louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00742807: Pain Evaluation During Follicle Aspiration: Comparison of Two Sedation Protocols
Official title: Pain Evaluation During Follicle Aspiration: Comparison of Two Sedation Protocols
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Pain
Keywords: sensation
relief
during
surgery
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2008-08-28
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Giving infiltration analgesia around the neck of the womb (= paracervical block, PCB) is frequently experienced as a painful procedure by women undergoing follicle aspiration. Two sedation protocols, where in the one protocol a low dose of alfentanil hydrochloride is already administered before the PCB, will be compared with each other and pain relief measured using the 'Visual Analogue Scale' and the 'Short-Form McGill Questionnaire'


Eligibility criteria: Inclusion Criteria:

* Healthy women and female infertility patients
* Between 18 and 43 years of age

Exclusion Criteria:

* Patients with a known allergy to alfentanil hydrochloride or comparable drugs (morphine, cocaine)

Primary outcomes:
measure: Pain relief
timeFrame: During and immediately after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital
Study officials:
affiliation: University Hospital, Ghent
name: Frank Dumortier, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00419107: Beta Cell Function in Women With Turner Syndrome
Official title: Beta Cell Function in Women With Turner Syndrome
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Turner Syndrome
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2007-01-08
Enrollment: 25
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 13 women with TS and 12 control women

Brief summary: Diabetes is more frequent in women with Turner syndrome. The purpose of this study is to see, in what ways the glucose metabolism is different in this study population. The hypothesis is that women with Turner Syndrome have an impaired insulin production (beta cell function).


Eligibility criteria: Inclusion Criteria:

* Turner syndrome

Exclusion Criteria:

* Diagnosed diabetes
* BMI\>30
* Untreated cardiac or thyroid disease
* Cancer illness

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Medical Department M (Endocrinology and Diabetes), Aarhus University Hospital
state: Aarhus C
Study officials:
name: Jens Sandahl Christiansen, prof. dr.med
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hjerrild BE, Holst JJ, Juhl CB, Christiansen JS, Schmitz O, Gravholt CH. Delayed beta-cell response and glucose intolerance in young women with Turner syndrome. BMC Endocr Disord. 2011 Mar 15;11:6. doi: 10.1186/1472-6823-11-6.
Clinical trial NCT00163488: Safety of Ciclesonide Nasal Spray Administered With Inhaled Fluticasone Dipropionate/Salmeterol in Adults With Perennial Allergic Rhinitis (BY9010/M1-409)
Official title: Investigation of Potential Additive Inhibitory Effects on HPA-Axis of Ciclesonide Nasal Spray When Administered Concomitantly With Orally Inhaled Fluticasone Propionate/Salmeterol (FP/SAL) in Patients (18-60 Years) With Perennial Allergic Rhinitis (PAR)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Perennial Allergic Rhinitis
Allergic Rhinitis
Hay Fever
Keywords: Allergy
Perennial Allergic Rhinitis
Allergic Rhinitis
Hay Fever
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-09-14
Enrollment: 106
Sex: ALL
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: The purpose of this study is to evaluate the safety and tolerability of combined ciclesonide nasal spray administered along with a fixed combination of inhaled fluticasone dipropionate/salmeterol.


Eligibility criteria: Main Inclusion Criteria:

* General good health, other than perennial allergic rhinitis
* History and diagnosis of perennial allergic rhinitis by skin prick
* Normal body weight as defined by the study protocol

Main Exclusion Criteria:

* Pregnancy, nursing, or plans to become pregnant or donate gametes (ova or sperm) for in vitro fertilization during the study period or for 30 days following the study period
* Participation in any investigational drug trial within the 30 days preceding the Screening Visit
* A known hypersensitivity to any corticosteroid or any of the excipients in the formulations
* Use of any prohibited concomitant medications as defined by the study protocol
* Previous participation in an intranasal ciclesonide study
* Non-vaccinated exposure to or active infection with, chickenpox or measles within the 21 days preceding the Screening Visit

Primary outcomes:
measure: safety.
Secondary outcomes:
measure: safety and tolerability.
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Altana Pharma/Nycomed
state: California
Study officials:
affiliation: AstraZeneca
name: AstraZeneca AstraZeneca
role: STUDY_DIRECTOR
References:
Clinical trial NCT02802488: Age Related D-dimer Evaluation for the Exclusion of a Left Atrium Thrombus in Patients With Atrial Fibrillation (ADDIT-AF)
Official title: Age Related D-dimer Evaluation for the Exclusion of a Left Atrium Thrombus in Patients With Atrial Fibrillation (ADDIT-AF)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: D-dimers
Atrial fibrillation
Lead sponsor: Brugmann University Hospital
Sponsor class: OTHER
First posted: 2016-06-16
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Patients with atrial fibrillation are at increased risk of thrombus formation in the left heart, especially in the auricula and the atrium. Their presence increases the risk of ischemic stroke, especially during cardioversion, performed either by drug or by external electric shock. The gold standard to exclude this thrombus and consider cardioversion is the transesophageal echocardiography.

D-dimers, products of the degradation of fibrin, have been studied several times to assess the presence of thrombi in the body, especially in pulmonary embolism. In cardiology and despite several studies on the matter, there is currently no blood D-dimers value allowing to detect the presence of a thrombus with a good predictive value. Correlating the D-dimer values with age, as has been done for some years in pulmonary embolism, would give the opportunity to create a simple, inexpensive and widely applicable tool to eliminate the presence of a thrombus in the left heart.

If the results are satisfactory, the investigators might consider not using transesophageal echocardiography as this examination is unpleasant for the patient and operator dependant, unlike a standard blood sampling.

This study aims to test the following hypothesis: D-dimers values superior or equal to ten times the patient's age is predictive of a thrombus.


Eligibility criteria: Inclusion Criteria:

* Patients with de novo or recent atrial fibrillation requiring cardioversion, either by drug, by an electric shock or an intervention.

Exclusion Criteria:

* valvulopathy
* infection
* neoplasia
* inflammatory disease
* recent surgery
* pregnancy
* aorta aneurism
* deep vein thrombosis
* pulmonary embolism

Primary outcomes:
measure: D-dimers concentration
timeFrame: first day of hospitalization
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: CHU Brugmann
Study officials:
affiliation: CHU Brugmann
name: José Castro, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Brugmann
name: Alexandre Almorad, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00858988: Trial of Rifaximin in the Treatment of Tropical Enteropathy
Official title: A Randomized, Double-blind, Placebo-controlled Trial of Rifaximin, a Non-absorbable Antibiotic, in the Treatment of Tropical Enteropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tropical Enteropathy
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Baylor College of Medicine
name: Kamuzu University of Health Sciences
name: United States Department of Agriculture (USDA)
First posted: 2009-03-10
Enrollment: 147
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether rifaximin is effective in the treatment of tropical enteropathy in a population of African children at high risk for this disease.


Eligibility criteria: Inclusion Criteria:

* live in single village

Exclusion Criteria:

* acutely malnourished
* acutely ill
* chronic disease

Primary outcomes:
measure: Difference in the Urinary L:M Ratio Before and After the Intervention
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Limela
country: Malawi
Study officials:
affiliation: Washington University School of Medicine
name: Mark J Manary
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05700188: Outcome of GI Cancer in NCKUH
Official title: Explore the Diagnosis and Treatment Outcome of Alimentary Tract Cancer in National Cheng Kung University Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Collection of Real-world Data in a Single Institute
Lead sponsor: National Health Research Institutes, Taiwan
Sponsor class: OTHER
First posted: 2023-01-26
Enrollment: 730
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with pancreatic cancer treated at National Cheng Kung University Hospital during 2013/01/01 to 2020/12/31 were retrospectively reviewed.

Brief summary: Alimentary tract cancer patients treated at National Cheng Kung University Hospital during 2013/01/01 to 2020/12/31 were reviewed.

Detailed description: We would like to explore the treatment strategy and clinical outcome of alimentary tract cancer in National Cheng Kung University Hospital. The result could help physician to further realize the real world practice of cancer treatment in Taiwan and might also help clinician to optimize the diagnosis and treatment strategy in alimentary tract cancer patients. Alimentary tract cancer patients treated at National Cheng Kung University Hospital during 2013/01/01 to 2020/12/31.

Eligibility criteria: Inclusion Criteria:

All patients with pancreatic cancer treated at National Cheng Kung University Hospital during 2013/01/01 to 2020/12/31

Exclusion Criteria:

No treatment or refuse treatment

Primary outcomes:
measure: Overall survival (OS)
timeFrame: 10 years
Secondary outcomes:
measure: Progression-free survival (PFS)
timeFrame: 10 years
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng-Kung University Hospital
city: Tainan
country: Taiwan
facility: National Institute of Cancer Research
Study officials:
References:
Clinical trial NCT02631109: L-DEP Regimen as a Salvage Therapy for Refractory Epstein Barr Virus-induced Hemophagocytic Lymphohistiocytosis
Official title: L-DEP Regimen as a Salvage Therapy for Refractory Epstein Barr Virus-induced Hemophagocytic Lymphohistiocytosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hemophagocytic Lymphohistiocytosis
Keywords: Pegaspargase
hemophagocytic lymphohistiocytosis
Epstein Barr virus
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2015-12-16
Enrollment: 120
Sex: ALL
Minimum age (years): 14
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aimed to investigate the efficacy and safety of Pegaspargase together with liposomal doxorubicin, etoposide and high dose methylprednisolone (L-DEP) as a salvage therapy for refractory Epstein Barr virus-induced hemophagocytic lymphohistiocytosis.


Eligibility criteria: Inclusion Criteria:

1. Patients were older than 14 years of age
2. Diagnosed as EBV-Hemophagocytic Lymphohistiocytosis (HLH)
3. Patients did not achieve at lease partial response after initial treatment including HLH-94 or DEP no less than 2 weeks
4. Informed consent

Exclusion Criteria:

1. Heart function above grade II (NYHA)
2. Accumulated dose of doxorubicin above 300mg/m2 or epirubicin above 450mg/m2
3. Pregnancy or lactating Women
4. Allergic to Pegaspargase, doxorubicin or etoposide
5. Active bleeding of the internal organs
6. uncontrollable infection
7. history of acute and chronic pancreatitis
8. Participate in other clinical research at the same time

Primary outcomes:
measure: Evaluation of treatment response
timeFrame: Change from before and 2,4,6 and 8 weeks after initiating L-DEP salvage therapy
measure: Change of Epstein-Barr virus(EBV)-DNA
timeFrame: Change from before and 2, 4, 6 and 8 weeks after initiating L-DEP salvage therapy
Secondary outcomes:
measure: Survival
timeFrame: from the time patients received L-DEP salvage therapy up to 24 months or November 2019
measure: Adverse events that are related to treatment
timeFrame: through study completion, an average of 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Friendship Hospital
name: zhao wang, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wang Y, Huang W, Hu L, Cen X, Li L, Wang J, Shen J, Wei N, Wang Z. Multicenter study of combination DEP regimen as a salvage therapy for adult refractory hemophagocytic lymphohistiocytosis. Blood. 2015 Nov 5;126(19):2186-92. doi: 10.1182/blood-2015-05-644914. Epub 2015 Aug 19.
citation: Wang J, Wang Y, Wu L, Zhang J, Lai W, Wang Z. PEG-aspargase and DEP regimen combination therapy for refractory Epstein-Barr virus-associated hemophagocytic lymphohistiocytosis. J Hematol Oncol. 2016 Sep 9;9(1):84. doi: 10.1186/s13045-016-0317-7.
Clinical trial NCT05190809: Immediate Breast Reconstruction With Hybrid Fat Transfer
Official title: Immediate Breast Reconstruction With Hybrid Fat Transfer: Prospective Single-arm Interventional Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Appearance Reconstruction Disproportion
Keywords: Goldilocks Mastectomy
Fat grafting
Breast reconstruction
skin sparing mastectomy
Lead sponsor: Abouqir General Hospital
Sponsor class: OTHER
Collaborators: name: Alexandria University
First posted: 2022-01-13
Enrollment: 25
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Investigators in this study describe a new perspective for female patients that will undergo skin-sparing mastectomy in which there will be an immediate reconstruction of the mastectomized breast for more satisfactory aesthetic results.

Detailed description: This study introduces a new perspective for women who will undergo mastectomy especially Goldilocks mastectomy in which the investigators do fat grafting to the medial and lateral pillars of the breast as well as the inferior dermal flap in order to have a voluminous remaining breast shape that is close enough in size with the contralateral breast for more aesthetic results and to observe the lipografted tissue reaction after radiotherapy

Eligibility criteria: Inclusion Criteria:

* Female patients
* Age 20 - 65 years old
* females with unilateral breast malignancy
* candidate for Goldilocks mastectomy procedure

Exclusion Criteria:

* Females with ages beyond the study frame.
* Females refusing to participate
* Fameles that not accepting the liposuction, lipofilling procedure
* Females with contralateral previously operated or mastectomized breast.

Primary outcomes:
measure: Immediate breast reconstruction and equalizing the operated breast cup size with the no-operated breast cup size
timeFrame: 6 months follow up post-surgical
Secondary outcomes:
measure: Evaluate the skin changes and the trophic effect of radiotherapy on the fat grafted tissue
timeFrame: through the radiotherapy course and 1 month after
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Abouqir General Hospital
Study officials:
References:
Clinical trial NCT01003509: A New Approach in Inguinal Hernia Repair: Double Repair. A Prospective, Randomized, Controlled Clinical Trial
Official title: A New Approach in Inguinal Hernia Repair: Double Repair. A Prospective, Randomized, Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hernia
Keywords: inguinal
hernia
new
repair
modified shouldice
double
Lead sponsor: SB Istanbul Education and Research Hospital
Sponsor class: OTHER
First posted: 2009-10-28
Enrollment: 50
Sex: ALL
Minimum age (years): 16
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a new inguinal hernia repair technique.

Detailed description: In this study we are revealing a new inguinal hernia repair technique. It is constructed from two layers. Deep layer is modified Shouldice technique, the other superficial one is moloney technique.

Eligibility criteria: Inclusion Criteria:

* Inguinal hernia

Exclusion Criteria:

* Recurrences, child

Primary outcomes:
measure: complications, recurrences
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: S.B. Istanbul Educational & Teaching Hospital
state: Marmara
Study officials:
affiliation: S.B. Istanbul Educational & Teaching Hospital
name: Arslan Kaygusuz, surgeon
role: STUDY_CHAIR
References:
Clinical trial NCT03786809: Vascular Effect of CIMICIFUGA RACEMOSA
Official title: Vascular Effect of CIMICIFUGA RACEMOSA Versus Placebo Evaluated by Flow Mediated Dilatation of Brachial Artery (CRDILA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postmenopausal Symptoms
Keywords: postmenopause
vascular effects
CIMICIFUGA RACEMOSA
Lead sponsor: Federal University of Minas Gerais
Sponsor class: OTHER
First posted: 2018-12-26
Enrollment: 60
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Postmenopausal women with vascular symptoms will use Cimifuga Racemosa or Placebo and the effects will be evaluated using Flow-Mediated Dilatation of the brachial artery.

Detailed description: The interruption of the secretion of ovarian steroids after menopause, determines a change in the vascular pattern in several levels. Thus, several vascular effects might interfere with women's health. The use of hormone replacement therapy has contributed to the improvement in these effects. In previous studies, the investigators observed the effects of hormonal replacement therapy in improving such effects in postmenopausal women. The aim of the present study is to evaluate the effects of CIMICIFUGA RACEMOSA on the Flow-Mediated Dilatation of the brachial artery.

Eligibility criteria: Inclusion Criteria:

* Women with postmenopausal vascular symptoms
* Women without menstrual cycles within the last 12 months and follicle stimulating hormone (FSH) \> 30 International Units(IU)/Litre
* Women that were not using drugs with potential vascular effect within the last 1 year
* Women that were not using hormone replacement therapy within the last 1 year

Exclusion Criteria:

* Smoking
* Blood Pressure \> 160/90 mm Hg.
* Breast and or endometrial cancer
* History of acute myocardial infarction
* Diabetes
* Vaginal bleeding of any origin
* Hepatic disease
* Thrombophlebitis or thromboembolic disorders

Primary outcomes:
measure: Measurement of the brachial artery using flow-mediated dilation of post menopausal women, before and after use of Cimifuga Racemosa
timeFrame: 28 days
Secondary outcomes:
measure: Frequency of symptoms and side effects
timeFrame: 28 days
Other outcomes:
Locations:
city: Belo Horizonte
country: Brazil
facility: Hospital das Clinicas - Universidade Federal de Minas Gerais
state: Minas Gerais
Study officials:
affiliation: Universidde Federal de Minas Gerais
name: Selmo Geber, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: