louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01419327: Fosrenol Post-marketing Surveillance for Hemodialysis in Japan
Official title: Special Drug Use Investigation of Fosrenol (Long-term Investigation for Patients With Hemodialysis)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyperphosphatemia
Keywords: Fosrenol
Hyperphosphatemia
Hemodialysis
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2011-08-18
Enrollment: 3267
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The target population of this study is patients who have received a prescription of Fosrenol on the basis of the decision of the physician. The study is expected to collect data of 3,000 patients in about 300 practices in Japan.

Brief summary: This study is a regulatory post marketing surveillance in Japan, and it is a local prospective and observational study of patients in hemodialysis who received Fosrenol for hyperphosphatemia. The objective of this study is to assess safety and efficacy of using Fosrenol in clinical practice. A total 3,000 patients will be recruited and followed 5 years.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing hemodialysis who received Fosrenol for hyperphosphatemia

Exclusion Criteria:

* Patients who are contraindicated based on the product label

Primary outcomes:
measure: Incidence of adverse drug reactions in subjects who received Fosrenol
timeFrame: After Fosrenol administration, up to 8 years
Secondary outcomes:
measure: Timing of onset of common ADRs related to the priority survey items
timeFrame: After Fosrenol administration, up to 8 years
measure: Effect on bones: Alkaline phosphatase over time
timeFrame: After Fosrenol administration, up to 8 years
measure: Effect on bones: Change in bone density
timeFrame: After Fosrenol administration, up to 8 years
measure: Cardiothoracic ratio over time
timeFrame: After Fosrenol administration, up to 8 years
measure: PWV and ABI over time
timeFrame: After Fosrenol administration, up to 8 years
measure: Serum P, albumin-corrected serum Ca and serum intact PTH, and Ca-P product over time
timeFrame: After Fosrenol administration, up to 8 years
measure: Percentage of patients achieving the serum P control goal
timeFrame: After Fosrenol administration, up to 8 years
Other outcomes:
Locations:
city: Multiple Locations
country: Japan
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03725527: Effect of Rectus Sheath Block on Diaphragmatic Function After Elective Upper Abdominal Surgery
Official title: Respiratory Effects of Rectus Sheath Block in Patients Undergoing Major Upper Abdominal Surgery.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Pain
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-10-31
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will be undertaken to investigate the respiratory and analgesic effects of ultrasound guided rectus sheath block analgesia after elective abdominal surgery with midline incision.

Detailed description: A major proportion of pain experienced by patients undergoing abdominal surgeries is due to somatic pain signals derived from the abdominal wall. The central portion of anterior abdominal wall components (skin, muscles and parietal peritoneum) is innervated by sensory neurons branching from the anterior rami of spinal nerves T7 to T1. These neurons lie between the rectus abdominis muscle and posterior rectus sheath, and pierce the rectus muscle close to the midline. The tendinous intersections of the rectus muscle do not fuse with the posterior rectus sheath, thereby allowing the injectate to spread cephalo-caudally within this potential space. Rectus sheath (RS) block has been described for any midline abdominal incisions (epigastric and umbilical hernia repairs). As visceral pain becomes attenuated by the 2nd postoperative day, rectus sheath block can also be administered for midline laparotomy.

However, the effects of rectus sheath block analgesia on the respiratory function after abdominal surgery with midline incisions are still under investigation.

Eligibility criteria: Inclusion Criteria:

* Age: 18-50 years.
* Sex: both males and females.
* BMI\< 30kg/m2.
* ASA physical status: 1, II and III.
* Elective abdominal surgery with midline incisions.

Exclusion Criteria:

* Patient refusal.
* Infection at injection site
* Coagulation disorders.
* Allergy to study medications.
* Pregnancy.
* Respiratory tract infection within the last 2 weeks.
* Urgent abdominal surgery

Primary outcomes:
measure: Diaphragmatic inspiratory amplitude during quiet/deep breathing (DIA)/cm
timeFrame: 24 hours Postoperative
Secondary outcomes:
measure: Verbal Rating Scale
timeFrame: 24 hours Postoperatively
measure: Forced Vital Capacity/L
timeFrame: 24 hours Postoperatively
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university main hospital, ICUs
state: Assiut Governorate
Study officials:
affiliation: Lecturer in anesthesia and intensive care department, faculty of medicine, Assiut university, Egypt.
name: Noha Y Mohamed, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06025227: Provide Pre-approval Single Patient Expanded Access (Compassionate Use) of Etrasimod for Patients.
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Colitis, Ulcerative
Keywords: Ulcerative Colitis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2023-09-06
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: Provide pre-approval single patient Expanded Access (Compassionate Use) of Etrasimod for patients.

Detailed description: In Expanded Access, treating physicians are the Sponsors. Expanded Access requests from treating physicians may be submitted to www.pfizercares.com. Availability will depend on location and country.

Eligibility criteria: Patient must be intolerant, have a contraindication or had inadequate response to at least 3 therapies available for Ulcerative Colitis (UC) in this country or provide a rationale of why therapy was not used.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05026827: Iyengar Yoga for Prolonged Grief Disorder
Official title: Iyengar Yoga As a Probe of Prolonged Grief Disorder Neurobiology
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Prolonged Grief Disorder
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2021-08-30
Enrollment: 68
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Experiencing the death of a loved one is inevitable for older adults. Before the coronavirus disease 2019 (COVID-19) pandemic, over 2.5 million people died annually in the United States, including 52,000 in Wisconsin alone, and COVID-19 has added to this toll. Each person who dies leaves an average of five grieving people behind. Most grieving older adults are resilient and recover their pre-loss functioning within one year. However, in about 10%, acute grief becomes protracted and debilitating, leading to the development of prolonged grief disorder (PGD), a clinically diagnosable mental health condition. PGD in older adults increases the risk for poorer medical, mental health, and cognitive outcomes; lower quality of life; disability; premature mortality; and suicide. Despite the magnitude of this problem, the neurobiology of PGD in older adults is poorly understood. By using Iyengar Yoga (IY) as a probe for PGD neurobiology, this pilot project aims to address this critical gap.

Detailed description: Our goal is to conduct a pilot study to examine in PGD the modulating effects of 10-week IY on circulating endocannabinoid and emotion processing brain circuit, and the associations between biological changes and clinical response.

Eligibility criteria: Inclusion Criteria:

* Male or female greater than or equal to 40 years of age
* Bereavement \>6 months
* Score greater than or equal to 25 on the Inventory of Complicated Grief (ICG)
* Presence of PGD (subsyndromal and syndromal)
* Adequate visual and auditory acuity

Exclusion Criteria:

* Delirium/unstable medical conditions
* Lifetime history of neurological illnesses: seizures, stroke, dementia of any etiology, severe head injury, brain tumor or surgery
* Serious back, joint or neck injuries within the past 3 months
* Currently practicing yoga
* Gross structural abnormalities on T1-weighted images
* Lifetime history of the following psychiatric disorders: bipolar or psychotic disorders, including psychotic depression
* Current alcohol/drug abuse or dependence
* Magnetic resonance imaging (MRI) contraindications
* Acute suicidality

Primary outcomes:
measure: Change in circulating endocannabinoid concentrations
timeFrame: 10 weeks
Secondary outcomes:
measure: Change in neural activity measured using Functional magnetic resonance imaging (fMRI)
timeFrame: 10 weeks
measure: Inventory of Complicated Grief (ICG) scale score change
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Wauwatosa
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
References:
Clinical trial NCT02584127: Tobacco-Related Disease Prevention Among Korean Americans
Official title: Tobacco-Related Disease Prevention Among Korean Americans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Keywords: Smoking
cessation
Internet program
Lead sponsor: University of California, Berkeley
Sponsor class: OTHER
First posted: 2015-10-22
Enrollment: 405
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study evaluates the effectiveness of an internet-based smoking cessation program for Korean Americans.

Detailed description: Smoking is prevalent among Korean American men. Quitting is Winning, an internet-based, cognitive-behavioral smoking cessation program, was developed using community-based participatory research principles.

A randomized controlled trial was used to evaluate whether participants were more likely to complete the program and quit smoking at 6-month follow-up with additional reinforcement including financial incentives for program completion and interim surveys.

Eligibility criteria: Inclusion Criteria:

* self-identified Korean American ethnicity
* age 18 years or older
* daily smoker (i.e., smoked at least one cigarette per day during the previous seven days)
* current U.S. resident
* valid email address
* regular internet access.

Exclusion Criteria: None

Primary outcomes:
measure: smoking status
timeFrame: six month followup
Secondary outcomes:
measure: program completion
timeFrame: six months
Other outcomes:
Locations:
city: Berkeley
country: United States
facility: Joel Moskowitz
state: California
Study officials:
References:
citation: Moskowitz JM, McDonnell DD, Kazinets G, Lee HJ. Online smoking cessation program for Korean Americans: Randomized trial to test effects of incentives for program completion and interim surveys. Prev Med. 2016 May;86:70-6. doi: 10.1016/j.ypmed.2016.01.019. Epub 2016 Feb 1.
Clinical trial NCT00400127: The Effect of Silicone Suspension on Standing Balance for Transfemoral Amputees
Official title: The Effect of Silicone Suspension on Standing Balance for Transfemoral Amputees
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Amputee
Keywords: transfemoral amputee
silicon suspension
balance
gait
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
First posted: 2006-11-16
Enrollment: 6
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study is to test the hypothesis that silicone suction suspension without additional belt support does not significantly diminish the postural sway or walking performance of persons with transfemoral amputation.


Eligibility criteria: Inclusion Criteria:

* be forty-five (45) or older;
* unilateral transfemoral amputee;
* current patients of the QEII Health Sciences Centre Amputee Service based at the Rehab Site;
* can walk comfortably with their prosthesis for a minimum of 5 minutes, regardless of whether they require ambulation aids (i.e. canes, walkers, etc.);
* are in the process of being fitted with a silicon suction liner and pin system;
* are competent to give informed consent or have a proxy with power of attorney;
* have the written permission of the attending physician to participate;
* be willing to take part in the study, including signing the consent after carefully reading it.

Exclusion Criteria:

* have an unstable medical condition (e.g. angina, seizures), as determined by the attending or house physician;
* have major medical or neurological conditions that affect balance (specifically Parkinson's disease, stroke or Multiple Sclerosis), as determined by the physician or house staff physician;
* have an emotional or psychiatric problem of a type or extent that might make participation unpleasant, as determined by the attending or house physician.

Primary outcomes:
measure: Quiet standing balance
measure: Timed-up and Go
measure: ambulation profile
measure: questionnaire
Secondary outcomes:
measure: demographics
measure: prosthetic components
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Nova Scotia Rehabilitation Centre
state: Nova Scotia
Study officials:
affiliation: Capital Health, Canada
name: James Adderson
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05646927: Effect of Child Preference for Parental Selection During Induction
Official title: Effect of Child Preference for Parental Selection During Induction in Children Undergoing Elective Day Case Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anxiety State
Child Behavior
Keywords: day- case surgery
anxiety
children
Lead sponsor: Karaman Training and Research Hospital
Sponsor class: OTHER
First posted: 2022-12-12
Enrollment: 80
Sex: ALL
Minimum age (years): 4
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 80 children of both sex, aged 4-8 years with ASA physical Status I-II will be enrolled

Brief summary: Induction of anesthesia can be distressing both for children and their parents. Nonpharmacological behavioral interventions can reduce the anxiety of children without significant adverse effects as seen with sedative drugs. has not been documented.

The aim of this study will be to evaluate the effect of children's preference on parental selection during the induction of anesthesia on children and parental anxiety during the perioperative period.

Detailed description: Anesthetic induction can be one of the most stressful experiences for the child during the perioperative period, with almost 50% of the children showing significant anxiety. . To minimize the effect of anxiety, several methods have been adopted, such as the introduction of day-case surgery, parental presence at the induction of anesthesia, distractions and the use of pharmacological agents like midazolam to reduce anxiety.

Although the effect of parental presence on the anxiety of children and parents was studied in various studies. Whether the children's choice of parental selection affects anxiety is not studied yet. In this study, we will evaluate the anxiety of children by using mYPAS .

Eligibility criteria: Inclusion Criteria:

* 80 children of both sex, aged 4-15 years with ASA physical Status I-II will be enrolled

Exclusion Criteria:

1. Mentally challenged
2. Deaf Child
3. Cerebral Palsy
4. Premedicated Child
5. Language Problem
6. Unco-operative
7. Previous surgery or anesthesia history

Primary outcomes:
measure: Modified Yale Preoperative Anxiety Scale (mYPAS) of the children undergoing elective surgery under general anesthesia.
timeFrame: Perioperative period
Secondary outcomes:
Other outcomes:
Locations:
city: Karaman
country: Turkey
facility: Karaman Training and Research Hospital
Study officials:
affiliation: Karaman Training and Research Hospital
name: Fatih Yucedag, Assist Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01276327: Bioequivalence of a Fixed Dose Combination Tablet Linagliptin/Pioglitazone Compared With Its Mono-components
Official title: Bioequivalence of a Fixed Dose Combination Tablet of Linagliptin 5 mg / Pioglitazone 30 mg Compared With Its Mono-components in Healthy Male and Female Subjects (an Open-label, Randomised, Single-dose, Replicate Design Study With Two Treatments in Four Crossover Periods)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2011-01-13
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of the current study is to establish the bioequivalence of linagliptin/ pioglitazone fixed dose combination tablet compared to single tablets of linagliptin and pioglitazone administered together.


Eligibility criteria: Inclusion criteria:

Healthy male and female subjects

Exclusion criteria:

Any relevant deviation from healthy conditions

Primary outcomes:
measure: AUC0-72 of Linagliptin
timeFrame: 0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)
measure: Cmax of Linagliptin
timeFrame: 0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)
measure: AUC0-tz of Pioglitazone
timeFrame: 0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)
measure: Cmax of Pioglitazone
timeFrame: 0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)
Secondary outcomes:
measure: AUC0-tz for Linagliptin
timeFrame: 0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)
measure: AUC0-∞ of Linagliptin
timeFrame: 0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)
measure: AUC0-∞ of Pioglitazone
timeFrame: 0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)
measure: Tmax for Linagliptin
timeFrame: 0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)
measure: Tmax for Pioglitazone
timeFrame: 0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)
Other outcomes:
Locations:
city: Biberach
country: Germany
facility: 1264.14.1 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
Clinical trial NCT02196727: Evaluation of Postoperative Pain Following Bascom Cleft Lift Operation
Official title: Evaluation of Post-operative Pain in Bascom Cleft Lift Operation Receiving Multimodal Analgesia and Spinal Saddle Block in Day Case Surgery Setting.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Pain
Keywords: Postoperative pain
Multimodal analgesia
Bascom Cleft Lift
Day-case.
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2014-07-22
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing Bascom Cleft Lift operation in a day-case surgery setting

Brief summary: The purpose of this study is to evaluate postoperative pain in Bascom Cleft Lift operation receiving multimodal analgesia in day-case surgery setting.

Hypothesis: Multimodal analgesia provides adequate pain relief in patients undergoing Bascom Cleft Lift operation.


Eligibility criteria: Inclusion Criteria:

* Age \> 18
* ASA physical status 1 and 2
* Patient undergoing Bascom operation in prone position

Exclusion Criteria:

* Pregnancy
* Current regular use of drug belonging to the class of opioids
* Allergy/ intolerance to drugs included in multimodal analgesia regime

Primary outcomes:
measure: Numerical Rating Scale (NRS) pain score (0=no pain, 10= maximum imaginable pain)
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: Numerical Rating Scale (NRS) pain score (0=no pain, 10= maximum imaginable pain)
timeFrame: 2 hours, 48 hours and 30 days postoperatively
Other outcomes:
measure: Nausea
timeFrame: 2 hours postoperatively
measure: Returning to work
timeFrame: 30 days
measure: Returning to leisure activities
timeFrame: 30 days
measure: Wound condition
timeFrame: 30 days
measure: Vomiting
timeFrame: 2 hours postoperatively
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre Univarsity Hospital
state: Copenhagen
Study officials:
References:
citation: Mohamed SJ, Kristensen BB, Lindgaard L, Bisgaard T. Acceptable effect of multimodal analgesic treatment after a Bascom cleft lift operation. Dan Med J. 2015 Jan;62(1):A4985.
Clinical trial NCT06783127: Clinical Outcomes of Use of Olaparib in Castration Resistant Prostate Cancer
Official title: Clinical Outcomes of Use of Olaparib in Castration Resistant Prostate Cancer: An Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prostate Cancer
Castrate Resistant Prostate Cancer
BRCA Mutation
Lead sponsor: Santa Chiara Hospital
Sponsor class: OTHER
First posted: 2025-01-20
Enrollment: 3000
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: BRCA mutant Metastatic castration-resistant prostate cancer patients progressing after first-line ARPI who are treated with olaparib in clinical practice

Brief summary: This is an observational, retrospective/prospective, multicenter study designed to define, overall survival, clinical outcomes and predictive/prognostic factors of a consecutive population of mCRPC patients treated with olaparib in clinical practice.


Eligibility criteria: Inclusion Criteria:

BRCA mutant Metastatic castration-resistant prostate cancer patients treatment with olaparib in clinical practice

Exclusion Criteria:

Olaparib treatment in a clinical trial

Primary outcomes:
measure: disease control
timeFrame: From the date of treatment start until the date of last follow-up or date of death from any cause, whichever came first, assessed up to 120 months
Secondary outcomes:
measure: biochemical response
timeFrame: Through study completion, an average of 1 years
measure: response rate
timeFrame: Through study completion, an average of 1 years
measure: PFS
timeFrame: From the date of treatment start until the date of first progression or date of death from any cause, whichever came first, assessed up to 120 months
measure: toxicity rate
timeFrame: Through study completion, an average of 1 years
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: Sabrina Rossetti
city: Trento
country: Italy
facility: Orazio Caffo
Study officials:
References: