cyrilzakka/clinical-trials huggingface dataset:
Sciatic Block Increases Regional Saturation in Peripheral Artery Occlusive Disease.

We conducted Single-center prospective observational study to evaluate the improvement of peripheral vascular perfusion monitored with near-infrared spectroscopy, in patients undergoing endovascular surgery after performing sciatic nervous block.

The aims of that study is to check regional oxigen saturation variability in patients suffering from Peripheral Artery Occlusive Disease (IIa to III Fontaine classification) undergoing popliteal sciatic nerve block as analgesic procedure before vascular surgery. We want to evaluate the increase in regional microcirculation after the popliteal nerve blocks due to vasoplegic response and vasodilatation after performing regional anaesthesia. We will place NIRS electrode on the instep of the foot to evaluate regional oxigen saturation in the interested leg before the performing of popliteal sciatic nerve block and then during the surgery (after 5 minuts, 15 minuts, 30 minuts), and after the end of the procedure.

Eligibility Criteria:
Inclusion Criteria:

* age: \> 18 years
* Peripheral artery occlusive desease involving popliteal, tibial and/or peroneal artery
* Stadiation IIa to III in Fontaine classification
* Eligibility for PTA or Stenting

Exclusion Criteria:

* trophic alteration of the application site of the NIRS
* less than 18 years
* Pregnancy
* need of sedation during the procedure
* revascularization performed as emergency surgery
* Allergic reactions with local anaesthetic
* Previous surgery involving the interested artery
In Children, Does Using a Synera Patch Decrease Pain When Injecting Propofol at Anesthesia Induction?

The purpose of this study is to evaluate if the Synera Patch (lidocaine/tetracaine patch), used to numb the skin before IV placement, is effective in reducing pain associated with propofol IV administration when inducing general anesthesia, compared to Gebauer's Ethyl Chloride topical anesthetic skin refrigerant.

Commonly, anesthesiologists inject Propofol, a sleeping medication, intravenously to induce general anesthesia. Propofol injection is associated with pain that can be severe.

The investigators also place a lidocaine/tetracaine skin patch (Synera) to decrease pain associated with IV placement. Because the local anesthetics of the Synera patch diffuse deep underneath the skin, in this study the investigators would like to evaluate whether the application of Synera Patch can decrease the pain associated with propofol injection.

Children will be randomized to receive either the patch or the Ethyl Chloride before the IV placement. A total of 33 patients will be enrolled in each group.

Eligibility Criteria:
Inclusion Criteria:

* Healthy, outpatient children, 6-17 years old
* American Society of Anesthesiologist Physical Classification rating of 1 or 2
* Elective procedure requiring general anesthesia at Memorial Herman Hospital, The Medical Center, Houston, Texas

Exclusion Criteria:

* Skin disease or infection (on dorsum of hands)
* Allergy to lidocaine or tetracaine
Local Anesthetic Response in Ehlers-Danlos Syndrome (EDS) and Healthy Volunteers

Local anesthetic resistance is commonly reported by patients with EDS. However, there are no objective data on the occurrence of local anesthetic resistance in EDS patients and in healthy volunteers. The investigators propose to collect such objective data on the frequency of drug resistance and whether any problems with local anesthesia are due to initial ineffectiveness or due to its effects dissipating too soon.

There was a prior large online questionnaire to better understand the issues around local anesthetic resistance. By November 2018, 933 EDS patients (total 1059 respondents) completed the survey, 99.2% of which had previously received local anesthetics. Among these patients, 88% reported that they have "had a problem with local anesthetic injection not working adequately or properly," while only 54% of respondents without EDS reported a similar problem. These data suggests that local anesthetic resistance might be more prevalent in patients with EDS than in the general population. If these findings are true, then this might have significant implications for the appropriate management of these patients during minor surgery and dental procedures.

This study aims to assess the frequency and related issues around local anesthetic resistance in EDS patients, including whether the problem is a lack of analgesia or a timing effect (short duration of action or delayed onset of action), and whether the problem relates only to some local anesthetics or whether there is a problem with the whole class of local anesthetics. This study is completing data originally collected during a 2019 EDS conference.

Eligibility Criteria:
Inclusion Criteria:

* EDS patients, clinically diagnosed hypermobile EDS based on 2017 criteria
* EDS patients with genetically proven non-hypermobile EDS
* Healthy participants, no EDS
* Able and willing to provide informed consent

Exclusion Criteria:

* Known allergy to Lidocaine
* Unable to provide informed consent
A Study of the Safety and Efficacy of Combination Therapy With Morphine, Phenylephrine and Sorbitol in Human Subjects

Efficacy and Safety of the combined oral adjuvants phenylephrine and sorbitol on oral low dose morphine analgesia.

The primary objective of this study is to determine the efficacy of the combined oral adjuvants phenylephrine and sorbitol on oral low dose morphine analgesia.

Eligibility Criteria:
Inclusion Criteria:

* Ability to provide written informed consent
* Healthy male or female between 18 and 40 years of age, inclusive.
* Women have to test negative for pregnancy.
* Body weight within 15% of ideal body weight based on Metropolitan Life assurance tables.
* No concomitant medications (prescription, OTC, vitamins, dietary supplements) within 7 days prior to administration of study medication and during the study period.
* Ability to adhere to the visit schedule and protocol requirements and be available to complete the study
* Ability to participate successfully in training sessions that will be arranged for the volunteers prior to the study day, during which they will acquire consistency in the tests to be performed.
* Ability to satisfy a medical examiner about fitness to participate in the study

Exclusion Criteria:

* prior use of chronic opioids
* mental illness prior or present
* evidence of significant concomitant disease, including renal, hepatic, cardiovascular, pulmonary, endocrinological, hematopoietic, or gastrointestinal disease, a neoplasm or any other clinically significant medical disorder, which in the Investigator's judgment contraindicate administration of the study medications
* known allergy to any of the drugs used in this study
* history of drug or alcohol abuse
* significant abnormalities in screening physical exam
* administration of drugs that may potentially inhibit or induce liver cytochrome P450 activity within 3 weeks prior to Day 0
* any acute medical situation (e.g. acute infection) within 48 hours of Day 0, which is considered of significance by the Principal Investigator
* unusual diet
* administration of experimental medications within the previous 12 weeks.
* inability to communicate well with the Investigator (i.e., language problem, poor mental development or impaired cerebral function)
* subjects who, in the judgment of the investigators, are likely to be non-compliant or uncooperative or unwilling to sign a consent form
Cilostazol Verse Asprin for Vascular Dementia in Poststroke Patients With White Matter Lesions

The purpose of this study is to evaluate the efficacy of PDE-3 inhibitor, cilostazol, in prevention and treatment of vascular dementia, in those with brain white matter lesions and vascular risk factors.


Eligibility Criteria:
Inclusion Criteria:

1. Age ranging from 40 to 80 years
2. After newly ischemic stroke from 3 months to 2 years
3. Brain CT or MRI shows stroke lesions and white matter lesions, ARWMC(Age Related White Matter Change)\>=4
4. Moderate or mild cognitive deficits: MMSE 12-26
5. Vascular or mixed dementia: Hachinski ischemic score\>4
6. Moderate or mild disability: MRS\<=4,NIHSS\<20
7. Informed consent

Exclusion Criteria:

1. Definitive diagnosis of dementia prior to the stroke
2. Cerebral hemorrhage in the past
3. Cerebral embolism result from cardiogenic embolus
4. Critically ills: MRS\>4,NIHSS\>=20
5. Bed-ridden patient who is hardly discovered newly stroke
6. patient with sever cardiac, hepatic or nephric complication
7. dementia caused not by vascular lesions
8. other diseases disturb the cognitive evaluation
9. susceptibility to varieties of allergen
10. abstain from Cilostazol or Asprin
11. antiplatelet treatment, anticoagulation or fibrinolysis are needed because of other diseases
12. rejected to participate by the patient or the family
Low Pain Prediction in Cesarean Section Patients

The investigators are attempting to see if eliminating the amount of long acting spinal narcotic during cesarean section delivery will demonstrate pain scores with movement when evaluated 24 hours postoperatively as those that receive the standard dosage of spinal narcotic when combined with oral acetaminophen or placebo. The investigators also are evaluating if there are decreased side effects related to decreased narcotic usage.

Subjects are randomized on the morning of surgery to receive a standard dose of spinal narcotic or to receive no long acting spinal narcotic. The subjects may or may not also receive acetaminophen orally postoperatively. Pain scores are done on postoperative day one as well as evaluation of potential narcotic side effects such as nausea/vomiting, itching, and sedation.

Eligibility Criteria:
Inclusion Criteria:

* anticipated pain level estimated to be in the lowest 20th percentile (calculated \<34.3 utilizing our standard preoperative questionnaire)
* age \>/= 18
* not allergic to any study medications to be utilized in this study
* singleton pregnancy

Exclusion Criteria:

* allergies to morphine or acetaminophen
* diagnosis of a chronic pain disorder
* weight \>300 lbs
* hepatic disease
Assessment of the Impact of Polycystic Ovary Syndrome on Women's Sexuality

This study, titled SexOPK, aims to evaluate the impact of polycystic ovary syndrome (PCOS) on women's sexual health. PCOS is a common endocrine disorder affecting 5-20% of women of reproductive age, often leading to hormonal imbalances, metabolic issues, and psychological distress. Despite existing studies on the subject, the level of sexual distress associated with PCOS-related sexual dysfunction remains unclear.

The study will compare sexual function and distress levels between women diagnosed with PCOS and a control group without PCOS. Participants will complete an online questionnaire assessing various aspects of sexual health, body image, anxiety, and depression. The findings may help healthcare professionals better understand and address sexual dysfunction in women with PCOS.


Eligibility Criteria:
Inclusion Criteria:

For patients in the test group (PCOS):

* Adults
* Carriers of medically diagnosed polycystic ovarian syndrome
* Non-opposition

For patients in the control group:

* Adults
* Not carriers of polycystic ovarian syndrome
* Unopposed

Exclusion Criteria:

* Patient under court protection, guardianship, or curatorship
* Does not understand or speak French
Multi-center Clinical Study of Guli Capsules in the Treatment of Knee Osteoarthritis

Previous study showed that Guli capsule could suppress the adjuvant multiple arthritis; have inhibitory effect on carrageenan gelatinous and formaldehyde foot swelling; improve the symptom of osteoporosis patients; and improve pain and limited joint activities of rheumatoid patients.

To further verify the clinical effect of Guli capsule in the treatment of knee osteoarthritis, the investigators perform this multi-center clinical study.

Guli capsule, an approved Chinese patent drug, its main indications are for rheumatism, rheumatoid arthritis.

Previous study showed that Guli capsule could suppress the adjuvant multiple arthritis; have inhibitory effect on carrageenan gelatinous and formaldehyde foot swelling; improve the symptom of osteoporosis patients; and improve pain and limited joint activities of rheumatoid patients.

To further verify the clinical effect of Guli capsule in the treatment of knee osteoarthritis, the investigators perform this multi-center clinical study.

Eligibility Criteria:
Inclusion Criteria:

* Ages between 40 and 70 years, both gender
* Kellgren and Lawrence grades of I to III;
* The subjects volunteered participate in the study and complied with the regulations and signed the written consent voluntarily.
* Meet the following clinical and radiological criteria for diagnosis:
* Clinical criteria:

  1. most of the time have knee pain nearly a month
  2. bone fricative
  3. morning stiffness is less than or equal to 30 min
  4. age is more than or equal to 38 years
  5. bony enlargement. Who meet (1) + (2) or (1) + (4) + (5) can be diagnosed as knee osteoarthritis.
* Radiological criteria:

  1. most of the time have knee pain nearly a month
  2. the X-ray showed osteophyte formation
  3. joint fluid examination confirmed with osteoarthritis
  4. age is more than or equal to 40 years
  5. morning stiffness is less than or equal to 30 min
  6. bone fricative. Meet (1) + (2) or (1) + (3) + (5) + (6) or (1) + (4) + (5) + (6).

Exclusion Criteria:

* Patient with a history of allergy to similar constituents or chemical components of the drug;
* Patients with limited liver and kidney function;
* Patients with hematopoietic system disease;
* Patients with diabetes, Cushing's syndrome and other endocrine disorders;
* Patients with severe heart and brain disease;
* Patients with low immunity;
* Patients directly involved with the staff in the study;
* Women during pregnancy or lactation;
* Participating in other clinical studies or Participated in 3 months;
* The investigators judged who be unfit for the study.
Novel ECCO2R Device for Hypercapnic Respiratory Failure

The objective of this study is to assess the efficacy and safety of this new Prismalung+ membrane in its intended clinical setting by demonstrating a reduction in ventilatory parameters and pulmonary energy load or the successful maintenance of spontaneous breathing, respectively, the absence of the need to initiate vv-ECMO therapy, and initial survival.

Our hypotheses are that decarboxylation therapy by means of the novel Prismalung+ membrane in patients with hypercapnic respiratory failure (I) allows the reduction of tidal volume, peak airway pressure, dP and pulmonary energy load (as measured by AUC over 72 hours) as compared to baseline in mechanically ventilated patients OR is associated with successful continuation of spontaneous breathing despite respiratory exhaustion (no decision to intubate), and that these patients (II) warrant no decision to initiate vv-ECMO therapy and (III) do not experience early mortality.

The primary Objectives of the study are to test our hypotheses I to III by applying the novel Prismalung+ ECCO2R device in mechanically ventilated patients and spontaneously breathing patients experiencing hypercapnic respiratory failure in a multi-central prospective trial in three experienced intensive care units in Switzerland.

Eligibility Criteria:
Inclusion Criteria:

* Mechanically ventilated patient: (I) Progressive respiratory failure (pH≤7.25 and/ or PaCO2 ≥9 kPa) during mechanical ventilation (II) with an inability to maintain lung protective ventilation (VT\<4 mL/kg, Ppeak \<30 mbar, Driving Pressure ≤12 mbar)
* OR awake spontaneously breathing patient: Respiratory exhaustion (pH≤7.25 and/or PaCO2 ≥9 kPa)
* AND Informed Consent as documented by signature

Exclusion Criteria:

* Mechanical Ventilation group: Need for v-v ECMO
* Awake spontaneously breathing group: Need for mechanical ventilation due to inability to remain un-sedated
* Thrombocytopenia (\<100G/l)
* Contraindications for Heparin therapy (history of heparin antibodies, previous history of intracranial bleeding)
* Patients under 18 years of age
* Women who are pregnant or breast feeding
* Previous enrolment into the current study
* Enrolment of the investigator, his/her family members, employees and other dependent persons
MCC-24-GYN-11: Comparison of Nodal Sampling in Endometrial Cancer

This study aims to estimate the recurrence-free survival rates in women with endometrial cancer treated with selective versus sentinel node surgical staging. This study will gather information to help determine the best way to evaluate lymph nodes during surgery for endometrial cancer.


Eligibility Criteria:
Inclusion Criteria:

* Surgical candidate for complete hysterectomy and bilateral salpingooophorectomy with pelvic and aortic lymphadenectomy
* Histologically or cytologically confirmed carcinoma of the endometrium confined to the uterine corpus
* No clinical evidence of extra-uterine disease on pre-operative evaluation. Preoperative evaluation to rule-out extra-uterine disease may include a CT scan, MRI or ultrasound. Note: preoperative imaging is not mandatory for study enrollment.
* Prior systemic chemotherapy is allowed so long as it was at least five years prior to study enrollment, and there is no evidence of disease after such therapy.

Neoadjuvant chemotherapy for this endometrial cancer is not allowed.

* Life expectancy (estimated survival) of at least 6 months.
* AST(SGOT)/ALT(SGPT) \< 3.0X upper limit of normal
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* GOG Performance Status greater than 2 (Appendix II)
* Uterine sarcoma
* Clinical evidence of disease that extends beyond the uterus, including the presence of suspicious aortic or inguinal nodes on imaging or clinical exam
* Previous vaginal, pelvic or abdominal irradiation
* Chemotherapy, hormone therapy or immunotherapy directed at the present disease
* Previous pelvic lymphadenectomy or retroperitoneal surgery
* Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen should be excluded
* Known allergy to iodine or indocyanine green (ICG) tracer, or allergic reactions to compounds of similar chemical or biologic composition
* Patients with uncontrolled intercurrent illness
* Patients with psychiatric illness/social situations that would limit compliance with study requirements
* Pregnant or lactating women. Women of child-bearing potential will be excluded if they have a positive serum/urine pregnancy test
Venous Cannulation Pain to Guide Choice of Anesthetic Method

The investigators have recently shown that pain associated with peripheral venous cannulation can be used to predict the risk of postoperative pain, where patients grading their pain associated with venous cannulation (VCP) above 2.0 VAS units had 3.4 times higher risk of moderate or severe postoperative pain after laparoscopic cholecystectomy and 1.7 times higher risk in a mixed group of patients and surgeries.

The aim of this study is to investigate whether pain sensitivity measurements using VCP can be used to choose anesthesia treatment protocol with the aim to lower acute postoperative pain in those with high risk. In patients with low risk we aim to lower the amount of opioids given.

The investigators will perform a randomized controlled trial randomizing patients to different treatment protocols depending on their pain associated with venous cannulation. There will be two set of instructions for perioperative treatment, one for those grading pain associated with venous cannulation \<2.0 (low-pain) and another for those grading VCP ≥2.0 (high-pain).

The low-pain group will be randomized to standard treatment or opioid-free anesthesia. The high-pain group will be randomized to standard treatment or extra in form of additives like esketamine and clonidine.

In the low-pain group the investigators aim for non-inferiority with the gain being avoiding opioids. In the high-pain group the investigators aim for lower post-operative pain.

Eligibility Criteria:
Inclusion Criteria:

* Adults with an American Society of Anesthesiologists (ASA) physical status I or II, undergoing elective laparoscopic surgery at Hallands´ hospital.

Exclusion Criteria:

* Inability to understand information regarding the study. Refusal to give consent. Severe cardiovascular disease. AV-block II. Requirement of additional procedures during surgery, like conversion of laparoscopic to open surgery, incomplete registration of study measurements.
A Phase II Study of Docetaxel and Carboplatin in Late Relapse of Ovarian Cancer

A phase II single arm study of carboplatin and docetaxel in treatment of first sensitive relapse of epithelial ovarian, peritoneal or tubal cancer.

Hypothesis: Treatment with this combination in second line is safe and with a low frequency of neurologic side effect.

Evaluation of toxicity and response of treatment with carboplatin and docetaxel to patients with epithelial cancer of ovary, fallopian tube or peritoneum with their first relapse occurring at least 6 months after end of first line treatment- Evaluation of toxicity according to Clinical Toxicity Criteria version 2.

Eligibility Criteria:
Inclusion Criteria:

* Epithelial carcinoma of ovarian, peritoneal or fallopian tube origin.
* Female
* age above 18 years
* WHO performance status 0-2
* Life expectancy \> 3 months
* Previous treatment with one platinum and taxane containing regimen.
* Platinum and taxane sensitive relapse
* At least one evaluable/measurable lesion.
* Adequate hematologic, renal and liver function
* Consent form signed and dated before inclusion

Exclusion Criteria:

* Prior treatment with more than one line of chemotherapy
* Concurrent severe and/or uncontrolled co-morbid medical condition.
* History of previous or concurrent malignancy within the previous 5 years • History of prior serious allergic reactions such as anaphylactic shock
* Pregnant or lactating women (or potentially fertile women not using adequate contraception)
* Peripheral neuropathy \> Grade 2
* History of allergy to drugs containing the excipient TWEEN 80®.
* Concomitant administration of any other experimental drug under investigation or concurrent treatment with any other anti-cancer therapy
* Clinical evidence of brain metastases