louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02143375: Gingival Depigmentation by Diode Laser
Official title: Efficacy of810 nm Diode Laser on Gingival Pigmentation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Laser-induced Hypopigmentation
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2014-05-21
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Physiologic gingival pigmentation(PGP) is the most common type of gingival pigmentation and cosmetic concern particularly in gummy smile patients. Laser therapy is an effective and noninvasive treatment option. The aim of this study was to evaluate the efficacy of diod laser on the treatment of PGP in patients.

Detailed description: Preoperative and postoperative photographic and clinical observations about the gingival melanin pigmentation were made according to Dummett-Gupta Oral Pigmentation Index scoring criteria given by Dummett C.O. in 1964 The investigators classified pigmented gingiva in patients as:

1. Mild:Pink to slightly brown
2. Moderate:Deep brown or black
3. Severe:Mixed in color Score in each tooth was taken including one full inter dental papilla. Observations were made in natural light. The assessment of the scoring of the pigmentation index were done by all the three examiners, and the agreed upon score was assigned to prevent individual variations.

The investigators compared the intensity of pigmentation in each patient in recall sessions after 1month and 3mounth postoperative.

Eligibility criteria: Inclusion Criteria:

* 19 adult patients who had been referred to oral medicine department of Shahid Beheshti dental school with the chief complaint of melanin pigmentation were selected for inclusion in this study.

Exclusion Criteria:

1. Hyperpigmentation that was associated with systemic disease or drug administration,disease that could compromise wound healing (uncontrolled diabetes, autoimmune disease)
2. Pregnancy or lactation
3. Evidence of relationship between hyperpigmentation and malignancy
4. History of previous treatment of hyperpigmentation
5. Smoking
6. Periodontal problems

Primary outcomes:
measure: improvement of gingival pigmentation
timeFrame: 1 month
Secondary outcomes:
measure: changes in pigmentation based on standard digital photographs and index of Dummett et al.
timeFrame: 3month
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Shahid Beheshti medical university,Dental Faculty
Study officials:
affiliation: Associate Professor of Oral Medicine Department ,Shahid Beheshti Medical University
name: Mahin Bakhshi, DDS.MS
role: STUDY_CHAIR
References:
Clinical trial NCT05263375: TVMR With the Innovalve System Trial - TWIST-BE TWIST-PILOT-BE
Official title: TVMR With the Innovalve System Trial - Pilot Study in Belgium
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Mitral Valve Regurgitation (Degenerative or Functional)
Lead sponsor: Innovalve Bio Medical Ltd.
Sponsor class: INDUSTRY
First posted: 2022-03-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Study to evaluate the safety and performance of the Innovalve mitral valve replacement system


Eligibility criteria: Inclusion Criteria:

* Clinically significant, symptomatic mitral regurgitation
* High risk for open-heart surgery
* Meets anatomical criteria

Exclusion Criteria:

* Unsuitable anatomy
* Patient is inoperable
* EF \<30%

Primary outcomes:
measure: Number of patients with implant or delivery related serious adverse events at 30 days
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04406675: Social Cognition in Patients With Amyotrophic Lateral Sclerosis
Official title: Social Cognition in Patients With Amyotrophic Lateral Sclerosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Social Cognition
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2020-05-28
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Amyotrophic Lateral Sclerosis, also known as Charcot disease, is a neurodegenerative disease evidenced by gradual paralysis of the muscles involved in voluntary motor function. The clinical hallmark of Amyotrophic Lateral Sclerosis is the combination of upper and lower motor neuron signs and symptoms. The most recent studies suggest that up to 50% of Amyotrophic Lateral Sclerosis patients demonstrate mild to moderate cognitive disturbance. Impaired social cognition, including a deficit in the recognition of facial emotions and the identification of vocal prosody, is recognized as a part of the cognitive phenotype of Amyotrophic Lateral Sclerosis, with crucial implications for patients' and caregivers' training. However, studies remain scarce and the data acquired must be supported. The evolution of these manifestations during the disease is still poorly understood.

In this study the investigators aim to assess the social cognition capacities of patients with Amyotrophic Lateral Sclerosis compared to healthy matched control subjects.


Eligibility criteria: Inclusion Criteria:

Patient Amyotrophic Lateral Sclerosis :

* Education of at least 7 years
* Native language: French
* Patients Amyotrophic Lateral Sclerosis
* Signature of informed consent to participate in the study
* Accompanied patient

Control subject :

* People without any pathology
* Education of at least 7 years
* Native language: French
* Signature of informed consent to participate in the study

Exclusion Criteria:

Patient Amyotrophic Lateral Sclerosis and control subject :

* Simultaneous participation in another interventional protocol with experimental treatment
* Inability to perform cognitive study tests
* Pregnant, lactating or parturient women
* Persons deprived of their liberty by administrative or judicial decision
* Persons under psychiatric care under duress
* Persons subject to legal protection measures
* Persons out of state to express their consent
* People not affiliated or not beneficiaries of a social security scheme
* History likely to disturb cognition

Primary outcomes:
measure: Evaluate the social cognition capacities
timeFrame: One day
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
Study officials:
References:
Clinical trial NCT05683275: Short and Long Term Effects of IASTM and ESWT Therapy in Individuals With Lateral Epicondylitis
Official title: Short and Long Term Effects of Instrument Assisted Soft Tissue Mobilization and Extracorporeal Shock Wave Therapy in Individuals With Lateral Epicondylitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lateral Epicondylitis
Keywords: Lateral epicondylitis
pain
function
grip strength
Lead sponsor: KTO Karatay University
Sponsor class: OTHER
First posted: 2023-01-13
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pain, decreased grip strength, and loss of function are observed in individuals with lateral epicondylitis. The aim of this study is to investigate the effects of ESWT and IASTM applications on pain, grip strength and function in individuals with lateral epicondylitis.

Detailed description: The study will be carried out on volunteers after the approval of the ethics committee. Before the research, individuals and / or their relatives will be informed about the purpose and content of the study. Participants will be randomly divided into three groups: IASTM, ESWT and home exercise group. In addition to home exercise, IASTM and ESWT groups will be given 2 sessions per week for 4 weeks. Pain, grip strength and functionality of the participants will be evaluated before the application, after 4 weeks of application and 4 weeks after the end of the application.

Eligibility criteria: Inclusion Criteria:

* being diagnosed with chronic LET by a physician
* visual analog scale (VAS) pain score ≥ 3

Exclusion Criteria:

* any accompanying pathology in the wrist and forearm, such as a fracture or dislocation of the elbow;
* treatment with corticosteroid injections in the past 6 months

Primary outcomes:
measure: Change from Baseline Pain assessed by Visual Analog Scale.
timeFrame: Baseline, 4 weeks
Secondary outcomes:
measure: Grip strength
timeFrame: Baseline, 4 weeks
measure: Function assessed by Patient-rated Forearm Evaluation Questionnaire
timeFrame: Baseline, 4 weeks
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: KTO Karatay University
state: Karatay
Study officials:
References:
Clinical trial NCT03530475: Diagnostic Accuracy of Doppler Ultrasound and Role of Uterine Artery Doppler
Official title: Diagnostic Accuracy of Doppler Ultrasound and Role of Uterine Artery Doppler in Cases of Placenta Accreta
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Placenta Accreta
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2018-05-21
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study will be conducted on (100) pregnant women diagnosed as placenta previa by ultrasonography and are candidates for either emergency or elective repeated cesarean section or hysterectomy (if the diagnosis of placenta accreta is confirmed).

All of those patients are presenting during the period of may 2018 to july 2018 to Kasr-Al Ainy Obstetrics outpatient clinic or casualty department during their 3rd trimester.

All of them will be assorted according to certain inclusion and exclusion criterions as follow:

Detailed description: This study will be conducted on (100) pregnant women diagnosed as placenta previa by ultrasonography and are candidates for either emergency or elective repeated cesarean section or hysterectomy (if the diagnosis of placenta accreta is confirmed).

Those patients are attending to Kasr-Al Ainy Obstetrics outpatient clinic or casualty department during their 3rd trimester.

Ultrasound and doppler will be done to all patients to diagnose placenta accreta . The diagnosis will be confirmed by intraoperative assessments and histopathological examination of the uterus after cesarean hysterectomy

Eligibility criteria: Criteria:Inclusion Criteria

* Gestational age more than 28 weeks
* Single living fetus.
* One or more cesarean section or hysterotomy.
* Placenta previa (all grades) with high possibility of morbidly adherent placenta accreta (all types).

Exclusion Criteria:

* Maternal chronic medical disorder (diabetes mellitus or hypertension).
* Pregnancy induced disorders (pre-eclampsia or gestational diabetes).
* Associated fetal anomalies.

Primary outcomes:
measure: accuracy of ultrasound and doppler in detecting placenta accreta
timeFrame: 3 moths
Secondary outcomes:
measure: accuracy of ultrasound in detecting placenta accreta diagnosed intraoperative or by histopathological examination done after cesarian hysterectomy
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Hala Nabil, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02746575: Pilot - Peri-operative Beta Blockade
Official title: Novel Strategy For Perioperative Beta-Blocker Therapy - Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Adrenergic Beta-Receptor Blockader
Troponin Levels
Cardiomyopathy, Post-surgical
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2016-04-21
Enrollment: 70
Sex: ALL
Minimum age (years): 51
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Perioperative cardiac adverse events \[heart injuries caused by general anesthesia and surgical procedures\] are a significant public health issue, with more than 60,000 deaths per annum in patients having surgery for non-heart related issues. There are virtually no evidence-based medical strategies for effective prevention of these events. Preoperative drug treatment with beta blockade drugs used for high blood pressure, perioperative therapy with lipid lowering drugs such as statins, alpha-receptor agonists such as clonidine used for high blood pressure, and aspirin have all been investigated as potential mitigating treatments, but without positive clinical outcomes and, in some cases, creating more hemodynamic instabilities that result in heart injury. In light of this, investigators propose to evaluate the safety and efficacy of using increasing doses of beta blockade drugs immediately after surgery and to assess the value of high-sensitivity cardiac troponin level testing of the blood in predicting those patients who would benefit most from perioperative beta blocker therapy.


Eligibility criteria: Inclusion Criteria:

* Age \>50 years
* American Society of Anesthesiologists (ASA) risk status III-IV
* Revised Cardiac Risk Index ≥2
* β-blocker naïve (not having received β-blocker within 30 days prior to surgery)
* Previously diagnosed coronary artery disease (CAD) or at high risk for CAD:
* History of peripheral vascular disease, or
* Diabetes and currently on oral anti-diabetic drug or insulin therapy, or
* Chronic renal failure (eGFR \<30 m/min)
* Major non-cardiac surgery under general anesthesia

Exclusion Criteria:

* History of stroke
* Heart rate \<55bpm
* Heart failure
* Second or third degree AV block without pacemaker
* Active asthma or COPD
* Anemia \[Hb\<9g/dL\]
* Allergy to beta-blockade drugs
* Hemodynamic instability
* Uncontrolled hemorrhage
* Unwilling or unable to give consent for participation

Primary outcomes:
measure: Difference in hscTnI Values
timeFrame: Before surgery and Immediately after surgery (on the day of surgery)
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Barnes-Jewish Hospital/Washington University in St. Louis School of Medicine
state: Missouri
Study officials:
References:
Clinical trial NCT04124575: Prevalence of Sarcopenia in Geriatric Patients
Official title: Prevalence of Sarcopenia in Patients Admitted to a Swiss University Department of Geriatric Medicine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sarcopenia
Keywords: Prevalence
Sarcopenia
Geriatric
Lead sponsor: University Department of Geriatric Medicine FELIX PLATTER
Sponsor class: OTHER
First posted: 2019-10-11
Enrollment: 350
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be selected by the University Department of Geriatric Medicine FELIX PLATTER

Brief summary: To assess the prevalence of sarcopenia among inpatients on acute geriatrics and geriatric rehabilitation wards of a Swiss university department of geriatric medicine using the most recent diagnosis definitions from european guidelines.


Eligibility criteria: Inclusion Criteria:

- All patients \>65 years old admitted to acute geriatrics and geriatric rehabilitation at the study site

Exclusion Criteria:

* Lack of informed written consent
* Implanted defibrillation device
* Acute Sepsis, severe volume overload or dehydration
* Life expectancy of \< 3 months according to treating physician
* Unremovable bandages
* Patients in isolation rooms on the ward
* Measurement is not possible due to organizational reasons
* Inability to follow the procedures, e.g. due to language problems, psychological disorders

Primary outcomes:
measure: Presence of Sarcopenia (yes/no)
timeFrame: Baseline
measure: Muscle quantity, measured by Body Impedance Analysis (kg)
timeFrame: Baseline
measure: Hand Grip Strength (kPa)
timeFrame: Baseline
measure: Gait Speed (m/s)
timeFrame: Baseline
measure: Timed up and go Test (s)
timeFrame: Baseline
Secondary outcomes:
measure: Mini Mental Status (Score range from 0 to 30 Points; higher scores reflect better cognitive status)
timeFrame: Baseline
measure: Nutritional risk Screening (Score range from 0 to 7 Points; higher scores reflect higher risk of malnutrition)
timeFrame: Baseline
measure: Geriatric Depression Scale short version (Score range from 0 to 6 Points; higher scores reflect higher risk of depression)
timeFrame: Baseline
measure: Functional Independence Measure at Admission (Score range from 18 to 126 Points; higher scores reflect better functionality)
timeFrame: Baseline
measure: Calf and Mid-upper arm Circumference (cm)
timeFrame: Baseline
measure: Body Mass Index (kg/m^2)
timeFrame: Baseline
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Department of Geriatric Medicine FELIX PLATTER
Study officials:
affiliation: University Department of Geriatric Medicine FELIX PLATTER
name: Dominic K. Bertschi, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Department of Geriatric Medicine FELIX PLATTER
name: Caroline Kiss, Dr.
role: STUDY_CHAIR
affiliation: University Department of Geriatric Medicine FELIX PLATTER
name: Reto W. Kressig, Prof. Dr.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01782859: Effect of Steroids on Thrombosis (Blood Clot Formation) and Inflammation in Patients Undergoing Hip Surgery
Official title: Effect of Steroids Given Over 24 Hours on Cytokine Release, Urinary Desmosine Level and Thrombogenic Markers in Patients Undergoing Unilateral Total Hip Replacement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Hip Replacement
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2013-02-04
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Studies have shown that surgery causes some reactions in your body consistent with inflammation. When the inflammation is extensive, it may affect different parts of the body including the lungs. Corticosteroids are commonly used to treat inflammation and are different from performance enhancing steroids associated with athletics. The purpose of this study is to determine the influence of low dose steroids given 3 times in a 24 hour period on thrombotic markers (markers that are associated with increased risks of clotting, a possible complication of surgery), interleukin (IL)-6 cytokine release (part of the stress response seen with surgery), and urine desmosine levels (a marker of lung injury) in a randomized placebo controlled trial patients undergoing total hip replacement.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing unilateral total hip replacement with Drs. Douglas Padgett, Thomas Sculco, or Edwin Su.
* Patients between the age of 50 and 90

Exclusion Criteria:

* Patients on steroid therapy regardless of dose or duration of treatment or those requiring stress-dose steroids preoperatively
* Patients who are smokers
* Patients who have diabetes
* Patients who are \<50 and \>90 years of age
* Patients with history of prior difficulties tolerating corticosteroids

Primary outcomes:
measure: Serum Prothrombin Fragment 1 and 2 (PF 1.2)
timeFrame: First 24 hours after surgery
measure: Plasmin-a 2 Antiplasmin Complex (PAP)
timeFrame: First 24 hours after surgery
Secondary outcomes:
measure: Interleukin (IL)-6 Cytokine Release (Inflammatory Marker)
timeFrame: Participants will be followed from the time of surgery until discharge, expected average of 3-5 days
measure: Desmosine Level (Marker of Lung Injury)
timeFrame: Participants will be followed from the time of surgery until discharge, expected average of 3-5 days
measure: Pain at 3 Months Post-op
timeFrame: 3 months postoperatively
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
References:
Clinical trial NCT06036459: Uterine Peristalsis in IVF
Official title: Effect of Uterine Peristalsis at the Time of Embryo Transfer on the Outcomes of IVF Cycles: a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Infertility, Female
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-09-14
Enrollment: 117
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women undergoing IVF

Brief summary: An observational prospective cohort study to evaluate the effect of uterine peristalsis at the time of embryo transfer on IVF clinical outcomes performed in Women's Health hospital, Assiut University, Egypt.

Women performing fresh or frozen embryo transfer who do not have any uterine abnormalities will be included in the study


Eligibility criteria: Inclusion Criteria:

* • Women undergoing embryo transfer during IVF cycles.

  * Age: between 20 and 40 years.
  * Have at least 1 good quality embryo at the time of transfer
  * Fresh or frozen-thawed cycles.
  * Any stimulation protocol in fresh cycles, or any endometrial preparation protocol for frozen-thawed cycles

Exclusion Criteria:

* • Women refusing to participate in clinical research.

  * Any uncorrected uterine abnormality, such as septum, myoma, adenomyosis, or polyp
  * Hydrosalpinx without prior disconnection or excision

Primary outcomes:
measure: Clinical pregnancy
timeFrame: 2 weeks after a positive pregnancy test
Secondary outcomes:
measure: Biochemical pregnancy
timeFrame: 2 weeks after embryo transfer
measure: Miscarriage
timeFrame: From 6 weeks of gestation until 28 weeks of gestation
measure: Ectopic pregnancy
timeFrame: the site of the gestational sac will be assessed 2 weeks after embryo transfer
measure: Ongoing pregnancy
timeFrame: After 12 weeks of gestation until delivery
measure: Live birth
timeFrame: From 28 weeks of gestation until delivery
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Mahmoud Abdelaziz, M.Sc
role: STUDY_DIRECTOR
References: