louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01164293: Atopy Patch Test in Children With Food Allergy-related Gastrointestinal Symptoms
Official title: Prevalence of Positive Reactions in Atopy Patch Test in Children With Food Allergy-related Gastrointestinal Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Food Allergy
Keywords: Atopy patch test
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2010-07-16
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Positive reactions in Atopy patch test in children with food allergy-related gastrointestinal symptoms

Detailed description: The prevalence of food allergy seems to be increasing, which might explain the increased demand for reliable evaluation of patients with suspected food-related gastrointestinal symptoms. Little is known about the diagnostic accuracy of atopy patch tests(APT) in the clinical practice. APT seems to have a better specificity than the IgE methods and seems to reflect late-phase clinical reactions.The aims of this study were to evaluate:

(i) The prevalence of positive reaction of APTs for food allergy-related gastrointestinal diseases. (ii)Positive reaction of APT compare with skin prick test. (iii)Positive reaction of APT using lyophilized food vs commercially available food extracts. (iv)Side effect or adverse events of APT

Eligibility criteria: Inclusion Criteria:

* Patients who had history of suspected food allergy-related gastrointestinal symptoms eg. nausea and vomiting, diarrhea, abdominal pain or hematochezia after ingesting some food.
* Age 1 month-18 yrs
* Elimination diet was done at least 7 days before starting the study
* Written informed consent was obtained from the parents of each child enrolled in the study

Exclusion Criteria:

* Who have dermographism
* Who have chronic disease eg. autoimmune disease, immune deficiency, cancer or allergic disease
* Pregnant women
* Who have severe eczema
* Who receive antihistamine, topical steroid and systemic steroid \> 20 mg/day withiin 7 days prior study

Primary outcomes:
measure: Prevalence of positive reaction in APT in children with food allergy-related gastrointestinal symptoms
timeFrame: 3 days
Secondary outcomes:
measure: Comparisons atopy patch test reaction between lyophilized allergen and commercial allergen
timeFrame: 3 days
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Department of Pediatrics, Siriraj hospital, Mahidol University
Study officials:
affiliation: Mahidol University
name: Nualanong Visitsunthorn, MD
role: STUDY_DIRECTOR
References:
citation: Visitsunthorn N, Chatpornvorarux S, Pacharn P, Jirapongsananuruk O. Atopy patch test in children with atopic dermatitis. Ann Allergy Asthma Immunol. 2016 Dec;117(6):668-673. doi: 10.1016/j.anai.2016.09.446.
Clinical trial NCT02612493: Obesity and Metabolic Surgery in Patients With Type I Diabetes
Official title: Obesity and Metabolic Surgery in Patients With Type I Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type I Diabetes
Keywords: obesity surgery
type I diabetes
weight loss
insulin dosage
postsurgery metabolic changes
Lead sponsor: Sana Klinikum Offenbach
Sponsor class: OTHER
First posted: 2015-11-23
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All obeses patients with type I diabetes who underwent weight loss surgery in our department.

Brief summary: Obesity is the indication for bariatric surgery in type I diabetes. Interestingly postsurgery the patients improve remarkable in their need for insulin, not only in the daily total insulin dosage but also in the dosage of IU per kg.

Detailed description: The investigators performed a retrospective analysis on 16 patients undergoing weight loss surgery in obesity with concomitant type I diabetes. All patients were evaluated during Follow - Up to analyze insulin dosage and metabolic changes.

Eligibility criteria: Inclusion Criteria:

* type I diabetes
* BMI \> 40kg/m2

Exclusion Criteria:

* type II diabetes

Primary outcomes:
measure: Insulin dosage
timeFrame: up to 8 years
Secondary outcomes:
measure: Excess Weight loss in %
timeFrame: up to 8 years
measure: Change in HgA1c
timeFrame: up to 8 years
measure: Change in lipids
timeFrame: up to 8 years
Other outcomes:
Locations:
Study officials:
affiliation: Sana Klinikum Offenbach
name: Rudolf Weiner, MD, Prof.
role: STUDY_CHAIR
References:
citation: Raab H, Weiner RA, Frenken M, Rett K, Weiner S. Obesity and metabolic surgery in type 1 diabetes mellitus. Nutr Hosp. 2013 Mar;28 Suppl 2:31-4. doi: 10.3305/nh.2013.28.sup2.6711.
citation: Kirwan JP, Brethauer SA, Aminian A, Rosenthal RJ, Kashyap SR, Schauer PR. Response to comments on Brethauer et al. Bariatric surgery improves the metabolic profile of morbidly obese patients with type 1 diabetes. Diabetes care 2014;37:e51-e52. Diabetes Care. 2014 Nov;37(11):e251. doi: 10.2337/dc14-1769. No abstract available.
citation: Brethauer SA, Aminian A, Rosenthal RJ, Kirwan JP, Kashyap SR, Schauer PR. Bariatric surgery improves the metabolic profile of morbidly obese patients with type 1 diabetes. Diabetes Care. 2014;37(3):e51-2. doi: 10.2337/dc13-1736. No abstract available.
Clinical trial NCT04479293: Post COVID-19 Functional Status in Egypt
Official title: Assessment of Functional Recovery From COVID-19 Using the Proposed Post- COVID-19 Functional Status Score
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Coronavirus Disease
SARS-CoV-2
Keywords: Functional score
Radiologic changes
Psychologic changes
Laboratory
Sleep disturbance
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-07-21
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients diagnosed as COVID-19 on clinical, laboratory, radiologic or PCR based are included.

Patients with different severity mild, moderate, severe , managed at home or in hospitals are included.

Brief summary: Since the outbreak of coronavirus disease - COVID-19 pandemic, most attention has focused on mode of transmission, clinical picture of the disease, treatment and prevention. In the coming weeks and months emphasis will gradually involve the post- acute care of COVID-19 survivors. It is anticipated that COVID-19 may have major impact on physical, cognitive, mental, social health status even in patients with mild disease. Moreover, pulmonary, radiologic, laboratory, sleep issues remain to be addressed


Eligibility criteria: Inclusion Criteria:

* All confirmed cases with COVID-19

Exclusion Criteria:

* Non COVID-19 cases

Primary outcomes:
measure: number of functional limitations post COVID-19
timeFrame: 3-6 month
Secondary outcomes:
measure: number of psychologic changes
timeFrame: 3-6 months
measure: Sleep Disturbance and quality
timeFrame: 3-6 months
measure: Radiologic changes
timeFrame: 3-6 months
measure: Laboratory changes
timeFrame: 3-6 moths
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Aliaa Hussein
Study officials:
affiliation: Assiut University
name: Aliae Mohamed-Hussein, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02035293: Frequency of Diagnostic Symptomatic Pulmonary Embolism's in Patients Hospitalized for Clinical Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)
Official title: Frequency of Diagnostic Symptomatic Pulmonary Embolism's in Patients Hospitalized for Clinical Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Patients Hospitalized for a COPD Exacerbation
Keywords: COPD Exacerbation
Pulmonary embolism
Standardized and consensus diagnostic strategy
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2014-01-14
Enrollment: 750
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: A standardized diagnostic strategy of pulmonary embolism will be applied to eligible patients, incorporating a clinical probability score (revised Geneva score), plasma D-dimer assay and if necessary, a multidetector-row CT angiography thoracic and venous ultrasound of the lower limbs. All the patient with a pulmonary embolism diagnosed or not, will be followed for 3 months.


Eligibility criteria: Inclusion Criteria:

* Patients hospitalized for a COPD exacerbation
* COPD previously diagnosed

Exclusion Criteria:

* Allergy to iodinated contrast
* Creatinine clearance \< 30 mL / min
* Patient hospitalized for exacerbation of COPD for more than 48 hours
* Pneumothorax
* Exams impossible to be performed
* Pregnancy
* Life expectancy \< 3 months
* Patients already receiving anticoagulant therapy for another reason (mechanical valve, cardiac arrhythmia).

Primary outcomes:
measure: Frequency of pulmonary embolism in patients hospitalized for a clinical exacerbation of COPD.
timeFrame: 27 months
Secondary outcomes:
measure: The rate of pulmonary embolism diagnosed during the 3 month follow-up in patients whom pulmonary embolism was initially excluded when they've been included in the study
timeFrame: 27 months
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU
city: Brest
country: France
facility: CHRU de Brest
city: Brest
country: France
facility: HIA
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou
city: Quimper
country: France
facility: CH de Cornouaille Quimper
city: St-Etienne
country: France
facility: Hôpital Nord
Study officials:
affiliation: CHRU de Brest
name: Francis COUTURAUD, PU-PH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03774693: Regional Block of the Nose for Hypotensive Anaesthesia in Septo-rhinoplasty
Official title: Efficacy of Regional Block of the Nose in Achieving Hypotensive Anaesthesia in Septo-rhinoplasty Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypotensive Anesthesia
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2018-12-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Septorhinoplasty is a cosmetic surgery that many people are choosing to undergo. It can be done under general anesthesia, twilight anesthesia or regional anesthesia. Controlled hypotensive anesthesia is required to minimize bruising, swelling, and bleeding that reduces visibility in the operative field and hence satisfactory surgical outcome.

The goal of our study to prove that regional block of the nose provides efficient hypotensive anesthesia


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status I-II
* Scheduled for elective septo-rhinoplasty surgery

Exclusion Criteria:

* Patients with hypertension or coronary artery disease,
* Patients with renal, hepatic or cerebral insufficiency,
* Patients with coagulopathy or receiving drugs influencing blood coagulation,
* Patients with known sensitivity to any of the study drug

Primary outcomes:
measure: Hypotensive anesthesia
timeFrame: Intraoperative
measure: Requirements of Fentanyl
timeFrame: Intraoperative
Secondary outcomes:
measure: Average category scale (ACS)
timeFrame: Intraoperative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
References:
Clinical trial NCT06065293: Mental Health, Gender-Based Violence, and Stunting in Tanzania
Official title: Establishing a Community-led, Family-centered Mental Wellness Initiative in Rural Tanzania
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mental Health Issue
Substance Use
Child Development
Lead sponsor: Colorado State University
Sponsor class: OTHER
First posted: 2023-10-03
Enrollment: 162
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 162 mothers participating in a local non-profit organization in Tanzania

Brief summary: One in three children under the age of five in Tanzania experience stunting, which is defined as impairments in growth and development that often occur after poor nutrition, poor health, and low psychosocial stimulation. Research suggests that mental health problems of parents may be related to stunting outcomes and parental mental health is closely related to experiences of intimate partner violence, also called gender-based violence. However, very little research exists on the connection between these elements, and interventions may be necessary in order to reduce the impacts that mental health and gender-based violence may have on stunting.

This study is a secondary data analysis of de-identified survey and stunting data that were conducted as a part of a needs assessment by a local nonprofit organization in Tanzania. The needs assessment was conducted to inform a mental health initiative organized by the established nonprofit across 5 villages in rural Tanzania. This project's primary aims are:

* To determine the prevalence of mental health and family relationship problems in five villages
* To determine associations between intimate partner violence (IPV) mental health and substance use and childhood stunting


Eligibility criteria: Inclusion Criteria:

* Living within the 5 rural villages
* participating in a local nonprofit
* pregnant or having a child under 2 years old

Exclusion Criteria:

* Living outside of the 5 villages
* Not participating in the local nonprofit
* Not pregnant or having a child under 2 years old

Primary outcomes:
measure: Depression and anxiety
timeFrame: Through study completion, approximately 2 months
measure: Substance use
timeFrame: Through study completion, approximately 2 months
measure: World Health Organization (WHO) Violence Against Women
timeFrame: Through study completion, approximately 2 months
measure: Childhood stunting
timeFrame: Through study completion, approximately 2 months
Secondary outcomes:
measure: Women's Empowerment
timeFrame: Through study completion, approximately 2 months
Other outcomes:
Locations:
city: Fort Collins
country: United States
facility: Colorado State University
state: Colorado
Study officials:
affiliation: Colorado State University
name: Shelley Haddock, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02683993: Utilizing Holmium Laser for FURS Renal Stone Lithotripsy Comparing Stone Breaking vs. Stone Dusting Settings
Official title: Utilizing Holmium Laser for FURS Renal Stone Lithotripsy Comparing Stone Breaking vs. Stone Dusting Settings
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stone Clearance
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
Collaborators: name: Lumenis Be Ltd.
First posted: 2016-02-17
Enrollment: 20
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: Twenty (20) subjects presenting with a renal stone and candidates for FURS (flexible ureteroscopic renal surgery) will undergo a single FURS procedure for a kidney stone as part of the study, using the study device. These subjects will be randomized into stone breaking treatment or stone dusting.

Detailed description: Twenty (20) subjects presenting with a renal stone and candidates for FURS (flexible ureteroscopic renal surgery) will undergo a single FURS procedure for a kidney stone as part of the study, using the study device. These subjects will be randomized into stone breaking treatment or stone dusting.

Eligibility criteria: Inclusion Criteria:

1. Subject will be older than 18 years of age
2. Subject was diagnosed with renal calculi meeting the following criteria:

   * Largest stone measures no more than 2cm on a single diameter and is no less than 0.8cm as defined by X-ray or CT.
   * Accumulative stone burden (addition of all stone diameters) is no more than 2.5cm.
3. Subject is a candidate for FURS procedure
4. Subject is willing and has signed the Informed Consent Form

Exclusion Criteria:

1. Subject has undergone a previous treatment for stones in the same kidney
2. Subject requires another, concomitant procedure, other than FURS, to be performed during this treatment session.
3. Female subject is pregnant
4. Concomitant anticoagulant medication that cannot be suspended during surgery

Primary outcomes:
measure: Stone Clearance
timeFrame: Stone clearance based on 1 month follow-up imaging data as compared to baseline
measure: Duration of catheterization time
timeFrame: Change from 1 month to baseline
measure: Procedure time
timeFrame: during the procedure
measure: Usage of alternative stone extracting devices
timeFrame: as measured during the procedure
measure: hospital stay
timeFrame: Change from 1 month to baseline
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York Methodist Hospital
state: New York
Study officials:
References:
Clinical trial NCT00518193: Phase II Study , Association of Cisplatine Topotecan and Cetuximab in Patients Whith Late or in Progress Epithelial Cancer of the Cervix
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Cervix Cancer
Lead sponsor: ARCAGY/ GINECO GROUP
Sponsor class: OTHER
First posted: 2007-08-20
Enrollment: 44
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The efficacy of chimiotherapy in cervix epithelial cancer is low even with the association cisplatine - topotecan .

News thérapeutics are needed in the goal of increase the survival and quality of life in patients with cervix cancer.

Cetuximab has shown the potentialisation on the efficacy of cisplatine and irinotecan.

Cisplatine and topotecan have shown an efficacy in cervix cancer. Cetuximab is well tolerate. Many clinical trials shown the faisability of the association of cetuximab and cisplatine in cancer.

Many clinical trials have shown the faisability of association of cetuximab and irinotecan in colorectals metastatiques cancers .


Eligibility criteria: Inclusion Criteria:

* More than 18 years old.
* Epidermoïde carcinoma or adenocarcinoma of the cervix, hystologic proved
* Patientes in a late stage or with progresive desease.
* One mesurable lesion in irradiated zone.
* Patient who have already treated radio-chimiothérapy with platine should have a 6 month free interval.
* Index status of ECOG (" Eastern Cooperative Oncology Group ")less than 2.
* Good biologicals and hematologicals fonctions:
* Neutrophiles noless than 1,5.109/L.
* Platelets nolss than 100.109/L.
* Total bilirubin no more than 1,5 time the normal superior range.
* Transaminases no mote than 3 x Time NSR
* Creatinine clairance Cockroft) more than 50 mL/min .
* Inform consent signed.

Exclusion Criteria:

* Previous cytotoxic traitement exept radio-chaemiotherapy of the pelvis cerebrals metastasis.
* Other cancer in the last 5 years exept treated BCC.
* Dermatologic desease.
* Crohn desease or Hemorragic rectal-Colitis.
* Neuropathy.
* Psychologic disorder.
* Social troubles.
* Pregnant women.

Primary outcomes:
measure: responses rate regarding the RECIST criteria.
timeFrame: up to progression
Secondary outcomes:
measure: Quality of life, free interval, safety.
timeFrame: up to progression
Other outcomes:
Locations:
city: Montpellier
country: France
facility: CRLC Val d'Aurelle
city: Paris
country: France
facility: Hôpital HOTEL DIEU
city: Paris
country: France
facility: Oncologie, Hôtel-Dieu, 1 place du parvis Notre-Dame
city: Toulouse
country: France
facility: Centre Claudius Régaud
Study officials:
affiliation: STRASBOURG
name: Pr KURTZ Jean Emmanuel
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06847893: The Effect of Rebozo Technique on Perceived Support and Control in Childbirth
Official title: The Effect of Rebozo Technique on Perceived Support and Control in Childbirth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnant Women
Keywords: rebozo
support
control
pregnant
birth
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
Collaborators: name: Uskudar University
First posted: 2025-02-26
Enrollment: 44
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study was designed as a randomized controlled, 2-group (intervention and control), experimental research.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study was designed as a randomized controlled, 2-group, experimental study to measure the levels of perceived birth support and control between women with and without rebozo technique.

Detailed description: Objective: This study was conducted to measure the perceived support during labor and the level of control over their own labor in pregnant women who underwent rebozo technique.

Method: The study was conducted in a randomized controlled experimental design between September and December 2024. The population of the study consisted of 44 primiparous pregnant women admitted to a district state hospital for delivery. The sample size was calculated and the study was conducted with 44 pregnant women (experiment: 22, control: 22). While rebozo technique was applied to the experimental group during the trauma process, routine midwifery care was applied to the control group. Introductory Information Form, Perceived Support and Control Scale in Childbirth were used to collect data in the study.

Eligibility criteria: Inclusion Criteria:

* Volunteering to participate in the research,
* Don't speak Turkish,
* Being literate,
* Having a low-risk pregnancy,
* Primiparous pregnancy

Exclusion Criteria:

* Being out of position
* Having a high-risk pregnancy (vaginal bleeding, no hypertension, etc.),
* Dilatation below 4 cm and above 6 cm,
* Initiation of labor induction,
* Having received childbirth preparation training,
* Absence of a birth attendant in trauma,

Primary outcomes:
measure: Perception of Control and Support in the Birth Scale
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Uskudar University
state: Ümraniye
Study officials:
affiliation: Üsküdar University NP Health Campus Institute of Health Sciences Department of Midwifery
name: Ayça DEMİR YILDIRIM, PhD
role: PRINCIPAL_INVESTIGATOR
References: