louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01625065: Study of Medication Compliance - a Comparison of Patients in Pain Management and Pre-surgical Patients
Official title: Toxicological Analyses of Blood and Urine Samples in Pain Patients and Pre-surgical Control Patients to Investigate Incidences of Concealed and Feigned Substances
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Keywords: medication compliance
adherence
toxicological analyzes
GC-MS
HPLC
pain patients
opioid misuse
patients with current pain
Lead sponsor: Ruhr University of Bochum
Sponsor class: OTHER
First posted: 2012-06-21
Enrollment: 343
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pain management and surgical outpatient department of a University hospital

Brief summary: In this study medication compliance regarding current drug use is investigated using toxicological analyzes in two patient groups: patients from a pain management department and pre-surgical control patients. The aim is to explore the incidence of concealed and feigned substances and to determine the respective substance classes. Expecting that noncompliance is higher in the pain patient group, the investigators want to identify clinical risk factors for noncompliant drug report.


Eligibility criteria: Inclusion Criteria:

* provided informed consent
* current pain

Exclusion Criteria:

* no taking of blood sample possible
* no consent with toxicological analyzes
* insufficient comprehension of the German language

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bochum
country: Germany
facility: University hospital Bergmannsheil
Study officials:
References:
citation: Kipping K, Maier C, Bussemas HH, Schwarzer A. Medication compliance in patients with chronic pain. Pain Physician. 2014 Jan-Feb;17(1):81-94.
Clinical trial NCT00690365: Safety and Efficacy of Switching to Quetiapine in Outpatients With Schizophrenia
Official title: A Non-interventional, Open Label, Phase IV Observational Study for the Safety and Efficacy of Switching to Quetiapine (Seroquel) in Outpatients With Schizophrenia Who Have Been Unsuccessfully Treated With Other Antipsychotics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Keywords: Switching
Quetiapine
schizophrenia
unsuccessfully treated
antipsychotics
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-06-04
Enrollment: 576
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary Care

Brief summary: This is a single-arm, phase IV, open-label, prospective, non interventional study in approximately 600 patients that will be followed for 6 months in order to evaluate the safety and efficacy of quetiapine. Patients will be switched over a 4 to 7 day cross-titration period from their previous antipsychotic medication to quetiapine according to the approved SPC.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of schizophrenia at least 1 year prior to screening
* Inadequate response or poor safety /tolerability or non-compliance to previous antipsychotic medication
* Provision of Informed Consent prior to enrolment

Exclusion Criteria:

* Known hypersensitivity to active substance of excipients
* Patients receiving P450 3A4 inhibitors
* Pregnancy or lactation
* Substance abuse or dependence

Primary outcomes:
measure: Safety of quetiapine assessed through analysis of AE/SAE data (rate of patients presenting SAEs, rate of patients who discontinue treatment due to any AE, time to treatment discontinuation due to any AEs)
timeFrame: 5 visits (Day 0, Week 1, Week 4, Week 12, Week 24); SAEs will be reported during all study period
Secondary outcomes:
measure: Changes in the Clinical Global Impression of Severity and Improvement (CGI-S, CGI-I) and in Brief psychiatric Rating Scale (BPRS) from baseline to end of study treatment
timeFrame: 5 visits (Day 0, Week 1, Week 4, Week 12, Week 24)
measure: Percentage of extra-pyramidal side effects assessed using the Simpson-Angus Scale (SAS)
timeFrame: Changes from baseline to end of study treatment or (6 months) or early withdrawal
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06709365: Tibio-talo-calcaneal Fusion by Hindfoot Nail Versus Open Reduction and Internal Fixation in Treatment of Complex Fractures Distal Tibial and Fragility Ankle Fractures in Elderly
Official title: Tibio-talo-calcaneal Fusion by Hindfoot Nail Versus Open Reduction and Internal Fixation in Treatment of Complex Fractures Distal Tibial and Fragility Ankle Fractures in Elderly
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fragility Ankle Fractures and Complex Distal Tibial Fractures
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-11-29
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Tibiotalar calcaneal fusion by hindfoot nail Vs open reduction and internal fixation in treatment of complex distal tibial fractures and ankle fragility ankle fractures in elderly


Eligibility criteria: Inclusion Criteria:

* pilon fractures complex distal tibial fractures ankle comminuted fractures age more than 65yrs osteoprotic fractures surgically fit patients

Exclusion Criteria:

Ankle fractures unimalleolar undisplaced Pathological fractures Young adults DVT Peripheral vascular diseases Age less than 65 Unfit patient for surgery

-

Primary outcomes:
measure: AOFAS American orthopedic foot and ankle score (Score for clinical effects of our intervention)
timeFrame: 2years
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag university hospitals
Study officials:
References:
Clinical trial NCT01885065: Efficacy of Novel Edible Gel-based Artificial Saliva in Cancer Patients
Official title: Efficacy Study of Novel Edible Gel-based Artificial Saliva in Xerostomic Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer of Head and Neck
Cancer
Radiation-induced Xerostomia
Dry Mouth
Lead sponsor: Dental Innovation Foundation Under Royal Patronage
Sponsor class: OTHER
Collaborators: name: Thammasat University
name: Srinakharinwirot University
name: Mahidol University
name: Ministry of Health, Thailand
First posted: 2013-06-24
Enrollment: 25
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine whether continuous use of edible, gel-based artificial saliva in cancer patients with dry mouth problems will reduce signs and symptoms of dry mouth and improve quality of patients' saliva.


Eligibility criteria: Inclusion Criteria:

* cancer patients who receive/ had received radiotherapy and/or chemotherapy and have dry mouth problems

Exclusion Criteria:

* mucositis more than grade 1
* cannot perform oral intake of gel-based artificial saliva eg. aspirate

Primary outcomes:
measure: Changes in subjective dry mouth score
timeFrame: baseline, 2 weeks and 4 weeks after intervention
Secondary outcomes:
measure: Changes in objective dry mouth score
timeFrame: Baseline, 2 week and 4 weeks after the start date
measure: Changes in salivary pH
timeFrame: Baseline, 2 weeks and 4 weeks after the start date
measure: Changes in salivary buffering capacity
timeFrame: Baseline, 2 weeks and 4 weeks after the start date
Other outcomes:
Locations:
city: Pathumthani
country: Thailand
facility: Mahavachiralongkorn cancer hospital
Study officials:
affiliation: Faculty of Dentistry, Srinakharinwirot University
name: Aroonwan Lam-ubol, DDS, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02290665: Localized Therapeutics for the Treatment of Gastrointestinal Disorders
Official title: Localized Therapeutics for the Treatment of Gastrointestinal Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Adults
Keywords: enema
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2014-11-14
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this study is to determine the patient preference for a biocompatible thermosensitive solution-gel versus water or saline (liquid) enema. The thermosensitive solution-gel is comprised of poloxamer, an inactive compound that is designated as GRAS (generally recognized as safe) by FDA. It could subsequently be used as a medium for drug delivery. The poloxamer (gel) is administered to study participants in order to assess preference and proximal distribution.


Eligibility criteria: Inclusion Criteria:

* Generally healthy
* Age 18 to 70 years old
* Non-pregnant

Exclusion Criteria:

* GI complaints
* Pregnancy
* Patients with previous colonic surgery or current bowel injury or obstruction
* Allergies to contrast

Primary outcomes:
measure: Patient preference, as assessed by questionnaire
timeFrame: Up to 3 hours post-administration
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Sidhartha Sinha, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Aida Habtezion, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05642065: Hip Activation and FSDT
Official title: Does a Hip Muscle Activation Home Exercise Program Change Patient Performance on the Forward Step-Down Test? A Single-Arm Clinical Trail
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Movement, Abnormal
Lower Extremity Problem
Lead sponsor: Louisiana State University Health Sciences Center Shreveport
Sponsor class: OTHER
First posted: 2022-12-08
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if activation training of the hip musculature affects muscle activation and frontal plane mechanics in healthy individuals.

Specific Aim 1: Determine whether performance on the forward step-down test (FSDT) changes after an eight-week home exercise program (HEP) focused on hip musculature activation in healthy individuals.

Specific Aim 2: Determine whether surface electromyography (sEMG) hip musculature changes following an eight-week HEP focused on hip musculature activation in healthy individuals.

Specific Aim 3: Determine whether a dose-response relationship exists between compliance on the HEP and changes in FSDT scores in healthy individuals.

Specific Aim 4: Determine whether a dose-response relationship exists between compliance on the HEP and sEMG changes in hip musculature activation in healthy individuals.


Eligibility criteria: Inclusion Criteria:

* Participants must be current first or second year Doctor of Physical Therapy students in the School of Allied Health Professions at LSU Health Shreveport.

Exclusion Criteria:

* Current knee pain or pathology in the dominant leg, and women with known pregnancy.

Primary outcomes:
measure: Scores on the Forward Step Down Test
timeFrame: Pre- and Post- Intervention Program (8 weeks)
Secondary outcomes:
measure: Surface electromyography (sEMG) - Gluteus Maximus
timeFrame: Pre- and Post- Intervention Program (8 weeks)
measure: Surface electromyography (sEMG) - Gluteus Medius
timeFrame: Pre- and Post- Intervention Program (8 weeks)
measure: Home Exercise Program (HEP) Compliance
timeFrame: Pre- and Post- Intervention Program (8 weeks)
Other outcomes:
Locations:
city: Shreveport
country: United States
facility: Louisiana State University Health Sciences Center - Shreveport
state: Louisiana
Study officials:
affiliation: Louisiana State University Health Sciences Center Shreveport
name: Daniel W. Flowers, DPT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02598765: Micro vs. Standard Trabeculectomy Study
Official title: Micro vs. Standard Trabeculectomy Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Glaucoma
Keywords: Glaucoma
Trabeculectomy
Eye Disease
Intraocular Pressure
Visual Acuity
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Seva Foundation
name: Lumbini Eye Institute and Hospital
First posted: 2015-11-06
Enrollment: 240
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the reduction in intraocular pressure and cumulative incidence of complications between the standard and micro trabeculectomy surgeries 3 months after surgery.

Detailed description: This study is a randomized, double-masked (study participants and outcome assessors) trial. During the enrollment period, consecutive patients from LEI who are planning to have trabeculectomy surgery and who meet the study enrollment criteria will be randomized to receive standard trabeculectomy or microtrabeculectomy. The primary outcome is complications and change in intraocular pressure after a 3 month follow-up period. We will perform subgroup analyses by stratifying the population according to skin pigmentation to determine whether pigmentation is a predictor of treatment success.

Eligibility criteria: Inclusion Criteria:

* Age \>= 40
* Planning to have a trabeculectomy

Exclusion Criteria:

* Life threatening or debilitating disease
* Inability to complete necessary exams and/or ocular disease that would preclude assessment of intraocular pressure, visual field, or optic disc
* Contralateral eye already enrolled in study

Primary outcomes:
measure: Cumulative incidence of complications
timeFrame: 3 months after surgery
Secondary outcomes:
measure: Reduction in intraocular pressure
timeFrame: 3 months after surgery
measure: Cumulative incidence of complications
timeFrame: 6 and 12 months after surgery
measure: Reduction of intraocular pressure
timeFrame: 6 and 12 months after surgery
Other outcomes:
Locations:
city: Siddharthanagar
country: Nepal
facility: Lumbini Eye Institute, Nepal
Study officials:
affiliation: F. I. Proctor Foundation, UCSF
name: Jeremy D Keenan, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03619265: Evaluation of Activity Levels, Inflammatory Markers, and Overall Wellness.
Official title: Evaluation of Activity Levels, Inflammatory Markers, and Overall Wellness. A Randomized, Double-blind, Placebo-controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Range of Motion
Lead sponsor: Natural Immune Systems Inc
Sponsor class: OTHER
First posted: 2018-08-07
Enrollment: 40
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A double-blinded, randomized, placebo-controlled, parallel-arm clinical study design will be used.
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose for this protocol is to perform a double-blind, randomized, placebo-controlled, parallel-arm clinical study in healthy subjects to evaluate the efficacy of a nutraceutical product on physical and mental energy levels and overall wellness.


Eligibility criteria: Inclusion Criteria:

* Healthy adults of either gender;
* 35-75 years old;
* Chronic joint/muscle related pain for at least past 6 months;
* Body mass index (BMI) at or below 34.9 kg/m2.

Exclusion Criteria:

* Bariatric surgery;
* Diagnosed with diabetes Type I;
* Taking medication for diabetes Type II;
* Known serious chronic health condition;
* Serious active illness within past 12 months;
* Major surgery within the past 3 months;
* Major trauma within the past 3 months;
* Alcohol consumption of more than four standard units/day (for example more than four regular 12 oz beers (5% alcohol), four small 5-oz glasses of wine (12% alcohol), or four 1.5 oz shots of 80-proof spirits), or more than 28 units per week;
* Daily consumption of Nopalea or similar juice products during the past month;
* Currently taking anti-inflammatory nutritional supplements judged by the study coordinator to negate or camouflage the effects of the test product;
* Taking anti-inflammatory medications on a daily basis (81 mg aspirin is acceptable);
* Use of oral, inhaled or injected steroid medication within the last 6 months (for example: prednisone, dexamethasone). Nasal sprays for allergies are allowed;
* Any other significant disease or disorder that the investigator judges may put the subject at risk because of participation in the study, or may influence the result of the study;
* Any other condition or observation that the investigator judges may adversely affect the person's ability to complete the study;
* Women of child-bearing potential: Pregnant, breast-feeding, or trying to become pregnant;
* Known allergies to ingredients in the test and placebo products.

Primary outcomes:
measure: Pain level
timeFrame: Baseline, 2 weeks, and 8 weeks.
Secondary outcomes:
measure: Range of motion
timeFrame: Baseline and 8 weeks.
Other outcomes:
Locations:
city: Klamath Falls
country: United States
facility: NIS Labs
state: Oregon
Study officials:
affiliation: NIS Labs
name: Gitte Jensen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01150565: Safety Study of LiRIS in Interstitial Cystitis (IC) Patients
Official title: Phase 1B Pilot Safety Study of LiRIS-TM, A Novel Bladder Drug Delivery Platform in Patients With Interstitial Cystitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Interstitial Cystitis
Lead sponsor: Allergan
Sponsor class: INDUSTRY
Collaborators: name: TARIS Biomedical, Inc.
First posted: 2010-06-25
Enrollment: 18
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is primarily to evaluate the safety and tolerability of two dose levels of an investigational drug-delivery system (LiRIS) in patients who have moderate to severe symptoms of interstitial cystitis.

Detailed description: Approximately 20 female patients with interstitial cystitis will be enrolled in this study at multiple centers in Canada. LiRIS is being developed to provide drug therapy directly into the urinary bladder. LiRIS contains Lidocaine, a marketed drug (approved by Health Canada) which is commonly used for local (skin or oral)anaesthesia. LiRIS is designed to release a controlled amount of lidocaine while in the bladder over a 2 week period.

Two dose groups of approximately 10 patients per group will be enrolled into the study; the first group of patients will receive low dose LiRIS, and the second group will receive high dose LiRIS. All patients receive LiRIS treatment for 14 days, and clinic follow-up at 7 and 14 days after treatment. Additional telephone follow-up occurs at approximately 6 and 10 weeks after LiRIS treatment. The maximum duration of participation, including a screening period of up to 14 days, will be 104 days.

Eligibility criteria: Inclusion Criteria:

* Female patients ≥ 18 years of age
* If of child-bearing potential, agrees to use effective contraception defined by protocol
* Capable of understanding and completing symptom diaries and questionnaires as required in the study
* Diagnosed with IC, as defined by protocol criteria

Exclusion Criteria:

* Bladder or urethra anatomical feature that, in the opinion of the investigator, might prevent the safe placement, indwelling use, or removal of LiRIS
* History or presence of any medical condition that would interfere with ability to assess symptoms
* Pregnant or lactating patients

Primary outcomes:
measure: Cystoscopic examination
timeFrame: Days 1 and 14
Secondary outcomes:
measure: Bladder pain
timeFrame: During and following treatment; study days 1 to 90
Other outcomes:
Locations:
city: Victoria
country: Canada
facility: Dr. Steinhoff Clinical Research
state: British Columbia
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Centre, Halifax Infirmary
state: Nova Scotia
city: Kingston
country: Canada
facility: Centre for Applied Urological Research
state: Ontario
Study officials:
affiliation: Queen's University/Kingston General Hospital
name: Curtis Nickel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06100965: Reduced-dose Alemtuzumab for Kidney Transplant Rejection
Official title: The Effects of Reduced Dose Alemtuzumab for Severe Kidney Transplant Rejection
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Kidney Transplant Rejection
Keywords: alemtuzumab
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2023-10-25
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Kidney transplant recipients who experience severe or glucocorticoid-resistant rejection of their allograft.

Brief summary: Prospective, follow-up study of kidney transplant recipients treated with alemtuzumab anti-rejection therapy for severe or glucocorticoid-resistant kidney transplant rejection.

Detailed description: Study design: Prospective observational cohort study. Study population: Adult patients who are treated with alemtuzumab for severe or glucocorticoid-resistant kidney transplant rejection.

Intervention (if applicable): Not applicable. Main study parameters/endpoints: Lymphocyte (subtype) repopulation, serious infections, one-year graft survival, alemtuzumab plasma levels, intra-cellular signalling of repopulated T and B cells, cytokine-levels, donor-specificity of repopulated T cells, differences pre- and post-treatment of donor-derived cell-free DNA, plasma nucleosomes, urinary chemokines, urinary extracellular vesicles, breath-pattern analysis.

Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Treatment for severe or glucocorticoid-resistant kidney transplant rejection with alemtuzumab.

Exclusion Criteria:

* Treatment with a different lymphocyte depleting agent (e.g. rATG) prior to treatment with alemtuzumab for the same rejection episode.
* Recipients who have T cell counts below 200 × 106/L before the start of therapy (for instance, because of lymphocyte depleting induction therapies).
* Inability to provide written informed consent

Primary outcomes:
measure: Proportion of patients with lymphocyte repopulation
timeFrame: 6 months and 1 year
Secondary outcomes:
measure: Cumulative incidence of graft loss
timeFrame: 6 months, 1 year
measure: Serious infections
timeFrame: 6 months, 1 year
measure: Patient survival
timeFrame: 6 months, 1 year
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus MC
state: Zuid-Holland
Study officials:
References: