louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00374777: A Double-blind, Group-comparison P-III Study With Zolpidem MR Using Placebo and Nitrazepam in Insomnia Patients
Official title: FK199B (Zolpidem MR Tablet) Phase III Clinical Study -A Double-Blind, Placebo- and Nitrazepam-Controlled, Group-Comparison Study in Patients With Insomnia Associated With Schizophrenia and Manic-Depressive Psychosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Sleep Initiation and Maintenance Disorders
Keywords: Insomnia
schizophrenia
manic-depressive psychosis
zolpidem
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2006-09-11
Enrollment: 450
Sex: ALL
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A multicenter, randomized, double-blind, triple-dummy, group-comparison study using placebo and nitrazepam as a comparative drug.


Eligibility criteria: Inclusion Criteria:

* Nonorganic insomnia associated with schizophrenia and manic-depressive psychosis.

Exclusion Criteria:

* Patients with allergic reactions to zolpidem or nitrazepam; Patients with serious cardiac disorders; serious hepatic impairment; serious renal diseases.

Primary outcomes:
measure: Mean wake time after sleep onset during the double-blind period
timeFrame: 2 Weeks
Secondary outcomes:
measure: Mean total sleep time during the double-blind period
timeFrame: 2 Weeks
measure: Mean number of nightly awakenings during the double-blind period
timeFrame: 2 Weeks
measure: Mean sleep latency during the double-blind period
timeFrame: 2 Weeks
measure: Patient impression during the double-blind period
timeFrame: 2 Weeks
Other outcomes:
Locations:
city: Chubu region
country: Japan
city: Hokkaido region
country: Japan
city: Kansai region
country: Japan
city: Kanto region
country: Japan
city: Kyushu region
country: Japan
city: Shikoku region
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Use Central Contact
role: STUDY_CHAIR
References:
Clinical trial NCT06305377: Achieving Rapid, Safe and Sustained Glucose Control in Adolescents With Suboptimally Controlled Type 1 Diabetes Using Advanced Hybrid Closed Loop Systems
Official title: Turning the Tides: Achieving Rapid, Safe and Sustained Glucose Control in Adolescents With Suboptimally Controlled Type 1 Diabetes Using Advanced Hybrid Closed Loop Systems
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 20
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: diabetics adolescents in not good glicaemic control

Brief summary: The rational of this study is to assess if AHCL systems are able to achieve a better metabolic control (better glucometric data) after 2 weeks, 1 months. 6 months and 1 year after the start, in adolescents in not good glycaemic control.


Eligibility criteria: Inclusion Criteria:

* All children met the American Diabetes Association (ADA) criteria for T1D diagnosis with a current HbA1c of ≥8.5%.
* Age range 12-17 yrs old

Exclusion Criteria:

* Patients with a diagnose of genetic form of diabetes will be excluded.

Primary outcomes:
measure: Glucometric data
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: IRCCS San Raffaele
name: Riccardo Bonfanti, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00095277: Darbepoetin Alfa Administered Once Every 4 Weeks in the Treatment of Subjects With Anemia of Cancer
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of Darbepoetin Alfa Administered Once Every 4 Weeks in the Treatment of Subjects With Anemia of Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Anemia
Keywords: non-myeloid malignancies
myeloma
Anemia of Cancer
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2004-11-03
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to demonstrate benefit with respect to hematopoietic response in subjects with anemia of cancer randomized to Darbepoetin Alfa once every 4 weeks.


Eligibility criteria: Eligibility Criteria: - Subjects with non-myeloid malignancies - Subjects can not be on chemotherapy - Anemia of cancer - Eastern Cooperative Oncology Group (ECOG) status of 0 to 2 - Hemoglobin less than or equal to 11.0 g/dL - Adequate renal and liver function - Written informed consent

Primary outcomes:
measure: To demonstrate benefit with respect to hematopoietic response in subjects with anemia of cancer randomized to darbepoetin alfa once every 4 weeks.
Secondary outcomes:
measure: Assess efficacy
measure: Assess PROs
measure: Assess relationship between PROs and hemoglobin concentration
measure: Assess safety of dose and frequency
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Gordon D, Nichols G, Ben-Jacob A, Tomita D, Lillie T, Miller C. Treating anemia of cancer with every-4-week darbepoetin alfa: final efficacy and safety results from a phase II, randomized, double-blind, placebo-controlled study. Oncologist. 2008 Jun;13(6):715-24. doi: 10.1634/theoncologist.2007-0241.
Clinical trial NCT01657877: Anti-caries Potential of a Sodium Monofluorophosphate and Calcium Sodium Phosphosilicate Dentifrice
Official title: In Situ Study to Confirm the Anti-caries Potential of a 1.1365% w/w Sodium Monofluorophosphate (1500ppm F) Dentifrice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Caries
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2012-08-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: In situ study to compare treatment effect on enamel remineralization potential, measured by surface microhardness recovery (SMHR) and Enamel Fluoride Uptake (EFU). The study will explore the efficacy of an experimental sodium monofluorophosphate (SMFP) dentifrice containing calcium sodium phosphosilicate (CSP) in comparison to an experimental SMFP only dentifrice.


Eligibility criteria: Inclusion Criteria:

* Wears a removable bilateral mandibular partial denture that has good stability and support, with sufficient room on each side in the posterior buccal flange area to accommodate two enamel specimens \[required dimensions 12 x 7 millimeters (mm)\].

Primary outcomes:
measure: Percentage (%) Change in Surface Microhardness (SMH) Following 21 Days of Twice Daily Treatment With the 1500 Ppm Fluoride + 5% CSP Dentifrice and With the 1500 Ppm Fluoride Dentifrice.
timeFrame: Baseline to 21 days
Secondary outcomes:
measure: Percentage (%) Change in SMH Following 21 Days of Twice Daily Treatment With 500 Ppm Fluoride as SMFP and 0 % CSP Dentifrice, 0 Ppm Fluoride and 0% CSP, and 0 Ppm Fluoride and 5 % CSP.
timeFrame: Baseline to 21 days
measure: Enamel Fluoride Uptake (EFU)
timeFrame: Baseline to 21 days
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University School of Dentistry
state: Indiana
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT05247177: Multimodal GA for Lumbar Spine Surgery
Official title: Effects of Multimodal General Anesthesia for Older Patients Undergoing Lumbar Spine Fusion Surgery: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lumbar Spine Fusion Surgery
Keywords: multimodal general anesthesia,lumbar spine surgery,electroencephalographic,EEG,density spectrum array,DSA,bispectral index(BIS)
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2022-02-18
Enrollment: 160
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the effects of multimodal general anesthesia on the recovery profile of elder patients undergoing lumbar spine fusion surgery.

Detailed description: Multimodal general anesthesia has been proposed in recent years. By administration of multiple agents acting on a different component of the nociceptive pathways, the multimodal general anesthesia may elicit maximal anesthetic effects with minimal anesthetic dose. These may be beneficial to improve postoperative recovery and reduce adverse effects such as postoperative delirium and perioperative neurocognitive impairment. It is not uncommon that elder patients undergoing lumbar spine fusion surgery suffer from postoperative poor recovery, postoperative delirium as well as the postoperative neurocognitive disorder. Therefore, this study aims to explore the potential effects of multimodal general anesthesia, which comprised with electroencephalography density spectrum array guided co-administration of sevoflurane, ketamine and dexmedetomidine, on the postoperative recovery profiles for elder patients undergoing lumbar spine fusion surgery.

Eligibility criteria: Inclusion criteria:

1. patients with ages at least 60-year undergoing elective lumbar spine surgery

Exclusion:

1. A history of dementia
2. Impaired liver function, eg. AST or ALT \>100; liver cirrhosis \> Child B class
3. Impaired renal function, cGFR\< 60 ml/min/1.73 m2
4. Cardiac dysfunction, such as heart failure \> NYHA class II

Primary outcomes:
measure: Postoperative Quality of Recovery Score
timeFrame: Change from Baseline QoR-15 to 24 hour after surgery
Secondary outcomes:
measure: Postoperative delirium
timeFrame: 3 days
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Chun-Yu Wu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02300077: Methadone in Ambulatory Surgery
Official title: Methadone in Ambulatory Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-operative Pain
Anesthesia
Keywords: fentanyl, morphine
methadone
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2014-11-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The μ-opioid receptor agonist methadone is frequently used in adult anesthesia and adult pain therapy. Methadone has an extremely long half-life, which confers therapeutic advantage by providing more stable plasma concentrations and long-lasting pain relief. Methadone perioperative pharmacokinetics and effectiveness in perioperative pain relief in inpatients is well characterized. There is, however, no information on methadone use in an ambulatory surgery setting and outpatient procedures. This pilot investigation will determine effectiveness of intraoperative methadone in reducing postoperative opioid consumption and providing improved pain relief in patients undergoing moderately painful, ambulatory surgical procedures.


Eligibility criteria: Inclusion Criteria:

* Age 18-65 years
* Undergoing general anesthesia and moderately painful, ambulatory surgical procedures with anticipated overnight, postop hospital stay of \< 24 hours
* Signed, written, informed consent

Exclusion Criteria:

* History of or known liver or kidney disease.
* Females who are pregnant or nursing.
* Opioid tolerant patients (e.g. preoperative methadone therapy or use of fentanyl transdermal patches)
* History of allergy to methadone

Primary outcomes:
measure: Intraoperative Opioid Administration
timeFrame: Administered at induction of anesthesia
measure: Postoperative Opioid Administration
timeFrame: EMR reviewed at 24 hours post-administration or at hospital discharge
Secondary outcomes:
measure: Opioid Consumption Within First 30 Postoperative Days
timeFrame: 30 days
measure: Pain Relief Within First 30 Postoperative Days
timeFrame: 30 days
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Barnes-Jewish Hospital
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Helga Komen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Komen H, Brunt LM, Deych E, Blood J, Kharasch ED. Intraoperative Methadone in Same-Day Ambulatory Surgery: A Randomized, Double-Blinded, Dose-Finding Pilot Study. Anesth Analg. 2019 Apr;128(4):802-810. doi: 10.1213/ANE.0000000000003464.
Clinical trial NCT02216877: Magnesium Supplementation for Hypomagnesemia in Chronic Kidney Disease
Official title: Magnesium Supplementation for Hypomagnesemia in Chronic Kidney Disease - A Dose-Finding Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Chronic Kidney Disease
Hypomagnesemia
Keywords: Chronic Kidney Disease
Hypomagnesemia
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
First posted: 2014-08-15
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized placebo-controlled interventional trial to investigate the effect of oral magnesium supplementation on intracellular magnesium in subjects with chronic kidney disease. We hypothesize that oral magnesium supplementation will increase intracellular magnesium in subjects with chronic kidney disease as well as increase serum magnesium.

Detailed description: Chronic kidney disease (CKD) is associated with increase cardiovascular morbidity and mortality independent of traditional cardiovascular risk factors due to increased vascular calcification. Epidemiological and experimental data suggest that hypermagnesemia and magnesium supplementation reduce vascular calcification in chronic kidney disease by increasing calcium/phosphate solubility in serum, by inhibiting calcium influx into vascular smooth muscle cells (VSMC), by inhibiting intracellular pro-calcification enzymes in VSMC and by increasing activity of intracellular anti-calcification enzymes in VSMC. A trial to investigate the effect of oral magnesium supplementation on vascular calcification in subjects with CKD is currently being planned, but prior to initiating such a trial it is necessary to determine the dose of oral magnesium needed to increase intracellular magnesium and serum magnesium.

Eligibility criteria: Inclusion Criteria:

* Estimated Glomerular filtration rate (eGFR) \< 60 mL/min.
* Serum magnesium \< 0.82 mmol/L.
* Written informed consent.

Exclusion Criteria:

* Hemodialysis.
* Peritoneal dialysis.
* Kidney transplant recipient.
* Parathyroid hormone \> 600 pg/L.
* Pregnancy.
* Comorbidity that makes study participation and completion impossible.

Primary outcomes:
measure: Intracellular magnesium
timeFrame: 8 weeks
Secondary outcomes:
measure: Total serum magnesium
timeFrame: 8 weeks
measure: Ionized serum magnesium
timeFrame: 8 weeks
Other outcomes:
measure: Markers of CKD-MBD (Chronic Kidney Disease - Mineral and Bone Disorder)
timeFrame: 8 weeks
Locations:
city: Roskilde
country: Denmark
facility: Department of Medicine, Division of Nephrology, Roskilde County Hospital
Study officials:
affiliation: Department of Medicine, Division of Nephrology, Roskilde County Hospital
name: Iain B Bressendorff, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06851377: Expanding NGS Data with Optical Genome Mapping (OGM)
Official title: Expanding NGS Data with Optical Genome Mapping (OGM): More Comprehensive Variant Detection in Children with Unexplained Rare Genetic Disorders
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neurodevelopmental Disorder (Diagnosis)
Keywords: Optical Genome Mapping, neurodevelopmental disorders, genome sequencing
Lead sponsor: IRCCS Eugenio Medea
Sponsor class: OTHER
First posted: 2025-02-28
Enrollment: 60
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Over 50% of pediatric neurological and neurodevelopmental disorders lack a molecular diagnosis after standard DNA sequencing and molecular karyotyping. This is due to technical limitations, incomplete variant interpretation, and inadequate genotype-phenotype correlations. New sequencing technologies are crucial for clinical decision-making, offering complete profiles of variants in a patient's DNA to personalize treatment. Optical Genome Mapping (OGM) can detect nearly all structural variants in one experiment. This project aims to use OGM alongside NGS to improve diagnostic yield in 60 children with severe disorders who tested negative for NGS/CMA.


Eligibility criteria: Inclusion Criteria:

* individuals without a molecular diagnosis (negative to ES/CMA analyses);
* individuals with genetic diagnoses that explain only one component of their primary phenotype;
* individuals carrying one or more variants of uncertain clinical significance
* individuals with a phenotype highly reminiscent of clinically and molecularly well-defined syndromes (i.e., Marfan Syndrome) but negative to routine molecular analysis.

Exclusion Criteria:

* individuals who have not undergone initial diagnostic genetic tests (ES/CMA)

Primary outcomes:
measure: Genotype-phenotype correlation
timeFrame: once at recruitment
Secondary outcomes:
Other outcomes:
Locations:
city: Bosisio Parini
country: Italy
facility: Cytogenetic Unit of Medical Genetic Laboratory
state: Lecco
Study officials:
References:
Clinical trial NCT05032677: Dural Puncture Epidural Technique Versus Conventional Epidural Techmique
Official title: Comparative Study Between Dural Puncture Epidural Technique Versus Conventional Epidural Technique During Laparoscopic Hysterectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gynecologic Disease Requiring Laparoscopic Hysterectomy Under Neuraxial Anesthesia
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-09-02
Enrollment: 50
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study will be conducted on 50 patients of ASA grade I and II aged from 25 to 55 years and presented for laparoscopic hysterectomy. Patients will be divided into two equal groups; group A control group for conventional epidural technique(n=25) and group B for 25G dural puncture epidural with 25G pencil point Whitacre spinal needle (n=25). Randomization will be done using computer generated number and concealed using sequentially numbered, sealed opaque envelope.


Eligibility criteria: Inclusion Criteria:

* ASA I and II
* Height(150-170 cm)

Exclusion Criteria:

* patient refusal
* hypersensitivity to local anesthetic drugs
* bleeding disorders and coagulopathy(platelets count less than 80000,INR less than 1.5 or therapeutic dose of anticoagulant).

Primary outcomes:
measure: incidence of bilateral sacral blockade
timeFrame: Up to 30 minutes after local anesthetic injection
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Department of Anesthesia, Surgical ICU, and Pain Management
Study officials:
affiliation: Cairo University
name: Reham Ali Abdelrahman, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00903877: Study of T3 for the Treatment of Fibromyalgia
Official title: T3 for Fibromyalgia: a Pilot Double-blind Non-randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2009-05-19
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Determine if T3 - the active form of thyroid hormone - is beneficial in fibromyalgia. Determine the feasibility and promise of an appropriately powered future prospective randomized controlled study of using T3 (the active form of thyroid hormone) for the treatment of fibromyalgia. We specifically aim to assess the feasibility, cost, obstacles and promise of conducting a prospective controlled study in the future.


Eligibility criteria: Inclusion Criteria:

1. Age 18-50
2. Meet american college of rheumatology criteria for fibromyalgia
3. at baseline report an average pain of 4 or more on a brief Pain Inventory.
4. can climb 2 flights of stairs without shortness of breath.

Exclusion Criteria:

1. new medication change in the last 2 months
2. any cardiac disease at all
3. known thyroid disease before or after thyroid screening bloodwork
4. unstable medical or psychiatric disease.
5. Known inflammatory or rheumatic disease other than fibromyalgia
6. substance abuse in the last year
7. suicidality or depression as indicated by a Beck Depression Inventory of 30 or above
8. concomitant herbal medications
9. multiple severe medication allergies
10. the assessment of the research team that inclusion of the subject could in some way compromise the safety and validity of the study.
11. diabetes
12. smoking
13. Known uncontrolled hypertension
14. known uncontrolled hypercholesterolemia

Primary outcomes:
measure: Visual Analogue Scale of Pain Intensity
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Ian R Carroll
role: PRINCIPAL_INVESTIGATOR
References: