louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05972928: Effect of Sitagliptin on Polycystic Ovarian Syndrome Patients
Official title: Effect of Sitagliptin on Clinical, Metabolic and Hormonal Parameters in Polycystic Ovarian Syndrome Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Polycystic Ovary Syndrome
Keywords: Polycystic Ovary Syndrome
Sitagliptin
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2023-08-02
Enrollment: 80
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Study aims to determine the proposed positive influence of Sitagliptin in manipulating hormonal , metabolic and inflammatory parameters in the treatment of Polycystic ovary syndrome and subsequent infertility

Detailed description: Study Design : a Prospective Randomized Controlled Trial.

A Total of 80 infertile Adult Females aged between 18 and 45 years currently diagnosed with Polycystic ovary syndrome , Meeting the Diagnosis of Rotterdam criteria be diagnosed if any two of the following are present: (1) clinical or biochemical hyperandrogenism, (2) evidence of oligo-anovulation, (3) polycystic appearing-ovarian morphology on ultrasound are to be included in the study.

The study will include two groups; each group consists of 40 patients:- Group A : Control Group Group B : Test Group ( will Receive Sitagliptin at a dose of 100 mg every 24 hours

Eligibility criteria: Inclusion Criteria:

polycystic ovary syndrome usually diagnosed based on the Rotterdam criteria if 2 of 3 criteria are present:

1. oligo- and/or anovulation
2. hyperandrogenism (HA) (clinical and/or biochemical)
3. polycystic ovary morphology (PCOM) on ultrasonography (either 12 or more follicles measuring 2-9 mm in diameter and/or an increased ovarian volume \>10 cm3).

Exclusion Criteria:

1. congenital adrenal hyperplasia
2. Brittle control of a thyroid disorder
3. Diabetic on Metformin or any another antidiabetic drugs affecting insulin resistance
4. chronic kidney disease
5. liver dysfunction
6. documented use of oral hormonal contraceptives and hormone-releasing implants in the past 6 months prior to study entry 7.Lipid lowering Consumption

Primary outcomes:
measure: Body weight loss in Kilograms
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Banī Suwayf
country: Egypt
facility: Beni-suef university Hospital
state: Beni Suef
Study officials:
References:
Clinical trial NCT04484428: A Study to Evaluate the Efficacy and Safety of K-285 Compared With Menthol Gel for the Treatment of Delayed Onset Muscle Soreness (DOMS) in the Lower Extremity
Official title: A Phase II, Randomized, Double-blind, Active Comparator, Parallel Group Study to Evaluate the Efficacy and Safety of K-285 Compared With Menthol Gel for the Treatment of Delayed Onset Muscle Soreness (DOMS) in the Lower Extremity
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Acute Pain
Lead sponsor: Kowa Research Institute, Inc.
Sponsor class: INDUSTRY
First posted: 2020-07-23
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study to evaluate the efficacy and safety of K-285 compared with menthol gel for the treatment of delayed onset muscle soreness (DOMS) in the lower extremity.


Eligibility criteria: Inclusion Criteria:

* Subject must provide informed consent before any study-specific evaluation is performed.
* Subject is male and female aged 18 to 35 years, inclusive.
* Subject has a body mass index of 18 to 32 kg/m2, inclusive.
* Subject meets all inclusion criteria outlined in the Clinical Study Protocol.

Exclusion Criteria:

* Subject has a job (e.g., movers, construction workers) that requires regular lifting or involvement of the lower extremities.
* Subject has restless leg syndrome, a chronic pain condition, a history of intermittent claudication, or has taken any medication (e.g., analgesic medication, sleep medication, muscle relaxant, anticonvulsant, or antidepressant) in the last 6 months to treat a chronic pain condition, or has another painful physical condition in a lower extremity that, in the opinion of the investigator, may confound study assessments.
* Subject has received oral or topical analgesic medications within 14 days before the Screening Visit.
* Subject meet any other exclusion criteria outlined in the Clinical Study Protocol.

Primary outcomes:
measure: Sum of Pain Intensity Difference Between 0 to 24 Hours (SPID0-24) for Study Leg While Standing
timeFrame: Baseline to 24 Hours
Secondary outcomes:
measure: SPID0-24 at Rest for Study Leg
timeFrame: Baseline to 24 Hours
measure: SPID0-12 While Standing for Study Leg
timeFrame: Baseline to 12 Hours
measure: SPID0-12 at Rest for Study Leg
timeFrame: Baseline to 12 Hours
measure: SPID0-48 While Standing for Study Leg
timeFrame: Baseline to 48 Hours
measure: SPID0-48 at Rest for Study Leg
timeFrame: Baseline to 48 Hours
measure: SPID0-72 While Standing for Study Leg
timeFrame: Baseline to 72 Hours
measure: SPID0-72 at Rest for Study Leg
timeFrame: Baseline to 72 Hours
Other outcomes:
Locations:
city: Pasadena
country: United States
facility: Lotus Clinical Research, LLC
state: California
Study officials:
References:
Clinical trial NCT01497028: Plicated Laparoscopic Adjustable Gastric Banding (Lap Band)
Official title: Prospective Randomized Clinical Trial of Plicated Laparoscopic Adjustable Gastric Banding
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Weight Loss
Keywords: Co-morbid disease resolution
Lead sponsor: Jacksonville Surgical Associates
Sponsor class: OTHER
First posted: 2011-12-22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients between the ages of 18-80 years of age who are severly or morbidly obese and meet NIH and FDA criteria for baratric surgery (BMI\>30+ co-morbid disease or BMI\>35) who are undergoing baratric surgery at Jacksonville Surgical Associates, P.A. or Ventura Advanced Surgical Associates will be returned. All enrolled patients will be assigned to either the SLAGB (control)group or the PLAGB (study) group.

Brief summary: This is a dual site, prospective study which will compare plicated-Laparoscopic Adjustable Gastric Banding (PLAGB) to standard LABG (SLAGB) to identify significant differences in bariatric surgical outcomes

* Weight Loss
* Co-morbid disease resolution


Eligibility criteria: Inclusion Criteria:

Subjects must meet the following criteria to be eligible for study entry:

* Age between 18 - 80 years, and
* Severely or Morbidly obese:

  * BMI \> 35, or
  * BMI \> 30 + co-morbid obesity related disease condition
* Without any contraindications to bariatric surgery, and
* Without any metabolic or medically correctable causes for obesity (eg. Untreated hypothyroidism, Prader-Willi, etc.)
* Patients who have had previous LAGB surgery requiring revision for complications such as slippage, stalled weight loss or weight regain

Exclusion Criteria:

Subjects meeting the following criteria will be excluded from study entry:

* Any patient not meeting the inclusion criteria
* Patients with any major medical problems contraindicating surgery
* Patients with a medically treatable cause of obesity (eg. untreated hypothyroidism, Prader-Willi, etc.)
* Patients who elect to undergo a surgery other than a PLAGB or SLAGB
* Pregnant or planning pregnancy within 12 months
* Alcohol or drug addiction
* Established infection anywhere in the body at the time of surgery
* Previous history of other bariatric surgery (except LAGB)
* Family or patient history of autoimmune disease

Primary outcomes:
measure: Weight Loss
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Ventura
country: United States
facility: Ventura Advanced Surgical Associates
state: California
city: Jacksonville
country: United States
facility: Jacksonville Surgical Associates
state: Florida
Study officials:
References:
Clinical trial NCT04154228: Non-invasive Evaluation of Lymphoma Patients Based on Artificial Intelligence and PET/MRI
Official title: Non-invasive Evaluation of Lymphoma Patients Based on Artificial Intelligence and PET/MRI
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lymphoma
Non Hodgkin Lymphoma
Follicular Lymphoma
Keywords: Lymphoma
Non Hodgkin Lymphoma
Follicular Lymphoma
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2019-11-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 18F-FDG PET/MR imaging protocol integrating advanced MR vascular imaging sequences, along with computerized quantitative methods for data analysis, is expected to serve as an objective tool for assessment of lymphoma patients. The aim of this prospective study is to develop an automatic artificial intelligence-based tool for the assessment of early response to treatment and evaluation of residual masses in patients with lymphoma. Specific objectives are:

1. To evaluate the added value of 18F-FDG PET/MRI compared with PET/CT in imaging lymphoma.
2. To optimize PET/MR imaging protocol for lymphoma assessment.
3. To develop an automated tool for staging patients with lymphoma.
4. To develop an automated method for early prediction of response to therapy and prognosis in patients with lymphoma.
5. To develop an automated non-invasive tool for discriminating benign from active residual masses at end of treatment in patients with lymphoma.


Eligibility criteria: Inclusion Criteria:

1. patients with newly diagnosed hodgkin's, aggressive non-hodgkin's and follicular lymphoma (for whom the PET/CT is the imaging modality of choice)/
2. Patients aged 18 years or older of both sexes.
3. Patients treated at Tel-Aviv Sourasky Medical center.

Exclusion Criteria:

1. pregnancy,
2. contraindication to MRI or to intravenous gadolinium injection.

Primary outcomes:
measure: Patients that preform 18F-FDG PET/MRI and the routinely PET/CT
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00724828: Study Evaluating Streptococcus Pneumoniae Serotype Carriage Rate for Nasopharyngeal Carriage in Filipino Children
Official title: An Evaluation of Streptococcus Pneumoniae Serotype Carriage Rate For Nasopharyngeal Carriage in Filipino Children Attending Well Baby Clinic in Hospitals and Primary Care Centers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pneumonia, Bacterial
Keywords: Bacterial otitis media
pneumoniae
sepsis
bacteremia
meningitis
Streptococcus pneumoniae carriage rate
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2008-07-30
Enrollment: 500
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primary care clinic

Brief summary: Evaluation of the carriage rate of Streptococcus pneumoniae in the nasopharynx of healthy children and the carriage rate and distribution of Streptococcus pneumoniae serotypes


Eligibility criteria: Inclusion Criteria:

* Healthy children aged between 2 months and 5 years attending the well baby clinic in hospital.
* Informed consent obtained from parents or legal guardian.

Primary outcomes:
measure: Streptococcus pneumoniae serotype carriage rate based on a nasopharyngeal swab.
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT04106128: Prevalence, Impact and Reversibility of Acute Diaprhagmatic Dysfunction in Acute Respiratory Detresse
Official title: Prevalence, Impact and Reversibility of Acute Diaprhagmatic Dysfunction in Acute Respiratory Detresse Measured by Diaphragmatic Echogaphy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Distress Syndrome,Adult
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2019-09-26
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The diaphragm is a fine striated muscle with both extra respiratory and respiratory functions. It does most of the breathing work in interaction with the accessory respiratory muscles, the rib cage and the abdomen. Its activity can be measured by the transdiaphragmatic pressure generated by the magnetic stimulation of phrenic nerves (gold standard). It has been shown in the literature that diaphragmatic ultrasound, via the measurement of diaphragmatic excursion and especially the thickening fraction, is an easily accessible, non-invasive, reproducible and relevant technique for evaluating acute diaphragmatic dysfunction in resuscitation patients.

The objective of this project is to evaluate the prevalence of diaphragmatic dysfunction at admission in patients hospitalized in intensive care / respiratory intensive care unit for hypercapnic and/or hypoxic acute respiratory distress and requiring ventilatory support by non-invasive ventilation or high flow oxygen therapy. A subgroup analysis will then be carried out on 3 populations:

* Hypercapnic exacerbation of chronic obstructive pulmonary disease
* Hypoxic acute respiratory distress on infectious lung disease
* Acute pulmonary edema


Eligibility criteria: Inclusion Criteria:

* Hospitalization for acute respiratory distress management
* Etiological diagnosis either:
* Exacerbation of chronic obstructive pulmonary disease
* Infectious pneumonitis
* Acute pulmonary edema
* Need for a ventilatory support by either:
* Non-invasive ventilation
* High flow oxygen therapy (flow rate \> 40L/min and oxygen inspired fraction \> 40%)
* Mask oxygen therapy with flow rate \> 5L/min

Exclusion Criteria:

* Exacerbation of interstitial pathology / pulmonary fibrosis
* Deformation of the thoracic cage
* Neurodegenerative pathology
* Need for oro-tracheal intubation from the beginning for mechanical ventilation
* Contraindication to Non-invasive Ventilation
* Patients undergoing diaphragmatic rehabilitation
* Immunocompromised patients
* History of known diaphragmatic dysfunction

Primary outcomes:
measure: Thickening fraction
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: Céline SANFIORENZO, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00447928: Phase II Dose-Ranging Study of OrthoDerm Patch for Patients With Tennis Elbow
Official title: A Randomized, Double-Blind, Placebo-Controlled Phase II Dose-Ranging Study of the OrthoDerm Transdermal Nitroglycerin Patch for Patients With Chronic Lateral Epicondylitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Tendonitis
Keywords: tendonitis
nitroglycerin
nitric oxide
lateral epicondylitis
Lead sponsor: Cure Therapeutics
Sponsor class: INDUSTRY
First posted: 2007-03-15
Enrollment: 164
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 purpose of the study is to evaluate the effectiveness and safety of the use of low-dose nitroglycerin transdermal patches to treat pain and function in chronic tennis elbow.

Detailed description: Chronic tendonitis remains difficult to treat. Nitric oxide has been demonstrated to stimulate tenocytes to proliferate, differentiate and produce matrix components including collagen. Studies have demonstrated that nitroglycerin transdermal patches, which release nitric oxide, reduce pain and increase function in patients with chronic tendonitis. The purpose of the present study is to examine the efficacy of three dose levels of nitroglycerin, compared to placebo, in reducing pain and increasing function in patients with chronic (greater than three months' duration) lateral epicondylitis.

Eligibility criteria: Inclusion Criteria:

* males \>18 yr and \< 70 yr
* BMI \< 38
* chronic lateral epicondylitis (symptomatic \> 3 mo)
* pain on provocation \>/- 4 on 11 point scale

Exclusion Criteria:

* patients on other pain medications
* bilateral elbow pain
* any humerus elbow or forearm fracture or surgery
* signs of injury other than lateral epicondylitis
* any concomitant disease or pain of the upper extremity
* orthostatic hypotension
* patients taking MAO inhibitors, phosphodiesterase inhibitors, adrenergic agents
* pregnant or nursing women

Primary outcomes:
measure: pain-free grip strength
Secondary outcomes:
measure: pain at rest
measure: pain on provocation
measure: function
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: to Be Determined
Study officials:
affiliation: Cure Therapeutics, Inc
name: Ronald M Burch, MD, PhD
role: STUDY_CHAIR
References:
citation: Paoloni JA, Murrell GA, Burch RM, Ang RY. Randomised, double-blind, placebo-controlled clinical trial of a new topical glyceryl trinitrate patch for chronic lateral epicondylosis. Br J Sports Med. 2009 Apr;43(4):299-302. doi: 10.1136/bjsm.2008.053108. Epub 2008 Oct 29.
Clinical trial NCT01003028: Reduction of Remifentanil-related Complications
Official title: Reduction of Remifentanil-related Complications by Limiting Maximum Plasma Concentration During Target-controlled Infusion
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Anesthesia
Keywords: Total intravenous anesthesia
Maximum plasma concentration of remifentanil
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2009-10-28
Enrollment: 160
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: PREVENTION

Brief summary: This study is intended to evaluate the effect of decreasing the maximum plasma concentration target of remifentanil of the Target Controlled Infusion system on the the incidence of major and minor side-effects.


Eligibility criteria: Inclusion Criteria:

* 18-70 year old
* ASA class 1-3 scheduled for elective surgery

Exclusion Criteria:

* history of neurologic or mental disorder
* uncontrolled pulmonary or cardiovascular disease
* history of adverse reactions to opioids
* history of drug abuse

Primary outcomes:
measure: hypotension more than 25% from baseline
timeFrame: during remifentanil loading
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT03800628: Resource Availability Following Critical Illness
Official title: Perception of Quality of Life and Resource Availability After Surviving Critical Illness
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Quality of Life
Keywords: survivor
QOL
resources
Lead sponsor: Walden University
Sponsor class: OTHER
Collaborators: name: Wake Forest University Health Sciences
First posted: 2019-01-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: critical illness survivors

Brief summary: The purpose of this qualitative study is to explore the vital issues in recovery of QOL from the perspective of survivors of critical illness and understand these patients' views on rehabilitative services in the United States (U.S.). The theoretical framework for this study is Max Weber's Rational Choice Theory (RCT). The research questions will focus on understanding post-ICU QOL and the patients' experience with rehabilitative services following critical illness. A phenomenological study design is being employed, using semi-structured individual interviews with critical illness survivors. Data from the interviews will be coded for thematic analysis. The implications for social change include defining the meaning of QOL for an ICU survivor and improving healthcare policies for the therapies necessary to return survivors to a life worth living.

Detailed description: The purpose of this qualitative study is to understand the patient perception of QOL after surviving critical illness and how survivors can help illuminate gaps in current health policies to provide better recovery resources for this growing population.

The central research questions are:

RQ1: What are the issues important to preserve quality of life from the perspective of critical illness survivors? RQ2: How do survivors of critical illness describe rehabilitative services after discharge?

Eligibility criteria: Inclusion Criteria:

* critical illness survivors within 18 months of ICU discharge
* minimum 48 hours of mechanical ventilation
* ability to read and understand English
* over the age of 18

Exclusion Criteria:

* emotional or psychological inability to participate in a 30-min interview
* not meeting inclusion criteria

Primary outcomes:
measure: RQ1: What are the issues important to preserve quality of life from the perspective of critical illness survivors?
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health
state: North Carolina
Study officials:
References:
Clinical trial NCT02969993: Very Long Term VHI Voice Outcome After MTIS
Official title: Very Long Term VHI Voice Outcome After MTIS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laryngeal Paralysis
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2016-11-21
Enrollment: 53
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Long term assesment of voice outcome after Montgomery Thyroplastie by performing a Survey of operated patients using the voice handicap index scale


Eligibility criteria: Inclusion Criteria:

* patients presenting UVFP of neurogenic origin treated by MTIS \> 2 years before inclusion.
* No superior limit in terms of years.
* Age 18-80 years at the time of MTIS
* No other treatment before MTIS other than resorbing material injection laryngoplasty (maximum twice)
* No further voice treatment after MTIS except speech therapy.
* VHI or VHI-10 performed before MTIS and within the 6 months after MTIS. In case of multiple post-op VHI tests, only the earliest post-op. VHI test will be taken into account
* VHI tests validated for the utilized language

Exclusion Criteria:

* patient not able to answer VHI questionnaire personally
* Post MTIS new health condition affecting the voice tract and/ or the respiratory function.
* Post MTIS appearance of other voice/ vocal cord pathology

Primary outcomes:
measure: Voice handicap index
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels Capital Region
country: Belgium
facility: Cliniques universitaires Saint-Luc
state: Brussels
city: Yvoir
country: Belgium
facility: CHU Namur -Mont-Godinne
state: Namur
city: Valencia
country: Spain
facility: Valencia Medical School - Hospital General Universitario
state: Levante
Study officials:
References: