louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02366377: The PK/PD, Efficacy, Safety and Tolerability Study of SHR3824 in Combination With Metformin in Type 2 Diabetes Mellitus Patients
Official title: An Efficacy, Safety, and Tolerability Study of SHR3824 in the Treatment of Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Monotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-02-19
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
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 3 different doses of SHR3824 compared with placebo in patients with type 2 diabetes mellitus who are receiving treatment with metformin monotherapy (ie, treatment with a single drug) and have inadequate glycemic (blood sugar) control.


Eligibility criteria: Inclusion Criteria:

* Patients must have a diagnosis of type 2 diabetes mellitus;
* Hemoglobin A1c levels \>=7.5% and \<=10.5%;
* Body mass index (BMI) 25 to 45 kg/m2;
* Patient either has been treated with metformin for more than 8 weeks with dose more than 1500mg/day.

Exclusion Criteria:

* Type I diabetes mellitus, diabetes mellitus resulting from pancreatic disorder, or secondary diabetes mellitus (acromegaly, Cushing's syndrome, etc.);
* Past or current history of severe diabetic complications (proliferative diabetic retinopathy, stage III or later stage overt nephropathy, diabetic ketoacidosis, or serious diabetic neuropathy);
* Systolic blood pressure of ≥160 mmHg or diastolic blood pressure of ≥100 mmHg on the start or end day of the run-in period;
* History of myocardial infarction, unstable angina, or cerebrovascular disorder within 6 months before the start of the run-in period;
* Past or current history of malignant tumor;
* Past or current history of drug hypersensitivity such as shock and anaphylactoid symptoms;
* Pregnant women, lactating mothers, or women of childbearing potential;
* Any condition that subjects are assessed to be ineligible by the investigator (sub investigator).

Primary outcomes:
measure: Adjusted Mean Change in HbA1c Levels
timeFrame: Baseline to Week 12
measure: The number of volunteers with adverse events as a measure of safety and tolerability
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: Adjusted Mean Change in Fasting Plasma Glucose
timeFrame: Baseline to Week 12
measure: Proportion of Participants Achieving Glycemic Response Defined as HbA1c <7%
timeFrame: Baseline to Week 12
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01015677: A Study of MK-6913 for the Treatment of Hot Flashes in Postmenopausal Women (6913-004)
Official title: A Phase IIa, Randomized, Double-Blind, Placebo- and Active-Controlled Study to Examine MK-6913 for the Treatment of Vasomotor Symptoms in Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Moderate to Severe Vasomotor Symptoms in Postmenopausal
Women
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-11-18
Enrollment: 99
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess the safety, tolerability, and efficacy of MK-6913 for the treatment of moderate-to-very-severe vasomotor symptoms (hot flashes or hot flushes) in postmenopausal women. The primary study hypothesis is that one or more doses of MK-6913 will result in a significantly greater reduction from baseline, compared to placebo, in the number of moderate to very severe hot flashes after 4 weeks of treatment.


Eligibility criteria: Inclusion Criteria:

* Woman with at least 50 moderate to very severe hot flash episodes per week
* Postmenopausal
* Between 45 and 60 years of age if naturally menopausal, or between 35 and 60 if she underwent a bilateral oophorectomy
* Not receiving hormone therapy
* Has had both a normal mammogram and a normal Pap test in the past 6 months
* Generally healthy

Exclusion Criteria:

* A history of cancer, except for certain skin cancers
* Undiagnosed vaginal bleeding or any uterine endometrial disorder
* Currently uses tobacco products, or has used them in the last 6 months
* Has human immunodeficiency virus (HIV)

Primary outcomes:
measure: Percent Change From Baseline in the Number of Weekly Moderate to Very Severe Hot Flashes (Excluding Outliers) at Week 4
timeFrame: Baseline and Week 4
measure: Number of Participants Who Experienced at Least One or More Adverse Events (AE)
timeFrame: Up to 6 weeks
measure: Number of Participants Who Discontinued Study Drug Due to an AE
timeFrame: Up to 4 weeks
Secondary outcomes:
measure: Percent Change From Baseline in the Weekly Hot Flash Severity Score (Combining Severe and Very Severe Score) at Week 4
timeFrame: Baseline and Week 4
measure: Change From Baseline in Follicle-stimulating Hormone (FSH) Level at Week 4
timeFrame: Baseline and Week 4
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT04703777: Relationship Between Social Status and Use of Healthcare Services During the Confinement Period Linked to the COVID-19 Epidemic
Official title: Retrospective Study on the Relationship Between Social Status and Use of Healthcare Services During the Confinement Period Linked to the COVID-19 Epidemic in Bas-Rhin, France
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid-19
Keywords: COVID-19
Coronavirus
Sars-cov-2
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2021-01-11
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patient suspected of covid-19

Brief summary: Epidemics have always affected the most disadvantaged social categories more intensely. This social inequality is expressed in the use of care and emergencies: greater frequency but also greater seriousness. Our hypothesis is that, during a period of confinement, the most disadvantaged populations are more affected by the COVID-19 infection than the rest of the population. The number of remedies is greater, as is the severity of the forms of infection.


Eligibility criteria: Inclusion Criteria:

* Male or female aged 18 or over
* Calling center 15 from March 17 at noon and until the end of the confinement period (May 31, 2020) for one of the following reasons that may be related to COVID-19: cough, fever, rhinitis, diarrhea, pain thoracic, odynophagia, diarrhea, anosmia, ageusia, whose calling address belongs to Bas-Rhin Or
* Supported (consultation or hospitalization) at the HUS for a COVID-19 infection and included in the COVID-HUS base and residing in the Bas-Rhin.

Exclusion Criteria:

* Patient under the protection of justice
* Patient under guardianship, curatorship
* Patient taken care of at the screening center

Primary outcomes:
measure: Retrospective study on the relationship between social status and use of healthcare services during the confinement period linked to the COVID-19 epidemic in Bas-Rhin, France
timeFrame: Files analysed retrospectily from March 17, 2020 to May 31, 2020 will be examined]
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Adult Emergency Department - Strasbourg University Hospitals
Study officials:
affiliation: Adult Emergency Department - Strasbourg University Hospitals
name: Mathieu OBERLIN
role: STUDY_DIRECTOR
References:
Clinical trial NCT06220877: Efficacy of Buccal Pad of Fat, Advanced Platelet Rich Fibrin, Fibrin Glue and Oxidized Cellulose Plug in Management of Oro-Antral Communication, Comparative Clinical Study
Official title: Efficacy of Buccal Pad of Fat, Advanced Platelet Rich Fibrin, Fibrin Glue and Oxidized Cellulose Plug in Management of Oro-Antral Communication, Comparative Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers Only
Keywords: Benacel;
bone regeneration;
platelet rich growth factor;
Oro-Antral Communication
buccal pad of fat
fibrin glue
Lead sponsor: October 6 University
Sponsor class: OTHER
First posted: 2024-01-24
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluation of the efficacy of different treatment protocols in the management of Oro-Antral Communications.

Detailed description: the current study was carried on 24 patients suffering from Oro-Antral Communications. All patients were divided into 4 equal groups.

Eligibility criteria: Inclusion Criteria:

* patients suffering from oroantral communications
* patients suffering from oroantral fistula.
* The Diameter of the opening ranged from 4-9 mm,
* communication resulted from recent extraction,
* foreign body; or
* cyst enucleation

Exclusion Criteria:

Patients suffering from any systemic diseases were excluded from the study.

* diabetes,
* autoimmune diseases,
* cancers,
* nephropathy,
* coagulation disorders

Primary outcomes:
measure: o Recurrence
timeFrame: 6 months
Secondary outcomes:
measure: pain, visual analog scale
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: October 6U
Study officials:
References:
Clinical trial NCT05327777: Toward Zero Prescribed Opioids for Outpatient General Surgery
Official title: Toward Zero Prescribed Opioids for Outpatient General Surgery Procedures: a Prospective Cohort Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Opioid Misuse and Addiction
Pain
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2022-04-14
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Control group, opioid sparing arm, and zero opioid arm
Primary purpose: PREVENTION

Brief summary: Investigators have created an opioid reduction "package" which includes patient education, non-narcotic pain control instructions, and limited (or no) opioid pain prescriptions provided at discharge in an attempt to reduce the number of opioid consumption after outpatient general surgery.

Detailed description: Between November 2019 and July 2021, patients undergoing elective inguinal hernia repair (IHR) or cholecystectomy were enrolled in the study. Patients were divided into three cohorts: Control, opioid sparing (OS), or zero-opioid (ZO). Control patients did not have any intervention; OS patients had an opioid reduction intervention protocol applied (patient education and perioperative multimodal analgesia) and were provided an opioid prescription at discharge; the ZO had the same protocol, however patients were not provided opioid prescriptions at discharge. Two weeks after discharge patients were interviewed to record opioid consumption, pain scores, and level of satisfaction since discharge.

Eligibility criteria: Inclusion Criteria:

* Opioid naïve patients
* Age \> 18
* Being scheduled for an outpatient elective inguinal hernia repair or cholecystectomy

Exclusion Criteria:

* Urgent/emergent status
* Previous cholecystostomy tube placement

Primary outcomes:
measure: Morphine Milligram Equivalents Taken by Participants
timeFrame: 14 days
Secondary outcomes:
measure: Satisfaction Scores Ranging From 1 - 10
timeFrame: 14 days
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: Francesco Palazzo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00117247: A Study of Repeat-Dose Subcutaneous Darbepoetin Alfa in Subjects With Congestive Heart Failure and Anemia, and a Single Dose in Healthy Age- and Sex-Matched Control Subjects
Official title: A Study to Assess the Pharmacokinetics and Pharmacodynamics of Repeat-Sose Subcutaneous Darbepoetin Alfa in Subjects With Congestive Heart Failure and Anemia, and a Single Dose in Healthy Age- and Sex-Matched Control Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Anemia
Congestive Heart Failure
Keywords: Heart Failure
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2005-07-06
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 purpose of this study is to evaluate the single dose pharmacokinetics (PK) of subcutaneous (SC) darbepoetin alfa in subjects with congestive heart failure (CHF) and anemia.


Eligibility criteria: Inclusion Criteria: - Symptomatic CHF despite optimized therapy for at least the previous 3 months (treatment included a diuretic, angiotensin converting enzyme \[ACE\] inhibitor, and/or an A2 antagonist, unless not tolerated) - Hemoglobin greater than or equal to 12.5 g/dL at the time of screening

Primary outcomes:
measure: Pharmacokinetic profiling of Aranesp® in HF pts
Secondary outcomes:
measure: Pharmacodynamic responses (hgb) following Aranesp® administration in HF patients
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04461847: ESM Versus OM ：A Randomized Controlled Trial
Official title: A Randomized Controlled Trial of Endoscopic Subcutaneous Mastectomy Versus Open Mastectomy in Early Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Endoscopic Subcutaneous Mastectomy
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2020-07-08
Enrollment: 287
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The consideration of quality of life issues has led to the development of alternative surgeries for breast cancer patients, particularly in the case of localized disease. Nipple-sparing subcutaneous mastectomy (SM), for example, was designed to preserve the nipple-areola complex which facilitates breast reconstruction. However, SM still leaves behind a conspicuous scar.There have already been some observation study show that endoscopic subcutaneous mastectomy(ESM) can improve the cosmesis outcomes and at the same time as safe as the traditional SM.However there is no RCT in this field.That is why the investigators design this study.


Eligibility criteria: Inclusion Criteria:

1. Diagnosis of stages I or II ductal carcinoma
2. The distance from the tumor to the edge of the papilla is more than 3cm, the tumor volume is less than 3cm, the axillary lymph nodes have no obvious fusion and no adhesion with the axillary vein and brachial plexus
3. Age from 18\~70
4. ECOG scores 0\~2
5. Normal function of liver, kidney and bone marrow

Exclusion Criteria:

1. Through physical examination and MRI, it was confirmed that the tumor did not invade the skin, but was confined to the gland and did not invade the surface of the gland.
2. There are serious medical diseases
3. Pregnant or lactating women women of childbearing age -

Primary outcomes:
measure: local recurrence rate
timeFrame: 12 months after operation
Secondary outcomes:
measure: Distant metastasis
timeFrame: 12 months after operation
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital
state: Beijing
Study officials:
References:
citation: Wang ZH, Ding G, Wu S, Song JN, Ge ZC, Zhang H, Yuan Z, Gao YG, Gang TR, Zhang Z, Qu X. Oncological outcome of single-port insufflation endoscopic nipple-sparing mastectomy versus open mastectomy in early breast cancer patients: a study protocol for a randomised controlled trial. BMJ Open. 2022 May 2;12(5):e047866. doi: 10.1136/bmjopen-2020-047866.
Clinical trial NCT03421847: Study of Rotatory Vestibular Tests in Major Depression Patients and Healthy Control Subjects.
Official title: Study of Rotatory Vestibular Tests in Major Depression Patients and Healthy Control Subjects.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depression
Vestibular Disorder
Keywords: depression
vestibular disorder
rotatory test
electronystagmography
Lead sponsor: Vest Brain,Centro de Estudios Neurovestibulares
Sponsor class: OTHER
Collaborators: name: Centro de Medicina Aeroespacial.
First posted: 2018-02-05
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Depression Group patients were selected by psychiatrists from the ambulatory Mental Health consult of the Hospital; the Control Group included 20 healthy volunteers, composed by desk workers from the center.

Brief summary: This study evaluates the vestibular activity in major depression patients and healthy controls using the rotatory test and electronystagmography.

Detailed description: Previous studies showed abnormal vestibular activity in major depression patients using caloric vestibular tests. The present study investigates the vestibular response to vestibular rotatory tests in major depression subjects and healthy controls.

Eligibility criteria: Inclusion Criteria:

* male and females adults (18 years or older)
* met the Diagnosing and Statistical Manual of Mental Disorders (DSM-IV-R, American Psychiatric Association, 2000) criterion.
* had a score of 12 or more in the Hamilton Rating Scale, 21 items for Depression.
* with or without actual pharmacological treatment, except benzodiazepines that were suspended 24 hours before the rotary test when corresponding.

Exclusion Criteria:

* pregnant women
* neurologic disorders.

Primary outcomes:
measure: Vestibular Activity
timeFrame: Vestibular rotatory test for each participant is about 50- 60 minutes. One rotatory test per participant.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01256047: Effects of Preoperative Immunonutrition in Patients Undergoing Hepatectomy
Official title: Effects of Preoperative Immunonutrition on Infectious Complication and Th1/Th2 Differentiation in Patients Undergoing Hepatectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bile Duct Cancer
Keywords: immunonutrition
hepatectomy
Th1
Th2
Lead sponsor: Chiba University
Sponsor class: OTHER
First posted: 2010-12-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether preoperative immunonutrition is effective on infectious complication and Th1/Th2 differentiation in patients with major hepatectomy.

Detailed description: The investigators reported that preoperative immunonutrition improve the incidence of postoperative infectious complication in patients after hepatectomy, and modulation of Th1/Th2 differentiation may play important roles in this effect.

Object of this study is to investigate the effects of preoperative immunonutrition on incidence of postoperative infectious complication, and Th1/Th2 balance after hepatectomy.

Eligibility criteria: Inclusion Criteria:

* hepatectomy

Exclusion Criteria:

* age younger than 18 years
* ongoing infection
* gastrointestinal obstruction
* respiratory dysfunction
* cardiac dysfunction
* hepatic dysfunction
* renal failure
* history of recent immunosuppressive or immunological disease
* preoperative evidence of widespread metastatic disease

Primary outcomes:
measure: postoperative infectious complication
timeFrame: 30 days
Secondary outcomes:
measure: plasma IL-6, CRP, Th1/Th2 balance
timeFrame: 14 days
Other outcomes:
Locations:
city: Chiba
country: Japan
facility: Chiba University
Study officials:
affiliation: Chiba University
name: Katsunori Furukawa, MD
role: STUDY_DIRECTOR
References:
citation: Uno H, Furukawa K, Suzuki D, Shimizu H, Ohtsuka M, Kato A, Yoshitomi H, Miyazaki M. Immunonutrition suppresses acute inflammatory responses through modulation of resolvin E1 in patients undergoing major hepatobiliary resection. Surgery. 2016 Jul;160(1):228-236. doi: 10.1016/j.surg.2016.01.019. Epub 2016 Mar 8.
Clinical trial NCT01089647: Montelukast and Inhaled Nasal Steroid Tx in Adult Obstructive Sleep Apnea (OSA)
Official title: Montelukast and Nasa ICS for Treatment of Mild Obstructive Sleep Apnea in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Obstructive Sleep Apnea
Keywords: OSA
Medical treatment
Lead sponsor: Romaker & Associates
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2010-03-18
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In children with mild apnea combined therapy with an inhaled nasal steroid and a medication that decreased nasal congestion (montelukast) was shown to be effective. We are testing to see if this combination works in adults with mild apnea as well.

Detailed description: 40 adults with mild OSA (\< 5 apneas/hypopneas per hour of sleep) will receive either a combination of two medicines that decrease nasal congestion-montelukast and nasal budesonide-or a placebo pill and nasal spray. After 3 months of therapy, a repeat sleep study will be done to determine the differences, if any, in the frequency of sleep disordered breathing in the two groups.

Eligibility criteria: Inclusion Criteria:

* age 18 - 100 years
* RDI between 5 - 15
* all races
* both sexes

Exclusion Criteria:

* craniofacial, syndromic, neurological abnormalities
* current or previous use of Singular, Rhinocort within last 6 months
* acute upper respiratory infections
* recent nasal trauma, nasal surgery, nasal septum perforation
* known immunodeficiency or under going immunosuppressant therapy
* current therapy with drugs that interact with Montelukast or Budesonide

Primary outcomes:
measure: Number of Participants With a Decrease in the Number of Apnea and/or Hypopnea Events to <5 Per Hour of Sleep
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Romaker & Associates
state: Missouri
city: Kansas City
country: United States
facility: Romaker & Assoc
state: Missouri
Study officials:
affiliation: Romaker & Associates
name: Ann Romaker, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Smith DF, Sarber KM, Spiceland CP, Ishman SL, Augelli DM, Romaker AM. Effects of Medical Therapy on Mild Obstructive Sleep Apnea in Adult Patients. J Clin Sleep Med. 2019 Jul 15;15(7):979-983. doi: 10.5664/jcsm.7876.