louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05351528: of Caregiver Family Members for the Disabled in Bukhara
Official title: Relationship Between Burdens and Healthy Lifestyle Behaviors of Caregiver Family Members for the Disabled in Bukhara
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Caregiver Burden
Keywords: handicapped
caregiver burden
healthy lifestyle
Lead sponsor: Karadeniz Technical University
Sponsor class: OTHER
First posted: 2022-04-28
Enrollment: 155
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: FAMILY_BASED
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Caregiver Family Member with disabled children

Brief summary: The responsibilities of caring for a disabled family member may cause caregivers to develop risky behaviors for caregiver's health. Therefore, we aimed to examine the relationship between caregiver burdens and healthy lifestyle behaviors of family members caring for a disabled child.

Detailed description: In the study, family members living in Bukhara, Uzbekistan, and caring for a disabled person under the age of 24 were evaluated. Caregiver burden was evaluated with the Caregiver Burden Scale and healthy lifestyle behaviors were evaluated with the Healthy Lifestyle Behaviors Scale II. The fact that there is no earlier study on caregivers of disabled people in Uzbekistan and no research in the literature examining the relationship between caregiving burden and healthy lifestyle behaviors in individuals with disabled children, make this study unique.

Eligibility criteria: Inclusion Criteria:

* Volunteering to participate in the study
* Having a disabled child to take care of
* Being literate

Exclusion Criteria:

* The age of the disabled person being cared for is over 24 years old.

Primary outcomes:
measure: Socio-demographic information
timeFrame: Two months
measure: Number of child
timeFrame: Two months
measure: Assessment of the child age
timeFrame: Two months
measure: Assessment of the child
timeFrame: Two months
measure: Caregiver Burden Scale
timeFrame: Two months
Secondary outcomes:
measure: Healthy Lifestyle Behaviors Scale II
timeFrame: Two months
Other outcomes:
Locations:
city: Trabzon
country: Turkey
facility: Karadeniz Technical University
Study officials:
affiliation: Karadeniz Technical University
name: Nurhayat Korkmaz, PhDstudent
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01152528: Va-Sense - Bacterial Vaginosis Once A Week Screening And Treatment To Reduce Infective Complications, Abortion And Preterm Delivery In Pregnant Women With Previous Preterm Delivery
Official title: VA-SENSE - BACTERIAL VAGINOSIS ONCE A WEEK SCREENING AND TREATMENT TO REDUCE INFECTIVE COMPLICATIONS, ABORTION AND PRETERM DELIVERY IN PREGNANT WOMEN WITH PREVIOUS PRETERM DELIVERY.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Vaginal Infections
Bacterial Vaginosis
Late Miscarriage
Preterm Birth
Preterm Premature Rupture of Membranes
Keywords: bacterial vaginosis
screening
abortion
preterm delivery
Lead sponsor: Common Sense
Sponsor class: OTHER
First posted: 2010-06-29
Enrollment: 248
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine whether screening of pregnant women with history of previous preterm delivery, once a week, for bacterial vaginosis using VA-SENSE, and treatment of positive women will reduce the risk of spontaneous preterm birth. We will compare between the effectiveness of once a week screening and once during pregnancy screening.


Eligibility criteria: Inclusion Criteria:

1. Pregnant subjects, aged 18-50 years, pregnancy week 10 or less or 20 or less, with history of previous preterm delivery.
2. Subject is ready to sign an informed consent form.

Exclusion Criteria:

1. Subject with ruptured membranes.
2. Subject with signs and symptoms of bacterial vaginosis or Trichomoniasis infections.
3. Subject with blood in her vaginal secretions.
4. Subject is currently participating in another clinical study.
5. Subject is unable or unwilling to cooperate with study procedures.

Primary outcomes:
measure: Incidence of preterm birth, gestational week at delivery.
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nahariya
country: Israel
facility: Western Galilee Hospital
state: Western Galilee
Study officials:
References:
Clinical trial NCT03857828: Seminal Level of Clusterin Before Testicular Sperm Extraction
Official title: Seminal Level of Clusterin in Infertile Men as a Predictor for Spermatogenesis Before Testicular Sperm Extraction
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Azoospermia, Nonobstructive
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-02-28
Enrollment: 88
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infertile Male patients (20 - 50 years ) with azoospermia undergoing testicular sperm extraction

Brief summary: Measurement of clusterin level in the semen of infertile males undergoing testicular sperm extraction.

Detailed description: Clusterin, known as apolipoprotein J, sulphated glycoprotein-2 or testosterone - repressed prostate message-2.

It plays important roles in several pathophysiological processes, including tissue remodelling, lipid transport, reproduction, complement regulation and apoptotic cell death .

As clusterin expression is markedly upregulated in various normal and malignant tissues undergoing apoptosis, it has been regarded as a marker for cell death.

There is a conflicting findings concerning the relationship between elevated clusterin expression and enhanced induction of apoptosis; that is, clusterin has appeared to have a powerful anti-apoptotic function through a chaperone-like activity.

In addition to the anti-apoptotic activity, seminal clusterin was reported to promote a tolerogenic response to male antigens, thereby contributing to female tolerance to seminal antigens.

In the testis, clusterin is secreted by Sertoli cells into the fluid of the seminiferous epithelium and deposited onto the membranes of elongating spermatids and mature spermatozoa.

To date, however, there has been little information with respect to the functional roles of clusterin in the male reproductive tract under physiological conditions.

In particular, it remains controversial as to whether or not clusterin helps assist the normal spermatogenesis.

Nonobstructive azoospermia (NOA) males are characterised by impaired spermatogenesis.

Although NOA patients have impaired global spermatogenic function, focal areas of spermatogenesis may still exist in their testes.

Focal spermatogenesis could possibly be obtained by testicular sperm extraction (TESE) technique .

A number of factors have been suggested to be of predictive value for patients with a good chance to retrieve sperm cell such as testicular volume, serum FSH levels , serum total testosterone and serum inhibin B levels.

Eligibility criteria: Inclusion Criteria:

* Infertile males , Azoospermia undergoing TESE as a preliminary step for ICSI .
* Age: 20-50 year

Exclusion Criteria:

* males \<20 years and \>50years
* Cryptorchidism .
* Testicular Agenesis and testicular atrophy .

Primary outcomes:
measure: The level of seminal clusterin before testicular sperm Extraction.
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01012128: Comparison of Three Methods of Taking Temperatures in the Newborn Intensive Care Unit
Official title: Comparison of Temporal Artery, Axillary, and Rectal Temperatures in Preterm Infants in the NICU
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Thermometry
Keywords: Temporal Artery Thermometer
Temperature
Preterm Infants
Lead sponsor: Christiana Care Health Services
Sponsor class: OTHER
First posted: 2009-11-11
Enrollment: 0
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Preterm infants corrected to 30-35 weeks gestation

Brief summary: Preterm infants will have their body temperature measured by three different devices in order to evaluate whether the newest device, a temporal artery scanning thermometer, is accurate for patients in the preterm period.


Eligibility criteria: Inclusion Criteria:

* preterm infants corrected to 30-35 weeks gestation
* current incubator set on air control between 28-30 degrees centigrade

Exclusion Criteria:

* infants \<30 and \>35 weeks gestation
* infants requiring \> 30 degrees centigrade in incubator on air control
* infants currently not in an incubator

Primary outcomes:
measure: Accuracy of temporal artery thermometer measurements
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Newark
country: United States
facility: Christiana Hospital
state: Delaware
Study officials:
affiliation: Christiana Hospital / Christiana Care Health System
name: Michael F Bruno, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02123628: Antibiotic Treatment Duration for Non-Surgically-Treated Diabetic Foot Osteomyelitis
Official title: Six- Versus Twelve-Week Therapy for Non-Surgically-Treated Diabetic Foot Osteomyelitis: A Multicenter Open-Label Controlled Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus
Keywords: diabetic foot osteomyelitis, antibiotic treatment duration
Lead sponsor: Tourcoing Hospital
Sponsor class: OTHER
First posted: 2014-04-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
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 compare the efficacy and tolerance of 6- versus 12-week antibiotic therapy in patients with diabetic foot osteomyelitis treated medically.

Detailed description: The aim of this randomized multicenter clinical study is to compare the efficacy and tolerance of 6 versus 12-week antibiotic treatment in patients with diabetic foot osteomyelitis treated medically as no equivalent data are currenty available in the literature.

Eligibility criteria: Inclusion Criteria:

* diabetic patients treated non-surgically (i.e. without amputation or resection of the infected bone) for an osteomyelitis of the foot complicating a neuropathic foot without ischemia of the foot defined as the absence of any pedal pulse. Patients aged of 18 years or more were included if they had type 2 diabetes and osteomyelitis of the foot (i.e.below the ankle).

Exclusion Criteria:

* Patients with gangrene or who require bone resection or amputation when osteomyelitis of the foot was diagnosed

Primary outcomes:
measure: Primary outcome measure was the proportion of patients of each group with remission of diabetic foot osteomyelitis at the end of follow-up.
timeFrame: one year
Secondary outcomes:
measure: tolerance to treatment in each group of patients
timeFrame: 6 or 12 weeks
Other outcomes:
Locations:
city: Tourcoing
country: France
facility: Dron Hospital
state: Nord
Study officials:
affiliation: Dron Hospital of Tourcoing France
name: Eric M Senneville, MD, PhD
role: STUDY_DIRECTOR
affiliation: Dron Hospital Tourcoing France
name: Alina Tone, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tone A, Nguyen S, Devemy F, Topolinski H, Valette M, Cazaubiel M, Fayard A, Beltrand E, Lemaire C, Senneville E. Six-week versus twelve-week antibiotic therapy for nonsurgically treated diabetic foot osteomyelitis: a multicenter open-label controlled randomized study. Diabetes Care. 2015 Feb;38(2):302-7. doi: 10.2337/dc14-1514. Epub 2014 Nov 20.
Clinical trial NCT05697328: Barotrauma in Hyperbaric Oxygen Therapy
Official title: Pseudoephedrine Prophylaxis for Prevention of Middle Ear Barotrauma in Hyperbaric Oxygen Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Barotrauma
Keywords: hyperbaric oxygen therapy
Lead sponsor: John Muir Health
Sponsor class: OTHER
First posted: 2023-01-25
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective randomized double-blind placebo control study design (enrollment ratio 1:1)
Primary purpose: PREVENTION

Brief summary: The purpose of this research is to study whether the use of pseudoephedrine can help prevent middle ear trauma during HBOT. Pseudoephedrine is an approved drug that is used for temporary relief of nasal or sinus pain and pressure.

Detailed description: Subjects will be asked to take a pill (pseudoephedrine or placebo) between 45 and 120 minutes before hyperbaric oxygen therapy. Subjects' ears will be examined before and after therapy and be asked to assess ear pain. There will be no further tests or procedures after completion of therapy session and ear examinations.

Eligibility criteria: Inclusion Criteria:

* New patient requiring HBOT (either inpatient or outpatient)
* Age greater than or equal to 18 years and less than 80 years
* Fluent in English
* Full decision capacity
* Able and medically cleared to swallow a pill

Exclusion Criteria:

* Enrollment would delay hyperbaric therapy more than 30 minutes in patients with emergent indications (example: Central Retinal Arterial Occlusion, Carbon Monoxide, Air Gas Embolism)
* Contraindication to pseudoephedrine (monoamine oxidase inhibitors (MAOI) use, pregnancy, glaucoma, heart disease, allergy to drug class)
* Systolic Blood Pressure \>160
* Diastolic Blood Pressure \> 90
* Heart Rate \>100
* Decongestant/antihistamine/pseudoephedrine/nasal steroid/oxymetazoline use within 12 hours.
* Prisoner
* Intubated
* Unable to swallow oral medications

Primary outcomes:
measure: Compare changes in self-reported ear pain during hyperbaric oxygen therapy
timeFrame: 45-60 minutes
Secondary outcomes:
measure: Incidence of completed compression
timeFrame: 1 minute
Other outcomes:
Locations:
city: Walnut Creek
country: United States
facility: John Muir Health
state: California
Study officials:
affiliation: John Muir Health
name: Jacinta Showers, RN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01181388: Impacts of Superselective Infarct-related Artery (IRA) Infusion of Tirofiban on Myocardial Reperfusion and Bleeding Complications in Acute Myocardial Infarction (AMI) Patients
Official title: Impacts of Superselective Infarct-related Artery Infusion of Tirofiban on Myocardial Reperfusion and Bleeding Complications in ST Segment Elevation Myocardial Infarction (STEMI) Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Myocardial Infarction
Lead sponsor: Beijing Anzhen Hospital
Sponsor class: OTHER
First posted: 2010-08-13
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Superselective IRA infusion of tirofiban may improve myocardial reperfusion and reduce bleeding complications in AMI patients.


Eligibility criteria: Inclusion Criteria:

* STEMI patients
* chest pain for less than 12hr
* plan to PCI

Exclusion Criteria:

* LM lesion
* stent thrombosis
* cardiac shock
* thrombocytopenia
* allergy to asprin

Primary outcomes:
measure: Major adverse cardiovascular events
timeFrame: 1 month after PCI
measure: Major adverse cardiovascular events
timeFrame: 3 months after PCI
measure: Major Adverse Cardiovascular Events
timeFrame: 6 months after PCI
Secondary outcomes:
measure: number of participants with bleeding events
timeFrame: 1 month
Other outcomes:
Locations:
city: Beijing
country: China
facility: the 28th division, Beijing Anzhen Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT01406288: Outbreak of Hemolytic Uremic Syndrome Linked to Escherichia Coli of Serotype O104:H4
Official title: Outbreak of Hemolytic Uremic Syndrome Linked to Escherichia Coli of Serotype O104:H4 in Bordeaux Urban Area, June 2011: Evaluation of Diagnostic, Prognostic and Pathophysiological Data
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemolytic-uremic Syndrome
Escherichia Coli Infections
Keywords: hemolytic-uremic syndrome
shiga-toxin-producing E. Coli
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2011-08-01
Enrollment: 9
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: dinner guest to a collective meal on June 8th, 2011 in Bègles, a city of Bordeaux urban area (CUB).

Brief summary: The Hemolytic Uremic Syndrome (HUS) in its typical form occurs after a food born infection with a shiga-toxin secreting bacteria, usually Escherichia coli of the O157H7 serotype. An outbreak of bloody diarrhea followed by HUS begun after a collective meal with 120 persons on June 8th, 2011 in Bègles, a city of Bordeaux urban area (CUB).

At least 9 patients, 8 adults and 1 child have been involved in this HUS outbreak, E. coli of the O104:H4 serotype being demonstrated in most patients. This outbreak is remarkable by its preponderance in adults and women, its aggressiveness with multiorgan involvement , i.e. the kidneys, brain, liver, pancreas, and skin.

Pathophysiology, prognosis, and treatment of typical HUS are poorly defined, particularly in adults who are usually not involved in typical E. coli O157H7 HUS.

The aim of the present study is to gain knowledge on these different aspects of the HUS, including response to therapy.


Eligibility criteria: Inclusion Criteria:

* All patients with HUS concomitant to the outbreak linked to E. coli O104:H4

Exclusion Criteria:

* Patient not willing to participate or to sign informed consent

Primary outcomes:
measure: Improve scientific knowledge on epidemic HUS in the context of an outbreak of E. coli O104:H4 HUS in the town of Bègles, urban area of Bordeaux, France
timeFrame: during patient hospitalization
Secondary outcomes:
measure: evaluate efficiency of therapeutic and diagnostic strategies
timeFrame: during patient hospitalization
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Service de Néphrologie, transplantation dialyse - Hôpital Pellegrin
Study officials:
affiliation: University Hospital, Bordeaux
name: christian COMBE, MD
role: STUDY_DIRECTOR
affiliation: University Hospital, Bordeaux
name: Christian COMBE, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02746588: Description of the Uterine Cavity in Patients With Recurrent Miscarriages
Official title: Description of the Uterine Cavity in Patients With Recurrent Miscarriages
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Recurrent Miscarriages
Habitual Abortions
Keywords: miscarriage
uterine abnormalities
Chronic infection
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2016-04-21
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with recurrent miscarriages and refurred to the specialist facility af Rigshospitalet

Brief summary: To be diagnosed with recurrent miscarriages, a couple might have a child, however experiences three or more miscarriages, primarily this happens during the first trimester.

These miscarriages often needs medical evacuation or a D \& C. Surgery or retained tissue increases the risk of complications as infection and/or adhesions, known as asherman syndrome, which may result in subfertility.

Recently chronic infection in the endometrium has been proposed to contribute to the condition, as protocols including treatment with antibiotics have led to birth at term for some of these women.

Using the very minimal invasive office hysteroscopy, the investigators aim to describe the uterine cavity in patients diagnosed with recurrent miscarriages regarding both abnormalities in the endometrium and chromic infection.

Detailed description: The Unit for Recurrent Pregnancy-loss at Rigshospitalet treats about 300 of couples with recurrent miscarriages a year. Together with the current examination program, the investigators plan to describe the uterine cavity according to abnormalities as septa, adhesions and further the condition for the endometrium regarding infection and hormone receptors. This description will include descriptive office hysteroscopy with biopsies for histologic - and immunohistochemically examinations.

Eligibility criteria: Inclusion Criteria:

* Correctly diagnosed with recurrent miscarriages

Exclusion Criteria:

* Known course of the condition

Primary outcomes:
measure: Description of the Uterine Cavity in Patients With Recurrent Miscarriages
timeFrame: 1 year
measure: Description of the Uterine Cavity in Patients With Recurrent Miscarriages
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Hvidovre Hospital, Department of Gynecology and Obstetrics
state: Hvidovre
Study officials:
References:
Clinical trial NCT04966078: Treatment of Mild and Moderate Cases of Gynaecomastia
Official title: Comparison Between Liposuction and Peri-areolar Surgical Excision in Mild and Moderate Cases of Gynaecomastia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gynecomastia
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2021-07-19
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to compare liposuction and periareolar surgical excision in mild and moderate cases of gynecomastia as regard cosmosis, complications, patient satisfaction, operation time, and hospital stay.

This study will be carried out on patients with gynecomastia presented to the Plastic Surgery Department, Sohag University, in the period between January 2021 to January 2022 as a retrospective and prospective study.

Patients will be divided into 2 groups:

group A treated with suction-assisted liposuction. group B treated with peri-areolar surgical excision. Each group contains 20 patients.


Eligibility criteria: Inclusion Criteria:

- The age of patients ranges from 18-60yrs. Mild and moderate cases of gynecomastia.

Exclusion Criteria:

* Patients with endocrine causes. Patients with genetic causes. Severe cases of gynecomastia. Patients who refused surgical intervention. Patients who are not fit for surgery. Patients with chronic illness.

Primary outcomes:
measure: Difference between group A and B in aesthetic satisfaction
timeFrame: difference between group A and B in aesthetic results according to visual analogue scale at 3 month post-operative
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University
Study officials:
affiliation: sohag univeristy hospital
name: Gamal Y Elsaied, MD
role: STUDY_CHAIR
References: