cyrilzakka/clinical-trials huggingface dataset:
High Flow Nasal Cannula on Exercise Endurance in COPD

Ventilation limitation has a significant adverse effects on cardiovascular function and cerebral oxygenation during exercise in patients with COPD. High flow nasal cannula (HFNC) has been shown to improve ventilation by washing out the anatomical dead space and permitting a better gas exchanges. Moreover, it is able to ensure the desired inspired oxygen fraction (FiO2) even at high level of patient's minute ventilation by minimizing the room air entrainment. The effects of HFNC on exercise performance in terms of hemodynamic changes and exercise endurance in COPD patients remain unclear. The primary purpose of this study is to examine the effects of HFNC on the exercise endurance in COPD patients. The investigator's secondary purpose is to investigate whether HFNC could improve efficiency of ventilation, leading to an improvement of hemodynamic and cerebral oxygenation response.

This is a randomized crossover study. Patients who have been diagnosed as COPD will be recruited from outpatient department. After signing informed consent form, patients undertake an incremental exercise test and two constant load exercise at the 70% of maximum workload achieved at a previous incremental exercise test on arm ergometer in two separate days. The constant load tests will be performed with HFNC and with nasal cannula at the same inhaled oxygen fraction in random order. The hemodynamics CO, SV, EF of all subjects during exercises will be measured by a bioelectrical impedance device (Physioflow), and cerebral oxygenation status (oxygenated hemoglobin (O2Hb), deoxygenated hemoglobin (HHb), total hemoglobin (tHb) was measured by a near infrared spectrophotometer (NIRS).

Eligibility Criteria:
Inclusion Criteria:

1. with diagnosis of COPD
2. OPD patients
3. has no AE (within 1 month)
4. not receiving any O2 therapy at home
5. no smoking or quick

Exclusion Criteria:

1. fever
2. unstable hemodynamics at resting
3. orthopadeic or neurologic problems that limited exercise
Efficacy of Genicular Block on Total Knee Arthroplasty Surgery

The aim of this study is to investigate the postoperative pain relieving effect of preoperative genicular block in total knee arthroplasty surgery. The main questions it aims to answer are:

1. Do visual analog scale (VAS) scores decrease in patients who underwent geniculate block?
2. Does opioid consumption decrease in patients who underwent geniculate block?

Researchers will compare postoperative pain in patients who received genicular block with those who did not.One group of patients will be administered 0.25% bupivacaine with the geniculate block method. The other group will not undergo any intervention. Both groups will be administered intravenous morphine for postoperative analgesia.

Patients scheduled for knee arthroplasty will be randomly assigned into two groups. One group will receive a genicular nerve block prior to surgery without the administration of general anesthesia, while the other group will not undergo any interventional procedure. The genicular nerve block will be administered in three quadrants around the knee, with each injection consisting of 5 mL of 0.25% Marcaine. All injections will be performed by investigator MA. Patient assessments will be conducted by investigator MO. Postoperative intravenous analgesia will be provided to both groups.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled for unilateral and primary total knee arthroplasty
* Older than 18 years of age

Exclusion Criteria:

* Younger than 18 years
* Bilateral knee arthroplasty
* Revision case of knee arthroplasty
Intra-arterial Sphenopalatine Ganglion Block for Patients With Refractory Headache

The purpose of this study is to evaluate the safety and efficacy of intra-arterial (IA) delivery of Dexamethasone and Ketorolac into the arteries supplying the sphenopalatine ganglion (SPG) - a collection of neurons that plays an important role in headache disorders - in patients with refractory migraine, cluster headache and trigeminal neuralgia. All patients must fail standard treatments prior to enrollment in the trial.

The investigators propose an outpatient, minimally invasive method to deliver Dexamethasone and Ketorolac to the SPG via the intra-arterial route. A microcatheter will be advanced via the radial (preferably) or the femoral artery (in case the radial approach is not feasible) using fluoroscopic guidance and standard interventional techniques, into the distal internal maxillary artery. This artery is a branch of the external carotid artery and supplies the territory of the sphenopalatine ganglion. The microcatheter will be advanced to the ostium of the distal small branches that supply the SPG (i.e. small arteries feeding the vasa nervosum). Once the microcatheter is in a good position, 15 mg Dexamethasone Sodium Phosphate and 15 mg of Ketorolac Tromethamine will be infused over 30 minutes.

The procedure will be performed with local anesthetic at the arterial puncture site. Conscious sedation will be used for anxious participants. After the procedure, the participant will be observed for 5 hours in ICU setting and then discharged to home.

The procedure will be performed unilaterally for participants with cluster headache and trigeminal neuralgia. The procedure could be performed bilaterally for participants with migraine.

Eligibility Criteria:
Inclusion Criteria:

* Established diagnosis of one of the three following headache or facial pain disorders as defined by the ICHD-329 \[chronic migraine, cluster headache, trigeminal neuralgia\] and failure to respond to two or more preventive therapies

A. Chronic migraine

Failure to respond to two or more preventive therapies including Onabotulinumtoxin A, erenumab, fremanezumab, galcanezumab, topiramate, valproic acid, metoprolol, propranolol, timolol, atenolol, nadolol, amitriptyline, nortriptyline, venlafaxine, duloxetine.

This will include status migrainosus.

B. Cluster headache

Failure to respond to Verapamil, AND one other preventive treatment including Prednisone, Dexamethasone, galcanezumab, lithium, valproic acid, topiramate, external vagus nerve stimulation

C. Trigeminal neuralgia

Failure to respond to two or more preventive therapies, including: Oxcarbazepine or carbamazepine, and One of the following: gabapentin, pregabalin, baclofen, lamotrigine, phenytoin

Exclusion Criteria:

* Patients with malignant neoplasm of the pterygopalatine fossa
* Pregnancy, lactation
* Severe allergic reaction to Dexamethasone
* Severe allergic reaction to NSAID
* Renal failure
* Active systemic infection or fever
* Known cerebral vascular disease
* Drug or alcohol abuse
* Opioid dependency (stable doses ok)
* Triptans within 48 hours from the procedure
The Effect of Traditional Chinese Treatment Combined Adjuvant Chemotherapy in IIIb and IIIc Gastric Cancer

This is a randomized, open-label study done in 3 hospitals in China. Patients with stage IIIB and IIIC gastric cancer who undergo curative D2 gastrostomy will be randomly assigned after surgery to receive adjuvant chemotherapy with oxaliplatin and capecitabine, or adjuvant chemotherapy combined Traditional Chinese treatment. The primary outcome was disease-free survival and 3-year disease-free survival rate in the intention-to-treat population.

The purpose of this study is to evaluate the Traditional Chinese Medicine combined adjuvant chemotherapy in the treatment of stage IIIb and IIIc gastric cancer through randomized controlled trial.

Metastasis and recurrence is the primary cause in decreasing the survival time of gastric cancer patients who experienced radical operation. Among whom, patients with stage IIIB and IIIC are especially in high risk of metastasis and recurrence, result in a significant poor survival time than patients with earlier stages.

Oxaliplatin with capecitabine is the standard adjuvant chemotherapy for curative D2 gastrostomy gastric cancer, contribute the 3-year disease free survival rate of 74% in ITT, and 61% in stage IIIB sub-group. Meanwhile, Traditional Chinese Medicine (TCM) treatment has been used for thousands of years in Chinese clinical practices. In China, the clinical curative effect of TCM in the treatment of gastric cancer has been part of affirmation. Some reports with large samples of clinical research show that the TCM is effective and safety for gastric cancer.In order to evaluate efficacy on TCM combined adjuvant chemotherapy in IIIB and IIIC gastric cancer, we design this randomized, open-label study.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven gastric carcinoma with radical operation, TNM (primary tumor, regional nodes, metastasis) stage IIIb or IIIc （The Eighth Edition American Joint Committee on Cancer \[AJCC\] gastric cancer staging）;
* Karnofsky performance status higher than 70;
* Adequate hepatic, renal, cardio and hematologic function;
* With patients' consent and comply to long term follow-up.

Exclusion Criteria:

* Gastrectomy beyond D2, or TNM stage beyond Ⅲb and Ⅲc;
* Histological type beyond gastric carcinoma;
* Conversion chemotherapy before surgery;
* Concurrent cancer;
* Women of gravid or lactating; patients with mental illness;
* Uncontrolled significant comorbid conditions.
Effectiveness of a Combined mHealth-CBT Psychological Intervention to Improve Psychological Well-Being in Young Patients With T1D

Type 1 diabetes (T1D) can lead to psychological adjustments that impact the acceptance and management of this health condition, as well as the overall quality of life of patients, especially among the young. Therefore, there is a need for psychological interventions aimed at enhancing the psychological well-being of children and adolescents with T1D. The goal of this non-randomized controlled trial is to evaluate whether a combined intervention comprising mHealth (using an app) and face-to-face psychological sessions based on Barlow's protocol and cognitive-behavioral therapy techniques (CBT) is effective in enhancing psychological well-being in children and adolescents with T1D. The main hypotheses are:

* H1: The primary results expected to be obtained are a significant increase in psychological well-being, which means a decreased diabetes distress (DDS) (H1a) an increased subjective well-being (PANAS) (H1b) and a better self-efficacy for managing their emotions (RESE) (H1c).
* H2: As secondary outcomes, it is also expected that the combined mHealth-CBT intervention would increase the level of positivity (P-Scale) (H2a), the self-esteem (RSES) (H2b) and the satisfaction with life (SWLS) (H2c).


Eligibility Criteria:
Inclusion Criteria:

* Girls and Boys with a diagnosis of T1D 6 - 18
* Having a smartphone compatible with the APP created used for the mHealth intervention and daily access to internet
* Having the required digital skills to follow the mHealth intervention
* Not currently participating in another clinical trial involving a psychological intervention

Exclusion Criteria:

* Girls and Boys with a diagnosis of T1D \>18 years
* Not Having a smartphone compatible with the APP created used for the mHealth intervention and daily access to internet
* Currently participating in another clinical trial involving a psychological intervention
The Role of Sugammadex in Posotoperative Urinary Retention in Patients Undergoing Pelvic Floor Reconstructive Procedures

The Investigator will perform a single-institution randomized double-blinded controlled trial comparing intraoperative Sugammadex vs. standard dose of glycopyrrolate/neostigmine combination for participants undergoing a total vaginal hysterectomy with or without pelvic organ prolapse procedures under general endotracheal anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* female patients undergoing a vaginal hysterectomy with the indications of pelvic organ prolapse or abnormal uterine bleeding

Exclusion Criteria:

* Patients who are already known to have voiding dysfunction
* Patients who have a contraindication or intolerance to any of the drugs used in the study
* Has a medical condition or surgical procedure that precludes reversal of neuromuscular block at the end of surgery.
* Has a neuromuscular disorder(s) that may affect neuromuscular block and/or trial assessments.
* Is dialysis-dependent or has severe renal insufficiency, defined as estimated creatinine clearance of \<30 mL/min.
* Has or is suspected of having a personal history or family history (parents, grandparents, or siblings) of malignant hyperthermia.
* Has or is suspected of having an allergy (e.g., hypersensitivity and/or anaphylactic reaction) to study treatments or its/their excipients, to opioids/opiates, muscle relaxants or their excipients, or other medication(s) used during general anesthesia.
* Has received or is planned to receive toremifene within 24 hours before or within 24 hours after study medication administration.
* Has any condition that would contraindicate the administration of study medication.
* Is pregnant, is attempting to become pregnant, or is lactating.
* Is currently participating in or has participated in an interventional clinical trial (including any other current or ongoing trial with a sugammadex treatment arm) with an investigational compound or device within 30 days of signing the informed consent form of this current trial.
* Male patients
* Patients undergoing a conventional laparoscopic or robotic approach
* Patients having a midurethral sling in addition to the vaginal hysterectomy
* Patients declining to participate in the study
* Patients allergic to any of the drugs used in the study (sugammadex, neostigmine and/or glycopyrrolate)
Evaluation of Pulp Symptoms After Minimal Caries Removal in Treatment of Deep Caries

The objective of this study is to assess and compare the possible post-operative pulpal symptoms (Spontaneous pain, pain on percussion, swelling, sinus or fistula), incidence of pulp exposure, child acceptance, chair time and radiographic success between two techniques for managing dental caries: minimal caries removal and complete caries removal in primary molars.

Minimal Caries Removal (MCR) technique was described in 2015 by Chompu-inwai et al., as a treatment option for primary molars with deep carious lesions or reversible pulpitis where only soft demineralized dentin around the lateral walls of the carious lesion is removed. The aim of this study is to assess the success of such a technique in managing primary molars with asymptomatic deep caries in terms of; post-operative pulpal symptoms(spontaneous pain, pain on percussion, fistula or sinus), incidence of pulp exposure, child acceptance, chair time and radiographic success.

Eligibility Criteria:
Inclusion Criteria:

* Primary molar with deep dentin caries involving occlusal \&/or occluso-proximal surfaces.
* Absence of clinical signs and symptoms of irreversible pulpitis such as spontaneous pain. Only presence of pain provoked with stimulation, such as complaints of food impaction when eating is allowed.
* Absence of clinical swelling or pus exudates/fistula of soft or periodontal tissues.
* Absence of abnormal tooth mobility.
* Absence of pain on percussion.
* Restorable tooth.

Radiographic inclusion criteria:

* Extension of dental caries one-third or more of the entire dentin thickness.
* No super- imposition of dental caries on the dental pulp.
* No widened periodontal ligament (PDL) space.
* No radiolucency in the peri-apical or furcation areas.
* No pathologic internal or external root resorption.
* No pulp canal calcification or obliteration.

Exclusion Criteria:

1. Patients experience any signs or symptoms of pulpal or peri-apical pathology.
2. Patients with systemic diseases requiring special dental consideration.
3. Unmotivated, uncooperative patients.
4. Patients unable to attend follow-up visits.
Flibanserin for the Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women

The objective of this trial is to assess the safety and efficacy of 24-week course of flibanserin for the treatment of Hypoactive Sexual Desire Disorder (HSDD) in naturally postmenopausal women.


Eligibility Criteria:
Inclusion criteria:

* Naturally postmenopausal women of any age with at least one ovary
* Diagnosis of Hypoactive Sexual Desire Disorder, generalized acquired type,of at least six months duration
* Stable, monogamous heterosexual relationship for at least one year
* Willing to discuss sexual issues
* Willing to engage in sexual activity at least once a month
* Normal Pap smear
* Normal mammogram
* Normal uterine lining
* Able to comply with daily use of handheld data entry device

Exclusion criteria:

* Sexual dysfunctions other than HSDD, such as Sexual Aversion Disorder, Substance-induced Sexual Dysfunction, Dyspareunia, Vaginismus, Gender Identity Disorder, Paraphilia and Sexual Dysfunction due to a General Medical Condition
* Partner with inadequately treated organic or psychosexual dysfunction
* Sexual function impaired by psychiatric disorder
* Sexual function impaired by gynecological disorder
* Major Depression
* Suicidal behavior or ideation
* Major life stress that could impair sexual function
* Substance abuse
The Merit WRAPSODY Central Feasibility Study

The purpose of the study is to demonstrate the safety and efficacy of the Merit WRAPSODY Endovascular Stent Graft for treatment of stenosis or occlusion within the dialysis access outflow circuit in the thoracic central veins


Eligibility Criteria:
Inclusion Criteria:

* Subject provides written informed consent
* Subject is male or female, with an age ≥ 18 years at date of enrollment.
* Subject is willing to undergo all follow-up assessments.
* Subject has a life expectancy ≥ 12 months.
* Subject is undergoing chronic hemodialysis.
* Subject has either a mature AVF or AVG in the arm.
* Target lesion(s) involves a non-stented restenotic lesion.
* Target lesion has ≥50% stenosis.
* Target lesion(s) reference vessel diameter is between 5.0 mm and 14.0 mm

Exclusion Criteria:

* Subject is unable or is unwilling to comply with the procedural requirements of the study protocol.
* Subject has a comorbidity that in the investigator's opinion would limit life expectancy to less than 12 months.
* Subject has a known or suspected infection of the hemodialysis access site, systemic infection and/or septicemia.
* Subject has a stroke diagnosis within 3 months prior to enrollment.
* Subject has a history of unstable angina or myocardial infarction within 60 days prior to enrollment.
* Subject is pregnant, breastfeeding, or intending to become pregnant within the next year.
* Target lesion is located within a stent / stent graft.
Plasma-free Replacement in Patients With Multiple Myeloma

To evaluate whether the technique of no plasma exchange is suitable for the treatment, clinical efficacy, safety, and suitability of multiple myeloma patients with M protein abnormality or renal failure.

Multiple myeloma (MM) is the second most common hematological tumor after non-Hodgkin's lymphoma. The tumor cells originate from plasma cells in the blood pulp and are classified as plasma cells blood myeloma plasmacytomas by the WHO Tumor. It is characterized by abnormal proliferation of blood medullary plasma cells, accompanied by monoclonal immunoglobulin or light chain. Few patients are classified as non-secretory MM that does not secrete M protein. Multiple myeloma is often accompanied by multiple hemolytic damages, hypercalcemia, anemia, kidney damage, and a serious threat to the patients' lives, health, and quality of life, which have brought a heavy burden to society. Large amounts of M protein pass through the kidneys. At times, it causes acute or chronic renal failure; M protein interferes with the activity of coagulation factors, blocking platelet function, inducing bleeding; and a large amount of M protein can also lead to hyperviscosity syndrome, increase circulatory resistance, and small blood vessel thrombosis Plug, cause various neurological diseases such as blindness, and further aggravate the progression of kidney injury. Patients with hematological myeloma nephropathy already existed at the time of diagnosis, severe patients may die due to renal insufficiency, so the patient was removed immunity globulin in the body to improve the signs of hyperviscosity and clinical symptoms is the focus of clinical research.

In this study, on the basis of previous studies, albumin-free plasma exchange fluid treatment was given to analyze the effects of clinical symptoms, erythrocyte sedimentation rate, blood routine, albumin, renal function, calcium content, and immunoglobulin.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of MM 2. A stable condition after routine treatment 3. Clinical diagnosis of renal insufficiency or M protein abnormalities 4．more than 18 years old 5．With liver and kidney function 6. With normal heart function; 7. Physical condition score 0-2 (ECOG score) 8. Get informed consent from the patient or family member.

Exclusion Criteria:

1. Allergies or obvious contraindications to any drug;
2. Myocardial infarction and cardiac insufficiency
3. Other malignant tumors
4. TB patients and HIV positive patients 5．Other blood system diseases

6. Pregnant or lactating women; 7. Not understand or follow the protocol; 8. Allergy