cyrilzakka/clinical-trials huggingface dataset:
Hybrid APC Therapy in Early Central Lung Neoplasms

1.1 Aims：This cohort study aims to investigate the clinical value of Hybrid APC for treatment of early central lung neoplasms.

1.2 methods：A total of 30 patients with early central lung neoplasms will be included in this open, multicenter, prospective study. Primary observation endpoint is recorded at 3 months follow-up, and after 3 months patients could be continued to follow up. The data are expressed in terms of mean and percentage. The categorical variables are analyzed by chi-square test, and the four table data is analyzed using the exact probability method. The continuous variable analysis is used by t test. Statistical analysis is performed with SPSS 20.0 software. P \< 0.05 is considered statistically significant.

This is a prospective, multicenter, and cohort study. Study subjects: patients with early central lung neoplasms meet inclusion/exclusion criteria and could receive interventional therapy.

There are 3 study site in this study and a total of 30 patients with early central lung cancer will be included.

HybridAPC is integrated with traditional APC and water-jet technique, which has been successfully applied for endoscopic treatment of mucosal lesions in GI, such as Barrett esophageal and lesions in colon. Submucosal injection of water jet can elevate superficial lesion, and then APC can be more effective in ablation of superficial tumor with a protection for muscular layer. The application of HybridAPC in respiratory intervention could theoretically protect cartilage, adventitia, reduce damage and formation of scare, and increase ablation energy to reach radical treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Bronchoscopy and fluorescence bronchoscopy found endoluminal growth lesions of upper segmental bronchus. AFB indicates malignant possibility.
2. Size ≤ 20 mm
3. Flat, nodule or polypoid type
4. Negative imaging: HRCT indicates no tumor in lung and lymph node enlargement; or PET-CT finds no lesions in lung or suspicious lymph node tumors involve.
5. Clinical stage: Tis or T1N0M0
6. High-grade intraepithelial neoplasia (including severe atypical dysplasia and carcinoma in situ) mucoepidermoid carcinomaand ,squamous cancer and etc. confirmed by biopsy histopathology
7. High-frequency EBUS indicates the depth of lesions is cartilage endomembrane or internal part of adventitia of tracheal membranous part
8. Patients are not suitable for surgery or refuse surgery
9. Inform consent is available

Exclusion Criteria:

1. Patients with severe cardiopulmonary dysfunction or other contraindication can not tolerate endoscopic examination and treatment
2. Severe bleeding tendency
3. Poor compliance
4. Unstable vital signs
5. Investigators consider subjects should not be included because of specific situations
Comparison of Analgesic Efficacy in Video-Assisted Thoracoscopic Surgery Patients

The 52 patients included in the study were divided into two groups as ESPB (n=26) and SPSIPB (n=26). Before the operation, 0.25% bupivacaine 30 ml was administered to both groups. After admission to the operating room, all patients underwent standard anaesthesia procedures. Morphine 0.05 mg/kg i.v. and parol 1 g i.v. were administered 30 min before the end of the operation. Post operatively the patient was followed up with controlled analgesia. Demographic data, ASA scores, body mass indexes, peri-operative haemodynamic values, remifentanil consumption and duration of surgery were recorded. Post-operative first 24 hours NRS scores, morphine consumption, number of nausea and vomiting episodes were recorded.

The aim of the study is to evaluate the effect of erector spina plan block (ESPB) and Serratus posterior superior intercostal plan block (SPSIPB) on postoperative analgesia management.

After providing asepsis and antisepsis conditions to the ESPB group in the sitting position, a high frequency linear USG probe will be placed approximately 2-3 cm lateral to the T5 spinous process in the longitudinal plane. After visualising the T5 transverse process with the in plane approach, the skin will be entered in the craniocaudal direction. Trapezius, rhomboid and erector spinae muscles will be passed and 5 ml of saline will be injected between the erector spinae muscle fascia and vertebral transverse process when the needle rests on the spinous process (approximately 3 cm deep) and the block site will be confirmed. Then 30 ml of 0.25% bupivacaine (1mg/kg) will be injected by negative aspiration.

In the SPSIPB group, the patient will be positioned in the lateral position, with the surgical side up and the upper extremity hanging over the patient's head for the USG-guided serratus posterior superior plan block. After asepsis and antisepsis conditions are provided, the spina scapula will be visualised above the scapula with our high frequency linear USG probe. The 3rd rib will be visualised with a high frequency probe medial to the scapula corresponding to the 3rd rib level. The ribs, pleura and the serratus muscle covering it will be determined and the needle tip will be advanced until it touches the 3rd rib.After the 3rd rib is visualised by USG, 5 ml isotonic is given and hydrodissection is performed, 30 ml 0.25% bupivacaine (1mg/kg) will be injected between the serratus posterior superior muscle and the 3rd rib. The craniocaudal spread of local anaesthetic will be visualised by USG. Afterwards, the patients will be taken to the operation room and routine monitoring including ECG, peripheral oxygen saturation, non-invasive blood pressure arterial pressure monitoring and bispectral index (BIS) monitoring will be performed.

Eligibility Criteria:
Inclusion Criteria:

* 52 healthy volunteers with VATS
* ASA 1-2-3
* 18 to 80 years old

Exclusion Criteria:

* patients with coagulopathy
* wound and infection in the block area
* allergy to local anaesthetic drugs
* mental retardation
LK Scleral Lens for Patients With Intractable Ocular Surface Diseases

Scleral lenses have emerged as an efficacious treatment option for various types of intractable ocular surface diseases with many advantageous results. The purpose of this study was to report the efficacy and safety of the LK scleral lenses and determine their suitability in Asian patients with intractable ocular surface diseases. Subjects with intractable ocular surface diseases are enrolled to fit LK scleral lenses for 12 weeks for a prospective study. Evaluations are performed at 1, 4, 8 and 12 weeks. General patient demographics and medical history, visual acuities, thorough ophthalmic evaluation, ocular surface disease index and National Eye Institute 25-Item Visual Function Questionnaire are collected for each patient.

To date, there are several commercially manufactured scleral lenses of different designs and sizes, all of which have been proven to be clinically beneficial in a wide spectrum of diseases. Especially in the management of intractable ocular surface diseases, scleral lenses with large diameters are commonly used so that the lens entirely rests on the sclera with sufficient tear reservoir. PROSE devices (Boston Foundation for Sight, Needham, MA), one of the first and representative scleral lenses shown to have long-term clinical benefits for complex corneal diseases, have large diameters of 17.5 to 23.0 mm. However, in Republic of Korea, only scleral lenses with small diameters are currently available. SoClearⓇ and OnefitⓇ scleral lenses, two of the most commonly used scleral lenses in Republic of Korea, possess diameters ranging from 14.1 to 15.5 mm and 13.3 to 15.0 mm, respectively, and are not actually fully scleral but more of a corneoscleral type lenses. Furthermore, Asians have smaller palpebral fissures with tighter eyelids than the Western population, which may restrict patients' tolerability of wearing a large scleral lens and limit its clinical benefits. Therefore, a more suitable scleral lens for Asians with larger diameter is required.

Accordingly, this study investigates the efficacy and safety of the LK scleral lens (Lucid Korea LTD, Seoul, Republic of Korea), which has been newly manufactured to have larger diameters than currently available commercial lenses, and determines their suitability in Asian patients with intractable ocular surface diseases.

Eligibility Criteria:
Inclusion Criteria:

* Age between 20 to 69 years
* Intractable ocular surface disease
* Uncorrected visual acuity better than count finger and ≥ 0.3 logMAR (log of the Minimum Angle of Resolution)
* Best-corrected visual acuity ≥ 0.3 logMAR (log of the Minimum Angle of Resolution)

Exclusion Criteria:

* Currently under treatment for infectious keratitis
* Difficulty of scleral lens application due to severe allergic conjunctivitis, low compliance, and other potential contraindications
* Diabetes mellitus and/or hypertension
* Pregnant or planning pregnancy E. Unwilling to follow study schedule F. Enrolled in another clinical study G. Determined inappropriate under investigators' discretion
Clinical Trial to Evaluate the Efficacy of Treatment With Hyperimmune Plasma Obtained From Convalescent Antibodies of COVID-19 Infection

Phase I / II multicentre, randomized and controlled clinical trial to evaluate the efficacy of treatment with hyperimmune plasma obtained from convalescent antibodies of COVID-19 infection.


Eligibility Criteria:
Inclusion Criteria:

1. Informed consent prior to performing procedures. the oral consent be accepted testified to prevent paper handling.
2. Patient of both sexes, and ≥18 years.
3. SARS-CoV-2 infection determined by PCR in a sample of naso-oropharyngeal exudate or other respiratory specimen or determination of specific positive IgM antibodies, in \<72 hours before randomization.
4. Patients requiring hospitalization for pneumonia COVID-19 without need until randomization of mechanical ventilation (invasive or non-invasive), and at least one of the following:

   * O2 saturation ≤ 94% in ambient air, or PaO2 / FiO2 ≤ 300 mm Hg.
   * Age\> 65 years.
   * Presence of: high blood pressure, chronic heart failure, chronic obstructive pulmonary disease, liver cirrhosis, or other chronic pulmonary and cardiovascular diseases, diabetes, or obesity

Exclusion Criteria:

1. Requirement before randomization of mechanical ventilation (invasive or non-invasive).
2. Any of the following analytical data before randomization: IL-6\> 80 pg / mL, D-dimer\> 10 times ULN, ferritin\> 1000ng / mL.
3. Participation in another clinical trial or experimental treatment for COVID-19.
4. In the opinion of the clinical team, progression to death or mechanical ventilation is highly probable within 24 hours, regardless of treatment provision.
5. Incompatibility or allergy to the administration of human plasma.
6. Severe chronic kidney disease grade 4 or requiring dialysis (ie eGFR \<30)
7. Pregnant, lactating, or fertile women who are not using an effective method of contraception. It is considered a woman of childbearing age all women from 18 years and up to a year after the last menstrual period in the case of menopausal women
A Study of LY2928057 in Hemodialysis Participants

This study will evaluate the safety of LY2928057 and how LY2928057 affects hemoglobin in hemodialysis participants. This study will involve multiple doses of LY2928057 given during a 6 week period either after a participant discontinues or reduces treatment to stimulate red blood cells. This study will last up to 26 weeks for each participant.


Eligibility Criteria:
Inclusion Criteria:

* Participants having end-stage renal disease (ESRD), have received an erythropoiesis stimulating agent (ESA) at least weekly for 2 weeks prior to screening, and have been receiving adequate maintenance hemodialysis (3 times weekly) for at least 12 weeks prior to screening (that is, an approximate Kt/V greater than 1.1 (K equals dialyzer clearance of urea, t equals dialysis duration time, V equals volume of distribution of urea, which is approximately equal to the participant's total body water) based on the clinical judgment of participant's nephrologist and investigator and who are willing to stop (Parts A and B) or reduce (Part C) their stable ESA dose from the week of randomization until completion of the 6-week treatment period (unless rescue therapy is needed)
* Have a hemoglobin value (taken prior to dialysis if taken on a dialysis day) greater than or equal to 9.5 grams per deciLiter (g/dL) and less than or equal to 12.5 g/dL at screening
* Have a body mass index (BMI) of 18.5 to 45 kilograms per square meter (kg/m\^2) inclusive at screening
* Have a transferrin saturation (TSat) greater than or equality to 15 percent and ferritin greater than 40 nanograms per milliliter (ng/mL) at screening

Exclusion Criteria:

* Any cause of anemia other than renal disease
* A history of hyporesponsiveness to ESA
Effectiveness of Multicomponent Lipid Emulsion in Preterm Infants Requiring Parenteral Nutrition

The purpose of this study is to compare the effects of a multicomponent lipid emulsion containing 30% soybean oil, 30% medium-chain triglycerides, 25% olive oil, and 15% fish oil with a conventional pure soybean oil lipid emulsion on the incidence of neonatal cholestasis, infant growth, infant morbidity and the biochemical assessment of liver enzymes.

Intravenous lipid emulsions are the major sources of non-protein energy and provision of required essential fatty acids.

The reference lipid emulsion, widely used for many years, is prepared from soybean oil, which is rich in omega 6 polyunsaturated fatty acids and phytosterols that contribute to hepatotoxicity and their metabolites result in pro-inflammatory eicosanoid production.

Existing evidence strongly supports a pathogenetic role of inflammation and oxidative stress on parenteral nutrition associated liver disease.

Subsequent development of lipid emulsions has focused on reducing the amount of soybean oil and replacing it with other oils.Moreover the omega 3 fatty acids from fish oil are metabolized to anti-inflammatory eicosanoids which can prevent inflammatory responses.

A novel multicomponent lipid emulsion may prevent liver injury, improve growth and decrease morbidity in preterm infants.

Eligibility Criteria:
Inclusion Criteria:

* Inborn infants with a gestational age of less than 30 weeks
* Who required parenteral nutrition for at least 7 days

Exclusion Criteria:

* Evidence of congenital infection
* Perinatal asphyxia
* Congenital anomalies
* Severe IVH
* Thrombocytopenia
* Shock or circulation failure
* Renal or hepatic disorders.
Renalof in the Dissolution of Renal Calculi in Patients With Recurrent Calcic Lithiasis

The purpose of this study is to determine whether Renalof administration promotes partial or total dissolution of urinary calculi and improves physicochemical parameters and metabolic activity in patients with recurrent calcic urolithiasis. The duration of this double-blind placebo controlled phase 3 clinical trial will be 12 weeks. The estimated number of patients to be recruited and randomized for the study is 110. Ultrasonographic and humoral parameters will be assessed every 4 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Idiopathic calcic lithiasis
* Calculus size lesser than or equal to 2.0 cm (0.79 inches)
* Signed informed consent

Exclusion Criteria:

* Calculus size greater than 2,0 cm (0.79 inches)
* Pregnancy
* Malignant neoplastic conditions
* Previous treatment for destruction of calculi in the urinary tract
A Study to Assess the Levels in Blood Plasma of BMS-986278 in Healthy Participants Following Administration of Tablets, With or Without Food, and in the Presence of an Antacid (Esomeprazole)

The purpose of this study is to assess levels in blood plasma of BMS-986278 and the food effect in healthy participants.


Eligibility Criteria:
Inclusion Criteria:

* Healthy participants, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations in the opinion of the investigator
* Women and men must agree to follow specific methods of contraception

Exclusion Criteria:

* Women of childbearing potential (WOCBP) and Women who are pregnant or breastfeeding
* Any significant acute or chronic medical condition that presents a potential risk to the participant and/or that may compromise the objectives of the study
* Exposure to any investigational drug or placebo within 4 weeks of first study treatment administration.
* History of any significant drug and/or food allergies (such as anaphylaxis or hepatotoxicity)

Other protocol-defined inclusion/exclusion criteria apply
Hypnotic Intervention for Women With Chronic Pelvic Pain

Objective: To establish whether the pilot online hypnosis design was well received by women with persistent pelvic pain and worthy of a full randomised control trial To establish whether hypnosis improves mental health outcomes, including anxiety, depression, life impact and catastrophizing, in women with chronic pelvic pain conditions.

Design: Pilot Randomised Control Trial Methods: Twenty women with persistent pelvic pain completed assessment questionnaires and were recruited from a variety of social media sites related to persistent pelvic pain and randomly allocated to either control or hypnotic intervention groups. The intervention group completed a seven week online hypnotic intervention. The control group received no intervention. Both groups completed assessment and concluding questionnaires related to demographic information and the outcomes of interest. This included measures for anxiety, depression, pain, coping styles, pain related disability, pain catastrophizing and suggestibility. The results of the intervention and waitlist control groups were compared using linear mixed-effects modelling. Suggestibility was screened for at baseline using the Short Suggestibility Scale, and included in a secondary set of linear effects modelling.

Eligibility Criteria:
Inclusion Criteria:

* Meets criteria for persistent pelvic pain. Having experienced pain in the pelvic region below the umbilicus for over three months either beyond the healing time of a pathology or injury or without a diagnosed cause.
* Must be biologically female.
* Must be over the age of 18 years old.

Exclusion Criteria:

* Must not have a previously diagnosed or current mental health disorder involving dissociative states. Examples include diagnosed or current symptoms of Bipolar Type 1 or 2, psychotic disorders, untreated Post-Traumatic Stress Disorder.
* Must not reported current plan or intent to commit suicide.
Acetazolamide for the Prevention of High Altitude Illness: a Comparison of Dosing

This is a phase 4, randomized, double-blinded interventional trial comparing alternative doses of Acetazolamide for the prevention of High Altitude Illness.

Acetazolamide, or Diamox, is the standard medical prophylaxis agent for high altitude illness. The medication is effective in preventing acute mountain sickness (AMS), high altitude pulmonary edema (HAPE), and high altitude cerebral edema (HACE). Its mechanism is via inhibition of the carbonic anhydrase enzyme which counteracts the respiratory alkalosis which occurs during ascent to altitude. It facilitates the excretion of bicarbonate in the urine. As a result, acetazolamide hastens acclimatization and helps prevent high altitude disorders.

Current recommended dosing is 125 mg, orally twice daily, started 24 hours prior to ascending in elevation. Side effects include tingling of the fingers and toes and perioral numbness which may be erroneously interpreted as stroke symptoms. Since acetazolamide is a mild diuretic, frequent micturition may occur leading to interruption of daytime activities as well as broken sleep. These effects can affect safety at high altitude. Acetazolamide is normally discontinued 2 days after the user has reached their highest elevation or a plateau in elevation.

A lower dose may be just as effective in preventing high altitude illnesses while preventing the disconcerting side effects resulting from its use. A smaller dose has not been studied, however. We will compare the common dose of 125 mg twice daily with a lower dose of 62.5 mg twice daily.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* English or Indian speaking
* Mountaineers or trekkers who plan to climb Mt. McKinley or trek to Base Camp on Mt. Everest

Exclusion Criteria:

* Low sodium and/potassium blood serum levels
* Kidney disease or dysfunction
* Liver disease, dysfunction, or cirrhosis
* Suprarenal gland failure or dysfunction
* Hyperchloremic acidosis
* Angle-closure glaucoma
* Taking high dose aspirin (over 325 mg/day)
* Any reaction to sulfa drugs or acetazolamide
* Pregnant or lactating women
Contribution of Oncogenetics in Breast Cancer in Reunion Epidemiology of Breast Cancer in Reunion: Study of the Reunion Mutation on BRCA2

In mainland France, breast cancer is the most common cancer in women, with an estimated incidence of over 58,000 new cases. Even if breast cancer is a cancer with a good prognosis, it is responsible for more than 12,000 deaths per year (first cause of death by cancer in women in France).

Breast cancer is a multifactorial disease, which results from the interaction between environmental, lifestyle, hormonal and genetic risk factors.

In Reunion, more than 400 cases of breast cancer are diagnosed annually. As in mainland France, it is by far the most common cancer in Reunionese women, and its incidence continues to increase significantly since the age-standardized incidence rate increased by 28% between 2007 and 2017 to establish at 64.2/100,000 AP.

Two studies carried out in patients carrying mutations in the breast-ovary predisposition genes in Reunion, showed that more than 50% of patients carrying BRCA mutation have a mutation specific to the Reunion population on the BRCA2 gene.

These two studies, which confirm the genetic specificities of Reunion already described in other pathologies (Mucoviscidosis or Friedreich's Ataxia), suggest that this mutation could have a significant frequency in patients with breast cancer. Thus, evaluating the prevalence of this mutation in patients with breast cancer in Réunion would make it possible to adapt the indications for access to the oncogenetics consultation and the associated preventive measures


Eligibility Criteria:
Inclusion Criteria:

* Domiciled in Reunion at the time of the diagnosis
* Who is diagnosed with a first breast cancer (in situ or invasive) confirmed by anatomopathological examination during the inclusion period Or Who is diagnosed with a second breast cancer (in situ or invasive) confirmed by pathological examination during the inclusion period, contralateral to the first or at least 5 years after remission of the first
* Having agreed to participate in the study;
* Affiliates or beneficiaries of a social security scheme

Exclusion Criteria:

* Carriers of breast lymphoma,
* Minor patients or patients under guardianship or curatorship
Pregnancy, Nitrate, Endothelial Function and Tissue Oxygen Saturation

Adequate macro and microvascular endothelial function during pregnancy is essential for the normal placental development and growing fetus. Beetroot juice (BJ) promotes improvement ins this parameters in no-pregnant individuals, however the beneficial effect did not avaliated in pregnant. The present study evaluated effects of BJ on macro and microvascular endothelial function in pregnant. Twelve pregnant were submitted to BJ and nitrate-depleted juice (PLA) interventions. Brachial flow-mediated dilation (FMD) and muscle oxygenation were measured 120 min after interventions. Urinary nitrate, nitrite were measured at baseline and 120 min after interventions.


Eligibility Criteria:
Inclusion Criteria:

* gestation between 20 and 35 weeks;
* over 18 years

Exclusion Criteria:

* diabetes mellitus and gestational diabetes;
* hypertensive syndromes;
* HIV positive;
* liver or kidney disease;
* beetroot allergy;
* use of antioxidants and medicament that alter endothelial function;
* use of antibiotics up to 2 weeks before the visits and using.