louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00399737: Effects of Peptides Derived From Fermented Milk on Blood Pressure Regulation System in Healthy Volunteers.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy
Keywords: ACE activity
Fermented milk peptides
Healthy male volunteers
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Danone Institute International
First posted: 2006-11-15
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Several milk proteins are precursors of peptides, released during fermentation, which possess various biochemical and physiological properties. Among them, some peptides have been reported to inhibit angiotensin-converting enzyme (ACE) in vitro (an enzyme implicated in blood pressure regulation) and to lower blood pressure (BP). in hypertensive rats and in a small sample of patients with hypertension. One possible mechanism for the BP lowering effect is inhibition of ACE. Prior investigating BP lowering effect of these peptides in a large cohort of hypertensive patients, it is necessary to assess in depth their potency to inhibit ACE in vivo in humans and to compare it to that induced by a well-known ACE inhibitor.


Eligibility criteria: Inclusion Criteria:

* Healthy male volunteers
* aged between 18 and 35 years
* informed written consent

Primary outcomes:
measure: ACE activity
Secondary outcomes:
measure: kinetics/dynamics
Other outcomes:
Locations:
city: Paris
country: France
facility: Clinical Investigation Center 920, Hôpital Européen Georges Pompidou
Study officials:
affiliation: APHP
name: Michel Azizi
role: PRINCIPAL_INVESTIGATOR
References:
citation: FitzGerald RJ, Murray BA, Walsh DJ. Hypotensive peptides from milk proteins. J Nutr. 2004 Apr;134(4):980S-8S. doi: 10.1093/jn/134.4.980S.
Clinical trial NCT01041937: Total Knee Arthroplasty (TKA) Cemented Versus Cementless Tibial Prosthesis Study
Official title: Total Knee Arthroplasty Randomized Clinical Trial- Cemented vs. Cementless Tibial Prosthesis Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Post-traumatic Osteoarthritis
Rheumatoid Arthritis
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Stryker Trauma and Extremities
First posted: 2010-01-05
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary purpose of TKA Randomized Clinical Trial- Cemented versus Cementless Tibial Prosthesis Study will determine whether there is a significant difference in patient-reported and measured clinical outcomes (e.g. pain, function, length of recovery, and patient satisfaction) between subjects treated with a cementless tibial prosthesis (the cementless group) and those treated with cemented tibial prosthesis (the cement group) over the first two postoperative years. Radiographs will be assessed before surgery and at established post-operative intervals to determine if there are any significant differences between patients in the two groups and to assess the influence of component fixation on radiographic stability over time. Complication and revision rates will also be assessed for comparison.


Eligibility criteria: Inclusion Criteria:

* BMI less than \<35
* Normal neurological function
* Primary total knee arthroplasty (Pre operative Medial Knee Patient)
* Patient age ≤ 70 years old

Exclusion Criteria:

* Revision surgery
* History of joint sepsis
* Recent systemic corticosteroids (\< 2 months prior to procedure)
* Primary or secondary carcinoma in the last five years
* Post operative renal transplant
* Psychosocial disorders limiting rehabilitation
* Previous intraarticular knee fracture
* Over 20° valgus or varus deformity
* Extension loss over 20°
* Unsuitable for cruciate- substituting arthroplasty
* Unsuitable for cementless fixation of the tibial component
* Need for augmentation wedges or bone graft
* Previous proximal tibial osteotomy

Primary outcomes:
measure: To use clinical outcome measures to assess for differences in patient function, quality of life and satisfaction between patients who have tibial component placement with either a cemented or a cementless technique
timeFrame: 2014
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: John Clohisy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00888537: Wiser Choices in Acute Myocardial Infarction
Official title: Wiser Choices in Acute Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Myocardial Infarction
Keywords: Decision aid
Heart attack
myocardial infarction
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2009-04-27
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients who are hospitalized because of a heart attack are prescribed a number of medicines to help the heart heal. The investigators will examine different ways in which clinicians share information about those treatment options with patients and the impact that this can have on patients' choices and health.


Eligibility criteria: Inclusion Criteria:

* Between the ages of 18 and 90
* Hospitalized at Saint Marys Hospital
* A primary diagnosis of AMI,
* Have heart rate, blood pressure, troponin and creatinine measurements,
* There is an intention to offer treatment medications
* Are able and willing to provide informed consent

Exclusion Criteria:

* Have not had a myocardial infarction
* Have significant cognitive, visual impairment,
* Non-English speaker
* Have a Do Not Intubate/Do Not Resuscitate (DNI/DNR) status
* Will be discharged to a nursing home
* AMI is not the presumptive diagnosis

Primary outcomes:
measure: Increases adherence to cardiac medications with proven benefits
timeFrame: 6 months
measure: Reduces patients' decisional conflict (increase patient decisional quality)
timeFrame: During hospital stay
measure: Decreases rehospitalization rates and death
timeFrame: 5 weeks and 6 months
measure: Increase patient knowledge of medication to help the heart heal
timeFrame: During hospital stay
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Saint Marys Hospital, Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Henry Ting, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Branda ME, Kunneman M, Meza-Contreras AI, Shah ND, Hess EP, LeBlanc A, Linderbaum JA, Nelson DM, Mc Donah MR, Sanvick C, Van Houten HK, Coylewright M, Dick SR, Ting HH, Montori VM. Shared Decision-Making for Patients Hospitalized with Acute Myocardial Infarction: A Randomized Trial. Patient Prefer Adherence. 2022 Jun 1;16:1395-1404. doi: 10.2147/PPA.S363528. eCollection 2022.
citation: Wyatt KD, Branda ME, Inselman JW, Ting HH, Hess EP, Montori VM, LeBlanc A. Genders of patients and clinicians and their effect on shared decision making: a participant-level meta-analysis. BMC Med Inform Decis Mak. 2014 Sep 2;14:81. doi: 10.1186/1472-6947-14-81.
Clinical trial NCT00965237: Multifocal Contact Lens Use in Previous Contact Lens Wearers With Near Vision Demands
Official title: P/331/09/C: Multifocal Pilot Study: Refitting Drop Outs (GARM)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Presbyopia
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
Collaborators: name: University of Waterloo
First posted: 2009-08-25
Enrollment: 16
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the use of a multifocal contact lens in people who previously wore contact lenses but discontinued due to age-related, near vision demands.


Eligibility criteria: Inclusion Criteria:

* has discontinued contact lens wear primarily due to age-related, near vision demands
* requires a reading add of +0.50 to +1.75 D (inclusive) and is correctable to at least 6/9 monocular, distance and near with spectacle correction
* has had an ocular examination in the last 2 years
* Other protocol-defined inclusion/exclusion criteria may apply

Exclusion Criteria:

* has any ocular disease
* has more than a 2.00D prescription difference between eyes
* cannot be fit successfully with the study contact lenses
* has any systemic disease affecting ocular health
* is using any systemic or topical medications that may affect ocular health
* has undergone corneal refractive surgery
* Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Overall Satisfaction With the Lenses
timeFrame: 1 week of wear
Secondary outcomes:
Other outcomes:
Locations:
city: Waterloo
country: Canada
facility: University of Waterloo Centre for Contact Lens Research
state: Ontario
Study officials:
References:
Clinical trial NCT01078337: T-cell Minimal Residual Disease (MRD) Evaluation Using Flow Cytometric Analysis
Official title: T-cell MRD Evaluation Using Flow Cytometric Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leukemia, Lymphocytic, Acute
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2010-03-02
Enrollment: 15
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children with newly diagnosed T-cell ALL

Brief summary: To determine if MRD (minimal residual disease) can be found in the blood (only) as opposed to bone marrow in children with ALL (acute lymphoblastic leukemia).


Eligibility criteria: Inclusion Criteria:

* Children with newly diagnosed T-cell ALL

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Gary V Dahl
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04561037: Pulsed Electromagnetic Field Therapy for TMJ Dysfunction After Facial Penetrating Injury
Official title: Efficacy of Adding Pulsed Electromagnetic Field Therapy to Mobilization and Exercises in Patients With TMJ Dysfunction After Facial Penetrating Injury: Randomized Single-blinded Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: TMJ Disorder
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2020-09-23
Enrollment: 33
Sex: ALL
Minimum age (years): 22
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is aiming to investigate the effect of magnetic therapy in combination with traditional physical therapy on the pain and mouth opening, after facial penetrating wound injury with no facial fractures, that treated conservatively


Eligibility criteria: Inclusion Criteria:

* TMJ pain and mouth opening limitation after 1 month of facial penetrating wound injury as the wound is fully healed.
* TMJ pain (in 1 or both joints) after facial penetrating wound injury.

Exclusion Criteria:

* Patient excluded from the study if they had one of the following:
* TMJ fracture or dislocation
* Previous TMJ surgeries
* Dental diseases
* Infectious or systemic diseases
* Pregnancy
* Malignancy
* Pacemaker or metal implants
* Systemic diseases that affect joint function such as rheumatoid arthritis.

Primary outcomes:
measure: Change in the Maximum mouth opening in millimeter (mm) before and after intervention.
timeFrame: Change between baseline and 4 weeks of treatment measures.
Secondary outcomes:
measure: Change in TMJ pain measured by Visual Analogue Scale (VAS)
timeFrame: Change between baseline and 4 weeks of treatment measures.
Other outcomes:
Locations:
city: Kafr Ash Shaykh
country: Egypt
facility: Kafrelsheikh University
state: Kafr El Sheikh
Study officials:
affiliation: Kafrelsheikh University
name: Ahmed Kadry, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04965337: Study to Evaluate Safety, Tolerability and Pharmacokinetics of ASC42 in Chinese Healthy Subjects
Official title: A Phase I Randomized, Double-Blind, Placebo-Controlled, Dose Escalation, Single Center Bridging Study to Evaluate Safety, Tolerability and Pharmacokinetics of ASC42 in Chinese Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy Subjects
ASC42
FXR agonist
Lead sponsor: Ascletis Pharma Inc
Sponsor class: INDUSTRY
First posted: 2021-07-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This is a Phase I Randomized, Double-Blind, Placebo-Controlled, Dose Escalation, Single Center Bridging Study to Evaluate Safety, Tolerability and Pharmacokinetics of ASC42 in Chinese Healthy Subjects.


Eligibility criteria: Key Inclusion Criteria:

* Healthy male and female volunteers aged 18-55 years.
* 19kg/m2 ≤ BMI \<24kg/m2.

Key Exclusion Criteria:

* A positive HBsAg, HCV Ab and/or HIV Ab.
* Pancreatic injury or pancreatitis.
* History of organ transplantation, including bone marrow transplantation.

Primary outcomes:
measure: AUC of ASC42
timeFrame: Up to 4 days
measure: Cmax of ASC42
timeFrame: Up to 4 days
Secondary outcomes:
measure: t1/2 of ASC42
timeFrame: Up to 4 days
measure: CL/F of ASC42
timeFrame: Up to 4 days
measure: Vd/F of ASC42
timeFrame: Up to 4 days
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: Up to 7 days
Other outcomes:
Locations:
city: Changsha
country: China
facility: Xiangya Boai Rehabilitation Hospital
state: Hunan
Study officials:
References:
Clinical trial NCT05267015: PRF for Treating Maxillary Gingival Recession
Official title: PRF for Treating Maxillary Gingival Recessions: A Split-mouth, Randomized, Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingival Recession
Keywords: connective tissue graft
PRF membrane
gingival recession
Lead sponsor: Arab American University (Palestine)
Sponsor class: OTHER
First posted: 2022-03-04
Enrollment: 15
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: This is a split-mouth, randomized, controlled clinical trial that aims to evaluate the clinical efficacy of platelet-rich fibrin (PRF) membranes in conjunction with coronally advanced flap (CAF) in treating maxillary gingival recession defects.


Eligibility criteria: Inclusion Criteria:

* Greater than 18 years old
* Bilateral Miller class I + II recession in the upper jaw

Exclusion Criteria:

* Smokers
* Patients with systemic diseases that could interfere with the healing
* Patients undergoing bisphosphonate therap .Patients who previously received radiation therapy of the jaws.

Primary outcomes:
measure: Increase in gingival height (recession coverage)
timeFrame: six weeks
measure: Shrinkage in gingival height
timeFrame: six months
Secondary outcomes:
measure: Postoperative pain visual analog scores (VAS) and surgery time
timeFrame: two weeks
Other outcomes:
Locations:
city: Ramallah
country: Palestinian Territory, occupied
facility: Arab American University
Study officials:
affiliation: Head of Department
name: Mahmoud F Abu-Ta'a, Periodontist
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05567315: Interest of Hypnosis in Virtual Reality on Nociception During Oocyte Retrieval in a Medically Assisted Reproduction Procedure
Official title: Interest of Hypnosis in Virtual Reality on Nociception During Oocyte Retrieval in a Medically Assisted Reproduction Procedure: a Randomised Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oocyte Retrieval
Lead sponsor: Clinique Mutualiste la Sagesse
Sponsor class: OTHER
First posted: 2022-10-05
Enrollment: 182
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-centre, comparative, randomised, parallel group study
Primary purpose: SUPPORTIVE_CARE

Brief summary: Study on the effect of the virtual hypnosis mask in addition to local anaesthesia on anxiety and perioperative pain during oocyte puncture


Eligibility criteria: Inclusion Criteria:

* Patient having an oocyte puncture as part of a medically assisted procreation procedure
* Surgical procedure planned in the operating theatre under local anaesthesia at the Clinique Mutualiste La Sagesse
* Patient capable of receiving and understanding information about the study and giving written informed consent.
* Affiliated to a social security system

Exclusion Criteria:

* Patient's refusal to participate in a study
* Patient having an oocyte retrieval as part of an oocyte donation
* Unbalanced epilepsy.
* Hearing and/or visual impairments that contraindicate the use of the virtual reality headset.
* Patient with a poor understanding of the French language.
* Medical indication to carry out the oocyte puncture under general anaesthesia
* Drug allergy or hypersensitivity to PARACETAMOL - IBUPROFEN or NEFOPAM prescribed during the pre-medication.
* Patient under legal protection

Primary outcomes:
measure: Analgesia Nociception Index (ANI) measurement
timeFrame: during oocyte puncture procedure
Secondary outcomes:
measure: Anxiety with beck anxiety inventory
timeFrame: 1 hour before intervention and immediately after the intervention
measure: Simulator Sickness Questionnaire (SSQ)
timeFrame: Immediately after the intervention
measure: Analog visual scale (AVS)
timeFrame: Immediately after the intervention
measure: Post intervention analgesic therapy
timeFrame: Immediately after the intervention
measure: Total duration of the procedure of oocyte ponction (min)
timeFrame: From the first ponction of local anesthesia to the end of the retrieval of the last oocyte
measure: Conversion rate from local anaesthesia to unplanned general anaesthesia
timeFrame: Immediately after the intervention
measure: Gynecologist's numerical satisfaction scale
timeFrame: Immediately after the intervention
measure: Patient's numerical satisfaction scale
timeFrame: Immediately after the intervention
Other outcomes:
Locations:
city: Rennes
country: France
facility: Clinique mutualiste La Sagesse
state: Bretagne
Study officials:
References:
Clinical trial NCT04022837: Effect of Proton Pump Inhibitor of Daily Use for One Month on Kidney Function Test
Official title: Effect of Proton Pump Inhibitor of Daily Use for One Month on Kidney Function Test
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Proton Pump Inhibitor Allergy
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-07-17
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The aim of this study to:

evaluate the association between prolonged use of PPI and adverse renal outcomes on patients with normal renal function and others with abnormal renal function

Detailed description: Proton pump inhibitors (PPIs) are one of the most widely used classes of drugs and are prescribed primarily for gastric acid-related diseases, eradication of Helicobacter pylori, and prevention of nonsteroidal anti-inflammatory drug (NSAID)-induced gastropathy,and gastroesophagial reflux diseases , Although PPIs have an excellent overall safety profile, some severe adverse effects, which include bone fracture, dementia, myocardial infarction, infections, micronutrient deficiencies, and kidney diseases, PPIs may trigger acute interstitial nephritis,a potentially sever adverse event commonly associated with acute kidney injury. The increase in prescription and inadequate use of this class of medication calls for studies on the effects of prolonged PPI therapy on renal function.

Eligibility criteria: Inclusion Criteria:

* patients with peptic ulcer disease or gastroesophagial reflux with normal l renal function
* patients with peptic ulcer disease or gastroeosophagial reflux with abnormal renal function

Exclusion Criteria:

* 1- cigarette smoker: Cigarette smoking status was defined categorically as current,former, or never smoker at baseline.

  2-biabetic patients: diabetes mellitus is defined by a fasting blood glucose concentration \>_ 126 mg/dl ,random glucose level of \>200 mg 3-patients take corticosteroid 4-patients with hypersensitivity to these drugs

Primary outcomes:
measure: kidney function
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: