louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01448798: Athermal Nerve-sparing During Robotic-assisted Radical Prostatectomy Using a Hemostatic Matrix.
Official title: Prospective Randomized Investigation of Athermal Nerve-sparing During Robotic-assisted Laparoscopic Prostatectomy Using a Hemostatic Gelatin-thrombin Matrix
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Cancer
Erectile Dysfunction
Keywords: radical prostatectomy
robotic surgery
erectile dysfunction
continence
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
First posted: 2011-10-07
Enrollment: 50
Sex: MALE
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 this study is to evaluate the use of a hemostatic gelatine-thrombin matrix during athermal nerve-sparing prostate resection compared to conventional hemostasis using electrocautery in patients with localized prostate cancer and to investigate effects on postoperative erectile function and continence.


Eligibility criteria: Inclusion Criteria:

* Patient age \>18
* Histologically proven prostate cancer ( Gleason \<8; PSA\<10ng/ml)
* Disease confined to prostate in clinical examination
* Preoperative IEEF-5-Score\>20
* Patient is able to give informed consent

Exclusion Criteria:

* ASA IV-V
* Prior extensive abdominal surgery
* Signs for metastatic disease
* Known allergy against bovine material
* Patient is unable to give informed consent

Primary outcomes:
measure: Postoperative erectile function
timeFrame: 12 months
Secondary outcomes:
measure: Postoperative continence
timeFrame: 12 months
measure: Intraoperative bloodloss
timeFrame: During surgery
measure: Intra- and postoperative complications
timeFrame: Perioperative period
Other outcomes:
Locations:
city: Frankfurt/M.
country: Germany
facility: Johann Wolfgang Goethe University Hospital
Study officials:
affiliation: Johann Wolfgang Goethe University Hospitals, Germany
name: Axel Haferkamp, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01492998: Role of FXR in Hepatitis C Virus Replication
Official title: Study of the Role of the Biliary Salts Nuclear Receptor FXR in Hepatitis C Virus Replication
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Hepatitis C
Keywords: Hepatitis C virus
Biliary salts
Farnesoid X receptor
Guggulsterone
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2011-12-15
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In vitro in the hepatitis C virus (HCV) replicon system, modulation of the biliary salts nuclear receptor FXR by either agonists or antagonists respectively increases or decreases the replication of HCV (J Hepatol, 2008, 48: 192-9). One antagonist of FXR is a vegetal sterol, guggulsterone, that is extracted from the Commiphora mukul tree and that has already been given safely to hyper cholesterolemic patients in a clinical trial (JAMA 2003, 290: 765-72). The aim of this trial is to test the effect of the FXR antagonist guggulsterone given orally, three times a day, on the viral load in 15 HCV genotype 1 chronically infected patients.


Eligibility criteria: Inclusion Criteria:

* Male patients infected by HCV genotype 1, with anti-HCV antibodies, non responders to at least one first line of therapy
* Viral load \> 1 x 105 UI/mL for more than 6 months and not treated for at least the last two months.
* METAVIR score \< F4

Exclusion Criteria:

* Alcohol intake \> 20 g/day
* Immuno - suppressive therapy
* Obesity BMI \> 30, diabetes
* Dyslipidemia requiring specific therapy
* Liver cirrhosis or carcinoma
* HIV or HBV co-infections
* Other liver diseases
* Major organ failures
* Therapy with cytochrome P450 metabolized drugs

Primary outcomes:
measure: Evolution of the HCV plasmatic viral load while taking the FXR inhibitor guggulsterone.
timeFrame: One week
Secondary outcomes:
measure: Modification of the fraction of the circulating viral forms associated with apolipoprotein B
timeFrame: One week
Other outcomes:
Locations:
city: Lyon
country: France
facility: Department of hepatology, Hospices Civils de Lyon, Hôtel Dieu
Study officials:
affiliation: Hospices Civils de Lyon
name: Christian Trépo, MD, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospices Civils de Lyon
name: Marianne Maynard, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Scholtes C, Andre P, Trepo C, Cornu C, Remontet L, Ecochard R, Bejan-Angoulvant T, Gueyffier F. Farnesoid X receptor targeting for hepatitis C: study protocol for a proof-of-concept trial. Therapie. 2012 Sep-Oct;67(5):423-7. doi: 10.2515/therapie/2012058. Epub 2012 Dec 18.
Clinical trial NCT00184405: Child Results Following Preventive Children of Parents With Psychiatric and Addictive Problems (COPP) Groups
Official title: Preventive Peer Groups for Children of Parents With Psychiatric and Addictive Problems (COPP). Child Experiences and Observed Child Changes Following the Intervention
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Psychiatric Disorder NOS
Keywords: Parents with psychiatric or addictive problems
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Helse Nord-Trøndelag HF
First posted: 2005-09-16
Enrollment: 6
Sex: ALL
Minimum age (years): 8
Maximum age (years): 110
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Families with at least one parent with psychiatric or addictive problem

Brief summary: This is a study evaluating changes in quality of life and global functioning across and after a manualized peer-group preventive intervention for children of parents with psychiatric or addictive problems.

Detailed description: Self-reported quality of life and based on the group-interviews "ILK" and "Kindl" and general adaptive functioning (CGAS) as reported by teachers and parents will be measured before, after and at follow-up relative to the manualized peer-group preventive intervention. Parents will also complete self-reports on anxiety and depressive symptoms, personality, bonding and attribution before the intervention.

Eligibility criteria: Inclusion Criteria:

* Family including Parent with psychiatric or addictive problems

Exclusion Criteria:

* acute severe disorder

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Norwegian University of Science and Technology (NTNU), Faculty of Medicine, Dept. of Neuroscience, Center for Child and Adolescent Mental Health
Study officials:
affiliation: Norwegian University of Science and Technology (NTNU), Faculty of Medicine, Dept. of Neuroscience, Center for Child and Adolescent Mental Health
name: Tormod Rimehaug, Asst. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02174705: Rotavirus vs. Sucrose for Vaccine Injection Pain
Official title: A Randomized Controlled Trial of Rotavirus Vaccine vs. Sugar Water for Vaccine Injection Pain Management in Infants
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Vaccination Pain Management
Keywords: vaccination
pain management
sucrose
rotavirus
Lead sponsor: University of Toronto
Sponsor class: OTHER
First posted: 2014-06-25
Enrollment: 120
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized trial will compare the analgesic effectiveness of oral rotavirus vaccine to sugar water for reducing vaccine injection pain in infants.


Eligibility criteria: Inclusion Criteria:

* healthy infants receiving rotavirus vaccine in conjunction with primary immunizations in the first 6 months of life

Exclusion Criteria:

* impaired neurological development, history of seizures, sedatives or narcotics in preceding 24 hours, parent unable to use study tools, prior participation in the trial

Primary outcomes:
measure: Distress
timeFrame: immediately after vaccinations in 15 seconds
Secondary outcomes:
measure: Distress
timeFrame: immediately after vaccinations in 1 minute intervals for 2 minutes
measure: Distress
timeFrame: immediately after vaccinations in 1 minute
measure: Distress
timeFrame: immediately after vaccinations in 1 minute
Other outcomes:
measure: Safety
timeFrame: immediately after vaccinations in 5 minutes
measure: Satisfaction
timeFrame: immediately after vaccination in 1 minute
Locations:
city: Toronto
country: Canada
facility: Kindercare
state: Ontario
city: Toronto
country: Canada
facility: Anna Taddio
state: Ontario
Study officials:
affiliation: University of Toronto
name: Anna Taddio, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06033105: Vitamin D Deficiency As a Risk Factor for the Development and Malignant Transformation of Oral Lichen Planus
Official title: Vitamin D Deficiency As a Risk Factor for the Development and Malignant Transformation of Oral Lichen Planus: a Case-control Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oral Lichen Planus
Vitamin D Deficiency
Lead sponsor: Fayoum University
Sponsor class: OTHER
First posted: 2023-09-13
Enrollment: 70
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients presenting with a clinical picture and histological findings that confirm the diagnosis of OLP (Group A) and age, sex, and dietary habits matched healthy controls (Group B).

Brief summary: To examine how a lack of vitamin D may increase the risk of developing oral lichen planus and its malignant progression while accounting for sex, food habits, sunlight, socioeconomic level, and psychological variables.


Eligibility criteria: Inclusion Criteria:

* (Group A) patients presenting with a clinical picture and histological findings that confirm the diagnosis of OLP
* (Group B) age, sex, and dietary habits matched healthy controls.

Exclusion Criteria:

* (1) subjects who have been receiving any kind of VD supplements, multivitamins, or any drug that may affect VD measurements
* (2) patients with suspected restoration-related or smokeless tobacco-related lesions.
* (3) patients with any systemic medical condition or pregnant females.
* (4) patients with VD toxicity (VD≥100 ng/ml).

Primary outcomes:
measure: serum vitamin D level in OLP
timeFrame: 1 month
Secondary outcomes:
measure: serum vitamin D level in correlation with sex, dietary habits and sun exposure.
timeFrame: 1 month
measure: serum vitamin D level in correlation with socioeconomic status
timeFrame: 1 month
measure: serum vitamin D level in correlation with Psychological factors
timeFrame: 1 month
Other outcomes:
Locations:
city: Fayoum
country: Egypt
facility: Fayoum University
Study officials:
References:
Clinical trial NCT04578405: Intracorporeal Anastomosis Accelerates Bowel Function in Comparison to Extracorporeal Anastomosis in Laparoscopic Right Hemicolectomy - a Randomized Control Trial.
Official title: Intracorporeal Anastomosis Accelerates Bowel Function in Comparison to Extracorporeal Anastomosis in Laparoscopic Right Hemicolectomy - a Randomized Control Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Right Hemicolectomy
Lead sponsor: Jagiellonian University
Sponsor class: OTHER
First posted: 2020-10-08
Enrollment: 110
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: Both extracorporeal and intracorporeal anastomosis in laparoscopic right hemicolectomy are renowned and performed worldwide. Many observational studies show conflicting results which method is better. This randomized control trial aimed to assess which technique is superior.


Eligibility criteria: Inclusion Criteria:

* malignant or benign neoplasm located in right side of the colon

Exclusion Criteria:

* stage IV disease
* conversion
* inflammatory bowel diseases
* corticosteroid intake
* immunodeficiency
* emergency surgery
* neoadjuvant therapy
* no technical possibility to perform either anastomosis

Primary outcomes:
measure: Time to first stool
timeFrame: 5 days
Secondary outcomes:
measure: Time to first flatus
timeFrame: 5 days
measure: Complications
timeFrame: 30 day
measure: Length of surgery
timeFrame: 1 day
measure: Length of hospital stay
timeFrame: 30 day
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06498505: HighCycle: Effect of Acetazolamide on Pulmonary Artery Pressure in Women Compared to Men
Official title: HighCycle: Effect of Acetazolamide on Pulmonary Artery Pressure in Women Compared to Men. A Randomized, Placebo-Controlled, Double-Blind Parallel Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: High Altitude
Keywords: Women
Hypoxia
Prevention
Acetazolamide
Echocardiography
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
name: University Hospital Heidelberg
name: Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques
First posted: 2024-07-12
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Randomized clinical trial evaluating the effect of acetazolamide on pulmonary artery pressure in women compared to men travelling to 3600 m.


Eligibility criteria: Inclusion Criteria:

* Healthy, non-smoking men and women, age 18-44 years, without any diseases and need of regular medication (including oral contraceptives).
* BMI \>18 kg/m2 and \<30 kg/m2
* Born, raised and currently living at altitudes \<1000 m
* Written informed consent
* Premenopausal women with an eumenorrheic cycle

Exclusion Criteria:

* Other types of contraceptvies (hormonal intrauterine device, vaginal ring, subcutaneous injections or implants, among others)
* Pregnancy or nursing
* Anaemic (haemoglobin concentration \<10g/dl)
* Any altitude trip \<4 weks before the study
* Allergy to acetazolamide and other sulfonamides

Primary outcomes:
measure: Pulmonary artery Pressure (PAP)
timeFrame: Day 2 at 760 m and Day 2 at 3600 m
Secondary outcomes:
measure: Lung comets
timeFrame: Day 2 at 760 m and Day 2 at 3600 m
measure: Parameters of right heart function
timeFrame: Day 2 at 760 m and Day 2 at 3600 m
Other outcomes:
Locations:
city: Bishkek
country: Kyrgyzstan
facility: National Center for Cardiology and Internal Medicine
Study officials:
affiliation: University of Zurich
name: Silvia Ulrich, Prof. Dr.
role: STUDY_CHAIR
affiliation: National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan
name: Talant Sooronbaev, Prof. Dr.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01178905: Clinical Evaluation of Ultrashort-term Heat Inactivation of Cytomegalovirus (CMV) Containing Raw Breast Milk to Prevent CMV-infection of Preterm Infants
Official title: Clinical Evaluation of a Gentle But Safe Ultrashort-term Heat Inactivation Procedure of Raw Breast Milk (BM) Containing Virulent Cytomegalovirus for Preventing CMV-infection of Preterm Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cytomegalovirus Infection
Preterm Infants
Keywords: Postnatal CMV infection of preterm infants
breast milk
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2010-08-10
Sex: ALL
Minimum age (years): 23
Maximum age (years): 40
Standard ages: CHILD
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: To evaluate, in a prospective multicenter study, ultrashort-term heat inactivation for the prevention of Cytomegalovirus (CMV) transmission in preterm infants (\<32 weeks gestational age or \<1500 g birth weight) under clinical conditions. Inactivation will be done only during the period of infectivity of breast milk, characterized by viral excretion strongly associated with subsequent infection, monitored by periodic virologic examinations of BM and urine of the infant. Thus the investigators hypothesis is that no CMV transmission through breast milk will occur using a gentle ultrashort heat inactivation procedure applied to infective breast milk.

The protocol has been approved by the ethics committee of Tuebingen University Hospital.


Eligibility criteria: Inclusion Criteria:

* \<32 Weeks or GA or \<1500g BW
* mother CMV IgG positive
* breast milk feeding

Exclusion Criteria:

* parents disagree

Primary outcomes:
measure: Number of participants with CMV viruria
timeFrame: 40 weeks gestational age, or at discharge from NICU (if this is earlier)
Secondary outcomes:
measure: Number of participants with specific neonatal outcome parameters as a measure of neonatal quality
timeFrame: 40 weeks of gestational age or at discharge from NICU (if this is earlier)
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: Tuebingen University Hospital
Study officials:
affiliation: Tuebingen University Hospital
name: Rangamr Goelz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bapistella S, Hamprecht K, Thomas W, Speer CP, Dietz K, Maschmann J, Poets CF, Goelz R. Short-term Pasteurization of Breast Milk to Prevent Postnatal Cytomegalovirus Transmission in Very Preterm Infants. Clin Infect Dis. 2019 Jul 18;69(3):438-444. doi: 10.1093/cid/ciy945.
Clinical trial NCT01333605: IGEV Followed by Autologous Transplantation for Refractory or Relapsed Hodgkin Lymphoma
Official title: Phase II Study of IGEV Followed by Autologous Stem Cell Transplantation in Patients With Refractory or Relapsed Hodgkin Lymphoma.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Hodgkin Lymphoma
Keywords: Hodgkin lymphoma
Chemotherapy
IGEV
Autologous stem cell transplantation
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2011-04-12
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of study is to prove IGEV regimen followed by autologous stem cell transplantation as salvage treatment in patients with refractory or relapsed Hodgkin lymphoma is effective.

Detailed description: The standard treatment in patients with refractory or relapsed Hodgkin lymphoma is salvage chemotherapy followed by autologous transplantation for responsive patients. However, the standard of salvage chemotherapy remains uncertain. This study is to evaluate the efficacy and safety of IGEV regimen in a single-center basis.

Eligibility criteria: Inclusion Criteria:

* Age range: 18-65 years old
* Histological confirmed refractory or relapsed Hodgkin lymphoma
* With at least one site of measurable disease according to IWC criteria
* ECOG performance status 0-1
* Life expectancy of more than 3 months
* Bone marrow function: ANC≧1.5×109/L, PLT≧100×109/L, Hb≧80g/L
* Liver function: total bilirubin, ALT and AST \<1.5×UNL
* Renal function: Cr\<1.5×UNL, CCR≧45ml/min
* No contraindication for transplantation

Exclusion Criteria:

* No prior chemotherapy
* With more than 2 lines of prior chemotherapy exposure
* Evidence of CNS and bone marrow involvement
* History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
* Pregnant or lactating women
* Significant active infection

Primary outcomes:
measure: Complete response rate
timeFrame: 6 weeks
Secondary outcomes:
measure: Overall response rate
timeFrame: 6 weeks
measure: 3-year progression-free survival rate
timeFrame: 3 years
measure: 3-year overall survival rate
timeFrame: 3 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
Study officials:
affiliation: Fudan University
name: Ye Guo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00219505: Effect of Acupuncture on Symptoms of Diarrhea and Pain in IBS
Official title: Effect of Acupuncture on Symptoms of Diarrhea and Pain in Diarrhea Predominant Irritable Bowel Syndrome (IBS) and Effect on Plasma Beta-endorphin and Serotonin Levels.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Irritable Bowel Syndrome
Keywords: Diarrhea-predominant irritable bowel syndrome
Acupuncture
abdominal pain
Lead sponsor: Penn State University
Sponsor class: OTHER
Collaborators: name: American College of Gastroenterology
First posted: 2005-09-22
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Acupuncture has been used for centuries in China in the treatment of diarrhea. Our hypothesis is that acupuncture is effective in the treatment of abdominal pain and diarrhea in patients with diarrhea-predominant IBS

Detailed description: Patients will complete a diary to determine if they qualify for the study. Patients will be randomized to receive either acupuncture or sham acupuncture (needle insertion 1 cm away from acupuncture site). Patients will be blinded to whether they are receiving acupuncture or sham acupuncture. The acupuncturist is blinded as to the patient response. The patients will undergo venupuncture to draw blood to determine sertotonin and beta-endorphin levels. They will receive treatment in 12 sessions over 4 weeks. They will maintain a diary during this time period to document level of pain and frequency of bowel movements. Blood will be drawn at week 2 and 4 and, 6 weeks after cessation of treatment, subjects will again record abdominal symptoms and frequency of bowel movements for 2 weeks. Blood will be drawn for hormone levels at 8 weeks after completion of study.

Eligibility criteria: Inclusion Criteria:

* frequence of bowel movement of at least 3/day
* global disease severity of at least 3

Exclusion Criteria:

* taking medications which will influence frequency of bowel movement
* patient taking anticoagulants or suffering from coagulopathy
* pregancy

Primary outcomes:
measure: Frequency of bowel movement
Secondary outcomes:
measure: Abdominal pain
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Penn State College of Medicine and Penn State Milton S. Hershey Medical Center
name: Ann Ouyangm, MD
role: PRINCIPAL_INVESTIGATOR
References: