0-2;
5. the expected survival time is more than 6 months;
6. the functional level of major organs meets the following standards: ANC≥3.0×109/L，PLT≥100×109/L，Hb≥90g/L, TBIL、BUN and Cr≤1.5×ULN， ALT、AST≤2.0×ULN
7. capable of eating solid food upon enrollment;
8. subjects will voluntarily participate in this study and sign the informed consent.

Exclusion Criteria:

1. have a history of chronic bronchial acute attack or severe pulmonary heart disease;
2. pneumonectomy;
3. tumor progression;
4. severe pulmonary infection;
5. creatinine clearance rate \< 30ml/min, severe renal disease or need dialysis;
6. concomitant with other serious diseases: for example, myocardial infarction within 6 months, uncontrolled diabetes, etc., were considered not suitable for the participants in the study;
7. patients with active peptic ulcer;
8. pregnant women and patients with mental illness;
9. participating in clinical trials of other drugs within 3 months;
10. the investigator determined that subject was not suitable.

Primary outcomes:
measure: DLco% change
timeFrame: Week 4, 8,16, and 24
Secondary outcomes:
measure: The grade change of radiation-induced lung injury
timeFrame: Week 4, 8,16, and 24
measure: The score change of CT
timeFrame: Week 4, 8,16, and 24
measure: Increase of effective lung volume
timeFrame: Week 4, 8,16, and 24
measure: The grade change of Cough, Dyspnea and Fever
timeFrame: Week 4, 8,16, and 24
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Science
state: Beijing
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
References:
Clinical trial NCT02731209: Functional Urodynamic Changes in Chronic Kidney Disease Patients and Does Insertion of Urinary Catheter Delay the Need for Kidney Dialysis
Official title: Functional Urodynamic Changes in Chronic Kidney Disease Patients and Does Insertion of Urinary Catheter in Chronic Kidney Disease Patients Grade 4 Delay the Need for Kidney Dialysis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Renal Insufficiency, Chronic
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2016-04-07
Enrollment: 100
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 aim of the investigators work is to describe the urodynamic results in the CKD (chronic kidney disease) grade 4 patients and to verify observations that urinary catheter may improve kidney function in those patients.

100 patients with CKD grade 4 will do urodynamic examination.

All patients will be randomized into two groups / the intervention group that will be inserted urinary catheter for 2 weeks and the follow up group. Kidney function will be monitored by creatinin values and the investigators will measure the time to dialysis in the two groups.


Eligibility criteria: Inclusion Criteria:

* age \> 18
* chronic kidney disease grade 4-5 (eGFR (estimated glomerular filtration rate) \<30)
* eligible to sign a consent form

Exclusion Criteria:

* non controlled Diabetes Melitus (HbA1C\>10%)
* not controlled HTN (Hypertension)
* cardiovascular event requiring cardiac stenting
* renal hydronephrosis or post void rest \> 200CC according to US (Ultrasound)
* acute renal failure
* not eligible for urodynamics for any reason
* constant urinary catheter for any reason

Primary outcomes:
measure: kidney function change
timeFrame: At the time of urinary catheter insertion. Two weeks from the insertion and than after 8,16, 24, 32, 40 and 48 weeks after the urinary catheter insertion. (at total 52 weeks of follow up)
Secondary outcomes:
measure: time to dialysis
timeFrame: at least 1 year from the time of catheter insertion
Other outcomes:
Locations:
city: Zrifin
country: Israel
facility: Asaf ha Rofeh, MC
Study officials:
References:
Clinical trial NCT01258309: Safety and Efficacy of Olopatadine Hydrochloride/Ketorolac Tromethamine Ophthalmic Solution Compared With Olopatadine Hydrochloride Ophthalmic Solution in Patients With Seasonal Allergic Conjunctivitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rhinitis, Allergic, Seasonal
Conjunctivitis, Allergic
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2010-12-10
Enrollment: 129
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: This study will investigate the safety and efficacy of olopatadine hydrochloride / ketorolac tromethamine fixed dose combination ophthalmic solution compared with olopatadine hydrochloride ophthalmic solution in patients with seasonal allergic conjunctivitis.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of seasonal allergic conjunctivitis

Exclusion Criteria:

* Ocular infection or history of ocular herpes infection
* History of retinal detachment or diabetic retinopathy
* Prior or current use of systemic or topical steroids, NSAIDs, anticholinergics, immunosuppressants, or antihistamines
* Ocular surgery within 8 weeks

Primary outcomes:
measure: Ocular Itching
timeFrame: Day 21
Secondary outcomes:
measure: Hyperemia
timeFrame: Day 21
measure: Chemosis
timeFrame: Day 21
measure: Ocular mucous discharge
timeFrame: Day 21
Other outcomes:
Locations:
city: Bangalore
country: India
state: Karnataka
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01669109: Hatha Yoga for Patients With Colorectal Cancer
Official title: Hatha Yoga for Patients With Colorectal Cancer - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Neoplasms
Keywords: Yoga
Colorectal Neoplasms
Quality of Life
Randomized Controlled Trial
Lead sponsor: Universität Duisburg-Essen
Sponsor class: OTHER
First posted: 2012-08-20
Enrollment: 54
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: Hatha Yoga is a traditional practice that encompasses aerobic exercise, breathing techniques, and meditation. It is used in India since centuries to improve well-being and cope with diseases and is gaining more and more interest in Europe and the US. While studies have demonstrated benefits of Hatha Yoga for patients with breast cancer, no studies on patients with colorectal cancer are available yet. The purpose of this study is to investigate the effect of Hatha Yoga in patients with colorectal cancer.


Eligibility criteria: Inclusion Criteria:

* Colorectal cancer
* UICC stage I-III
* between 2 and 48 months post-surgery
* age at least 18 years
* physical and cognitive ability to follow the yoga intervention

Exclusion Criteria:

* UICC stage IV
* further active oncological diseases
* diagnosed and pharmacologically treated psychiatric disorder except for cancer-related depression or adjustment disorder
* pregnancy or breastfeeding

Primary outcomes:
measure: Health-related quality of life
timeFrame: Week 10
Secondary outcomes:
measure: Health-related quality of life
timeFrame: Week 22
measure: Fatigue
timeFrame: Week 10, week 22
measure: Anxiety, depression
timeFrame: Week 10, week 22
measure: Sleep quality
timeFrame: Week 10, week 22
measure: Safety
timeFrame: Week 0-22
measure: Spiritual well-being
timeFrame: Week 10, week 22
Other outcomes:
measure: Body awareness/bodily dissociation
timeFrame: Week 10, week 22
measure: Body efficacy expectation
timeFrame: Week 10, week 22
measure: Qualitative Interviews
timeFrame: Week 11
Locations:
city: Berlin
country: Germany
facility: Department of Internal and Complementary Medicine, Immanuel Hospital Berlin
city: Essen
country: Germany
facility: Department for Internal and Integrative Medicine, Essen-Mitte Clinics
Study officials:
References:
citation: Cramer H, Pokhrel B, Fester C, Meier B, Gass F, Lauche R, Eggleston B, Walz M, Michalsen A, Kunz R, Dobos G, Langhorst J. A randomized controlled bicenter trial of yoga for patients with colorectal cancer. Psychooncology. 2016 Apr;25(4):412-20. doi: 10.1002/pon.3927. Epub 2015 Jul 29.
Clinical trial NCT04757909: Detection of Anemizations in Primary Care.
Official title: Early Detection of Anemizations in Primary Care Using Hemoglobinometer: Randomized Clinical Trial Protocol.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anemia
Red Blood Cell Transfusion
Keywords: Haemoglobinometry
Primary Care Nursing,
Advanced Practice Nursing
Lead sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Sponsor class: OTHER
First posted: 2021-02-17
Enrollment: 33
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Objective: To evaluate the effect of the use of the hemoglobinometer in primary care on the clinical results of patients with chronic anemia.

Methods: The ANHEMOG study is a randomized controlled trial with two parallel arms, intervention and control. It was approved at december 11, 2017. The study randomizes 138 patients with chronic anemia. In the intervention arm, a monthly capillary hemoglobin measurement will be performed with a hemoglobinometer. If a decrease in hemoglobin concentration is detected, an existing transfusion circuit will be followed. Social, demographic and quality of life variables will be collected from all participants.

Hypothesis:

The results of the research will have an impact on people with chronic anemia who would receive red blood cell transfusion when needed without delay. The improvement in the times of action would reduce decompensations from chronic diseases, visits to the emergency room and hospital admissions, and therefore would improve the quality of life of these patients. Furthermore, the management of the different interventions by the Case Management Nurse (EGC), in this regard, improves the current fragmentation of the different levels of care.


Eligibility criteria: Inclusion Criteria:

* People over 40 years old
* Had received 2 or more red blood cell transfusions due to chronic disease, during a year.
* The health provider in Primary Care is the Institut Català de la Salut.

Exclusion Criteria:

* Presenting kidney failure on hemodialysis treatment.
* Being in palliative care situation
* Presenting a moderate-severe cognitive impairment, with a Pfeiffer scale score higher than 5.
* Not having a caregiver able to detect signs of decompensation.

Primary outcomes:
measure: Mean Number of hospital admissions
timeFrame: 6 and 12 months.
measure: Mean Number of visits to the emergency room
timeFrame: 6 and 12 months.
Secondary outcomes:
measure: Quality of life self-assessment.
timeFrame: 6 and 12 months.
measure: Satisfaction with the intervention.
timeFrame: 6 and 12 months.
Other outcomes:
Locations:
city: Mataró
country: Spain
facility: CAP La Llàntia
state: Barcelona
Study officials:
References:
citation: Luengo BT, Garcia-Sierra R, Trinxant MAW, Mondelo ED, Baseda RM, Blanch MML, Del Pilar Montero Alia M, Toran-Monserrat P. Early detection of anaemia in primary care with haemoglobinometry: ANHEMOG clinical trial protocol. BMC Fam Pract. 2021 Oct 8;22(1):199. doi: 10.1186/s12875-021-01548-z.
Clinical trial NCT05134909: Customized Contact Lenses
Official title: Custom Vision-Corrective Lens Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Keratoconus
Lead sponsor: University of Houston
Sponsor class: OTHER
First posted: 2021-11-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The overall goal of this project is to improve the visual quality of individuals who have abnormal corneal conditions that alter the shape of their cornea (eg. keratoconus). Patients with an abnormal corneal shape have substantial lower and higher order aberrations (distortions in the eye). This results in reduced visual acuity which cannot be corrected by regular sphero-cylindrical correction. Compensating for these aberrations has been challenging due to difficulty measuring their wavefront aberrations accurately and, consequently, manufacturing the custom contact lenses with irregular optical profiles. This project is designed to systematically overcome these obstacles with a customized scleral and/or soft contact lens capable of compensating for the lower and higher order aberrations of the eye.


Eligibility criteria: Inclusion Criteria:

* Able to read and understand the informed consent document in English
* 18 to 75 years of age
* Received diagnosis of keratoconus by a clinician
* Willing and able to follow instructions

Exclusion Criteria:

* Has best corrected visual acuity of 20/20 or better in the keratoconic eye(s).
* Normal/typical subjects
* Is unable to handle, insert, remove or care for the study lenses.
* Has any active anterior segment disease, pathology, or surgery affecting vision, refraction, or the ability to wear a contact lens
* History of ocular pharmacological treatment
* History of ocular trauma or surgery causing abnormal corneal curvature or distorted vision History of contact lens intolerance
* Pregnant at the time of enrollment in the study (self-reported- It has been shown hormonal changes during pregnancy may affect corneal biomechanics negatively)
* Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers under the age of 18 because it has been shown the average age of the appearance of Keratoconus is the second decade of life ( 15-18 years of age)
* Prisoners

Primary outcomes:
measure: Visual acuity
timeFrame: up to 2 months
measure: Contrast sensitivity
timeFrame: up to 2 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Houston
name: Geunyoung Yoon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04864509: The Effects of Melatonin Treatment on Bone, Marrow, Sleep and Blood Pressure
Official title: The Effects of Melatonin Treatment on Bone, Marrow, Sleep and Blood Pressure in Post Menopausal Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Osteoporosis, Postmenopausal
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2021-04-29
Enrollment: 40
Sex: FEMALE
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Melatonin protects your bones while losing fat! This was previously demonstrated by our group. The mechanisms behind these findings are still elusive, and the aim of the present study is to assess the mechanisms.

In a double-blinded randomized controlled trial 40 postmenopausal woman are randomized to receive either 10 mg melatonin or placebo nightly for three months. Changes in gene expression in marrow cells will be assessed through micro array. Markers of bone metabolism will be assessed through biochemical markers. Cardiovascular health will be measured by tonometry and 24h blood pressure.

The results of the study will contribute with important knowledge about the beneficial effects of melatonin making it an interesting supplement to known treatment regimens against osteoporosis and overweight.


Eligibility criteria: Inclusion Criteria:

* Post-menopausal women between 55 and 75 years

Exclusion Criteria:

* Severely impaired renal function
* Severely impaired hepatic function
* Coagulation factors PP\<0.6
* Hypercalcemia (p-ion calcium \>1.32 nmol/l)
* Previous or present malignancies (except a treated skin cancer that is not melanoma or treated carcinoma in situ, 2 years since last therapy)
* Diseases affecting the calcium homeostasis including untreated thyroid diseases
* Regular use of medicine affecting the calcium homeostasis, including diuretics, fenemal, lithium, antiepileptica and glucosteroids
* Selective serotonin reuptake inhibitor (SSRI)-products with fluvoxamin
* Treatment with carbamazepin
* Treatment with rifampicin
* Severe malabsorption syndrome including gastric or intestinal resection
* Alcohol or drug abuse
* Smokers

Primary outcomes:
measure: Gene expression
timeFrame: After study completion. Up to one year
Secondary outcomes:
measure: Biochemical markers
timeFrame: After study completion. Up to one year
measure: Quality of sleep
timeFrame: After study completion. Up to one year
measure: Cardiovascular health
timeFrame: After study completion. Up to one year
Other outcomes:
Locations:
Study officials:
affiliation: Aarhus University Hospital
name: Anne Kristine Amstrup
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02515409: Heated Humidified High Flow Nasal Cannula for Children With Obstructive Sleep Apnea
Official title: Heated Humidified High Flow Nasal Cannula for Children With Obstructive Sleep Apnea
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sleep Apnea, Obstructive
Keywords: Obstructive Sleep Apnea Syndrome (OSAS)
Heated Humidified High Flow Nasal Cannula (HHHNC)
Continues positive airway pressure (CPAP)
Children
Non invasive ventilation
Treatment
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2015-08-04
Enrollment: 40
Sex: ALL
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children ages 0-16 years with obstractive sleep apnea, referred for treatment with non invasive ventilation.

Brief summary: The purpose of this study is to determine whether heated humidified high flow nasal cannula (HHHFNC) is effective as a treatment of obstructive sleep apnea syndrome (OSAS) compared to continues positive airway pressure (CPAP) treatments in children and to compare their adherence and compliance.


Eligibility criteria: Inclusion criterias:

* Age: 0-16 years old.
* Refered for treatment with non invasive ventilation.
* Diagnosed with OSAS and AHI\>=5

There are no exclusion criteria

Primary outcomes:
measure: Average hours per night and per week using HHHFNC .
timeFrame: One year
measure: Average hours per night and per week using CPAP.
timeFrame: One year
Secondary outcomes:
measure: Apnea hypopnea index (AHI)
timeFrame: One year
measure: Pediatric sleep questionnaire (PSQ) score
timeFrame: One year
Other outcomes:
Locations:
Study officials:
affiliation: Tel-Aviv Sourasky Medical Center
name: Keren Armoni-Domany, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00261209: Collagenase in the Treatment of Zone II Flexor Tendon Adhesions in the Hand
Official title: Study of Collagenase Injection Therapy for Treatment of Zone II Flexor Tendon Adhesions in the Hand
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Adhesion of Flexor Tendon of Hand
Keywords: Flexor Tendon Adhesions
Zone II of the Hand
Lead sponsor: Stony Brook University
Sponsor class: OTHER
First posted: 2005-12-02
Enrollment: 3
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 this study is to dissolve flexor tendon adhesions associated with failed tendon repair surgery.

Detailed description: In an open label study, collagenase injection therapy was investigated in 3 subjects for it's ability to lyse flexor tendon adhesions in zone II of the hand.

Results indicate that two of three subjects had improved range of finger motion at the PIP and DIP joints. This may obviate the need for patients to have tenolysis hand surgery to correct the finger flexion contracture of the PIP and DIP joints. Detailed controlled studies remain to be done.

Eligibility criteria: Inclusion Criteria:

* zone II flexor tendon adhesion of at least one finger

Exclusion Criteria:

* any chronic, serious or uncontrolled medical condition
* inability to conform to study visits (12-15 per year)

Primary outcomes:
measure: Restoration of PIP and DIP joint motion.
timeFrame: 6 months
Secondary outcomes:
measure: Hand Grip strength (kg)
timeFrame: 6 months
Other outcomes:
Locations:
city: Stony Brook
country: United States
facility: Dept. Orthopaedics, SUNY@Stony Brook
state: New York
Study officials:
affiliation: Dept. Orthopaedics, SUNY@Stony Brook, NY 11794
name: Marie A Badalamente, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept. Orthopaedics, SUNY@Stony Brook, NY 11794
name: Edward Wang, MD
role: PRINCIPAL_INVESTIGATOR
References: