louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01125943: Bevacizumab and Endothelium Dependent Vasodilation
Official title: Bevacizumab and Endothelium Dependent Vasodilation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Cancer
Endothelial Dysfunction
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Dutch Cancer Society
First posted: 2010-05-19
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The introduction of angiogenesis inhibitors has remarkably improved treatment of patients with several types of cancer. One of the most reported side effects of angiogenesis inhibitors is hypertension. In patients treated with bevacizumab, a monoclonal antibody against vascular endothelial growth factor, hypertension had an overall incidence up to 32%. The increase in blood pressure occurs early in treatment. The etiology of hypertension caused by treatment with angiogenesis inhibitors is unclear. Understanding the pathogenesis of this side effect is essential for optimal treatment with this class of drugs.

The primary objective is to explore the effect of bevacizumab infusion on endothelium-dependent vasodilation of forearm resistance arteries.


Eligibility criteria: Inclusion Criteria:

1. Age 18-50 years old
2. Male
3. Results of serum glucose, lipids and creatinine should be within the laboratory's reference ranges.
4. Subject is able and willing to sign the Informed Consent Form prior to screening evaluations.

Exclusion Criteria:

1. Documented history of sensitivity/idiosyncrasy to medicinal products or excipients.
2. History of or current abuse of drugs, alcohol or solvents.
3. History of malignant disease.
4. First degree relatives with a history of cancer before the age of 50
5. First degree relatives with a history of premature cardiovascular disease before the age of 50
6. Current use of medication.
7. Clinical evidence of cardiac or pulmonary disease
8. Hypertension ( systole \>140mmHG, diastole \>90mmHg)
9. Diabetes mellitus
10. Smoking
11. Any clinically relevant abnormality on ECG.
12. A history of thrombosis or first degree family members with a history of recurrent thrombosis
13. Inability to understand the nature and extent of the trial and the procedures required.
14. Previous participation in a study with bevacizumab

Primary outcomes:
measure: Vasomotor response assessed by venous occlusion strain gauge plethysmography
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Centre
Study officials:
References:
Clinical trial NCT02389543: Study of Selinexor (KPT- 330), Lenalidomide, & Dexamethasone in Relapsed/Refractory Multiple Myeloma Patients
Official title: A Multi-Center, Phase 1/2, Open-Label Study of Selinexor (KPT- 330), Lenalidomide, and Dexamethasone in Patients With Relapsed/Refractory Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Multiple Myeloma
Keywords: KPT-330
Selinexor
Multiple Myeloma
Relapsed/refractory
Lenalidomide
Dexamethasone
Karyopharm
Lead sponsor: Karyopharm Therapeutics Inc
Sponsor class: INDUSTRY
First posted: 2015-03-17
Enrollment: 0
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: This is an open-label, randomized clinical study with two stages to assess the maximum tolerated dose (MTD), efficacy, and safety of selinexor, lenalidomide, and dexamethasone (SLd) in patients with relapsed/refractory (RR) multiple myeloma (MM). The stages are dose escalation (Phase 1) and expansion (Phase 2).

Detailed description: In Phase 1 (Dose Escalation), patients will be randomized to either once-weekly (Arm A) or twice- weekly (Arm B) dosing with selinexor. Dose escalation will be performed within each arm for both lenalidomide and selinexor to determine the selinexor MTD for that arm. Each arm will be expanded until approximately 17 patients have been treated at the MTD in each arm. The Sponsor and Investigator will review the MTD, efficacy, and safety data from Phase 1 to determine which dose schedule (Arm A or B) to be used as the RP2D dose in the Expansion Phase.

In Phase 2 (Expansion), patients who had received the MTD dose that was nominated for RP2D will continue at the same dose. Patients who did not receive the RP2D for that arm will stay on their Phase 1 dose. Additional patients will be accrued, as needed, to achieve the target population size of approximately 34 patients at the RP2D.

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed diagnosis, measurable disease and evidence of disease progression of MM.
* Relapsed or refractory to the most recently received therapy. Relapsed is defined as documented evidence of PD after achieving at least SD for ≥ 1 cycle. Refractory disease is defined as ≤ 25% response (i.e., patients never achieved minimal response or better) or progression during therapy or within 60 days after completion of therapy.
* Symptomatic MM, based on IMWG guidelines. Patients must have measurable disease.

Exclusion Criteria:

* Smoldering MM.
* Multiple myeloma that does not express M-protein or FLC (i.e., non-secretory MM is excluded), and quantitative immunoglobulin levels cannot be used instead.
* Polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome
* Active MM involving the central nervous system (CNS).

Primary outcomes:
measure: Determine maximum tolerated dose (MTD)
timeFrame: 12 months
measure: Overall response rate (ORR)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05491343: Observation vs Progesterone Treatment for Management of Uterine Arteriovenous Malformation
Official title: Management of Uterine Arteriovenous Malformation- a Comparison of 2 Management Possibilities- Observation vs. Progesterone Treatment/ a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Arteriovenous Malformations
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2022-08-08
Enrollment: 28
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized trial which compares conservative management to progesterone based treatment for arteriovenous malformation


Eligibility criteria: Inclusion Criteria:

* women between age of 18 to 50, diagnosed with AVM
* hemodynamically stable at clinical presentation

Exclusion Criteria:

* unstable patients
* contraindication to treatment
* US examination not in the US department

Primary outcomes:
measure: AVM regression
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03936543: Comparison of the Needle Tip Location by the Position of the Operator During Ultrasound Guided LIJV Catheterization.
Official title: Comparison of the Needle Tip Location According to the Position of the Operator During Short Axis Ultrasound Guided Central Venous Catheterization in the Left Internal Jugular Vein
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Catheterization, Central Venous
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2019-05-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: When the left internal jugular vein catheterization under short-axis ultrasound guided, an operator should be stand around the lying patient's head. The investigators are going to evaluate to effects of the operator's location.

Detailed description: When placing the central line catheter in the left internal jugular vein under short-axis ultrasound guided, an operator should be stand around the lying patient's head. The investigators are going to evaluate to effects of the operator's location. (Above the midline of patient's head versus above the left extended axillary line)

Eligibility criteria: Inclusion Criteria:

* Central venous catheterization required on lt. IJV

Exclusion Criteria:

* History of cervical spine surgery
* Abnormal structure of cervical spine, carotid artery or jugular vein
* Disease of carotid artery
* Immobilization due to cervical spine fracture or other diseases.

Primary outcomes:
measure: Distance from needle tip to center of IJV
timeFrame: intraoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: SMG-SNU Boramae hospital
name: Tae Kyong Kim, MD, phD
role: STUDY_DIRECTOR
References:
citation: Ishizuka M, Nagata H, Takagi K, Kubota K. Right internal jugular vein is recommended for central venous catheterization. J Invest Surg. 2010 Apr;23(2):110-4. doi: 10.3109/08941930903469342.
citation: Lobato EB, Sulek CA, Moody RL, Morey TE. Cross-sectional area of the right and left internal jugular veins. J Cardiothorac Vasc Anesth. 1999 Apr;13(2):136-8. doi: 10.1016/s1053-0770(99)90075-7.
citation: Sulek CA, Blas ML, Lobato EB. A randomized study of left versus right internal jugular vein cannulation in adults. J Clin Anesth. 2000 Mar;12(2):142-5. doi: 10.1016/s0952-8180(00)00129-x.
citation: Lieberman JA, Williams KA, Rosenberg AL. Optimal head rotation for internal jugular vein cannulation when relying on external landmarks. Anesth Analg. 2004 Oct;99(4):982-988. doi: 10.1213/01.ANE.0000132908.77111.CA.
citation: Min SW, Kim H, Won D, Chang JE, Lee JM, Hwang JY, Kim TK. Comparison of the needle tip location with the operator's position during ultrasound-guided internal jugular vein catheterization: A randomized controlled study. Medicine (Baltimore). 2022 Oct 28;101(43):e31249. doi: 10.1097/MD.0000000000031249.
Clinical trial NCT02243943: Effect of Neuromuscular Reversal With Sugammadex on Postoperative Recovery Profile
Official title: Effect of Neuromuscular Blockade Reversal With Sugammadex on Oxygenation, Pain and Arousal States in the Post Anesthesia Care Unit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Respiratory Condition
Keywords: Neuromuscular block
neuromuscular reversal
postoperative conditions
respiratory failure
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
First posted: 2014-09-18
Enrollment: 100
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: Suboptimal reversal of neuromuscular blockage after surgery is possibly related to unfavorable postoperative respiratory conditions and elevated pain levels. Rapid and complete reversal of neuromuscular block was not possible untill sugammadex was discovered. The investigators hyposthesise that reversal with sugammadex leads to favorable postoperative respiratory conditions and less pain compared to reversal with neostigmine.


Eligibility criteria: Inclusion Criteria:

* Age 18 years
* - BMI \< 35
* -ASA class I- III
* -Patients scheduled for surgery requiring general anesthesia with the use of NMBA's

  * Patients with ability to give oral and written informed consent

Exclusion Criteria:

* Failure to meet the inclusion criteria

  * -Known or suspected neuromuscular disorders impairing neuromuscular function
  * -Allergies to muscle relaxants, anesthetics or narcotics
* A (family) history of malignant hyperthermia

  * -Women who are or may be pregnant or are currently breast feeding
  * -Contraindications for the use of neostigmine
* Intestinal obstruction,
* COPD GOLD 4

  * -Abnormal heart rhythm (eg. bradycardia: \< 40/min);
  * -Surgery requiring neuraxial anesthesia / analgesia
  * -Preoperative cognitive dysfunction or mental disabilities
  * -Preexistent significant pulmonary disease with preoperative SpO2 \< 90%
  * -Preoperative ICU treatment / intubation (ICU patient);
  * -Need for postoperative ICU treatment or ventilation;

Primary outcomes:
measure: Mean Lowest Saturation
timeFrame: 45 minutes post surgery
Secondary outcomes:
measure: Pain
timeFrame: 45 minutes post surgery
measure: Sedation
timeFrame: 45 minutes post surgery
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Leiden Medical University
state: Zuid Holland
Study officials:
affiliation: Leiden Medical University
name: Albert Dahan, MD, PhD, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03989843: Impact of Embryo Cryopreservation on Birth Weight
Official title: Is Cryopreserved Embryo Replacement is Associated With Higher Birthweight Compared With Fresh Embryo ? Sibling Embryo Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Keywords: ART
Birthweight
Siblings
Cryopreservation
Epigenetic
Medical assistance to procreation
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2019-06-18
Enrollment: 183
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: sibling pairs where fresh embryo replacement resulting in a singleton live birth was followed by transfer of one or two frozen embryos from the same cohort that resulted in a singleton live birth, between May 2007 and June 2015.

Twin pregnancies and stillbirths were excluded. If the BW of at least one sibling was unknown, the pair was not included in the study

Brief summary: Birth weight (BW) is higher after frozen embryo transfer (FET) than after fresh embryo replacement. No study has compared the BW of siblings conceived using the same oocyte/embryo cohort. The aim of this study was to determine whether the freezing-thawing procedure is involved in such difference.


Eligibility criteria: Inclusion Criteria:

* sibling pairs where fresh embryo replacement resulting in a singleton live birth was followed by transfer of one or two frozen embryos from the same cohort that resulted in a singleton live birth, between May 2007 and June 2015.

Exclusion Criteria:

* Twin pregnancies and stillbirths were excluded. If the BW of at least one sibling was unknown, the pair was not included in the study.

Primary outcomes:
measure: birthweight
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uh Montpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Margaux Anav, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03742843: A Multi-omics Study of Adenomyosis
Official title: A Multi-omics Study on the Tumorigenesis of Adenomyosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Adenomyosis
Endometriosis
Ectopic Endometrium
Eutopic Endometrium
Genomics
Transcriptomics
Metabolomics
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2018-11-15
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with adenomyosis and/or endomtriosis and feasible for biopsy will be included.

Brief summary: This study aims to analyze the multi-omics results between eutopic endometrium, adenomyosis and endometriosis of patients diagnosed of adenomyosis with and without endometriosis. The multi-omics profiles include whole exome sequencing, analysis of transcriptomics and metabolomics. A comprehensive multi-omics will reveal the pathogenesis of adenomyosis.


Eligibility criteria: Inclusion Criteria:

* Confirmed adenomyosis and/or endometriosis
* Signed an approved informed consents
* Feasible for biopsy

Exclusion Criteria:

* Not meeting all of the inclusion criteria

Primary outcomes:
measure: Frequencies of somatic driving mutations
timeFrame: Two years
Secondary outcomes:
measure: Frequencies of alteration of RNA expression
timeFrame: Two years
measure: Frequencies of alteration of protein expression and signal pathway
timeFrame: Two years
measure: Progression-free survival
timeFrame: Five years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Lei Li
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Lei Li, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01648543: Comparison of Methods of Lumbar Sympathetic Ganglion Block: Distance vs Angle
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lumbar Sympathetic Ganglion Block Indication: Neuropathic Pain, CRPS, Hyperhydrosis Etc.
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2012-07-24
Enrollment: 194
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Lumbar sympathetic ganglion block is used for several neuropathic pain syndromes. The best method of lumbar sympathetic ganglion block is not established. The investigators would compare two methods of lumbar sympathetic ganglion block. One is modified Reid method which's entry point is 7\~7.5cm from midline of spinous process of lumbar spine. The other is angular method which's entry angle is 30 degree from anterior-posterior view of C-arm. Comparison modified Reid method with angular method would be helpful for finding best method of lumbar sympathetic ganglion block.


Eligibility criteria: Inclusion Criteria:

1. Adults above age of 20
2. Undergoing lumbar sympathetic ganglion block indication

Exclusion Criteria:

1. Infection
2. Bleeding tendency
3. Previous spinal surgery history
4. Pregnancy
5. Illiteracy

Primary outcomes:
measure: temperature change
timeFrame: 30min
measure: muscle or vessel shadow
timeFrame: 30min
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
Study officials:
affiliation: Yonsei University
name: Jong Bum Choi
role: STUDY_DIRECTOR
References:
Clinical trial NCT03777943: Role of the Peritoneal Microenvironment in the Pathogenesis and Spread of Colorectal Carcinomatosis
Official title: Role of the Peritoneal Microenvironment in the Pathogenesis and Spread of Colorectal Carcinomatosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peritoneal Carcinomatosis
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: University Ghent
name: Belgian Federation Against Cancer
First posted: 2018-12-19
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting with colorectal peritoneal carcinomatosis

Brief summary: The goal of this project is to investigate the extent and role of mesothelial - mesenchymal transition (MMT) and cancer associated fibroblasts (CAFs) in the pathogenesis of colorectal peritoneal carcinomatosis (PC).


Eligibility criteria: Inclusion Criteria:

• Patients presenting with colorectal peritoneal carcinomatosis

Exclusion Criteria:

* Pregnancy or breast feeding
* Psychiatric pathology capable of affecting comprehension and judgment faculty
* HIPEC (hyperthermic intraperitoneal chemotherapy) or PIPAC (pressurized intraperitoneal aerosol chemotherapy) in the past
* Abdominal radiation treatment

Primary outcomes:
measure: Immunohistochemistry (IHC) analysis
timeFrame: Within 6 months after collection of the samples
Secondary outcomes:
measure: Intra-tumoral versus peritoneal vascularity
timeFrame: Within 6 months after collection of the samples
measure: Laser capture microdisssection (LCM) followed by gene expression analysis
timeFrame: Within 12 months after collection of the samples
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital
Study officials:
References:
Clinical trial NCT01999543: Post-prandial Glucose in Healthy Indian Subjects
Official title: Effect of Plant-based Ingredient in Different Food Formats on Post-prandial Glucose in Healthy Indian Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Subjects
Keywords: Blood glucose
Lead sponsor: Unilever R&D
Sponsor class: INDUSTRY
First posted: 2013-12-03
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The study is designed to determine the extent to which a plant-based ingredient on different food formats affect blood glucose responses in healthy subjects


Eligibility criteria: Inclusion Criteria:

* Willing to give consent to participate in the study in writing;
* Healthy male and female subjects, between the age of ≥20 and ≤50 yrs of age at first screening visit;
* Body Mass Index (BMI) between ≥18 and ≤ 25 kg/m2;
* Apparently healthy: no medical conditions which might affect study measurement, as judged by study physician and/or measured by questionnaire, and/or assessed by haematology, blood chemistry and urinalysis;
* Willing to comply to study protocol during the study;
* Agreeing to be informed about medically relevant personal test-results by study physician;
* Willing to refrain from drinking of alcohol on and one day before the blood withdrawal;
* Fasting blood glucose value of volunteer is ≥ 3.4 and ≤ 6.1 mmol/litre (i.e. 62-110 mg/dl) at screening;
* Haemoglobin level within clinically acceptable range (for male 12 to 17 gm/dL and for females 11 to 15 gm / dL; both inclusive)

Exclusion Criteria:

* Being an employee of Unilever or CRO;
* Chronic smokers, tobacco chewers and drinkers;
* Participation in any other biomedical study 3 months before screening visit day of this study and/or participating in any other biomedical study during the screening period;
* Use of medication which interferes with study measurements including vitamins, tonics;
* Reported intense exercise ≥10 h/week;
* Reported weight loss/gain ≥ 10% of body weight in the 6 months preceding screening
* Blood donation for 2 months prior to screening;
* Urine analysis that showed any drug abuse;
* Allergy to any food or cosmetics;
* If female, not being pregnant or planning pregnancy during the study period;
* If female, lactating or has been lactating for 6 weeks before pre-study investigation and/or during the study period.

Primary outcomes:
measure: Positive incremental post-prandial blood glucose area under the curve
timeFrame: 120 minutes
Secondary outcomes:
measure: Post-prandial insulin area under the curve
timeFrame: 120 minutes
Other outcomes:
Locations:
city: Ahemdabad
country: India
facility: Lambda Therapeutics Research Ltd (LTRL)
Study officials:
affiliation: Lambda Therapeutics Research Ltd (LTRL)
name: Dr Ketul Modi, MBBS
role: PRINCIPAL_INVESTIGATOR
References: