louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00861523: Does Thiamine Help Vomiting and Nausea in Pregnancy?
Official title: Comparison Between the Treatment of Thiamine and Promethazine for Improving Vomiting and Nausea in Pregnancy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Hyperemesis Gravidarum
Keywords: nausea
vomiting
pregnancy
thiamine
promethazine
nausea and vomiting in pregnancy
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2009-03-13
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: There are different treatments for nausea and vomiting in pregnancy. According to the ACOG recommendations, promethazine is the first line of parenteral treatment after oral treatment had failed. Thiamine is given to prevent wernicke encephalopathy. This research try to find out whether thiamine helps the vomiting and nausea as well, by comparing the response to thiamine and promethazine in women who suffer from nausea and vomiting in pregnancy.

Detailed description: * Research groups: pregnant women eho visit the emergency room for nausea and vomiting in pregnancy, pregnancy age 12 weeks or less
* After basic examinations and hydration, the women will randomized to thiamine or promethazine treatment.
* If no improvement is shown, the patient will be treated with the other drug
* The patients will be interviewed on their current visit and every two weeks until 14th week of gestation
* The interview includes medical history and details about their illness, other treatments, hospitalization etc.

Eligibility criteria: Inclusion Criteria:

* Pregnant women until 12th week of gestation
* The women visit the ER because of nausea and vomiting
* The women didn't received thiamine yet

Exclusion Criteria:

* Pregnant women over 12th week of gestation
* Women that received thiamine before
* women that allergic to the studied drugs

Primary outcomes:
measure: the improvement in nausea and/or vomiting after treatment
timeFrame: 2 months after first visit in ER (until 14 week of pregnancy)
Secondary outcomes:
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Gynecologic department, Haemek medical center
Study officials:
affiliation: haemek medical center
name: Yfat Kadan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02885623: Role of CX3CR1-expressing Cells in Hematologic Malignancy
Official title: Clinical Significance of CX3CR1 Adhesion Molecule-expressing Myeloid and Lymphoid Cells in Hematologic Malignancy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: CX3CR1 Protein
Diffuse Large B Cell Lymphoma
Multiple Myeloma
Lead sponsor: Saint Vincent's Hospital, Korea
Sponsor class: OTHER
First posted: 2016-08-31
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: newly diagnosed multiple myeloma patients newly diagnosed diffuse large B cell lymphoma patients

Brief summary: This study evaluates the clinical significance of CX3CR1-expressing myeloid and lymphoid cells in patients of hematologic malignancy.

Tumor cells either express membrane molecules or release tumor-derived soluble factors able to alter myelopoiesis and lymphopoiesis. Myeloid cells expressing CD11b play a critical role in sustaining cancer progression. Also, the fractalkine (CX3CL1; Fkn)/CX3CR1 axis plays an important function in the pathophysiology of various forms of cancers. Fkn is the only known ligand for CX3CR1, and it triggers recruitment of CX3CR1-positive cells through its unique receptor, CX3CR1. Therefore, the investigators focused the prognostic significance of CD11b+ myelo-monocytic cells expressing CX3CR1 and CD3+ lymphoid cells expressing CX3CR1 in the clinical outcomes of newly diagnosed Diffuse Large B-cell Lymphoma (DLBCL) and Multiple myeloma (MM).

Detailed description: Bone marrow aspirates will be obtained from newly diagnosed MM and DLBCL patients at the time of diagnosis and relapse. Peripheral blood will be obtained at the time of diagnosis, finishing treatment, 3 months after treatment and relapse.

The investigators will analyze the cell fractions of CD11b+ CX3CR1+ cells and CD3+CX3CR1+ cells in blood samples by flowcytometry. The investigators will find out the relationship between the tested cells and clinical outcome in MM and DLBCL.

Eligibility criteria: Inclusion Criteria:

* Subject newly diagnosed multiple myeloma.
* Subject newly diagnosed diffuse large B cell lymphoma.

Exclusion Criteria:

* History of other hematologic malignancy
* History of previous chemotherapy

Primary outcomes:
measure: progression free survival
timeFrame: 3 years
Secondary outcomes:
measure: overall survival
timeFrame: 3 years
measure: Death
timeFrame: 3 years
Other outcomes:
Locations:
city: Suwon-si
country: Korea, Republic of
facility: The Catholic University of Korea, St.Vincent's hospital
state: Gyeonggi-do
Study officials:
affiliation: Saint Vincent's Hospital, Korea
name: Jeong-A Kim, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03826823: Thin Catheter for Hysterosalpigography
Official title: Hysterosalpigography Using a Thin Catheter and Closing the Cervix With the Vaginal Speculum to Reduce the Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Keywords: hysterosalpingography, catheter, pain, visual analogue scale
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-02-01
Enrollment: 89
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Hysterosalpingography is usually painful and the use of thin catheters of IUI could be an attractive alternative . we conducted a randomised controlled trial to compare the standard metal cannula to the thin catheter originally manufactured for intrauterine insemination. Pain assessment was done using visual analogue scale

Detailed description: HSG is widely practiced in our country, however, for cost effective reasons, the standard metal cannula is the only method used at our hospital. It is painful procedure because it requires grasping the cervix with a tenaculum and inducing some cervical dilatation during introduction of the cannula. The aim of this pilot study was to modify the technique of HSG using a thinner than normal catheter, and without grasping the cervix with a tenaculum. Leakage of the dye through the cervix was prevented by pressing on the portiovaginalis of the cervix using the vaginal speculum.

Eligibility criteria: Inclusion Criteria:

* infertile women seeking evaluation of fallopian tubes

Exclusion Criteria:

* any woman with allergy to the iodine dye or condition contraindicating pregnancy

Primary outcomes:
measure: the level of pain using a visual analogue scale (VAS)
timeFrame: 8 month
Secondary outcomes:
measure: visualising uterus and tubes
timeFrame: 8 month
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01142323: Pilot Study of Fenofibrate for PSC
Official title: Pilot Study of Fenofibrate in Primary Sclerosing Cholangitis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Primary Sclerosing Cholangitis
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: University of Florida
First posted: 2010-06-11
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether fenofibrate is safe and effective in the treatment primary sclerosing cholangitis (PSC).


Eligibility criteria: Inclusion Criteria:

* Male and female patients of 18 to 75 years old
* Confirmed diagnosis of PSC including typical findings of stricturing and dilatations of the intra and/or extrahepatic biliary ducts in radiographic exam, (endoscopic retrograde cholangiopancreatography -ERCP, percutaneous cholangiogram - PTC or magnetic resonance cholangiopancreatography- MRCP)
* Serum alkaline phosphatase levels elevated to at least 1.5 times the upper limit of normal.

Exclusion Criteria:

* Hypersensitivity to fenofibrate
* Prisoners and institutionalized subjects
* Pregnant or nursing women
* Anticipated need for liver transplantation in one year
* Recipients of liver transplantation
* Recurrent variceal hemorrhage, uncontrolled encephalopathy or refractory ascites
* Co-existing liver diseases including auto-immune and viral hepatitis
* Acute or chronic renal failure, defined as glomerular filtration rate (GFR)\< 60 ml/min, GFR calculated using the Modification of Diet in Renal Disease (MDRF) GFR calculator
* Known cholecystitis
* Current use of statins
* Current use of coumadin anticoagulant therapy
* Previous history of, or known high risk for, venous thromboembolism,

Primary outcomes:
measure: Serum Alkaline Phosphatase
timeFrame: 6 months
Secondary outcomes:
measure: Mayo Risk Score for Primary Sclerosing Cholangitis
timeFrame: 6 months
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Cynthia Levy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03182023: Long-term Outcome of Patients Treated With Extracorporeal Membrane Oxygenation
Official title: Outcomes and Long-term Quality-of-life of Patients Treated With Extracorporeal Membrane Oxygenation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Long-term Outcome
Extracorporeal Membrane Oxygenation
Keywords: outcome,ECMO,Respiratory Failure,Circulatory Failure
Lead sponsor: Southeast University, China
Sponsor class: OTHER
First posted: 2017-06-09
Enrollment: 83
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients treated with ECMO from January 1，2015 to March 1,2017

Brief summary: Outcomes and Long-term Quality-of-life of Patients Treated With Extracorporeal Membrane Oxygenation are not known in china.A cross-section survey will be performed to assess the long-term outcome of these patients.

Detailed description: Patients admitted to ICUs and treated with extracorporeal membrane oxygenation from March 1,2011 to March 1,2017 were screened . Pre-Ecmo clinical parameters(diagnose,APACHE-II, SOFA,indications,expected mortality) and related treatment conditions(duration of ICU stay, duration of ECMO,duration of mechanical ventilation,ventilation conditions,prone ventilation,ECMO complications )will be used to assess the severity and curative effect of these patients.Short Form-36 Health Status Questionnaire,EuroQol-5 Dimensions and St. George's Respiratory Questionnaire(SGRQ) will deliver in these survivors ,which are used to assess the physical and mental health ,as well as the social adaptation. Finally a comprehensive assessment will be obtained to describe the outcomes and long-term quality-of-life of patients treated With ECMO.

Eligibility criteria: Inclusion Criteria:

* patients treated with ECMO

Exclusion Criteria:

* non-survivors of patients treated with ECMO，declined or lost to follow up

Primary outcomes:
measure: Short Form-36 Health Status Questionnaire
timeFrame: June,2017-May,2018
Secondary outcomes:
measure: EuroQol-5 Dimensions
timeFrame: June,2017-May,2018
measure: the St. George's Respiratory Questionnaire(SGRQ)
timeFrame: June,2017-May,2018
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Zhong-Da Hospital, Southeast University
state: Jiangsu
Study officials:
affiliation: professor
name: Haibo Qiu
role: STUDY_DIRECTOR
References:
Clinical trial NCT06887023: Clinicopathologic Characteristics, Progression, and Prognostic Analysis of IPNB
Official title: Clinicopathologic Characteristics, Progression, and Prognostic Analysis of Intraductal Papillary Neoplasm of Bile Duct
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bile Duct Neoplasms Malignant
Keywords: intraductal papilloma of bile duct
malignancy
progression
risk factors
prognosis
Lead sponsor: The First Hospital of Jilin University
Sponsor class: OTHER
First posted: 2025-03-20
Enrollment: 118
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with IPNB from eight Chinese hospitals over a 10-year period

Brief summary: The main aim of this observational study is to understand the clinicopathological and prognostic information of IPNB, a rare tumor. The participants have already received treatment during their previous routine medical management and took part in follow - up. We will look into their survival information after previous medical visits and treatment.


Eligibility criteria: Inclusion Criteria:

* IPNB with or without malignant transformation was confirmed by pathological examination

Exclusion Criteria:

* missing other essential clinical data
* coexisting malignant tumors of other digestive system organs

Primary outcomes:
measure: death
timeFrame: From January 2014 to June 2024
Secondary outcomes:
Other outcomes:
Locations:
city: Changchun
country: China
facility: the First Hospital of Jilin University
state: Jililn
Study officials:
References:
Clinical trial NCT04004923: Intracranial Pressure in Monopolar and Bipolar Hysteroscopy
Official title: Monopolar or Bipolar Hysteroscopy: Comparison of the Impact of Two Methods on Intracranial Pressure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intracranial Pressure Increase
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2019-07-02
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Two distinction fluids are used in operative hysteroscopy. One is monopolar and the second is bipolar. The monopolar fluid contains mannitol and the bipolar fluid contains serum physiologic. This study aims to compare intracranial pressure in patients undergoing monopolar and bipolar hysteroscopy.

Detailed description: Operative hysteroscopy is currently used in the treatment of several diseases including submucosal myomas, polyps, uterine septum, and abnormal intrauterine bleeding. Two different methods for distension of the uterus for hysteroscopy are available currently. One is monopolar and the second is bipolar. The monopolar fluid contains mannitol and the bipolar fluid contains serum physiologic. Passage of the distention fluid into the uterine veins during hysteroscopy might lead to volume overload, water intoxication, hyponatremia, pulmonary edema or brain edema. However, the effect of monopolar hysteroscopy or bipolar hysteroscopy on intracranial pressure in patients undergoing hysteroscopy is unknown. Optic nerve sheath diameter (ONSD) measurement is a surrogate marker of invasive intracranial pressure. This study aims to compare the impact of monopolar and bipolar hysteroscopy on intracranial pressure by using ONSD measurement in patients undergoing hysteroscopy.

Eligibility criteria: Inclusion Criteria:

* Must be scheduled to hysteroscopy for treatment of uterine myoma, polyp, septum, or for endometrial ablation.

Exclusion Criteria:

* Postmenopause;
* Kidney disease;
* Cardiovascular disease;
* Glaucoma

Primary outcomes:
measure: Intracranial pressure
timeFrame: ONSD will be measured 3 times in the two groups. Before completion of hysteroscopy, 2 hours after hysteroscopy and 6 hours after hysteroscopy
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Kanuni Sultan Suleyman Training and Research Hospital
state: Please Enter The State Or Province
Study officials:
affiliation: Kanuni Sultan Suleyman Hospital
name: Huseyin Kiyak, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00680823: Study of Intramuscular Ropivacaine Injections for Treatment of Pediatric Headache
Official title: Is Paraspinal Intramuscular Ropivacaine Injection an Effective Treatment for Headache in a Pediatric Emergency Department?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Headache
Migraine
Keywords: Headache
Migraine
Ropivacaine
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2008-05-20
Enrollment: 150
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objective: To determine if lower paracervical intramuscular ropivacaine injection is an effective treatment for pediatric headache in an emergency department setting.

Detailed description: Methods: The study will be a double-blind randomized control trial. Patients will be randomly assigned to receive either intramuscular injection of the lower cervical paraspinous muscles with 1 mL of 0.5% ropivacaine on each side, placebo injections with 1 mL normal saline on each side, or no intervention at all. If randomized to an injection, the investigator and the patient will both be blinded as to the nature of the injection.

The location of the child's pain as well as severity will be assessed immediately prior to intervention and every 10 minutes for 30 minutes. If after 30 minutes relief is insufficient for discharge to home, intravenous treatment will be instituted according to current protocol. Pain will be reassessed at the time of ultimate disposition. The scale used to assess severity will vary based on the child's age.

Eligibility criteria: Inclusion Criteria:

* Chief complaint of headache
* Age 7-17 years

Exclusion Criteria:

* Presence of fever
* meningismus
* headache that wakes the child at night
* known organic brain disease, mass, or tumor
* history of stroke
* history of allergy to ropivacaine or other aminoacyl local anesthetics
* history of liver disease
* history of impaired cardiac function
* abnormal neurologic signs
* a focal neurologic abnormality on exam that is not a known component of the child's headache syndrome
* cognitive inability to communicate the intensity of pain.
* history of shunt or other intracranial hardware

Primary outcomes:
measure: The Primary Outcome Will be Pain Relief Sufficient for Discharge From the Emergency Department.
timeFrame: 30 minutes
Secondary outcomes:
measure: Number and Percent of Patients Admitted to the Hospital for Additional Therapy in Each Treatment Arm Based Upon Treating Clinicians Decision
timeFrame: 3 hours
measure: Re-presentation to the Emergency Department With Headache Within 72 Hours of Participating in the Study
timeFrame: 72 hours
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Susan Sieminski, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00739323: Impaired Wound Healing in Diabetic Foot Ulceration
Official title: Impaired Wound Healing in Diabetic Foot Ulceration
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Healthy Volunteers
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2008-08-21
Enrollment: 137
Sex: MALE
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects may be selected from the Beth Israel Deaconess Foot Clinic or from the Boston area and surrounding locations.

Brief summary: An observational study to gather information about people who may have certain abnormalities in skin microcirculation and muscle metabolism and to determine whether these abnormalities affect wound healing. The study also examines the association of a specific type of cell with the rate of wound healing.

Detailed description: An observational study which entails: medical history; physical examination; blood tests; MRI; microcirculation tests (two noninvasive tests: 1) a procedure that measures the resting blood flow of the skin and 2) a technique that introduces acetylcholine and sodium nitroprusside in the skin and measures the ability of the skin's vessels to dilate and increase blood flow); and macrocirculation tests (noninvasive ultrasound of arm). This study also involves 2 Visits to the Beth Israel Deaconess Medical Center in Boston, MA. (Joslin-Beth Israel Deaconess Foot Center, Lowry Outpatient Laboratory, MRI Suite).

Eligibility criteria: Inclusion Criteria:

* Current diagnosis of Type I or Type II Diabetes Mellitus.
* Ulcer present for minimum 4 weeks
* Have adequate circulation to the foot
* Can return for follow-up visits
* Be able to read and sign the Informed Consent form before enrollment

Exclusion Criteria:

* Active Charcot's foot ulcer on the foot to be studied
* Presence of any serious disease that can affect wound healing including end stage renal failure requiring hemodialysis or renal transplantation, active malignant disease requiring treatment, hepatic, hematologic, neurologic, or immune disease
* Alcohol or drug abuse problems
* Treatment with oral or parenteral corticosteroids, immunosuppressive or cytotoxic agents
* Presence of infectious disease that can preclude EPC measurements (including HIV, Hepatitis B and C)
* Pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Aristidis Veves, DSc
role: PRINCIPAL_INVESTIGATOR
References: