louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06361342: Smartphones Aggravating Anxiety Symptoms
Official title: Smartphones Aggravating Anxiety Symptoms: Experimental Study From Southeastern
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Anxiety
Keywords: Smartphones
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-04-11
Enrollment: 100
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 goal of this study is to assess if excessive use of smartphone apps of social media can impact a person's mental health. The study is aimed at improving the usage of smartphones which might help improve the mental health of patients. The goal is not to discourage the use of smartphones but instead to utilize smartphones in a way that they do not impact lives.


Eligibility criteria: Inclusion Criteria:

* For patients aged 18 years or older experiencing mild symptoms of anxiety or depression and who have a GAD-7 score 5 and above.
* Patient should have smart phone and should be using Facebook, Instagram, Twitter, Tik Tok, and Pinterest social media apps.
* Patients should have email access.

Exclusion Criteria:

* Any patient who uses a smartphone for tracking glucose for diabetes management, heart rate, or any chronic illness which is being managed through a smartphone app.
* Any patient who uses more than one personal smartphone
* Any patient who is a suicide risk as per PHQ-9 score, current recreational drug usage, or alcohol abuse.
* Any patient who has suicidal ideation as per PHQ-9 assessment before or during the study period will be excluded, (all patients will be monitored for suicidal ideation by PHQ-9 scoring method at day 1, week 6, and week 12, but it is the responsibility of the patient to inform the study team if they have developed any suicidal ideation throughout the study period).
* Patients with activated POA (Power of Attorney - Healthcare), diagnosis of mental retardation or current disability due to any psychiatric disorder or severe depression with a high risk of suicide should be excluded.
* Any patient currently undergoing ECT (electroconvulsive therapy) for severe depression.
* Any patient taking prescribed SSRIs/SNRIs, with a change and not taking them continuously in last 30 days (not a new diagnosis of anxiety). If change they will be excluded.

Primary outcomes:
measure: Change in anxiety
timeFrame: Day 1, 12 weeks
Secondary outcomes:
measure: Change in depression
timeFrame: Day 1, 12 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Minnesota
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Gagandeep Singh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01267942: Intravenous Enhancin[Co-amoxiclav] Versus Postoperative Enhancin in Prevention of Postadenotonsillectomy Morbidity.
Official title: Single Intraoperative Intravenous Enhancin[Co-amoxiclav] Versus Postoperative Full Oral Course in Prevention of Post Adenotonsillectomy Morbidity:A Randomised Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adenotonsillar Hypertrophy,Under 12 Years.
Keywords: Adenotonsillectomy.
Lead sponsor: University of Nairobi
Sponsor class: OTHER
First posted: 2010-12-29
Enrollment: 126
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Null hypothesis; The efficacy of Enhancin\]Co-Amoxiclav given as a single intravenous dose at induction is not better than a five days oral course of the same given postoperatively in reducing postoperative morbidity after adenotonsillectomy.

Detailed description: Adenotonsillectomy results in morbidity that is reduced by the use of antibiotics.This study had the sole objective of comparing two route of administration to see which has superior results.

Eligibility criteria: Inclusion Criteria:

* Patients below 12year scheduled to undergo adenotonsillectomy whose parents or guardians give consent for recruitment into the study.

Exclusion Criteria:

* Non consenting parents or guardians. Antibiotic use in the week preceding surgery. Patients with co mordities. Known allergies to Co-amoxiclav. Patients who develop complication that warrant change of antibiotic.

Primary outcomes:
measure: POSTOPERATIVE FEVER
timeFrame: OPERATION DAY TO 7 DAYS POSTOPERATIVELY
Secondary outcomes:
Other outcomes:
Locations:
city: Nairobi.
country: Kenya
facility: Kenyatta National Hospital.
Study officials:
affiliation: Ministry of Health, Kenya
name: Musyoka D Mutiso, mmed ent
role: PRINCIPAL_INVESTIGATOR
References:
citation: Colreavy MP, Nanan D, Benamer M, Donnelly M, Blaney AW, O'Dwyer TP, Cafferkey M. Antibiotic prophylaxis post-tonsillectomy: is it of benefit? Int J Pediatr Otorhinolaryngol. 1999 Oct 15;50(1):15-22. doi: 10.1016/s0165-5876(99)00228-1.
citation: Mutiso MD, Macharia IM. Single intraoperative intravenous Co-Amoxiclav versus postoperative full oral course in prevention of postadenotonsillectomy morbidity: a randomised clinical trial. BMC Ear Nose Throat Disord. 2011 Sep 30;11:9. doi: 10.1186/1472-6815-11-9.
Clinical trial NCT00313742: The Effect of Exercise on Blood Glucose Levels in Patients With Type 1 Diabetes: A Comparison of 3 Long-acting Insulins
Official title: An Assessment of the Impact of Performing Physical Exercise on the Maximum Plasma Glucose Decline in Subjects With Type 1 Diabetes Managed on a Basal Bolus Insulin Regimen: A Comparison of 3 Basal Insulin Treatments - Insulin Detemir, Insulin Glargine and NPH Insulin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes
Diabetes Mellitus, Type 1
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2006-04-12
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this research is to assess the impact of three basal (long-acting) insulin treatments on blood glucose levels in people with type 1 diabetes when performing physical exercise.


Eligibility criteria: Inclusion Criteria:

* Type 1 Diabetes
* Current basal-bolus insulin therapy
* HbA1c \< 10%
* BMI \< 32 kg/m2

Exclusion Criteria:

* Proliferative Retinopathy / Maculopathy
* Recurrent major hypoglycaemias
* Impaired hepatic or renal function
* Cardiac Problems
* Uncontrolled hypertension

Primary outcomes:
measure: The difference between plasma glucose concentrations immediately pre-exercise and the minimum plasma glucose concentrations (nadir) in the period 0-150 min following exercise
timeFrame: following 4 weeks of treatment
Secondary outcomes:
measure: Plasma glucose pre-exercise & post-exercise
measure: Hypoglycaemia episodes (major and minor episodes) during exercise, afterwards & from end of study until 07:30 the following morning
measure: Plasma glucose profile post-exercise
measure: Incidence of adverse events during the trial
Other outcomes:
Locations:
city: Neuss
country: Germany
city: Newcastle upon Tyne
country: United Kingdom
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT04924842: COVID-19 - SARS-CoV-2 Community Contamination in Children and Adults - Impact of Variants (Dyn3CEA - Nosocor Phase 2)
Official title: Epidemiology of CoV-2 SARS Infections: Dynamics of Community Contamination in Children and Adults - Impact of Variants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infection Viral
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2021-06-14
Enrollment: 87
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospital-based population of children and adults:

* Hospitalized children, 0 to 17 years of age, 25 subjects, consecutive sample survey
* Hospitalized adults, 18 years and above, 50 matched subjects

Brief summary: Unlike other respiratory viruses such as influenza and RSV where the child is the essential reservoir and central vector of intrafamilial contamination, the child is likely to be a small player in the transmission of CoV2-CoRSA infection. This study aims to describe the age category of the first contact, within 14 days before the appearance of the first symptoms of the index case in order to describe the age categories of this first contaminant, globally, in the group of children and finally in the group of adults. This work is intended to provide food for discussion and to justify the distancing and containment measures imposed on children when their isolation has a deleterious impact that has now been established for some children.


Eligibility criteria: Inclusion Criteria:

* 1) Children hospitalized in the Pediatric department of the Hospices Civils de Lyon with PCR positive for a variant of the historical SARS-CoV2, 2) Adults hospitalized in the the Hospices Civils de Lyon, for a Covid-19 disease with documented infection by a variant of the SARS-CoV-2 and included in the NOSO-COR study with matching criteria described below.

Exclusion Criteria:

1. Any patient suspected of nosocomial infection.
2. Any patient death during the Covid-19 infection.
3. Any adult patient without children living home.
4. Opposition to participate.

Primary outcomes:
measure: Percentage of possible contaminants, adults, adolescents and children with Covid-19
timeFrame: At inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital Femme Mère et enfant
state: Auvergne Rhône Alpes
Study officials:
References:
Clinical trial NCT01570842: Anthropometry in Gastroesophageal Reflux Disease and Esophageal Injury
Official title: The Role of Anthropometry in Gastroesophageal Reflux Disease and Esophageal Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastroesophageal Reflux Disease (GERD)
Keywords: Gastroesophageal reflux disease
GERD
Barrett's esophagus
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2012-04-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Is waist to hip ratio (WHR), waist circumference (WC), (as markers of visceral adiposity) associated with an increase in acidic and non acidic reflux as well as systemic inflammation involving esophageal mucosa, thereby increasing esophageal injury and predisposing to subsequent development of Barrett's esophagus (BE)?

Detailed description: The investigators will study 100 adult subjects over the age of 18 from the esophageal motility lab who are undergoing clinically indicated 24 hour acidity or basicity (pH) impedance and/or pH studies off acid suppressing medication.. These subjects will not have a prior history of esophageal surgery, or diagnosis of BE. The investigators will obtain consent for taking anthropometric measurements (Waist and hip circumference), and the results of their study. Only those subjects that successfully complete the 24 hour pH impedance studies will be included. Subjects will also undergo clinically indicated endoscopy. The investigators will consent these subjects to obtain 4 biopsies (bx) from the gastroesophageal (GE) junction and 4 bx from 5 cm above the GE junction. These bio-specimens will be stored for assessment of tissue injury (PGE2) and tissue immune-histochemistry of BE precursors (CDX1 and CDX2) at a later date.

Eligibility criteria: Inclusion:

* Subjects over the age of 18 undergoing clinically indicated 24 hour pH impedance and/or pH studies. Many will also undergo clinically indicated endoscopy, and consent for acquiring tissue samples for future biomarker staining tests will be obtained.
* Able to give informed consent

Exclusion:

* Subjects with a prior history of esophageal surgery, or diagnosis of BE.

Primary outcomes:
measure: Correlate Anthropometry with number of acid reflux episodes
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Prasad G Iyer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03618342: Serum Metabolomics Study of Polycystic Ovary Syndrome
Official title: Serum Metabolomics Study of Polycystic Ovary Syndrome Based on Liquid Chromatography-Mass Spectrometry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Polycystic Ovary Syndrome
Lead sponsor: Heilongjiang University of Chinese Medicine
Sponsor class: OTHER
First posted: 2018-08-07
Enrollment: 1272
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: PCOS is a complex disease and its pathogenesis is not clear, but it is believed to be the result from genetic, environmental, and lifestyle interaction. It is relatively clear that PCOS is closely related with hormone abnormality. More and more evidence displayed that insulin signaling pathways are closely related to PCOS. PCOS may also be associated with chronic inflammation and increased level of oxidative stress.

Brief summary: Polycystic ovary syndrome (PCOS) is a complex, heterogeneous disorder, which produces in 5-20% reproductive age women. In this study, a nontargeted metabolomics approach based on ultra high-performance liquid chromatography coupled with quadrupole time-of-flight mass spectrometry will be used to investigate serum metabolic characteristics of PCOS. PCOS women and healthy control will be divided into two distinct groups based on multivariate statistical analysis. The findings of this study will offer a new insight to understand the pathogenesis mechanism, and the discriminating metabolites may provide a prospect for PCOS diagnosis.


Eligibility criteria: Inclusion Criteria:

* PCOS diagnostic criteria: According to the diagnostic criteria revised by the European Society of Human Reproduction and Embryology and the American Society for Reproductive Medicine at the Rotterdam in 2003,4 PCOS patients can be diagnosed if two of the three criteria are present after excluding congenial adrenal hyperplasia, Cushing's syndrome, androgen secreting tumors, or other related disorders. The three criteria are (1) oligo- and/or anovulation; (2) clinical and/or biochemical signs of hyperandrogenism (clinical manifestations of hyperandrogenism include presence of acne, hirsutism, and androgenic alopecia); (3) polycystic ovaries by ultrasound examination: presence of 12 or more follicles in each ovary measuring 2-9 mm on diameter and/or ovarian volume\>10 ml.
* Age between 14 and 40 years
* 2 years after menarche

Exclusion Criteria:

-

Primary outcomes:
measure: The fatty acid amides (FAAs) metabolite changes
timeFrame: one year
Secondary outcomes:
measure: The sulfated steroids metabolite changes
timeFrame: one year
measure: The free fatty acid metabolite changes
timeFrame: one year
Other outcomes:
Locations:
city: Harbin
country: China
facility: First Affiliated Hospital, Heilongjiang University of Chinese Medicine
state: Heilongjiang
Study officials:
References:
Clinical trial NCT02879942: First Trimester Placental Assessment in the Screening of Preeclampsia and Intrauterine Growth Restriction
Official title: First-trimester Study of the Morphometric Characteristics of the Placenta to Assess the Risk of Preeclampsia and Intrauterine Growth Restriction in Singleton Pregnancies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preeclampsia
Intrauterine Growth Restriction
Keywords: Placental volume
First-trimester screening
Ultrasound
Preeclampsia
Intrauterine growth restriction
Biochemical markers
Uterine artery doppler
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
Collaborators: name: Spanish Clinical Research Network - SCReN
First posted: 2016-08-26
Enrollment: 1390
Sex: FEMALE
Minimum age (years): 11
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with singleton pregnancies and ultrasonographic evaluation between 11+0 and 13+6 weeks of gestation

Brief summary: Preeclampsia (PE) and intrauterine growth restriction (IUGR) are clinical manifestations of placental insufficiency. These complications affect 5-15% of pregnancies, and are responsible for up to 20% of preterm births. Women who develop PE during pregnancy also have an increased risk for cardiovascular events, both at short and long term. This justifies the need to improve diagnostic tools to identify patients at risk for these complications. PE and IUGR are multifactorial entities. Screening algorithms should thus include several parameters to achieve high detection rates. Research has mainly focused in the analysis of biophysical and biochemical parameters, and the study of the placenta itself has not been included in current diagnostic strategies. Investigators hypothesize that detection rates of preeclampsia and intrauterine growth restriction could be improved by the study of placental characteristics in the first trimester of pregnancy.


Eligibility criteria: Inclusion Criteria:

* pregnancies with fetuses with CRL between 45 and 80mm
* absence of chromosomal abnormalities
* absence of congenital anomalies
* absence of congenital infections

Exclusion Criteria:

* patient not accepting to participate in the study
* multiple pregnancies
* pregnancies without ultrasonographic confirmation of gestational age

Primary outcomes:
measure: Development of preeclampsia
timeFrame: Up to birth
measure: Development of intrauterine growth restriction
timeFrame: At birth
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
Study officials:
affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Cristina Trilla, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05712642: A Dosing Study of Intravitreal Bevacizumab for Retinopathy of Prematurity
Official title: A Dosing Study of Two Different Doses (0.3125mg Versus 0.625mg) Intravitreal Bevacizumab for Type 1 ROP (Retinopathy of Prematurity)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Retinopathy of Prematurity
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-02-03
Enrollment: 19
Sex: ALL
Minimum age (years): 28
Maximum age (years): 40
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of our study was to determine whether a low dose of 0.3125mg intravitreal bevacizumab is effective in treatment of type 1 ROP as the standard 0.625 mg dose., regarding :

Serum Systemic VEGF levels. Retinal Vascularization.


Eligibility criteria: Inclusion Criteria:

Infants with Type 1 ROP according to ETROP study which is defined as:

* Zone I ROP with plus disease
* Zone I, stage 3 ROP without plus disease
* Zone II, stage 2 or 3 ROP with plus disease

Exclusion Criteria:

* Eyes with previous intravitreal injection
* Eyes with previous laser therapy
* Eyes with any other intraocular pathology other than ROP (congenital cataract, congenital glaucoma, any retinal pathology other than ROP)

Primary outcomes:
measure: Change in the serum systemic VEGF pre- and post- intravitreal injection of bevacizumab in both groups.
timeFrame: at day 0 (baseline ) , 1 week and 4 weeks post-injection
measure: The number of infants without need for rescue therapy until 60 weeks of postmenstrual age after initial treatment.
timeFrame: "up to 60 weeks postmenstrual age"
Secondary outcomes:
measure: Occurrence of any adverse events from intravitreal-injection
timeFrame: Within 4 weeks from intravitreal injection
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Medicine Cairo University
Study officials:
affiliation: Cairo University
name: Nooran Abdelkader, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06462742: Microwave Ablation Versus Liver Resection for Intrahepatic Cholangiocarcinoma
Official title: Microwave Ablation Versus Liver Resection for Intrahepatic Cholangiocarcinoma Within Milan Criteria
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Overall Survival
Disease-free Survival
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2024-06-17
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chinese patients pathologically diagnosed with intrahepatic cholangiocarcinoma

Brief summary: Thermal ablation has been recommended by worldwide guidelines as first-line treatment for hepatocellular carcinoma (HCC), while evidence regarding its efficacy for primary intrahepatic cholangiocarcinoma (iCCA) is lacking. The goal of this observational study is to study the efficacy of ablation in treating iCCA by comparing its prognosis with surgery. The main questions it aims to answer are:

* Whether microwave ablation could achieve similar efficacy with liver resection in treating iCCA
* What is the risk factor for ablation or surgery in treating iCCA
* What kind of iCCA patients could receive ablation as their first-line treatment In this real-world multicenter cohort study, we will collect data of iCCA patients from hospitals who underwent microwave ablation (MWA) or liver resection (LR) for tumors within Milan criteria. Survival will be compared between patients treated by MWA or LR.


Eligibility criteria: Inclusion Criteria:

1. pathologically diagnosed iCCA based on the WHO classifications;
2. curative-intent liver resection or microwave ablation;
3. tumor within Milan criteria, namely single tumor ≤5cm in maximum diameter; multiple tumors ≤3 in number and each ≤3cm; no evidence of major vascular/hilar invasion, extrahepatic/lymphatic metastasis or other malignancies;
4. age ≥18 years.

Exclusion Criteria:

Patients not meeting any one of the inclusion criteria were excluded.

Primary outcomes:
measure: Overall survival
timeFrame: More than 3 years]
measure: Disease-free survival
timeFrame: More than 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
References: