cyrilzakka/clinical-trials huggingface dataset:
Imaging Microcirculation and Gross Hemodynamics in Elective Colorectal Surgery

Rationale: The interaction between macro and microcirculation remains uncertain. Microvascular alterations can occur when systemic hemodynamic parameters are within an acceptable range. Perfusion changes and microvascular alterations may play an important role in anastomotic healing and the onset of anastomotic leakage after gastrointestinal surgery. Nowadays, assessment of bowel perfusion is macroscopically performed by the surgeon prior to anastomosis creation. However, local oxygen delivery may still be compromised as little is known about microcirculatory alterations of the bowel during colorectal surgery. Dark Field (DF) imaging is a technique using a stroboscopic light-emitting diode ring-based imaging modality incorporated in a hand-held device, which illuminates an area of interest and provides high contrast dynamic images of the microvasculature. DF-imaging enables to visualize the bowel's microcirculation.

Objective: To describe the human gastrointestinal microcirculation during gastrointestinal surgery under general anesthesia and to observe whether there is a correlation between bowel microcirculation and systemic hemodynamic parameters.

Study design: A prospective, single center, observational, clinical, pilot study.

Study population: 70 patients undergoing elective, gastrointestinal surgery during which the gastrointestinal tract is accessible for DF-imaging.

Main study parameters/endpoints: To describe human gastrointestinal microcirculation on both the serosal and mucosal side of the bowel during gastrointestinal surgery under general anesthesia. Main parameter: Microvascular perfusion is quantified using the Microvascular Flow Index (MFI).

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The extend of burden and risk associated with participation is negligible. Using DF imaging on the bowel is a non-invasive technique requiring a minimal amount of time as is described in the study procedure. Previous studies did not show any safety concerns. Measuring will be performed under sterile conditions and the occurrence of tissue damage is highly unlikely. Patients are under general anesthesia and will thus not experience any inconvenience.


Eligibility Criteria:
Inclusion Criteria:

* All patients aged \>18 scheduled for elective, gastrointestinal surgery (as described above) with signed informed consent.

Exclusion Criteria:

* • Age \<18 years;

  * Atrial fibrillation (because of possible interference with FloTrac™/Vigileo™ cardiac output monitor);
  * Left ventricular ejection fraction ≤30%;
  * Serious pulmonary disease (resting pO2 \<90% at room air);
  * Renal failure (clearance \<30 ml/min as calculated using the Modification of Diet in Renal Disease formula);
  * Liver failure;
  * No signed informed consent.
Blood Pressure Management on Cardiovascular AdveRse Events After Major Abdominal Surgery

This study is a multicenter randomized controlled trial comparing an intensive intraoperative blood pressure management strategy versus conventional practice for preventing cardiovascular events in high-risk patients undergoing major abdominal surgery.

Intraoperative hypotension has been associated with cardiovascular events after non-cardiac surgery. However, whether avoiding intraoperative hypotension can reduce the incidence of postoperative cardiovascular events remains unclear. The objective of this study is to assess the effects of an intensive intraoperative blood pressure management strategy (to maintain intraoperative MAP ≥ 80mmHg) with that of conventional practice (to maintain intraoperative MAP ≥ 65mmHg) on the incidence of cardiovascular events after major abdominal surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Aged ≥ 45 years;
2. Undergoing major abdominal surgery under general anesthesia (expected surgery time \>2h, expected length of postoperative stay \>2d);
3. Fulfill ≥1 of the following criteria (a-f): a. history of coronary artery disease; b. history of stroke; c. history of peripheral arterial disease; d. history of congestive heart failure; e. preoperative NT-proBNP \>200 pg/mL or BNP \>92 mg/L f. preoperative troponin \> upper limit of normal; or fulfill ≥2 of the following criteria (g-l); g. history of chronic kidney disease (preoperative sCr \>133μmol/L or 1.5 mg/dL); h. diabetes requiring medical treatment; i. smoking in the past \>2 years; j.≥ 65 years of age; k. hypertension requiring medical treatment l. history of hypercholesterolemia.

Exclusion Criteria:

1. ASA score ≥5;
2. Severe untreated or uncontrolled hypertension (preoperative SBP\>180mmHg and/or DBP\>110mmHg);
3. End-stage renal disease requiring renal-replacement therapy;
4. Acute cardiovascular event within 1 month of surgery, including acute heart failure, acute coronary syndrome and stroke;
5. Preoperative sepsis or septic shock;
6. Preoperative requirement of vasopressor infusion;
7. Current participation in another interventional study;
8. Previous participation in this study;
9. Pregnant or breastfeeding women.
Lupus Nephritis: Role of Environmental and Occupational Exposures

The purpose of this study is to examine hormonal and environmental risk factors (and possible gene-environmental interactions) involved in the etiology of lupus nephritis. Our study will focus on exposures to occupational and environmental agents that have been linked to the development of systemic lupus erythematosus (SLE) or renal disease (e.g., silica dust, smoking). We will also assess potential gene environment interactions. We will examine these exposures in 100 patients with renal biopsy with documented proliferative or membraneous nephritis. We will compare exposures in the lupus nephritis patients to lupus patients who do not have nephritis and to normal controls who have participated in the Carolina Lupus Study. One hundred lupus nephritis patients (age 18 years or older, of both genders and all races) will be identified through the Glomerular Disease Collaborative Network (GDCN) Nephropathology database and participating nephrologists at the Medical University of South Carolina, Duke University Medical Center and the East Carolina Medical School.

The purpose of this study is to examine hormonal and environmental risk factors (and possible gene-environmental interactions) involved in the etiology of lupus nephritis. Our study will focus on exposures to occupational and environmental agents that have been linked to the development of systemic lupus erythematosus (SLE) or renal disease (e.g., silica dust, smoking). We will also assess potential gene environment interactions. We will examine these exposures in 100 patients with renal biopsy with documented proliferative or membraneous nephritis. We will compare exposures in the lupus nephritis patients to lupus patients who do not have nephritis and to normal controls who have participated in the Carolina Lupus Study. One hundred lupus nephritis patients (age 18 years or older, of both genders and all races) will be identified through the Glomerular Disease Collaborative Network (GDCN) Nephropathology database and participating nephrologists at the Medical University of South Carolina, Duke University Medical Center and the East Carolina Medical School.

Eligibility Criteria:
* INCLUSION CRITERIA:

Have renal biopsy proven Lupus Nephritis (with the biopsy-based diagnosis date no earlier than January 1, 1995).

Reside within designated counties of eastern North Carolina and South Carolina.
Intraoperative Administration of Intravenous Morphine in Patients Undergoing Laparoscopic Cholecystectomy

The goal of this observational, quality improvement study is to compare the effect of a dose of morphine given during gall-bladder removal surgery. The main questions to answer are:

* Do participants, who are given given a dose of morphine during gall-bladder removal surgery, experience less pain after surgery?
* Does a dose of morphine during gall-bladder removal surgery cause more side effects? The investigators will compare the effects of two types of anesthesia: a) anesthesia without morphine during surgery, and b) anesthesia with morphine during surgery.

The investigators will use Redcap secure web application (via Open Patient Data Explorative Network, a subsidiary under University Hospital of Odense, Denmark) for data collection and data management.

No sample size has been collected as per the observational design. The investigators expect to include an equal number in each study arm, as there has been no indication of change in indications for surgery type.

The investigators expect to use students T-test for comparison of groups. If possible logistic regression analyses will be undertaken.

Eligibility Criteria:
Inclusion Criteria:

* patients who have had elective laparoscopic cholecystectomy/planned gall-bladder removal surgery

Exclusion Criteria:

* age limit as above
* patients unable to give consent to anesthesia
* patients unable to participate in pain scoring
* patients with chronic pain syndromes, characterized by patients receiving regular analgesic treatment and patients with active or previous contact to pain clinic)
* patients with active or previous substance abuse
* emergency surgery
Efficacy of TPI ASM8 During a 14-Day Allergen Challenge

This is a randomized, double-blind, placebo-controlled, 3-way crossover trial to evaluate the efficacy and safety of two different doses of inhaled TPI ASM8 administered daily for 14 days for the treatment of allergic asthma and allergen-induced asthma.

Two doses of TPI ASM8 will be compared to placebo and look at the effect on asthmatic responses after an allergen challenge during a 3-way cross over design. Sputum inflammation , mRNA gene expression on target receptors, ECP , biomarkers of mast cells activation et PK profile will be studied.

Eligibility Criteria:
Inclusion Criteria:

* Mild asthma, male and female aged 18-55 y.old
* Steroid-naive, non-smoker
* Dual responders

Exclusion Criteria:

* Any chronic disease(unstable)
* Immunosuppressed, recent or ongoing steroid intake
* Methacholine PC 20 \> 16 mg/mL
Assessment of the Effectiveness of Menopur in Intrauterine Insemination

The purpose of this study is to assess the effectiveness of Menopur to achieve clinical pregnancy in females undergoing intrauterine insemination in clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Infertile couples for over one year (primary or secondary) or infertile women (or not) with indication of PAI or DAI
* Seminal sample suitable for artificial insemination treatment according to the criterion of each centre
* Patient prescribed therapy with Menopur in artificial insemination

Exclusion Criteria:

* Contraindications to intrauterine insemination
* Contraindications to Menopur
Acupuncture for Chemical Therapy Induced Nausea and Vomiting: a Cross-over Trail

This is a randomized, controlled cross-over trial. The hypothesis of this study is that the differences in manual acupuncture manipulation can impact clinical effect though the acupuncturists follow the same needling regimen. In this study, acupuncturist 1 (clinical experience \>15 years) and acupuncturist 2 (\<5 years) will give treatments to cancer patients receiving cisplatin chemotherapy (n=36) for at least two continuous cycles, once per day, 5 days per cycle. Acupuncturist 1 determines all the treatment regimens (selection of acupoints and methods of needling manipulation, needle retention time). Randomly, half of the patients will receive treatments from acupuncturist 1 in the first treatment cycle and from acupuncturist 2 in the second cycle; while the other half will be treated in other way round. There is a washout period (21 days) between two cycles. The needling manipulation of two acupuncturists will be measured objectively during treatments. The clinical effect will be measured by the control of vomiting and nausea during and after chemotherapy treatments.

This is a randomized, controlled cross-over trial. The hypothesis of this study is that the differences in manual acupuncture manipulation can impact clinical effect though the acupuncturists follow the same needling regimen. In this study, acupuncturist 1 (clinical experience \>15 years) and acupuncturist 2 (\<5 years) will give treatments to cancer patients receiving cisplatin chemotherapy (n=36) for at least two continuous cycles, once per day, 5 days per cycle. Acupuncturist 1 determines all the treatment regimens (selection of acupoints and methods of needling manipulation, needle retention time). Randomly, half of the patients will receive treatments from acupuncturist 1 in the first treatment cycle and from acupuncturist 2 in the second cycle; while the other half will be treated in other way round. There is a washout period (21 days) between two cycles. The needling manipulation of two acupuncturists will be measured objectively during treatments. The clinical effect will be measured by the control of vomiting and nausea during and after chemotherapy treatments. The manual manipulation of two acupuncturists will be recorded by device Acusensor.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of cancer
* Must receive cancer chemotherapy containing cisplatin
* Able to complete at least two continuous chemotherapy treatment cycles
* Karnofsky performance status grade ≥60
* Must use 5-TH receptor antagonists as an antiemetic drug in the chemotherapy duration

Exclusion Criteria:

* Concurrent neoplasms or illness that induces nausea independent of chemotherapy
* Receiving radiotherapy
* Received acupuncture treatments for other conditions less than 4 weeks before chemotherapy treatment
* Severe infection
* Severe heart, liver, kidney and brain diseases
* Unconsciousness
* Psychosis
* Language barriers
* Cardiac pacemaker
* Radiotherapy or hormone therapy during chemotherapy treatments
Study of Vorinostat (MK-0683) or Placebo, in Combination With Bortezomib in Participants With Multiple Myeloma (MK-0683-088 AMN)

Study of the efficacy and safety of bortezomib administered in combination with vorinostat in patients with relapsed or refractory multiple myeloma. Histone deacetylases (HDAC) facilitate gene transcription by modulating the uncoiling of chromatin. HDAC function is dysregulated in hematologic and solid malignancies, and this dysregulation may result in over-expression of oncogenes. Thus, inhibition of HDACs may result in anti-cancer effects. HDAC inhibitors, like vorinostat, represent a new class of antitumor agents that have the ability to induce antiproliferative effects including cyto-differentiation, cell cycle growth arrest or apoptosis in various cancer cell lines. Several studies have investigated the in vitro antimyeloma activity of vorinostat in combination with bortezomib and have demonstrated that vorinostat may act synergistically with bortezomib to modulate tumor cell growth. Mitsiades et al have shown that vorinostat enhances the sensitivity of bortezomib. Pei et al found that exposure of human multiple myeloma cell lines \& patient-derived multiple myeloma cells to bortezomib and vorinostat resulted in synergistic interactions as a result of: (1) Interruption of NF-kB \& related signaling pathways (JNK, XIAP, Mcl-1, etc.) (2) Inhibition of Hsp90 (3)Induction of ER stress signal and (4) acetylation of Dynein/disruption of aggresome function/formation, salvage for ubiquitinated proteins. In addition a marked increase in mitochondrial injury, caspase activation, and apoptosis was also observed. Bortezomib is indicated for the treatment of patients with multiple myeloma. Two Phase I dose-ranging studies of a regimen combining vorinostat and bortezomib among patients with relapsed as well asend-stage, refractory multiple myeloma have been conducted. These studies enrolled a total of 57 patients. In these studies, administration of vorinostat with standard doses of bortezomib resulted in responses in 20/45 (44%) evaluable patients (Weber et al 2007, Badros et al 2007). The purpose of the present study is to definitively evaluate the clinical activity of vorinostat in combination with bortezomib inpatients with multiple myeloma.


Eligibility Criteria:
Inclusion criteria

* Participant has an established diagnosis of multiple myeloma based on the myeloma diagnostic criteria.
* Participant has received at least 1 but not more than 3 prior anti-myeloma regimens and has progressive disease after the most recent treatment regimen.
* Participant must have adequate organ function.

Exclusion criteria:

* Participant has had a prior allogeneic bone marrow transplant or plans to undergo any type of bone marrow transplantation within 4 weeks of the initiation of study therapy.
* Participant has known hypersensitivity to any components of bortezomib or vorinostat.
* Participant has active Hepatitis B or C, plasma cell leukemia, or is human immunodeficiency virus (HIV) positive.
* Participant has had prior treatment with vorinostat or histone deacetylase (HDAC) inhibitors.
Serial Measurement of Serum Antimullerian Hormone in Women Undergoing Laparoscopic Cystectomy of Endometrioma

The purpose of this trial is to study ovarian reserve after laparoscopic endometrioma cystectomy by measuring antimullerian hormone. The measurements were measured before the surgery and one week and three months after the surgery.

Antimullerian hormone will be obtained in patients with ovarian endometrioma before laparoscopic cystectomy is done. The measurements were compared with antimullerian hormone after one week and three months after the surgery. Forty three patients will be included in this study.

Eligibility Criteria:
Inclusion Criteria:

* 20-40 years
* ovarian endometrioma \> or = 3 cms
* laparoscopic cystectomy treatment

Exclusion Criteria:

* previous ovarian surgery
* other ovarian pathology
* previous drugs or hormonal treatment for endometrioma
Comparison of the Effects of TENS and CTM on Primary Dysmenorrhea

this study was to compare the early and short-term effects of high-frequency transcutaneous electrical nerve stimulation (TENS) versus connective tissue manipulation (CTM) in participants with primary dysmenorrhea. Half of the participants received CTM, while the other half received TENS.

CTM and TENS each relieve dysmenorrhea pain, but they do so by different. The electrotherapy modality that is most commonly used in the treatment of dysmenorrhea is TENS. It has been reported in studies that high-frequency TENS is more effective in reducing pain than either low-frequency TENS or placebo TENS.

A scan of the literature reveals that although there are differing opinions and applications related to the number and duration of CTM, it has been shown that women with primary dysmenorrhea experience reduced pain after CTM,

Eligibility Criteria:
Inclusion Criteria:

* being between the ages of 18-30
* having a diagnosis of primary dysmenorrhea

Exclusion Criteria:

* having used an oral contraceptive in the last 3 months,
* having an active sexual life,
* pregnancy,
* having gone through childbirth,
* having a neurological deficit,
* any kind of systemic condition,
* a diagnosed gynecological condition (pelvic inflammatory diseases, endometriosis, uterus cancers, ovarian cysts, etc.),
* taking psychotherapeutic drugs.
Exploratory Study of the Relationships Between the Biomarkers of Inflammation, Lipidome and Insulin Resistance and Disorders of Glycemic Regulation in a Cohort of Insulin-resistant Subjects Due to Excess Weight or Dunnigan's Lipodystrophy

The objective of this work is to identify biomarkers of interest in patients with insulin resistance leading to early disorders of glycemic regulation. For this the investigators want to assay the insulin resistance marker Insulin Regulated Amino Peptidase serique (IRAPs), the plasma lipidome and inflammation markers in 2 populations of insulin-resistant subjects due to Dunnigan's inherited lipodystrophy or overweight/obesity and insulin-sensitive subjects with or without a glycemic regulation disorder objectified during an Oral induced hyperglycemia. The results of the IRAPs, lipidome and inflammation assays will be compared in insulin-resistant subjects, between normoglycemic, prediabetic and diabetic subjects. Correlations will be made between these markers and the deterioration of glycemic regulation as well as with known insulin resistance parameters (HOmeostasis Assessment Model (HOMA), Quantitative Insulin-sensitivity Check Index (QUICKI),Insulin Sensitivity Index (Isi) MATSUDA).


Eligibility Criteria:
Inclusion Criteria:

* Subjects with Dunnigan's Lipodystrophy OR Non-lipodystrophic insulin-resistant subjects OR Insulin-sensitive non-lipodystrophic subjects
* major
* Subjects benefiting from metabolic exploration in the Endocrinology, Diabetology and Nutrition department of the Reunion University Hospital.
* Subject benefiting from an oral glucose tolerance test (OGTT) during his follow-up in the Endocrinology, Diabetology and Nutrition department of the Reunion University Hospital.
* Person affiliated or beneficiary of a social security scheme.
* Subject having been informed of the study in progress and having given their written consent.

Exclusion Criteria:

* Pregnant woman
* Person under guardianship or curators or deprived of liberty
Rehabilitation of Chronic Diseases and Smart Health Management System Service

In Republic of Korea, it is not easy to practice standard pulmonary rehabilitation (PR) or cardiac rehabilitation (CR). In this study, the investigators will provide newly developed smartphone application to patients with chronic respiratory, cardiac, or geriatric diseases. The investigators want to confirm whether participants, who perform smartphone application based 12-week PR or CR program, present improved exercise capacity, dyspnea symptom, muscle strength, or quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Dyspnea symptom \>= mMRC 1 or NYHA I
* adults between 20 years and 80 or years

Chronic respiratory disease

* FEV1/FVC \< 0.7 in pulmonary function test
* bronchiectasis in more than one lobe on chest computed tomography
* FVC of DLCO \< 0.8 of predicted value in pulmonary function test

Chronic cardiac disease

* Reperfusion Therapy for angina pectoris or myocardial infarction
* Heart failure with reduced ejection fraction (LVEF \< 50%)

Chronic geriatric disease

* Ages between 60 and 80 years
* Clinical frailty scale between 1 and 4

Exclusion Criteria:

* history of acute exacerbation within 4 weeks
* unable to comply rehabilitation program
* not suitable for study on decision by duty physician
* no consent
Dipole Density Mapping of Right and Left Atrial Supraventricular Tachycardia

Use of dipole density mapping to identify activation in complex supraventricular tachycardias


Eligibility Criteria:
Inclusion Criteria:

1. aged 18 to 75 years
2. scheduled for ablation of atypical atrial flutter or paroxysmal atrial fibrillation
3. able and willing to give informed consent

Exclusion Criteria:

1. implanted prosthetic, artificial, or repaired cardiac valves in the chamber being mapped, permanent pacemaker or ICD leads in the chamber being mapped, and/or hypercoagulopathy or an inability to tolerate anticoagulation .
2. myocardial infarction within the prior two months
3. cardiac surgery within the prior three months
4. intracardiac thrombus
5. clinically significant tricuspid valve regurgitation or stenosis
6. any cerebral ischemic event in the prior six months
7. pregnant or nursing
8. currently enrolled in any other clinical investigation