louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01809262: Single Dose Ranging Study of BI 1744 CL (Olodaterol) in Chronic Obstructive Pulmonary Disease
Official title: Single Dose Preliminary Dose-ranging and Safety in Patients With COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2013-03-12
Enrollment: 36
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Primary objective: To investigate bronchodilator effect and safety of single doses of BI 1744 CL inhaled via Respimat inhaler, Secondary objective: to characterize pharmacokinetics of BI 1744 CL. Olodaterol dose 40 mcg was investigated only in the open-label extension part for additional PK assessments which are not defined as primary or secondary endpoints.


Eligibility criteria: Inclusion criteria:

1. Diagnosis of chronic obstructive pulmonary disease
2. Smoking history of more than 10-pack years

Exclusion criteria:

1. History of asthma, allergic rhinitis, myocardial infarction or unstable of life-threatening cardiac arrhythmias
2. Marked baseline prolongation of QT/QTc interval

Primary outcomes:
measure: Forced Expiratory Volume in One Second (FEV1) at 24 Hours After a Single-dose of Study Treatment
timeFrame: 24 hours post-dosing
Secondary outcomes:
measure: FEV1 AUC 0 - 3 Hours
timeFrame: -10 minutes (min), 30min, 1 hour (h), 2h and 3h post-dosing
measure: FEV1 AUC 0 - 12 Hours
timeFrame: -10 minutes (min), 30min, 1 hour (h), 2h, 3h, 4h, 6h, 8h, 10h and 12h post-dosing
measure: FEV1 AUC 0 - 24 Hours
timeFrame: -10 minutes (min), 30min, 1 hour (h), 2h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 22h, 23h and 24h post-dosing
measure: FEV1 AUC 12 - 24 Hours
timeFrame: 12h, 14h, 22h, 23h and 24h post-dosing
measure: Peak FEV1 From 0 to 3 Hours
timeFrame: 0 to 3 hours post-dosing
measure: Peak Forced Vital Capacity (FVC) From 0 to 3 Hours
timeFrame: 0 to 3 hours post-dosing
measure: Time to Peak Bronchodilator Response
timeFrame: 0 to 3 hours post-dosing
measure: Time to Onset of Response
timeFrame: 0 to 3 hours post-dosing
measure: Number of Patients Requiring Rescue Medication on a Test-day
timeFrame: Visits 1,2,4,5,6
measure: Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG
timeFrame: 2 weeks
measure: Laboratory Testing: Average Change From Baseline of Potassium and Calcium
timeFrame: Baseline and Visit 6
Other outcomes:
Locations:
city: Heerlen
country: Netherlands
facility: 1222.3.1 Atrium medisch centrum
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
Clinical trial NCT04031391: Effects of a Physical Exercise Program on Patients Affected With Fibromyalgia
Official title: Effects of a Physical Exercise Program on Patients Affected With Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: physical activity
fibromyalgia
pain
exercice
quality of live
Lead sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Sponsor class: OTHER
Collaborators: name: Institut Catala de Salut
First posted: 2019-07-24
Enrollment: 48
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized, multi-center, clinical trial composed of two groups response variables and a twelve weeks follow up.
Primary purpose: TREATMENT

Brief summary: Physical activity has been used for a number of years in the treatment of fibromyalgia (FM). The main objective of this study is to compare the effects of physical activity on two groups of women diagnosed with fibromyalgia (FM) in terms of pain, quality of life and the impact of the condition on their daily lives. Methods: this was a randomized clinical trial to assess the effects of physical activity performed by subjects assigned to one of two groups on the scores of three questionnaires (the pain Visual Analogue Scale, the FIQ questionnaire and the SF-36 health questionnaire) administered before and after the intervention.


Eligibility criteria: Inclusion Criteria:

Women

* Ages of 40 and 75
* Diagnosis fibromyalgia (code M79.7)
* Anoia region

Exclusion Criteria:

* Pregnant
* Unable to participate in the physical activity program.

Primary outcomes:
measure: The visual analogue scale (VAS)
timeFrame: two months
measure: The Spanish version of the SF-36 questionnaire
timeFrame: two months
measure: the Fibromyalgia Impact Questionnaire (FIQ)
timeFrame: two months
Secondary outcomes:
Other outcomes:
Locations:
city: Igualada
country: Spain
facility: Espai Civic Centre
state: Barcelona
Study officials:
affiliation: Institut Catala de Salut
name: JACOBO MENDIOROZ PEÑA, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02726191: Computerized Cognitive Training in Epilepsy
Official title: Computerized Cognitive Training in Epilepsy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Epilepsy
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2016-04-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this randomized uncontrolled single-site trial is to evaluate the efficacy of two novel computerized cognitive enhancing software packages for improving cognitive and behavioral outcomes in patients with epilepsy.

Detailed description: The proposed investigation will be the first to pit two software packages against each other to evaluate the relative efficacy and feasibility of their use among patients with epilepsy. Pharmacotherapy fails to control seizures in approximately 30% of patients. Use of non-pharmacologic interventions, such as cognitive rehabilitation, has shown some benefit for improving cognitive functions and reducing mood symptoms. Each of the computer exercises employ a set of stimuli that are generalizable and mimic real-world experiences.

Eligibility criteria: Inclusion Criteria:

* Documented diagnosis of epilepsy based on medical records. The records will be reviewed by the PI and the approved study personnel to confirm that a diagnosis of epilepsy has been made.
* Must own a computer or have access to the internet.

Exclusion Criteria:

* Full Scale IQ \< 80, as assessed by the WASI-II.
* History of chronic progressive neurologic or neurodegenerative illnesses (e.g., Parkinson's disease, multiple sclerosis, dementia, primary or metastatic malignancy). Patients with headache or migraine are not excluded.
* History of Axis I psychiatric illness with psychotic features. (e.g., schizophrenia). Patients with depression or anxiety (treated or untreated) without psychotic features are not excluded.
* Visual or auditory impairment, which precludes participation in part, or all of the testing.
* English as a first language will not be required, but participants must have either received some of their schooling in English or used English in their work for \>10 years.

Primary outcomes:
measure: Total Index Score from the Repeatable Battery for the Assessment of Neurocognitive Status (RBANS)
timeFrame: 8 Weeks
Secondary outcomes:
measure: The Everyday Cognition Scale (ECog)
timeFrame: 8 Weeks
measure: Perceived cognitive abilities on an index of subjective cognitive abilities (Cognitive Self-Report Questionnaire; CSRQ-25)
timeFrame: 8 Weeks
measure: Measure of mood (Geriatric Depression Scale)
timeFrame: 8 Weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: New York University Medical School
name: Stella Karantzoulis, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03334591: Research On the Optimized Treatment Method For Apatinib's Cure Of Advanced Gastric Cancer
Official title: Research On the Optimized Treatment Method For Apatinib's Cure Of Advanced Gastric Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Two Different Treatment Methods
Lead sponsor: Anhui Provincial Hospital
Sponsor class: OTHER_GOV
First posted: 2017-11-07
Enrollment: 60
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 investigators hope that after this research, two different treatment methods' curative effects for advanced gastric cancer can be assessed. One is continuous use of apatinib, the other is 5 days' continuous use and 2 days' off of apatinib.


Eligibility criteria: Inclusion Criteria:

1. Male and female patients,age≥18years
2. Confirmed by Pathology or histology of Gastric cancer
3. Patients who failed first-line chemotherapy
4. The ECOG physical status score:0 to 2
5. Expected survival ≥3months
6. Patients should be voluntary to the trail and provide with signed informed consent.
7. The researchers believe patients can benefit from the study.

Exclusion Criteria:

1. Pregnant or lactating women
2. Patients with a knowm history of allergic reactions and/ou hypersensitivity attributed to apatinib or its accessories
3. Patients with apatinib contraindications
4. Patients of doctors considered unsuitable for the trail

Primary outcomes:
measure: progress free survival(PFS)
timeFrame: 1 year
Secondary outcomes:
measure: disease control rate (DCR)
timeFrame: 1year
measure: Objective tumor response rate(ORR)
timeFrame: 1year
measure: overall survival (os)
timeFrame: 1year
measure: Quality of life score
timeFrame: 1 year
measure: adverse events
timeFrame: 1 year
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Provincial Cancer Hospital
state: Anhui
Study officials:
affiliation: Anhui Provincial Cancer Hospital
name: yifu He, doctor
role: STUDY_CHAIR
References:
citation: Yan Y, Li H, Wu S, Wang G, Luo H, Niu J, Cao L, Hu X, Xu H, Jia W, Sun Y, Yao Y, Chen W, Ke L, Hu B, Ji C, Sun Y, Chen J, Li M, He Y. Efficacy and safety of intermittent versus continuous dose apatinib plus docetaxel as second-line therapy in patients with advanced gastric cancer or gastroesophageal junction adenocarcinoma: a randomized controlled study. Ann Transl Med. 2022 Feb;10(4):205. doi: 10.21037/atm-22-546.
Clinical trial NCT01534091: Enhancing the Amount of Physical Activity Carried Out by Overweight Children at Leisure Time
Official title: Enhancing the Amount of Physical Activity Carried Out by Overweight Children at Leisure Time
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Obesity
Keywords: overweight
obese
children
exercise
physical activity
pedometer
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2012-02-16
Enrollment: 25
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine if internet supervised by pedometer will contribute to enhance the amount of physical activity at leisure time by obese children.

The investigators hypothesize that using pedometer will increase the amount of physical activity done by obese children in the afternoon and will improve the likelihood of success in the intervention program.

Detailed description: Childhood overweight \& obesity is the most common chronic disease in the western society. The prevalence of childhood obesity in Israel is among the highest in Europe. Recent data suggest that the recommended treatment for childhood obesity should be intense, multi-disciplinary intervention, including dietary, behavioral and physical activity components. Such a program exists at the Meir Medical Center in Israel for a few years with promising results.

The program includes: physical activity(PA)exercise (twice a week/1h), dietary guidance, medical supervision and behavioral intervention. The participants are asked to enhance PA at their leisure time, and to report to their coaches. Yet, the amount of time they actually exercise is not controled by us.

This study will include 3 groups of overweight\& obese children:

1. Intervention with pedometers and supervision.
2. Intervention with pedometer without supervision.
3. Control. Obese and overweight children not taking part in a treatment program.

Eligibility criteria: Inclusion Criteria:

* overweight/obese children
* age 5-18
* boys and girls

Exclusion Criteria:

* children with genetic obesity or obesity cased by a disease

Primary outcomes:
measure: Decline in BMI percentiles
timeFrame: 3 months
Secondary outcomes:
measure: Aerobic fitness
timeFrame: 3 months intervention
Other outcomes:
Locations:
city: Kfar-Saba
country: Israel
facility: Meir Medical Center
Study officials:
affiliation: Meir Medical Center
name: Dan Nemet, Prof. MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00978991: Duke Urology Database and Specimen Bank
Official title: Duke Longitudinal Urologic Surgery Patient Outcome Database
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Bladder Cancer
Erectile Dysfunction
Incontinence
Keywords: Benign prostate hyperplasia
Erectile dysfunction
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2009-09-17
Enrollment: 87820
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Urology

Brief summary: The proposed project is aimed to build a Duke University-specific longitudinal urologic surgery database. It will be used as the main resource to support future research within Urology and Duke University.

Detailed description: Specifically, the database will be used for the following future studies. (i) To characterize the biomarkers/protein signature associated with urological diseases; (ii) To clarify the clinical role of the risk factors and their interactions for early detection and optimized treatment of urological diseases, and improvement of post-treatment quality of life; (iii) To develop algorithms and nomograms to accurately predict the outcome of urological diseases.

Retrospective review of subjects data prior to Institutional Review Board approval and prospective review of data on those consented after Institutional Review Board approval.

Eligibility criteria: Inclusion Criteria:

* Duke Urology patients

Exclusion Criteria:

* None

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Judd W Moul, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03885180: Randomized Evaluation of D-dimer Guiding dUration of Oral antiCoagulation thErapy
Official title: Randomized Evaluation of D-dimer Guiding Duration of Oral Anticoagulation Therapy in Patients With Bioprosthetic Heart Valves
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Valve Heart Disease
Anticoagulants; Increased
Keywords: bioprosthetic heart valves
oral anticoagulation
thrombotic events
Lead sponsor: Wuhan Asia Heart Hospital
Sponsor class: OTHER
First posted: 2019-03-21
Enrollment: 500
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: PREVENTION

Brief summary: Guidelines recommended that patients with bioprosthetic heart valves (BHV) only need 6 months oral anticoagulation therapy after operation. However, a small part of patients still suffered thrombotic events after withdrawal of warfarin, which means these patients may need extend anticoagulation therapy. D-dimer, a sensitive marker of thrombosis or prethromboembolism state. Previous studies have demostrated that patients with elevated D-dimer levels have significant more clinical outcomes than those with nagative D-dimer levels. The aim of this study was to evaluate whether D-dimer could guide the duration of oral anticoagulation therapy in patients with BHV.

Detailed description: Patients with BHV were screened and enrolled in this study. D-dimer levels were measured in the sixth months after BHV operation but before withdrawal of warfarin. Patients with elevated D-dimer were randomized to extend anticoagulation therapy group and routine stopping anticoagulation group.

Eligibility criteria: Inclusion Criteria:

* Patients received BHV within 3 months

Exclusion Criteria:

* Recently throboemblism within 6 months
* Recently bleedings within 3 months
* Evaluated lifetime less than 2 years

Primary outcomes:
measure: Thrombotic events
timeFrame: 24 months
measure: Bleeding events
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Wuhan Asia Heart Hospital
state: Hubei
Study officials:
References:
Clinical trial NCT05183880: Bioavailability of Orally Ingested Vitamin C
Official title: Investigating the Oral Bioavailability of Vitamin C Administered Using Phosphycell™ Technology - a Phosphatidylcholine-lipid Encapsulation Technology.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Healthy
Lead sponsor: University of Exeter
Sponsor class: OTHER
First posted: 2022-01-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine if crystalline vitamin C supplementation can acutely increase skeletal muscle vitamin C concentrations and if this can be potentiated by administering vitamin C using Phosphycell™ Technology - a phosphatidylcholine-lipid encapsulation technology.


Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI) 18.5 - 30 kg/m2
* Age 18 - 40
* Non-smoker

Exclusion Criteria:

* Body mass index (BMI) \< 18.5 or \> 30 kg/m2
* Age \< 18 or \> 40
* Smoking
* Cardiovascular disease
* Hypertension (≥ 140/90 mmHg)
* Metabolic disease
* Medications known to affect vitamin C metabolism
* A known vitamin C deficiency
* Less than 2 hours per week of physical activity or following a structured exercise training program.
* Routine use of vitamin supplements

Primary outcomes:
measure: Skeletal muscle vitamin C concentrations
timeFrame: 6 hours after vitamin C ingestion
measure: Skeletal muscle vitamin C concentrations
timeFrame: 12 hours after vitamin C ingestion
Secondary outcomes:
measure: Blood plasma vitamin C concentrations
timeFrame: 24 hours after vitamin C ingestion
measure: White blood cell vitamin C concentrations
timeFrame: 6 hours after vitamin C ingestion
measure: White blood cell vitamin C concentrations
timeFrame: 24 hours after vitamin C ingestion
measure: Cardiovascular function
timeFrame: 24 hours after vitamin C ingestion
Other outcomes:
Locations:
city: Exeter
country: United Kingdom
facility: Sport and Health Sciences
state: Devon
Study officials:
affiliation: University of Exeter
name: Francis Stephens
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05694780: Sleep Health Care in Pregnancy: A Randomized Controlled Trial
Official title: Sleep Health Care in Pregnancy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pregnancy Related
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2023-01-23
Enrollment: 300
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Sleep disturbances are one of the most frequent complaints brought to the healthcare professionals during routine prenatal care visits.The purpose of this study is to develop and evaluate a Sleep Training and Education Program (STEP) for improving sleep and health in women during pregnancy.

Detailed description: Women in the intervention group will receive standard obstetric care plus the STEP intervention which is a 8-week program based on sleep hygiene education and cognitive-behavioral training.

Eligibility criteria: Inclusion Criteria:

* During the first trimester of pregnancy
* Singleton pregnancies

Exclusion Criteria:

* Women have pregnancy-related complications
* Women have diagnosed a psychiatric or sleep disorder

Primary outcomes:
measure: Sleep by actigraphy
timeFrame: Through study completion, an average of 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University
name: Shao-Yu Tsai
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01637480: Effects of Lumbopelvic Manipulation on Hip and Knee Neuromuscular Activity
Official title: Effects of Lumbopelvic Manipulation on Hip and Knee Neuromuscular Activity in People With and Without Patellofemoral Pain Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patellofemoral Pain Syndrome
Lead sponsor: Texas Woman's University
Sponsor class: OTHER
First posted: 2012-07-11
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determined if a lower back treatment would change the hip and knee muscle activities in people with and without anterior knee pain. The investigators hypothesized that the lower back treatment may change the hip and knee muscle activities in people with anterior knee pain but not in people without anterior knee pain.


Eligibility criteria: Inclusion Criteria for participants in the patellofemoral pain syndrome group:

1. insidious onset of symptoms of non-traumatic origin
2. pain with patellar facet palpation or compression
3. subjective knee pain rating of at least 3/10 on the pain visual analog scale during at least one of the following activities:

   * ascending stair
   * descending stair
   * kneeling
   * squatting
   * running
   * jumping
   * prolong sitting for more than 20 minutes

Exclusion criteria for all participants:

1. history of spine, hip or knee surgery
2. history of hip pathology or other knee condition
3. current significant injury of any lower extremity joints
4. pregnancy
5. sign of nerve root compression
6. osteoporosis or history of compression fracture

Age- and gender- matched control participants will be recruited if they have no signs or symptoms of patellofemoral pain syndrome and have none of the exclusion criteria

Primary outcomes:
measure: Electromyography (EMG)
timeFrame: The EMG data will be collected within 48 hours for all participants in both groups. On Day 1, data will be collected twice at baseline. On Day 2, data will be collected before and immediately after as well as 15, 30, and 45 min after the intervention.
Secondary outcomes:
measure: Pain Visual Analog Scale (VAS)
timeFrame: The Pain Visual Analog Scale (VAS) will be assessed before and 45 min after the lower back treatment (lumbopelvic manipulation) for participants in the patellofemoral pain syndrome group on Day 2 only.
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Texas Woman's University, School of Physical Therapy - Dallas Campus
state: Texas
Study officials:
affiliation: Texas Woman's University
name: Ammar M Al Abbad, Master
role: PRINCIPAL_INVESTIGATOR
References: