louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01663935: Vision Response to Dopamine Replacement
Official title: Interventional Study of Levodopa Replacement on Retinal Function in Oculocutaneous Albinism
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Albinism
Oculocutaneous Albinism
Keywords: levodopa
Albinism
dopamine
oculocutaneous albinism
vision
retina function
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2012-08-14
Enrollment: 20
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate and document physiologic and functional changes in visual performance and retinal function of patients diagnosed with albinism (a dopamine deficiency state) following a trial of oral Levodopa/carbidopa treatment.

Detailed description: In this study the investigators propose that the retina itself in albinism is deficient in dopamine, and vision improvement will occur as a result of improved retinal function in response to the deficient neurotransmitter dopamine. This study has a pretest-posttest design in order to determine if improvement in vision is in response to replacement of deficiency (dopamine). The electroretinography (ERG) testing and optical coherence tomography (OCT) will be critical determinants to confirm vision improvement as a result of improved retinal function, but are not primary outcome data. Main outcome measures will be collected at pre-treatment, 1 month, 3 months, and 4 months. Change in visual acuity as measured in logMAR by Snellen or sweep visual evoked potential (SVEP) after 3 months of treatment is the primary outcome. Patients include OCA1a patients, OCA1b, OCA2, and unclassified Oculocutaneous albinism (OCA). OCA1a patients clinically are known to have the worst vision, and physiologically have the lowest (or absent) levels of tyrosinase function (Dopamine Production). All patients will be treated with Levodopa/carbidopa 4mg/kg/day in three divided doses.

Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of oculocutaneous albinism
* age over 3 and weight over 25 lbs.

Exclusion Criteria:

* ocular only albinism
* ocular pathology other than albinism
* neurologic disease, history of myocardial infarction, history of clinical depression, pregnancy

Primary outcomes:
measure: Visual Acuity Change
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
measure: Contrast Sensitivity
timeFrame: 3 months
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Michael C Struck, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06263335: MBI for Psychological Distress, SI and NSSI Among Young Adults
Official title: Impact of Mindfulness Based Therapeutic Intervention on Psychological Distress, Suicidal Ideation and Non-Suicidal Self Injury Among Young Adults: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychological Distress
Suicidal Ideation
Non-Suicidal Self Injury
Keywords: Mindfulness Based Intervention
Psychological Distress
Suicidal Ideation
Non-Suicidal Self Injury
Lead sponsor: Fatima Jinnah Women University
Sponsor class: OTHER
First posted: 2024-02-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Designed to measure the impact of Mindfulness Based Intervention on depression, anxiety, stress, psychological distress, Suicidal Ideation, Non-Suicidal Self Injury urge and Mindfulness in young adults. Those individuals who agree to participate in the trial and identified with high levels of psychological distress and Suicidal Ideation, randomly divided into interventional (n=30) and control (n=30) groups. The Mindfulness Based Stress Reduction intervention then administered to the interventional group for eight weeks and pre and post intervention assessment done for both the groups.

Detailed description: Study assessment measures:

* Informed consent form
* Demographic questionnaire
* Screener questions form
* Assessment instruments:
* Depression Anxiety and Stress Scale (DASS-21)
* Suicide Ideation Scale (SIS)
* Alexian Brothers Urge to Self Injure Scale (ABUSI)
* Mindfulness Attention Awareness Scale

Eligibility criteria: Inclusion Criteria:

* Participants aged 18-24, of any gender, who consented to participate and could comprehend English (the language of the questionnaires).
* Selected respondents from the initial survey were included based on specific criteria:
* Willingness to continue participation.
* Unmarried status.
* Pursuing education (Bachelors, Masters, or Ph.D.) , Pakistan.
* Non-hosteller and unemployed.
* Residing with both parents.
* Affirmative response to screener questions about suicidal ideation (SI) and non-suicidal self-injury (NSSI).
* High scores on psychological distress and SI scales.

Exclusion Criteria:

* Participants failing to meet inclusion criteria or falling under the following categories were excluded:
* Non-students.
* History of present or past psychiatric illness, with recent medication or treatment within the past year.
* Presence of debilitating physical diseases or disabilities. Involvement in or history of substance use.
* Long-term medication for any condition, as these factors could impact study results.

Primary outcomes:
measure: Psychological Distress
timeFrame: 8-12 weeks
measure: Suicidal Ideation
timeFrame: 8-12 weeks
measure: Non-Suicidal Self-Injury (NSSI)
timeFrame: 8-12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Fatima Jinnah Women University
state: Punjab
Study officials:
References:
Clinical trial NCT01270035: Efficacy and Safety of Adalimumab 80 mg Every Other Week With Methotrexate
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Lead sponsor: Keio University
Sponsor class: OTHER
Collaborators: name: Saitama Medical University
First posted: 2011-01-05
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In Japan, as well as in other countries, the dose of adalimumab (ADA) is limited to 40 mg every other week when used in combination with methotrexate (MTX) for patients with rheumatoid arthritis (RA). However, ADA 80 mg with MTX may be required for some RA patients, especially for those with high disease activity. Therefore, we tried to increase the ADA dose to 80 mg every other week with concomitant MTX, only if the disease activity did not decrease below moderate activity defined by DAS28 \< 3.2. The primary endpoint was the rate of patients who achieved disease remission (DAS28 \< 2.6) at 30 weeks with this predifined treatment strategy.


Eligibility criteria: Inclusion Criteria:

* patients with rheumatoid arthritis receiving MTX ≧ 6 mg/week for at least 3 months disease activity : DAS28 \> 5.1

Exclusion Criteria:

* allergy to ADA present active infection including TB history of demyelinating disease, HBV infection and malignancy

Primary outcomes:
measure: The rate of achieving remission at week 30
timeFrame: 30 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Kawagoe
country: Japan
facility: Saitama Medical Center
state: Saitama
city: Shinanomachi
country: Japan
facility: Keio University Hospital
state: Tokyo
Study officials:
References:
Clinical trial NCT01684735: Diffusion Weighted Magnetic Resonance Imaging of the Breast During Chemotherapy: Response Evaluation
Official title: Diffusion Weighted Magnetic Resonance Imaging of the Breast During Chemotherapy: Response Evaluation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: diffusion-weighted magnetic resonance imaging
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2012-09-13
Enrollment: 45
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: women diagnosed with breast cancer and treated with neo-adjuvant chemotherapy

Brief summary: Evaluation of the response to chemotherapy in breast cancer patients by the use of Diffusion-weighted magnetic resonance imaging of the breast before the start of chemotherapy, after one and 3 cycles of therapy and at the end of the therapy.


Eligibility criteria: Inclusion Criteria:

* core biopsy with diagnosis of breast cancer
* start of neo-adjuvant chemotherapy

Exclusion Criteria:

* magnetic resonance imaging incompatibility

Primary outcomes:
measure: Response to chemotherapy
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Chantal Van Ongeval, MD, Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00000335: Activity Monitoring Assessment of Opiate Withdrawal - 4
Official title: Activity Monitoring Assessment of Opiate Withdrawal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Opioid-Related Disorders
Keywords: opioid dependence
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: Washington D.C. Veterans Affairs Medical Center
First posted: 1999-09-21
Enrollment: 0
Sex: MALE
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if hyperactivity accompanies abrupt opiate withdrawal in heroin addicts, to determine if computerized solid state activity monitors are capable of quantifying hyperactivity, and to quantify the physical and affective symptoms occurring during abrupt withdrawal in heroin addicts and morphine's capacity to alleviate these symptoms.


Eligibility criteria: Please contact site for information.

Primary outcomes:
measure: Depression
measure: Anxiety
measure: Withdrawal severity
measure: Activity
measure: Opiate secondary withdrawal
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Washington DC VA
state: District of Columbia
Study officials:
affiliation: Washington D.C. Veterans Affairs Medical Center
name: Steven Deutsch, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 1996 CPDD, NIDA Research Monograph
Clinical trial NCT00335335: Safety and Effectiveness of Visipaque 320mg-I/ml for Use in Contrast-Enhanced CT Angiography of Arteries of the Heart
Official title: Phase 3, Open-label, Multicenter Studies to Determine Efficacy and Safety of VISIPAQUETM (Iodixanol) Injection for Use in Intravenous Contrast-Enhanced CT Angiography of Coronary Arteries
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Coronary Artery Disease
Keywords: Coronary
Angiography
X-ray
CAD
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
First posted: 2006-06-09
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: CT (computed tomography) angiography (CTA) is an examination similar to a CAT scan that uses x-rays and a contrast medium (also called dye) to visualize blood flow in arteries and veins throughout the body.

VISIPAQUE™ will be given through a vein in the arm before having the CTA scan of the heart arteries. The pictures it produces of the heart and its blood vessels will be reviewed and compared to those obtained during the catheter-based coronary angiography to see if the CTA shows the same blockages.


Eligibility criteria: Inclusion Criteria:

* Subject is ≥18 years old.
* Subject must have been referred for an elective coronary angiography for one of several specified conditions.

Exclusion Criteria:

* The subject has impaired renal function with a serum creatinine level ≥1.7 mg/dL (150 µmol/L). If the institution's practising guideline(s) regarding the serum creatinine limits for receiving radiologic contrast medium are lower than 1.7 mg/dL (150 µmol/L), the investigator should follow the practising guideline(s) of their institution.

Subject has a known allergy to iodinated contrast agent

Subject has atrial fibrillation/flutter or any irregular heart rhythm considered to interfere with temporal acquisition of cardiac CT images.

The subject's resting heart rate is 66-100 bpm and β-blocker therapy is contraindicated.

Use of nitroglycerin is contraindicated.

Subject has had a prior CABG procedure.

Subject has a metal cardiac stent in place or artificial heart valve(s).

Subject has had a prior pacemaker or internal defibrillator lead implantation. Subject must agree to discontinue metformin day of and for 48 hours after the CTA procedure.

Primary outcomes:
measure: To evaluate diagnostic performance and safety of Visipaque-enhanced CTA images for determination of presence or absence of coronary artery obstruction
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Princeton
country: United States
state: New Jersey
Study officials:
affiliation: GE Healthcare
name: Veronica Reichl
role: STUDY_DIRECTOR
References:
Clinical trial NCT01563835: Analgesia for 2nd Trimester Termination of Pregnancy
Official title: Analgesia for 2nd Trimester Termination of Pregnancy: a Randomized Controlled Trial of Intravenous Versus Epidural Patient Controlled Analgesia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pain
Keywords: Termination of pregnancy
Epidural
IV PCA
Lead sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Sponsor class: OTHER
First posted: 2012-03-27
Enrollment: 42
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There has been very little investigation into the management of pain from 2nd trimester termination of pregnancy or unexpected fetal loss. The standard of practice in North America is usually intravenous patient controlled analgesia (IV PCA), using a narcotic wuch as fentanyl. The goal of this study is to compare the quality of recovery after termination of pregnancy using fentanyl IV PCA or patient controlled epidural analgesia (PCEA), a standard of care for live births. The study will be conducted as a randomized controlled trial.

Detailed description: Epidural analgesia is known to provide superior analgesia for labour with minimal maternal and fetal side effects. This mode of analgesia is not usually offered to patients who require termination of their pregnancies or who suffer unexpected fetal losses, although they go through labour and delivery with likely more difficult psychological circumstances.

We plan to compare patient controlled epidural analgesia (PCEA) with intravenous patient controlled analgesia (IV PCA), for 2nd trimester terminations of pregnancy. We hypothesize that PCEA provides better quality of recovery than IV PCA. The previously validated Quality of Recovery - 40 questionnaire will be used to measure a patient's quality of recovery. The results of this study will determine the optimal method of pain relief for late termination of pregnancy or fetal loss.

Eligibility criteria: Inclusion Criteria:

* interruption of pregnancy between 12 and 23 6/7 weeks

Exclusion Criteria:

* documented allergy to fentanyl or bupivacaine
* coagulopathy
* drug or narcotic abuse
* contraindication to neuraxial analgesia
* inability to comply with IVPCA or PCEA
* inability to complete the QoR-40 questionnaire
* TOP due to maternal problems

Primary outcomes:
measure: Quality of Recovery - 40 score on discharge
timeFrame: up to 5 days
Secondary outcomes:
measure: Duration of procedure
timeFrame: 24 hours
measure: Pain score
timeFrame: 24 hours
measure: Narcotic-related complications
timeFrame: 24 hours
measure: Epidural-related complications
timeFrame: 24 hours
measure: Surgical intervention
timeFrame: 24 hours
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
Study officials:
affiliation: MOUNT SINAI HOSPITAL
name: Jose CA Carvalho, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01736735: Evaluation of Cross-Linked Polyelectrolyte (CLP) With Placebo in Heart Failure Subjects
Official title: A Phase 2b, Randomized, Double-Blind, Multi-center Study Comparing Cross-linked Polyelectrolyte (CLP) With Placebo in Heart Failure Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Heart Failure
Lead sponsor: Sorbent Therapeutics
Sponsor class: INDUSTRY
First posted: 2012-11-29
Enrollment: 270
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a placebo-controlled study to determine the effect of CLP in heart failure subjects with fluid overload.


Eligibility criteria: Selected Inclusion Criteria:

* Age 21 years or older at randomization
* Heart failure with at least one of the following signs of current fluid overload:

  1. Peripheral (or sacral) edema \>1+ or ascites during screening or on day of randomization
  2. Pulmonary congestion as determined by chest X-ray during the screening period
* Ambulatory and able to perform the 6-minute walk test

Selected Exclusion Criteria:

* Participation in another clinical trial of an investigational or marketed drug within 30 days or 5 half-lives (whichever is longer) preceding screening
* Any hospitalization or unscheduled outpatient decongestion therapy using IV diuretics, ultrafiltration, or paracentesis within 8 weeks prior to or during screening
* Coronary-artery bypass graft, percutaneous intervention (e.g., cardiac, cerebrovascular, aortic), or major surgery including thoracic and cardiac, within 2 months prior to or during screening or anticipated need during study participation
* Heart transplant recipient, or anticipated need for transplant or LVAD during study participation
* Any of the following events having occurred within 8 weeks prior to or during screening: myocardial infarction, transient ischemic attack, stroke, or acute coronary syndrome as judged by the Investigator

Primary outcomes:
measure: Composite endpoint comprised of: 6-Minute Walk Test, Body weight, KCCQ Score, Log2 NT-proBNP, time to first occurrence of heart/renal failure hospitalization, unscheduled outpatient intravenous or mechanical therapy for heart/renal failure or death
timeFrame: Baseline, Week 8
Secondary outcomes:
measure: Change in 6-Minute Walk Test distance from baseline to Week 8.
timeFrame: Baseline, Week 8
measure: Time to heart failure or renal failure hospitalization, unscheduled outpatient intravenous or mechanical therapy for heart failure or renal failure, or death
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Tustin
country: United States
facility: Orange Country Research Center
state: California
city: Buenos Aires
country: Argentina
city: Ashkelon
country: Israel
Study officials:
affiliation: Sorbent Therapeutics, Study Sponsor
name: Howard Dittrich, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01731535: Evaluation of the Risk for Radiographic and Clinical Nonunion in Patients With Previous Bisphosphonates Therapy.
Official title: Evaluation of the Risk for Radiographic and Clinical Nonunion in Patients With Previous Bisphosphonates Therapy.
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Non-union or Delayed Healing Fractures
Keywords: osteoporosis, low trauma fracture, non-union fracture, delayed healing fracture, bisphosphonate
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2012-11-21
Enrollment: 0
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men and women older than 60 years old with delayed or nonunion low trauma fracture beween 01/01/2000 - 12/31/2011.

Brief summary: Dose and duration of bisphosphonate therapy will increase the likelihood that patients experience delayed healing of non-union fractures.

Detailed description: We intend to review the UWHealth patient database to identify individuals with delayed or nonunion fractures. Subsequently, we will collect associated medical information related to fractures such as age of osteoporosis diagnosis, BMI, previous bisphosphonate treatment, type and location of fracture, time to complete union, other treatment needed for nonunion etc. With this information, we will evaluate the risk of delayed and nonunion fractures in patients previously receiving bisphosphonate treatment compared to a normal population. We also will investigate other potential causes of delayed or nonunion fractures in this population.

Eligibility criteria: Inclusion Criteria:

* Men and women older than 60 years old with delayed or nonunion low trauma fracture between 01/01/2000 - 12/31/2011.

Exclusion Criteria:

* None

Primary outcomes:
measure: The number of patients with delayed healing or non-union fractures with prior bisphosphonate use
timeFrame: 01/01/2000 - 12/31/2011
Secondary outcomes:
measure: Evaluation of patient variables (demographic or medical history) related to non-union or delayed healing fractures.
timeFrame: 1/1/2000-12-31-2012
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Neil Binkley, MD
role: STUDY_DIRECTOR
References: