louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00645424: A Study To Evaluate The Safety And Efficacy Of Atorvastatin In Patients With Diabetes And High Cholesterol
Official title: A Randomized, 12-Week, Open Labeled Study To Evaluate The Efficacy And Safety Of Once Daily Atorvastatin In Diabetes Mellitus Type 2 With Hyperlipidemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hyperlipidemias
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-03-27
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
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 evaluate the efficacy and safety of atorvastatin for the treatment of Taiwanese patients with diabetes and high cholesterol.


Eligibility criteria: Inclusion Criteria:

* Adult Taiwanese outpatients with type 2 diabetes mellitus and high cholesterol
* Hemoglobin A1c levels of ≤10%, LDL-C levels of ≥130 mg/dL, and serum triglyceride levels of \<400 mg/dL

Exclusion Criteria:

* Type I diabetes mellitus
* Secondary causes of high cholesterol
* Elevated liver enzymes

Primary outcomes:
measure: Percentage change in LDL-C levels from baseline to Week 12
timeFrame: Week 12
measure: Percentage of subjects with low-density lipoprotein cholesterol (LDL-C) levels of <100 mg/dL (LDL-C responders) at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: Percentage change from baseline in TC, high-density lipoprotein cholesterol, triglycerides, and high sensitivity C-reactive protein at Weeks 4, 8, and 12
timeFrame: Weeks 4, 8, and 12
measure: Adverse events at Weeks 4, 8, and 12
timeFrame: Baseline and at Weeks 4, 8, and 12
measure: Clinical laboratory changes at Weeks 4, 8, and 12
timeFrame: Screening and at Weeks 4, 8, and 12
measure: Vital signs at Weeks 4, 8, and 12
timeFrame: Screening and at Weeks 4, 8, and 12
measure: Percentage change in LDL-C levels from baseline at Weeks 4 and 8
timeFrame: Weeks 4 and 8
measure: Percentage of LDL-C responders at Weeks 4 and 8
timeFrame: Weeks 4 and 8
measure: Percentage of subjects with total cholesterol (TC) levels of <160 mg/dL (TC responders) at Weeks 4, 8, and 12
timeFrame: Weeks 4, 8, and 12
Other outcomes:
Locations:
city: Kaohsiung Hsien
country: Taiwan
facility: Pfizer Investigational Site
city: Kaohsiung
country: Taiwan
facility: Pfizer Investigational Site
city: Taichung
country: Taiwan
facility: Pfizer Investigational Site
city: Taipei
country: Taiwan
facility: Pfizer Investigational Site
city: Taoyuan Hsien
country: Taiwan
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02013024: The Effect of Vitrification Versus Slow Freezing on Day 3: a Randomised Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cryopreservation of Embryos
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2013-12-17
Enrollment: 417
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized controlled trial (RCT) testing the hypothesis that vitrification is superior to slow freezing.


Eligibility criteria: Inclusion Criteria:

* Patients (with female age \< 40 years)
* Patients undergoing a 1st oocyte retrieval for an IVF/Intracytoplasmatic Sperm Injection (ICSI) treatment
* Patients planned for an embryo transfer on day 3.
* Patients with supernumerary embryos of sufficient quality for freezing/vitrifying on day 3.
* Fresh personal (own oocytes)
* One inclusion in the study per patient.

Exclusion Criteria:

* Patients undergoing a 2nd or higher ranked oocyte retrieval after a fresh cycle with failed pregnancy.
* Female age ≥ 40 year
* Patients with Preimplantation Genetic Diagnosis (PGD)
* Patients with donor oocytes
* Patients with positive serology whose embryos may not be frozen.
* Patients planned for a transfer on day 2 or day 5.
* Patients receiving assisted hatching in the embryo transfer in the frozen cycles.
* Patients who have been included in the study before.

Primary outcomes:
measure: Life birth rate per embryo thawed
timeFrame: 3 years
Secondary outcomes:
measure: live birth rate per embryo transferred
timeFrame: 3
measure: survival rate
timeFrame: 3 year
measure: implantation rate per embryo transferred
timeFrame: 3 years
measure: implantation rate per embryo thawed
timeFrame: 3 years
measure: abortion rate
timeFrame: 3 years
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Leuven University Fertility Center
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Thomas M D'Hooghe, Prof Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Debrock S, Peeraer K, Fernandez Gallardo E, De Neubourg D, Spiessens C, D'Hooghe TM. Vitrification of cleavage stage day 3 embryos results in higher live birth rates than conventional slow freezing: a RCT. Hum Reprod. 2015 Aug;30(8):1820-30. doi: 10.1093/humrep/dev134. Epub 2015 Jun 18.
Clinical trial NCT05074524: Repetitive Transcranial Magnetic Stimulation to Reduce Heroin Cravings
Official title: Evaluating Repetitive Transcranial Magnetic Stimulation to Reduce Opioid Cravings in Adults Who Use Heroin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid-use Disorder
Heroin Abuse
Craving
Transcranial Magnetic Stimulation
Lead sponsor: University of Nevada, Las Vegas
Sponsor class: OTHER
First posted: 2021-10-12
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to test the effect of repetitive transcranial magnetic stimulation (rTMS) on opioid cravings among adult patients with Opioid Use Disorder.

Detailed description: This study will use rTMS, a neuromagnetic and non-invasive treatment, to reduce opioid cravings in individuals who are diagnosed with opioid use disorder. Repetitive transcranial magnetic stimulation is currently used for the treatment of Major Depressive Disorder and Obsessive Compulsive Disorder in clinical practice. This proposed study will employ a randomized, single-blind, experimental design. Participants will be randomly assigned to two groups using a computer-based randomization program: treatment and sham-control groups.

Eligibility criteria: Inclusion Criteria:

* Adult aged 18-64, used heroin in the past 30 days;
* has a history of heroin use for at least one year;
* meets the clinical criteria for Opioid Use Disorder (only heroin use will be considered to meet this criteria);
* meets the clinician clearance using the rTMS Patient Screening Form.

Exclusion Criteria:

* do not currently take and medications for a substance use disorder such as methadone, buprenorphine, naltrexone, acamprosate, disulfiram;
* do not have a psychotic disorder;
* do not have a diagnosis of another substance use disorder;
* do not have a history of seizures or other neurological disorders including organic brain disease; epilepsy, stroke, brain lesions, multiple sclerosis, previous neurosurgery;
* do not have a personal history of head trauma that resulted in a loss of consciousness for more than 5 minutes and retrograde amnesia for more than 30 minutes;
* do not have a presence of non-fixed metal in body 30 cm to treatment coil.
* have not taken any medication for a substance use disorder within the last 72 hours before the first rTMS treatment;
* are not pregnant or think you may be pregnant.

Primary outcomes:
measure: Desires for Drug Questionnaire
timeFrame: Days 1, 3, 5, 8, 10, 12, 42
Secondary outcomes:
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: University of Nevada, Las Vegas
state: Nevada
Study officials:
References:
Clinical trial NCT03030924: Wearable Suicidal Early Warning System for Adolescents
Official title: Physiologic Parameters for Monitoring Adolescent Suicidality
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Suicide
Adolescent Behavior
Keywords: suicide
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2017-01-25
Enrollment: 250
Sex: ALL
Minimum age (years): 13
Maximum age (years): 19
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adolescents presenting with acute suicidal thoughts or attempts in the pediatric emergency department (13-19 years of age).

Brief summary: This study is prospectively enrolling a cohort of adolescent patients who present to the Emergency Department and an inpatient psychiatric adolescent unit with acute suicidality.

Detailed description: This study is prospectively enrolling a cohort of adolescent patients who present to the Emergency Department with acute suicidality or are admitted to an inpatient psychiatric adolescent unit. The plan is to monitor basic physiologic parameters to assess for trends associated with suicidality noninvasively in an objective manner beyond subjective questionnaires currently available. Upon discharge they will be sent home with a noninvasive monitor to track physiologic parameters.

Eligibility criteria: Inclusion Criteria:

* acute suicidality
* consenting individual present in the emergency department

Exclusion Criteria:

* medical admission for an ingestion or other reason

Primary outcomes:
measure: Heart Rate Variability
timeFrame: 1 week
Secondary outcomes:
measure: Gender
timeFrame: At enrollment
measure: Age
timeFrame: at enrollment
measure: Columbia Suicide Severity Score
timeFrame: 1 week
measure: PHQ-9 Depression Scale
timeFrame: 1 week
measure: Motion
timeFrame: 1 week
Other outcomes:
measure: past Medical History
timeFrame: At enrollment
measure: Medications
timeFrame: At enrollment and daily for one week after discharge
Locations:
city: Portland
country: United States
facility: OHSU
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: David Sheridan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sheridan DC, Lin A. Emergency Department Adolescent Suicidality: A Pilot Study to Determine How Common Actual Attempts Are. Pediatr Emerg Care. 2022 Feb 1;38(2):e458-e461. doi: 10.1097/PEC.0000000000002629.
citation: Sheridan DC, Dehart R, Lin A, Sabbaj M, Baker SD. Heart Rate Variability Analysis: How Much Artifact Can We Remove? Psychiatry Investig. 2020 Sep;17(9):960-965. doi: 10.30773/pi.2020.0168. Epub 2020 Sep 18.
Clinical trial NCT05727124: Poul Gjessing Versus T Loops for Orthodontic Maxillary Canine Retraction
Official title: Evaluation of Poul Gjessing Versus T Loops for Orthodontic Maxillary Canine Retraction: A Randomized Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Canine Retraction
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2023-02-14
Enrollment: 20
Sex: ALL
Minimum age (years): 12
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Poul Gjessing versus T loops for orthodontic maxillary canine

Detailed description: Split mouth study one side using Poul Gjessing spring and other side using T loops

Eligibility criteria: Inclusion Criteria:

* - Class I or II div 1, orthodontic patients, with moderate to severe crowding who are indicated for maxillary first premolar extraction. 2- All permanent teeth are erupted (3rd molars are not included). 3- Good oral and general health. 4- No previous orthodontic treatment.

Exclusion Criteria:

- 1- Orthodontic cases that could be treated with no indication for extraction therapy.

2- Orthodontic cases that are indicate for the extraction of any tooth other than maxillary first premolars. 3- Patients with systemic diseases that might interfere with the of orthodontic tooth movement.

Primary outcomes:
measure: rate of canine retraction distance
timeFrame: six months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Alazhar university
Study officials:
References:
Clinical trial NCT00403624: Evaluation of the Neoadjuvant Treatment With Oxaliplatin -UFT- Radiotherapy in Rectal Cancer
Official title: Clinical Study to Evaluate a Protocol of Oxaliplatin -UFT- Radiotherapy for the Neoadjuvant Treatment Rectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Rectal Neoplasms
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-11-27
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Primary objective:

- To evaluate the rate of responses to neoadjuvant therapy + radiotherapy

Secondary objective:

- tolerability (toxicity) and time to progression


Eligibility criteria: The following information on clinical trials is provided for information purposes only to allow patients and physicians to have an initial discussion about the trial. This information is not intended to be complete information about the trial, to contain all considerations that may be relevant to potential participation in the trial, or to replace the advice of a personal physician or health professional.

Main criteria are listed hereafter:

Inclusion Criteria:

* Patients with measurable, histologically proven rectal cancer.
* No history of previous malignancy but adequately treated skin / cervical cancer.
* Adequate haematological, renal and liver function.

Exclusion Criteria:

* No cardiopulmonary insufficiency or coronary disease. No sensory neuropathy prior to study.

Primary outcomes:
measure: Tumour response
Secondary outcomes:
measure: Disease free and Overall survival ; Adverse events
Other outcomes:
Locations:
Study officials:
affiliation: Sanofi
name: José Mª Taboada, Dr.
role: STUDY_DIRECTOR
References:
Clinical trial NCT06535724: Endoscopic Debridement of Chronic Plantar Fasciitis
Official title: Endoscopic Debridement of Chronic Plantar Fasciitis With Heel Spur Resection: a Novel Technique With Promising Outcomes - a Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fasciitis, Plantar
Fasciitis, Plantar, Chronic
Heel Spur
Lead sponsor: Rehasport Clinic
Sponsor class: OTHER
First posted: 2024-08-02
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the study was to prospectively evaluate the results of endoscopic treatment of chronic plantar fasciitis with resection of the heel spur. Treatment was assessed based on the results of clinical examinations and functional assessment as well as X-ray examination.

Detailed description: Hypothesis: Conducting research on a group of patients will prove that the use of endoscopic technique with heel spur resection for the treatment of chronic plantar fasciitis will improve the functional results of the foot.

Methods: Patients diagnosed with chronic plantar fasciitis will undergo surgical treatment. An inspection is planned before and after 3, 6, 12, 24 and 60 months. During the check-up, the patient will undergo an X-ray examination, medical and physiotherapeutic assessment.

Study plan:

Participation in the research involves arriving at the Rehasport Clinic in Poznań on the dates set by the Chief Investigator (3, 6, 12, 24 and 60 months after the surgical treatment). During the visit, members of the research team ask participants to complete a set of questionnaires, perform a medical examination with a physiotherapeutic assessment described in detail below, and an X-ray examination. The entire examination will last approximately 3 hours.

1. During all visits to Rehasport Clinic, the participant will be asked to complete the surveys ACFAS ankle and foot assessment scale.
2. During the same visits, research team members perform the following tests and examinations:

   1. medical examination - aimed at assessing current ailments and range of motion,
   2. X-ray examination of the foot.

Eligibility criteria: Inclusion Criteria:

* symptoms of chronic plantar fasciitis that have persisted for at least 6 months. despite previous conservative treatment, including corticosteroid injections, autologous PRP injections, physiotherapy, use of orthoses and NSAIDs,
* age ≥ 18 years,
* written consent to participate in the study

Exclusion Criteria:

* previous foot surgery,
* advanced diabetes impeding healing,
* significant obesity,
* contraindications to anesthesia

Primary outcomes:
measure: American Orthopedic Foot and Ankle Society (AOFAS) AnkleHindfoot Scale
timeFrame: 3 months - 60 months after the treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: tomasz.piontek@rehasport.pl
name: Tomasz Piontek, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05409924: First-in-human Single and Multiple Dose Trial of ATR-258
Official title: The ATTRACTIVE 1 Trial - a First-in-human Phase I, Dose Escalating, Double-blind, Placebo-controlled, Single and Multiple Dose Trial of ATR-258 in Healthy Participants and Participants With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Atrogi AB
Sponsor class: INDUSTRY
Collaborators: name: Key2Compliance
name: CRS Clinical Research Services Mannheim GmbH
First posted: 2022-06-08
Enrollment: 71
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is a single-site, randomized, double-blinded, placebo-controlled, First-in-Human trial, conducted in 3 parts.


Eligibility criteria: Inclusion Criteria Phase A and B:

* Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent.
* Body mass index (BMI) within the range 18.5 - 29.9 kg/m2 (inclusive) at screening.
* Male

Inclusion Criteria Phase C:

* Participant must be 30 to 75 years of age inclusive, at the time of signing the informed consent.
* BMI within the range 25.0 to 45.0 kg/m2 and body weight from 80 to 160 kg (inclusive) at screening.
* Male

Exclusion Criteria Phase C:

* Type 1 diabetes mellitus (T1DM) or ketosis-prone T2D based on diagnosis

Primary outcomes:
measure: Safety analyses after single dose of ATR-258
timeFrame: maximum 7 days post dosing
measure: Safety analyses after multiple doses of ATR-258
timeFrame: maximum 56 days post dosing
Secondary outcomes:
measure: PK analyses will be performed after PK of ATR-258 single dose
timeFrame: maximum 7 days post dosing
measure: PK analyses will be performed after PK of ATR-258 single dose
timeFrame: maximum 7 days post dosing
measure: PK analyses will be performed after PK of ATR-258 single dose
timeFrame: maximum 7 days post dosing
measure: PK analyses will be performed after PK of ATR-258 multiple dose
timeFrame: maximum 56 days post dosing
measure: PK analyses will be performed after PK of ATR-258 multiple dose
timeFrame: maximum 56 days post dosing
measure: PK analyses will be performed after PK of ATR-258 multiple dose
timeFrame: maximum 56 days post dosing
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: CRS Clinical Research Services
Study officials:
References:
Clinical trial NCT02861924: Locally Applied Pressure-induced Vasodilatation
Official title: Réponse à l'Application d'Une Pression Locale en Laser Speckle Imaging Locally Applied Pressure-induced Vasodilatation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vascular Diseases
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2016-08-10
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Measure microcirculatory responses after localized ischemia obtained by local application of pressure (laser speckle).

Detailed description: Measure microcirculatory responses after localized ischemia obtained by local application of pressure (laser speckle). The purpose of this study is to perform measurements of the methodological points made.

The study will investigate :

* The effect of the duration and intensity of the pressure
* The reproducibility of measurements
* The correlation with ischemic hyperemia post

Eligibility criteria: Inclusion Criteria:

* subjects without vascular pathology

Exclusion Criteria:

* pregnancy
* allergy tape

Primary outcomes:
measure: microcirculatory response to local pressure. Measurements are made with the Imager SPECKLE imager (LSCI) give the microvascular perfusion data in arbitrary units called perfusion units (UP).
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
Study officials:
affiliation: UH ANGERS
name: Pierre ABRAHAM, professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Henni S, Hersant J, Loufrani L, Duval G, Humeau-Heurtier A; SIMS Group; Riou J, Abraham P; SOCOS Group. Painless local pressure application to test microvascular reactivity to ischemia. Microvasc Res. 2019 Mar;122:13-21. doi: 10.1016/j.mvr.2018.10.013. Epub 2018 Nov 3.