louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01428518: Special Drug Use Investigation for LAMICTAL Bipolar
Official title: Special Drug Use Investigation for LAMICTAL Bipolar
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bipolar Disorder
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-09-05
Enrollment: 1036
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Japanese patients with bipolar disorder prescribed lamotrigine tablets for the first time

Brief summary: This post-marketing surveillance study is designed to collect and assess information on safety and effectiveness of lamotrigine tablets in patients with bipolar disorder in routine clinical practice.

("LAMICTAL" is a trademark of the GlaxoSmithKline group of companies.)


Eligibility criteria: Inclusion Criteria:

* Patients with bipolar disorder
* Patients treated with lamotrigine tablets for the first time

Exclusion Criteria:

* Not applicable

Primary outcomes:
measure: Number of patients with any adverse drug reaction
timeFrame: 1 year
Secondary outcomes:
measure: Occurrence of skin disorder
timeFrame: 1 year
measure: Occurrence of suicide-related event and self injurious behaviour
timeFrame: 1 year
measure: Occurrence of harming others
timeFrame: 1 year
measure: Occurrence of withdrawal symptoms after treatment
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01734018: An Observational Study of Pegasys (Peginterferon Alfa-2a) in Patients With HBeAg-Positive or HBeAg-Negative Chronic Hepatitis B
Official title: A Multicenter, Prospective, Non-Interventional Study Evaluating Response Parameters During and After Therapy With PEGASYS (Peginterferon Alfa-2a 40KD) in Subjects With HBeAg Positive or HBeAg Negative Chronic Hepatitis B
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis B, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-11-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with chronic hepatitis B receiving treatment with Pegasys

Brief summary: This multicenter, prospective, observational study will evaluate the efficacy and safety of Pegasys (peginterferon alfa-2a) in routine clinical practice in patients with HBeAg-positive or HBeAg-negative chronic hepatitis B. Eligible patients receiving treatment with Pegasys according to standard of care and the summary od product characteristics/local labelling will be followed for the duration of treatment and up to 2 years of follow-up.


Eligibility criteria: Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* HBeAg-positive or HBeAg-negative serologically proven chronic hepatitis B with or without cirrhosis
* Elevated serum ALT \> ULN (upper limit of normal) but \</=10 x ULN according to local label

Exclusion Criteria:

* Contra-indications to Pegasys as detailed in the label
* Co-infection with hepatitis A, hepatitis B or HIV
* Concomitant therapy with telbivudine (concomitant peginterferon alfa-2a therapy is contra-indicated according to telbivudine label)
* Pregnant or breastfeeding women

Primary outcomes:
measure: Change in HBsAg (IU/ml) levels during therapy (up to 48 weeks) and follow-up
timeFrame: from baseline to up to approximately 3 years
measure: Change in HBV DNA (IU/ml) during therapy (up to 48 weeks) and follow-up
timeFrame: from baseline to up to approximately 3 years
Secondary outcomes:
measure: Percentage of patients with sustained immune control (sustained HBV DNA <2000 IU/ml in HBeAg-negative and HBeAg-positive patients or HBeAg seroconversion in HBeAg-positive patients)
timeFrame: approximately 4 years
measure: Percentage of patients with normalisation of serum alanine transaminase (ALT) levels
timeFrame: approximately 4 years
measure: Percentage of patients with HBsAg clearance/seroconversion
timeFrame: approximately 4 years
measure: Safety: Incidence of adverse events
timeFrame: approximately 4 years
Other outcomes:
Locations:
city: Berlin
country: Germany
city: Leipzig
country: Germany
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT02816918: Extraluminal Use of the Bronchial Blocker of Univent Tube
Official title: Extraluminal Use of the Bronchial Blocker of Univent Tube During Adult One-lung Ventilation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Therapeutic Procedural Complication
Lead sponsor: The First Hospital of Qinhuangdao
Sponsor class: OTHER_GOV
First posted: 2016-06-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: intends to evaluate the feasibility and security issues of univent bronchial blockers outside the single lumen endotracheal tube for one- lung ventilation in left thoracic surgery patients.

Detailed description: One-lung ventilation is desirable for Several clinical procedures, such as thoracic,pulmonary, and cardiac surgery to facilitate lung exposure for these surgical procedures by collapsing the lung and most commonly used device is the double-lumen tube (DLT) for this surgical procedures.Bronchial blockers (BBs), such as univent tube with an bronchial Blocker, has more advantages than the double-lumen tube: no need exchange tube when mechanical ventilation is required postoperative, easier insertion,less postoperative sore throat (ST) and hoarseness. However, BBs requires more time for placement and more difficult to position, especially patients undergoing left-side thoracic surgery. So, this study intends to evaluate the feasibility and security issues of univent bronchial blockers outside the single lumen endotracheal tube for one- lung ventilation in left thoracic surgery patients.

Eligibility criteria: Inclusion Criteria:

* sixty patients undergoing left thoracic surgery
* ASA classifications of I-II, modified Mallampati classification of 1 or 2, requiring general anesthesia were included.

Exclusion Criteria:

* age younger than 18 yr or older than 70 yr
* BMI\>30 kg/m2
* with upper respiratory tract infection,asthma
* Abnormalities of the heart, brain, liver, lung, kidney and coagulation functions

Primary outcomes:
measure: time for positioning
timeFrame: 15 min
Secondary outcomes:
measure: frequency of malpositions
timeFrame: 5 min
measure: frequency of fiberoptic
timeFrame: 10 min
Other outcomes:
Locations:
city: Qinhuangdao
country: China
facility: 中国
state: Hebei
Study officials:
affiliation: The First Hospital of Qinhuangdao
name: Ximing Qi
role: STUDY_DIRECTOR
References:
Clinical trial NCT06259318: Feasibility of Kanasina Gulabi, a Pilot Peer Support Intervention for Young Adults With Type 2 Diabetes in Mysore District, South India
Official title: Feasibility of Kanasina Gulabi, a Pilot Peer Support Intervention for Young Adults With Type 2 Diabetes in Mysore District, South India
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Quality of Life
Depression
Stigma, Social
Behavior, Health
Keywords: Young Adult
India
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Public Health Research Institute of India
First posted: 2024-02-14
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a Hybrid Type 2 Effectiveness-Implementation Trial of a pilot, 2-arm, parallel-group, quasi-randomized trial.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate a pilot peer support intervention, entitled "Kanasina Gulabi" (Translation "My Dream Rose" in Kannada), designed to improve quality of life and diabetes management among young adults living with type 2 diabetes. The intervention, delivered by non-specialist providers - trained young adult peer navigators who are also managing type 2 diabetes - is expected to improve physical and mental health outcomes among participants. The sample includes young adults aged 18-40 with a diagnosis of type 2 diabetes in Mysore district, South India. Participants were quasi-randomly allocated to the intervention or control group. With the support of their peer navigators, intervention participants will develop action plans to improve their physical and mental health outcomes. This study plans to assess the feasibility, acceptability, and preliminary effectiveness of the intervention.


Eligibility criteria: Inclusion Criteria:

* aged 18 - 40 years old
* self-reported to have type 2 diabetes
* living in Mysore district
* able to speak English or Kannada
* and able to access a cellular phone during the study period

Exclusion Criteria:

* pregnant
* living with a serious medical or psychological disorder that would impede study procedure

Primary outcomes:
measure: Reach
timeFrame: Week 0 - 5, Week 12
measure: Glycemic Control
timeFrame: Week 0, Week 12
measure: Diabetes Knowledge
timeFrame: Week 0, Week 5, Week 12
measure: Diabetes Distress
timeFrame: Week 0, Week 5, Week 12
measure: Diabetes-Related Stigma
timeFrame: Week 0, Week 5, Week 12
measure: Depressive Symptoms
timeFrame: Week 0, Week 5, Week 12
measure: Optimism
timeFrame: Week 0, Week 5, Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Mysore
country: India
facility: Public Health Research Institute of India
state: Karnataka
Study officials:
affiliation: Duke University
name: Eve S Puffer, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Sumedha Ariely, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03277118: Quantifying Activity Using Wireless Wearable Technology
Official title: Quantifying Activity After Cardiac Surgery Using Wireless Wearable Technology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Activity, Motor
Sleep
Delirium
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2017-09-08
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 18 years or older who are scheduled to undergo elective cardiac surgery at UT Southwestern Medical Center.

Brief summary: Wireless wearable devices (WWD) have been shown to be an effective means to measure patient activity and sleep-wake cycles in the ICU. However, no current studies involving WWD have demonstrated the ability of these devices to measure adverse outcomes, including delirium in critically ill patients. This study is unique because the investigators will implement monitoring with the WWD prior to extubation in the ICU to correctly measure first mobilization, as well as capture quality of sleep and episodes of delirium for the first five postoperative days.

Detailed description: In this single-center non-randomized prospective cohort study, cardiac surgical patients undergoing cardiac surgery with cardiopulmonary bypass will be enrolled consecutively with written informed consent from the time this protocol is approved by the IRB until 100 subjects are enrolled (expected duration of subject enrollment is 12 months). Upon arrival into the ICU, cardiac surgery subjects will have a Fitbit Charge 2 device placed on their wrist and will wear the device until the fifth post-operative day. This device will wirelessly transmit data regarding activity and sleep quality to a smartphone application for the duration of wear. No identifiable patient information will be entered into the smartphone application or transmitted to any external entity.

Eligibility criteria: Inclusion Criteria:

* Inclusion Criteria: Adult (Age \> 18) patients undergoing scheduled, elective cardiac surgery with cardiopulmonary bypass

Exclusion Criteria:

* Those who do not meet the inclusion criteria, pregnant women, prisoners, those with skin or systemic infections, those who are paraplegic or quadriplegic and those with allergies to the polyurethane material comprising the FitBit strap.

Primary outcomes:
measure: Number of steps walked
timeFrame: Postoperative day 2 to Postoperative day 5
Secondary outcomes:
measure: Length of sleep
timeFrame: Postoperative Day 1
measure: Delirium
timeFrame: Postoperative Day 2 (after extubation)
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: Sreekanth Cheruku, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00176618: The Effects of Curcuminoids on Aberrant Crypt Foci in the Human Colon
Official title: The Effects of Curcuminoids on Aberrant Crypt Foci in the Human Colon
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Aberrant Crypt Foci
Keywords: Aberrant Crypt Foci
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine the effectiveness of curcumin in reducing the number of aberrant crypt foci (ACF) in the colon.

Detailed description: Laboratory studies have indicated that this agent, which is derived from plants and found in foods we eat, has anti-inflammatory properties and prevents colon cancer in animal studies. ACFs are small abnormalities in the lining of the colon that with time may grow into colorectal adenomas (also called polyps, growths or small masses of tissue on the lining of the colon or rectum which have the potential to become cancerous) which can then grow into adenocarcinomas (cancer) in the colon or rectum.

Eligibility criteria: Inclusion Criteria:

* Subjects must be eligible for colorectal cancer (CRC) screening/surveillance by current criteria.
* Subjects must have at least 5 ACF on eligibility chromosigmoidoscopy examination.

Exclusion Criteria:

Subjects must not have:

* Alcohol consumption of greater than 2 glasses of wine or beer per day or illicit recreational drug use
* Platelet or coagulation abnormalities, or personal history of a bleeding disorder, including individuals taking warfarin.
* High risk for developing endocarditis (history of endocarditis or rheumatic fever, cardiac valve prostheses, or mitral valve prolapse that requires antibiotic prophylaxis).
* Uncontrolled hypertension, diabetes, or chronic congestive heart failure.
* Renal insufficiency defined as a serum creatinine \> 2.5 mg/dl
* History of colorectal surgery with removal of the distal 60 cm of colon or rectum.
* History of other gastrointestinal mucosal epithelial diseases (such as Barrett's esophagus, chronic or recurrent peptic ulcer disease, celiac sprue or other disorders of nutrient absorption).

Primary outcomes:
measure: To evaluate the effects of curcumin or the NSAID sulindac on the number of ACF in the left colon and rectum of normal volunteers found to have them on an initial magnifying chromoendoscopic screening exam
timeFrame: 48 months
Secondary outcomes:
measure: To determine the turnover (proliferation, apoptosis, and differentiation) of colorectal epithelial cells in the crypts in situ in response to each treatment
timeFrame: 48 months
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Cancer Institute of New Jersey
state: New Jersey
Study officials:
affiliation: Rutgers, The State University of New Jersey
name: Yang CS, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00796718: A Study of Xeloda (Capecitabine) Plus Radiotherapy in Participants With Locally Advanced Rectal Cancer
Official title: An Open Label Study of the Effect of Xeloda and Radiotherapy on Pathological Response Rate in Patients With Locally Advanced Rectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colorectal Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2008-11-24
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This single arm study will assess the efficacy and safety of treatment with Xeloda plus standard pelvic radiotherapy in participants with locally advanced rectal cancer. Eligible participants will receive Xeloda 825mg/m\^2 orally twice daily plus standard radiotherapy for 5 weeks, followed by surgery within 6 weeks after completion of treatment. The anticipated time on study treatment is \< 3 months, and the target sample size is \< 100 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients, 18-80 years of age;
* rectal cancer;
* planned surgery, and likely to benefit from pre-operative combined chemo-radiotherapy;
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Exclusion Criteria:

* previous radiotherapy or chemotherapy for colorectal cancer;
* clinically significant cardiovascular disease;
* significant gastric or small intestine disease;
* serious uncontrolled active infection

Primary outcomes:
measure: Percentage of Participants With Pathological Complete Response
timeFrame: Up to 11 weeks (assessed at the time of post-treatment surgery)
Secondary outcomes:
measure: Percentage of Participants With Response to Treatment Assessed 4-6 Weeks After the Completion of Radiochemotherapy (Complete Response, Partial Remission or No Response to the Treatment)
timeFrame: Up to 11 weeks (assessed 4-6 weeks after the completion of radiochemotherapy)
measure: Percentage of Participants With Response to the Treatment Assessed 1 Month After Surgery (Complete Response, Partial Remission or No Response to the Treatment)
timeFrame: Up to 15 weeks (assessed 1 month after surgery)
measure: Percentage of Participants With Adverse Events
timeFrame: Up to 15 weeks
Other outcomes:
Locations:
city: Banska Bystrica
country: Slovakia
city: Bratislava
country: Slovakia
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT04077918: Comparison of the Effects of Different Protein Diet in Hemodialysis Patients
Official title: Comparison of the Effects of Animal Protein Diet and Plant Protein Diet on Blood Test Result and Clinical Outcome in Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diffenence of Protein Diets on Hemodialysis Patients
Lead sponsor: Camillians Saint Mary's Hospital Luodong
Sponsor class: OTHER
First posted: 2019-09-04
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Chronic hemodialysis (CHD) patients are vulnerable to develop protein energy malnutrition and make a notion that to maintain the nutritional status is of paramount importance in these patients. However, proteins intake from vegetarian and meat diet were observed to have different impacts on nutritional and inflammatory status, mineral homeostasis and its related hormones, and clinical outcomes in non-dialysis CKD patients. In here, we aim to investigate these impacts in CHD patients.


Eligibility criteria: Inclusion Criteria:

* Chronic hemodialysis patient

Exclusion Criteria:

1. Hemodialysis less than 3 months
2. Age \< 20 years or \>90 years
3. Serum albumin \< 3 g/dL，
4. Daily protein diet \< 0.6 gm/kg/day or \> 1.2 gm/kg/ day，
5. Cannot obey the diet plan: Gastrectomy, difficult in swallowing
6. Active infection, severe illness: cancer patient, liver cirrhosis, etc.
7. Unable to cooperate in the study

Primary outcomes:
measure: Statistical difference of serum biomarkers ( P value)
timeFrame: 7 months
Secondary outcomes:
measure: Statistical difference of medical visits
timeFrame: 7 months
Other outcomes:
measure: Statistical difference of admissions
timeFrame: 7 months
Locations:
Study officials:
affiliation: St. Mary's Hospital Luodong
name: Shih-Ching Tsai, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00821418: Assessment of Treatment With PulseHaler on Patients With Chronic Obstructive Pulmonary Disease (COPD)
Official title: Assessment of the Safety and the Effect on Patients With COPD of Treatment With PulseHaler™ - a Novel Device for Pulsating Positive Expiratory Pressure Ventilation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Respinova LTD
Sponsor class: INDUSTRY
First posted: 2009-01-13
Enrollment: 30
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: The purpose of the study is to assess the safety and the effect of treatment by PulseHaler™ on patients with COPD, as measured by the change from baseline in full pulmonary functions, oxygen saturation, exercise tolerance and health related quality of life; and to assess the ease of use of PulseHaler™ by the patients.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of COPD
* Diagnosis established for at least 1 year;
* Post-bronchodilator FEV1/FVC \< 0.7
* Post bronchodilator FEV1 \<70% predicted
* Age: 40 years or older
* Smoking cigarettes, at least 10PY
* Patient signed the informed consent form

Exclusion Criteria:

* Bullous Emphysema (ruled out by recent CT)
* Hospitalization due to exacerbation of COPD within the last 3 months
* Upper respiratory infection and/or exacerbation of COPD in the last 4 weeks
* Systemic steroid treatment in the last 4 weeks
* Women at the age of fertility, who are pregnant, or plan pregnancy, or do not use contraceptive.
* Severe cardiac disease, e.g., CHF grade 3 or higher
* Acute MI within last 3 months
* CABG within last 3 months
* Other severe systemic disease

Primary outcomes:
measure: Pulmonary function tests
timeFrame: Within 2 hours from first treatment, and after 2 weeks of treatment
measure: Six minute walk test
timeFrame: Within 2 hours from first treatment, and after 2 weeks of treatment
measure: Health related quality of life
timeFrame: Within 2 hours from first treatment, and after 2 weeks of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
References:
citation: Fridlender ZG, Arish N, Laxer U, Berkman N, Leibovitz A, Fink G, Breuer R. Randomized controlled crossover trial of a new oscillatory device as add-on therapy for COPD. COPD. 2012 Dec;9(6):603-10. doi: 10.3109/15412555.2012.748625. Epub 2012 Dec 6.