cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Linzagolix for the Treatment of Endometriosis-associated Pain.

The primary objective of this study is to demonstrate the efficacy and safety of linzagolix administered orally once daily for 3 months at a dose of 75 mg alone or of 200 mg in combination with add-back hormone replacement therapy (ABT: estradiol (E2) 1 mg / norethisterone acetate (NETA) 0.5 mg) versus placebo, in the management of moderate to severe endometriosis-associated pain (EAP).

This is a prospective, randomized, double-blind, placebo-controlled study to demonstrate the efficacy and safety of linzagolix administered orally once daily at doses of 75 mg alone and 200 mg in combination with low dose ABT (E2 1 mg/NETA 0.5 mg) versus placebo in the management of moderate to severe EAP in 450 women.

Eligible subjects who have completed the 6-month treatment period may enter a separate extension study for 6 additional months of active treatment (no placebo control). Subjects who do not continue in the extension study will enter a 6 month treatment-free follow-up phase.

Eligibility Criteria:
Inclusion Criteria:

The subject must have:

* Her most recent surgical and - if available - histological diagnosis of pelvic endometriosis up to 10 years before screening.
* Moderate to severe endometriosis-associated pain during the screening period.
* Regular menstrual cycles.
* BMI ≥ 18 kg/m2 at the screening visit. -

Exclusion Criteria:

The subject will be excluded if she:

* Is pregnant or breast feeding or is planning a pregnancy within the duration of the treatment period of the study.
* Is less than 6 months postpartum or 3 months postabortion/ miscarriage at the time of entry into the screening period.
* Has had a surgical history of any major abdominal surgery within 6 months or any interventional surgery for endometriosis performed within a period of 2 months before screening.
* Did not respond to prior treatment with GnRH agonists or GnRH antagonists for endometriosis.
* Has a history of, or known, osteoporosis or other metabolic bone disease.
* Has chronic pelvic pain that is not caused by endometriosis and requires chronic analgesic or other chronic therapy which would interfere with the assessment of endometriosis-associated pain.
Effects of Denosumab on the Pharmacokinetics of Etanercept

The primary objective of the study was to characterize the effects of a single dose of denosumab on the pharmacokinetics (PK) of etanercept in postmenopausal women with low bone mineral density (BMD) and rheumatoid arthritis based on area under the serum concentration-time curve (AUC) and maximum observed serum concentration (Cmax).


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women (postmenopausal is defined as no vaginal bleeding or spotting for at least 12 months)
* Low bone mineral density (BMD) as determined by screening BMD T-scores of the lumbar spine (L1 to L4), or total evaluable vertebrae (if fewer than L1 to L4), or total hip ≤ -1.0
* Receiving a 50 mg dose of etanercept once weekly ≥ 6 months prior to screening and expected to continue etanercept treatment at this dose and frequency through end of study (EOS)
* If currently taking methotrexate (MTX), receiving a stable dose (7.5 to 20 mg/week) of MTX ≥ 8 weeks prior to screening
* Willing and able to take ≥ 1,000 mg elemental calcium and ≥ 400 IU vitamin D daily upon enrollment

Exclusion Criteria:

* Type 1 diabetes; OR poorly controlled Type 2 diabetes (hemoglobin A1c (HbA1c) \> 8.0% at screening; HbA1c ≤ 8.0% within 6 months of screening is acceptable if supporting laboratory documentation is available)
* History of heart failure, coronary artery bypass graft, or cardiac arrhythmia; OR history of acute coronary syndrome
* Comorbid autoimmune disease, demyelinating disease, or hematologic abnormalities
* History of joint replacement in hand and/or wrist; OR history of fused joint in hand and/or wrist
* Prior history or current evidence of osteonecrosis/osteomyelitis of the jaw; OR active dental or jaw condition that requires oral surgery, or non-healed dental/oral surgery; OR planned invasive dental procedure(s) during the course of the study
* Previous exposure to denosumab
Fractional Ablative Radiofrequency for the Treatment of Acne Scars and Wrinkles

To assess the safety and efficacy of the Pixel RF (fractional radio frequency) module in the treatment of acne scars and wrinkles.

The study design will be a prospective open label study. Up to 20 subjects of both genders with acne scars and/or wrinkles in the face will be recruited. The subjects will be treated once on clean acne scarred skin and three times on the the wrinkled skin with the Pixel RF handpiece. Each treatment duration will be approximately 30 minutes. The initial power and number of passes parameters shall be set according to the clinical indication and skin type of the subject treated (as well as the results of test sites).

Clinical improvement will be assessed by the investigator physician from the visual appearance of the treated area according to the following scale: -1 for exacerbation, 0 no change, 1 for 1%-25% improvement, 2 for 25%-50% improvement, 3 for 50%-75% improvement, and 4 for 75%-99% improvement. Adverse side effects will be scored by clinical evaluation of erythema, edema, and burns. Real-time assessments will be made as well by the investigators. Treatment and results will be documented in a Case Report Form and follow-up sessions (1, 5 days after the treatment and 1 month and 3 months after the treatment).

Eligibility Criteria:
Inclusion Criteria:

* Subjects meeting the following inclusion criteria may participate:

  * Male or female subject 18-60 years of age.
  * Clinically documented rolling and boxcar acne scars and/or wrinkles score of 2 or 3 per the Rao-Goldman scale (see section 6.5.1 for wrinkle classification).
  * Limitation to acne scared and wrinkles area: face.
  * Patients must commit to all follow-up visits.

Exclusion Criteria:

Subjects meeting any of the following criteria will be excluded from participation:

* Bacterial or viral infection
* Impaired immune system
* Isotretinoin (Accutane, Amnesteem, Claravis, and Sotret) in the past 6 months
* Scleroderma
* Extensive radiation therapy
* Burns in the treatment area
* Poor healing in the treatment area
* Metal implants near the treatment area
* Implantable pacemaker or automatic defibrillator/cardioverter (AICD)
* Ablative/non-ablative cosmetic intervention (deep peeling) in the past 3 months in the areas to be treated
* Active cancer
* Active collagen or vascular disease
* Pregnancy or IVF procedure
Oral Administration or Nasal Feeding of Huzhangxiefei Decoction for Treatment in Sepsis Induced Acute Lung Injury

Hypothesis 1A: Oral Administration or Nasal Feeding of Huzhangxiefei Decoction will significantly attenuate sepsis-induced systemic organ failure as measured by overall response rate.

Hypothesis 1B: Oral Administration or Nasal Feeding of Huzhangxiefei Decoction will attenuate sepsis-induced lung injury as assessed by the respiratory rate and oxygenation index.

Hypothesis 1C: Oral Administration or Nasal Feeding of Huzhangxiefei Decoction will attenuate sepsis-induced lung injury as assessed by chest x-ray scale score, Chinese Medicine scale score.

Hypothesis 1D: Oral Administration or Nasal Feeding of Huzhangxiefei Decoction will attenuate biomarkers of inflammation (C-Reactive Protein, Procalcitonin), vascular injury (Thrombomodulin, Angiopoietin-2), alveolar epithelial injury (Receptor for Advanced Glycation Products), while inducing the onset of a fibrinolytic state (Tissue Factor Pathway Inhibitor).

Huzhangxiefei Decoction is a prescription formulated by a professional doctor of traditional Chinese medicine

Eligibility Criteria:
Inclusion Criteria:

* Patients must have suspected or proven infection, and be accompanied by at least 1 criterion for sepsis-induced organ dysfunction, and meet all 5 criteria for Acute Respiratory Distress Syndrome (ARDS).

Suspected or proven infection: (e.g., thorax, urinary tract, abdomen, skin, sinuses, central venous catheters, and central nervous system).

The presence of sepsis associated organ dysfunction: (any of the following thought to be due to infection): Sepsis associated hypotension (systolic blood pressure (SBP) \< 90 mm Hg or an SBP decrease \> 40 mm Hg unexplained by other causes or use of vasopressors for blood pressure support (epinephrine, norepinephrine, dopamine =/\> 5mcg, phenylephrine, vasopressin); Arterial hypoxemia (PaO2/FiO2 \< 300) or supplemental O2 \> 6LPM; Lactate \> upper limits of normal laboratory results; Urine output \< 0.5 ml/kg/hour for \> two hours despite adequate fluid resuscitation; Platelet count \< 100,000 per mcL; Coagulopathy (INR \> 1.5); Bilirubin \> 2 mg/dL; Glasgow Coma Scale \< 11 or a positive CAM ICU score.

ARDS characterized by all the following criteria Lung injury of acute onset, within 1 week of an apparent clinical insult and with progression of respiratory symptoms Bilateral opacities on chest imaging not explained by other pulmonary pathology (e.g. pleural effusions, lung collapse, or nodules) Respiratory failure not explained by heart failure or volume overload Decreased arterial PaO2/FiO2 ratio ≤ 300 mm Hg Minimum PEEP of 5 cmH2O (may be delivered noninvasively with CPAP to diagnose mild ARDS

Exclusion Criteria:

* inability to obtain consent;
* age \< 18 years;
* pregnancy or breast feeding;
* moribund patient not expected to survive 24 hours;
* for patients with chronic liver insufficiency, renal insufficiency, blood system disease, etc., it is impossible to judge that the organ insufficiency occurred after this infection
Timing of Treatment Completion in Staged Selective Laser Trabeculoplasty (SLT): Early vs. Late Completion

This study will evaluate the effect of the timing of treatment completion in two-staged selective laser trabeculoplasty therapy on intraocular pressure lowering effect.

SLT therapy is used as an IOP lowering agent in patients with glaucoma. It is unknown whether the timing of a 2-staged approach to the laser therapy will result in better IOP lowering effect.

This study will evaluate the timing (early vs. late completion of SLT therapy) and determined the IOP lowering effect following the interventions.

Arm 1: Early Completion SLT

180 degrees of SLT on Day 1, 180 degrees of SLT on the other 180 degrees on Day 2

Arm 2: Late Completion SLT

180 degrees of SLT on Day 1, 180 degrees of SLT on the other 180 degrees at the 1 month follow up visit.

Primary Outcome: IOP (mmHg).

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age
* primary open angle glaucoma or pseudoexfoliation glaucoma

Exclusion Criteria:

* Unable to give informed consent
Perioperative Normothermia: Temperature and Prewarming Methods

The present proposal intends to determine the effect of prewarming on body temperature in the perioperative period of patients submitted to digestive system surgeries and to evaluate a perioperative "Zero-Heat-Flux Cutaneous" body temperature thermometer in comparison to the standard care (temporal thermometer in the preoperative and postoperative, and esophageal in the intraoperative period). This is a randomized clinical trial consisting of three groups, namely: preoperative warming of patients with blanket and cotton sheet (control); preoperative warming with forced air warming system for 20 minutes (Intervention 1), and participants submitted to preoperative warming with a forced air warming system for 30 minutes (Intervention 2).

The present proposal intends to determine the effect of prewarming on body temperature in the perioperative period of patients submitted to digestive system surgeries and to evaluate a perioperative "Zero-Heat-Flux Cutaneous" body temperature thermometer in comparison to the standard care (temporal thermometer in the preoperative and postoperative, and esophageal in the intraoperative period). This is a randomized clinical trial consisting of three groups, namely: preoperative warming of patients with blanket and cotton sheet (control); preoperative warming with forced air warming system for 20 minutes (Intervention 1), and participants submitted to preoperative warming with a forced air warming system for 30 minutes (Intervention 2)

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years and over at the time of data collection
* Patients submitted to elective oncological surgery of the digestive, curative or palliative system, with anesthesia duration of at least one hour

Exclusion Criteria:

* Subjects with body temperature equal to or greater than 38 ºC at the time of admission to the Surgical Center
* Patients submitted to video laparoscopic or minimally invasive surgeries
Hypofractionated Stereotactic Radiotherapy With Anlotinib in Patients With Recurrent High-Grade Gliomas

A Phase II Study of Hypofractionated Stereotactic Radiotherapy (HSRT) With Anlotinib in Patients With Recurrent High-Grade Glioma. The primary endpoint is overall survival after radiotherapy. Secondary endpoints included progress-free survival, objective response rate, cognitive function, quality of life, toxicity.

Original histopathologically proven diagnosis World Health Organization (WHO) Grade 3/4 glioma patients who underwent surgery, chemoradiotherapy and adjuvant chemotherapy (Stupp Protocol). Recurrence based on Response Assessment in Neuro-Oncology (RANO) criteria and/or histopathology. Intervention included CyberKnife hypofractionated stereotactic radiotherapy (25Gy/5fx) with Anlotinib once daily (12mg/d) on days 1-14 of a 21-day cycle.

Eligibility Criteria:
Inclusion Criteria:

1. 18-70 years of age;
2. Karnofsky performance status (KPS) ≥ 60;
3. Original histopathologically proven diagnosis World Health Organization (WHO) Grade 4 glioma;
4. Underwent surgery, chemoradiotherapy and adjuvant chemotherapy (Stupp Protocol) after initial diagnosis, recurrent based on the Response Assessment in Neuro-Oncology (RANO) criteria and/or histopathologically proven;
5. Measurable disease;
6. Estimated survival of at least 3 months;
7. Hgb \> 9 gm; absolute neutrophil count (ANC) \> 1500/μl; platelets \> 100,000; Creatinine \< 1.5 times the upper limit of laboratory normal value; Bilirubin \< 2 times the upper limit of laboratory normal value; serum glutamate pyruvate transaminase (SGPT) or serum glutamate oxaloacetate transaminase (SGOT) \< 3 times the upper limit of laboratory normal value;
8. Signed informed consent form;
9. Agreed to participate the follow-up.

Exclusion Criteria:

1. Prior invasive malignancy unless disease free;
2. Received re-irradiation;
3. More than 3 relapses or evidence of subtentorial recurrent disease or tumor greater than 6 cm in maximum diameter;
4. Prior therapy with an inhibitor of vascular endothelial growth factor (VEGF) or VEGFR;
5. Pregnancy or or nursing mothers;
6. Participated in other trials after diagnosis of recurrent;
7. Influence factors toward oral medications;
8. Patients with CTCAE5.0 grade 3+ bleeding;
9. Suffering from severe cardiovascular disease: myocardial ischemia or myocardial infarction above grade II, poorly controlled arrhythmias (including men with QTc interval ≥ 450 ms, women ≥ 470 ms); according to NYHA criteria, grades III to IV Insufficient function, or cardiac color Doppler ultrasound examination indicates left ventricular ejection fraction (LVEF) \<50%;
10. Long-term unhealed wounds or fractures;
11. History of organ transplantation;
12. Serious diseases that endanger patients' safety or affect patients' completion of research,according to the researchers' judgment.
Poul Gjessing Versus T Loops for Orthodontic Maxillary Canine Retraction

Poul Gjessing versus T loops for orthodontic maxillary canine

Split mouth study one side using Poul Gjessing spring and other side using T loops

Eligibility Criteria:
Inclusion Criteria:

* - Class I or II div 1, orthodontic patients, with moderate to severe crowding who are indicated for maxillary first premolar extraction. 2- All permanent teeth are erupted (3rd molars are not included). 3- Good oral and general health. 4- No previous orthodontic treatment.

Exclusion Criteria:

- 1- Orthodontic cases that could be treated with no indication for extraction therapy.

2- Orthodontic cases that are indicate for the extraction of any tooth other than maxillary first premolars. 3- Patients with systemic diseases that might interfere with the of orthodontic tooth movement.
Magnetic Resonance (MR) in Asthmatic Patients

Asthma is a disease of small airways. Affected areas have reduced lung ventilation causing reflex vasoconstriction. MR perfusion imaging of the lungs is a sensitive method of imaging zonal lung perfusion.

A cohort of 70 Asthmatic Patients and 10 controls, both sets of subjects have HRCT, MRI/A of the Thorax, and Pulmonary Function Tests to correlate the degree of pulmonary dysfunction with findings on imaging tests.

Eligibility Criteria:
Inclusion Criteria:

* All asthmatic patients are eligible.

Exclusion Criteria:

* Patients in whom MRI is contraindicated
The Role of 2-octyl Cyanoacrylate in Prevention of Recurrent Adhesions After Circumcision

The objective of this study is to evaluate whether 2-octyl cyanoacrylate skin adhesive decreased the incidence of recurrent adhesions after circumcision. The investigators hypothesize that the incidence of recurrent adhesions will be decreased with use of 2-octyl cyanoacrylate skin adhesive.

The objective of this study is to evaluate whether 2-octyl cyanoacrylate skin adhesive decreased the incidence of recurrent adhesions after circumcision. The investigators hypothesize that the incidence of recurrent adhesions will be decreased with use of 2-octyl cyanoacrylate skin adhesive.

Secondary Objective(s) To assess parent satisfaction and comfort level after circumcision with use of 2-octyl cyanoacrylate skin adhesive and compare to those undergoing circumcision without the use of 2-octyl cyanoacrylate skin adhesive.

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing circumcision
* Only male patients under the age of 7 years will be eligible

Exclusion Criteria:

* Any patient over 7 years of age
* Previous circumcision
* Any parents who are not English language speaking
Evaluation of Malglycemia Via Continuous Glucose Monitoring in the Pediatric HSCT Population

This study is designed to determine feasibility of using a continuous glucose monitor in pediatric, adolescent and young adult hematopoietic stem cell transplant (HSCT) recipients, and to identify the incidence and risk factors for malglycemia in primary admission for pediatric, adolescent and young adult HSCT patients as well as to characterize the relationship between outcomes and malglycemia in this population.

This study is a prospective observational cohort analysis examining the rate of malglycemia in the pediatric HSCT population and the effect of malglycemia on important post-HSCT outcomes. In addition to usual care during the peri-HSCT period, participants in this trial will be asked to wear a continuous glucose monitor for the duration of their initial hospital admission. Participants will wear this monitor while admitted to the hospital for up to one week prior to transplant, and up to 60 days after transplant.

Eligibility Criteria:
Inclusion Criteria:

1. Patients age 2 to 30 years old at time of transplant.
2. Patients undergoing hematopoietic stem cell transplantation at CHCO.
3. Subject willing to wear a continuous glucose monitor for the duration of the study.
4. Subject willing to follow study protocols.

Exclusion Criteria:

1. Preexisting diagnosis of type 1 diabetes, type 2 diabetes, or an insulin requirement in the 2 weeks preceding transplant.
2. Preexisting condition requiring use of steroids (other than HSCT)
3. Severe psychiatric disease or developmental delays that might interfere with ability to provide informed consent.
4. Any other medical condition which in the opinion of the investigators impairs the person's ability to safely participate in the trial.
5. Subject has an active skin condition that would affect sensor placement.
Driving Pressure Guided Ventilation Versus Conventional Lung Protective Strategy in Morbid Obese Patients Undergoing Laparoscopic Bariatric Surgery

This study will be conducted to evaluate the effect of driving pressure guided ventilation compared with conventional protective lung ventilation during laparoscopic bariatric surgeries in morbid obese patients.

* the primary outcome: Intraoperative oxygenation measured by the arterial partial pressure of oxygen (PaO2).
* the secondary outcome: incidence of early postoperative pulmonary complications e.g., postoperative hypoxia, the need for supplementary oxygen, atelectasis, barotrauma, and respiratory failure.

Protective mechanical ventilation during anesthesia aims at minimizing lung injury and has been associated to a decrease in postoperative pulmonary complications (PPCs). Conventional protective ventilation strategy is consisted of the use of a low tidal volume (VT) and fixed moderate positive end expiratory pressure (peep). However, low-VT may result in the reduction of the functional volume of the lung manifested as lung collapse. Another potential consequence of lung collapse is the impairment in ventilatory efficiency.

Bariatric surgery is proven to achieve significant and sustained weight loss in the morbidly obese. Major weight loss can lead to partial/complete resolution of a range of conditions including, diabetes mellitus, ischemic heart disease, and hypertension.

Obese patients undergoing general anesthesia and mechanical ventilation during abdominal and bariatric surgeries commonly have a higher incidence of postoperative pulmonary complications (PPCs), due to factors such as decreasing oxygen reserve, declining functional residual capacity, and reducing lung compliance. And also pneumoperitoneum aggravates pulmonary atelectasis caused by mechanical ventilation, especially in obese patients.

Driving pressure (DP) which is the difference between the airway pressure at the end of inspiration (plateau pressure, (Ppl) and PEEP was first introduced by Amato et al in 2015 in their meta-analy¬sis study for ARDS patients. The authors suggested that driving pressure is the stronger predictor of mortality as compared with low VT and Ppl.

Several retrospec¬tive and prospective studies confirmed the importance of driving pressure in ARDS pa¬tients and during general anesthesia without differentiation between obese and nonobese patients .only one retrospective study showed that driving pressure was not associated with mortality in obese-ARDS patients. we hypothesize that these results may be different in obese patients having healthy lungs.

Eligibility Criteria:
Inclusion Criteria:

* sixty patients have a BMI 40-50 kg/m2, ASA physical status III, aged between 18 and 60 years, scheduled to undergo laparoscopic bariatric surgeries.

Exclusion Criteria:

* patient refusal to participate in the study.
* Patients had a recent history of severe respiratory disease and previous major pulmonary surgeries.
* patients who are contraindicated with application of PEEP (high intracranial pressure, bronchopleural fistula, hypovolemic shock, right ventricular failure).