cyrilzakka/clinical-trials huggingface dataset:
The Therapeutic Effect of Catgut Embedding in Obesity

The aim of this double-blind, randomized, placebo-controlled trial is to evaluate the therapeutic effects of acupoint stimulation by catgut embedding on complexion, quality of life, lipid profile, inflammatory markers, and obesity-related hormone peptide of obese women.

We will recruit 90 females aged from 16 year-old to 65 year-old with body mass index(BMI) 27㎞/㎡ and waist circumference≧80cm. After inform consent, they will be randomly assigned into two groups. In group A, catgut embedding will be applied to six acupuncture points on the abdomen including Qihai (Ren-6), Shuifen (REN-9), bilateral shuidao (ST-28) and Siman (ST-26), which have been proved to be effective on obesity in our previous study, once each week for six times. In group B, sham catgut embedding will be applied on the same acupoints once each week for six weeks. This trial will go on for six weeks with six course of treatment.

Our primary outcome measurements is complexion which included body mass index(BMI),waist circumstances, and waist-hip ratio. In our second outcome measurments, we will evaluate the life quality of these patients using 12-Item Short Form Health Survey (SF-12) which developed for the Medical Outcomes Study (MOS) and also using questionnaire of quality of life that was designated by World Health Organization. We will also classify the patients by questionnaire designed for TCM syndrome of obesity. We will check blood test included lipid profile (TG, Chol, HDL-C, LDL-C), inflammatory markers, and hormone peptide related to obesity such as insulin,leptin,ghrelin,adiponectin. Each enrolling patients will be evaluated at the baseline before treatment and after 6 times treatments completed by above parameters to find out the therapeutic effects and mechanism of catgut embedding in acupoints in obese women.

Eligibility Criteria:
Inclusion Criteria:

* body mass index (BMI) ≥ 27 kg/m2 waist circumference (WC) ≥ 80 cm and willing to participate in and fill out the questionnaires for this trial.

Exclusion Criteria:

* Endocrine disease(Thyroid disease, pituitary disease, diabetes mellitus) Autoimmune disease（SLE、SSS、RA） Heart disease(Heart failure, arrhythmia etc.） Abnormal liver function（GOT\>80U/L、GPT\>80U/L） Abnormal kidney function（serum creatinine\>2.5 mg/dL） Stroke disease in past one year Under breast feeding or pregnancy Coagulation disorder Subjects with keloid disorder Accept weight reduction treatment in last two months
Evaluating ALLN-177 for Reducing Urinary Oxalate Excretion in Calcium Oxalate Kidney Stone Formers With Hyperoxaluria

The purpose of this study is to evaluate the effect of ALLN-177 to reduce urinary oxalate excretion in patients with recurring kidney stones and enteric or idiopathic hyperoxaluria.

A multi-center, open-label, single arm study to evaluate the safety and the effect of ALLN-177 to reduce urinary oxalate excretion in recurrent kidney stone formers with associated hyperoxaluria. The study design includes a screening period to confirm eligibility, followed by a 3-day baseline period, 4-day open label treatment period with ALLN-177 and 4-day follow up period.

Eligibility Criteria:
Inclusion Criteria:

* Able to provide informed consent
* Able to comply with study procedures
* History of enteric or idiopathic hyperoxaluria and at least one calcium oxalate kidney stone
* Hyperoxaluria \>36mg of oxalate/24-hr
* May be taking drugs for the prevention of stone disease as long as there have been no changes in these medications for at least 3 months

Exclusion Criteria:

* Uric acid ≥1.5g/24-hr
* Estimated glomerular filtration rate of \< 60 mL/min
* Positive results from drug urine screen
* Requires daily vitamin C (defined as \>10 days of \>300 mg/day)
* Diagnosis of hypercalcemia or hypothyroidism
* Obstructive uropathy, chronic urosepsis, renal failure, renal tubular acidosis, primary hyperparathyroidism, primary hyperoxaluria, pure uric acid and cystine stones, and/or medullary sponge kidney.
* Auto-immune disorder requiring high dose steroids or other immunosuppressant drugs.
* Subjects who are pregnant. Women of childbearing potential must have a negative pregnancy test prior to enrollment and must practice approved methods of birth control during the trial
* History of cancer diagnosis except for within the past 5 years excluding dermal squamous and/or basal cell carcinoma or cervical carcinoma in situ.
* Taken investigational compound within 30 days prior to the first day of the study
* Treatment with cholestyramine
* Average daily dietary intake of \<75 mg oxalate per day calculated from diet recalls
Safety and Feasibility of MR-guided Laser Thermal Ablation of Brain Lesions

This will be an open-label, pilot, exploratory, single centre clinical investigation. This is an early feasibility single arm study. No formal hypothesis is proposed. A total of up to 15 evaluable subjects receiving a non-radical ablation is planned.

The safety and feasibility outcomes will be measured directly post-treatment, 48h and 3 months post-treatment.

A minimal invasive neurosurgical approach with a Magnetic Resonance Imaging (MRI)-based stereotactic guidance system will be utilized for the planning, navigation, intracranial access, placement and confirmation of the Laser applicator prior to ablation.


Eligibility Criteria:
Inclusion Criteria:

1. Lesions eligible for Laser Interstitial ThermoTherapy (LITT), target tumor ≤10cc in volume
2. Age ≥ 18 and \< 80 years
3. Ability to undergo contrast-enhanced Computed Tomography (CT), Positron Emission Tomography (PET)-CT and contrast-enhanced MRI.
4. Women of childbearing potential must have a negative pregnancy test.
5. Eastern Cooperative Oncology Group (ECOG) performance status of ≤2
6. Primary glioblastoma/astrocytoma WHO grade IV confirmed by 1)Magnetic Resonance Imaging according to RANO citera and 2)Frozen section biosy diagnosis, and considered not suitable for open surgery or other primary treatment, or Recurrent glioblastoma/astrocytoma WHO grade IV confirmed by Magnetic Resonance Imaging according to RANO criteria.
7. ≥3 months since last radiotherapy of the brain
8. Supratentorial tumor localization with or without prior surgery for recurrence.
9. Life expectancy of ≥3 months
10. The subject reports having understood and has signed the Informed Consent Form (ICF) and is willing to comply with all investigation visits and assessments.
11. Anticipated compliance with treatment and follow-up

Exclusion Criteria:

1. Subject contraindicated for MRI, including subjects who may have contraindications due to implanted medical devices
2. Subject evaluated not to be fit for surgery due to liver/kidney/other organ dysfunction verified by laboratory tests
3. Identified intratumoral cystic or haemorrhagic transformation in target tumor
4. Known bleeding disorder
5. ECOG performance status of \>2
6. Previous (within 30 days prior to enrollment / randomization) and concurrent treatment during the treatment phase with other investigational drug/s or device/s
7. Pregnancy or breastfeeding
8. The subject has a cognitive incapacity or language barrier precluding adequate understanding or cooperation
9. The subject is considered by the Investigator to be unsuitable to participate in the investigation for any other reason.
10. Any severe diseases interfering with the performance, evaluation, and outcome of the clinical evaluation
A Research Study to Look at How Insulin 287 and Semaglutide Work in the Body of People With Type 2 Diabetes When Taken Alone or Together

The study will look at how insulin 287 and semaglutide work in the body, both when given alone or together. This study will look at the way insulin 287 and semaglutide reach and stay in participants' blood after injection when given alone or together. Participants will get 3 study medicines at 3 different time points: 1) a combination of semaglutide plus insulin 287, 2) insulin 287 alone and 3) semaglutide alone. The order in which participants get them is decided by chance. Participants will get all medicines as an injection under the skin in the thigh. The injections will be done by study staff. The time between injections is 6 to 9 weeks. The study will last for about 19 to 32 weeks in total.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 18-64 years (both inclusive) at the time of signing informed consent
* Diagnosed with type 2 diabetes mellitus more than or equal to 180 days prior to the day of screening
* Body weight between 80.0 to 120.0 kg (both inclusive)
* Glycosylated haemoglobin (HbA1c) 6.0 to 8.5% (both inclusive)
* No current and no regular previous intake of insulin. Previous insulin treatment for short periods of time (a maximum of 14 days) is allowed, as well as insulin use during a previous period of gestational diabetes in the past (as declared by the subject or reported in the medical records)
* Stable daily dose(s) of the following anti-diabetic drug(s)/regimen within the past 90 days prior to the day of screening: a) Any metformin formulation (dose as documented in the subject medical record), b) One other oral antidiabetic drug (dose as documented in the subject medical record) is allowed, but not mandatory: Insulin secretagogue (sulphonylureas), dipeptidyl peptidase 4 (DPP-4) inhibitor and sodium glucose co-transporter 2 (SGLT2) inhibitor

Exclusion Criteria:

* Known or suspected hypersensitivity to trial products or related products
* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods
* Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event within the past 180 days) or hypoglycaemic unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis within the past 180 days prior to the day of screening
* Receipt of any investigational medicinal product within 90 days before screening
* History of severe allergies to drugs or foods or a history of severe anaphylactic reaction
Austrian Registry on the Outcome of Monochorionic Pregnancies

About one third of twin pregnancies are resulting from a single fertilized oocyte. Two third of these monozygotic twins share a common placenta and are therefore called monochorionic. Due to placental sharing and the ever-present inter-fetal vascular connections, specific complications may arise and lead to an increased risk of intrauterine death and long-term neurodevelopmental impairment. Specific complications include twin-to-twin transfusion syndrome (TTTS), twin-anemia-polycythemia sequence (TAPS), selective intrauterine growth restriction (sIUGR) and discordant major anomalies, occurring in about 10%, 5%, 20% and 6% of monochorionic diamniotic twins. Prenatal interventions may improve perinatal and long-term outcome of affected fetuses. However, general knowledge about early diagnosis of monochorionic twins and their specific complications is still limited in a significant number of practitioners in Austria and systematic analysis of pregnancy outcomes are not conducted.

In this prospective multicenter registry study, the investigators aim to include all monochorionic pregnancies in Austria. Main outcome parameter is the occurrence of complications. Secondary outcomes are gestational age at occurrence of complications, gestational age delivery and neonatal outcome. The investigators also strive for long-term outcome, especially of infants following complicated pregnancies or preterm birth.


Eligibility Criteria:
Inclusion Criteria:

* All monochorionic pregnancies diagnosed from 11+0 weeks of gestation

Exclusion Criteria:

* Dichorionic twin pregnancies or higher-grade multiples without a monochorionic pair
A 28-Day Polysomnographic Study of Gabapentin in Transient Insomnia Induced by a Sleep Phase Advance

The purpose of this study is to to assess the effect of gabapentin compared to placebo on sleep, using polysomnography along with subjective sleep assessments, in subjects with transient insomnia induced by a sleep phase advance.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older with occasional sleeplessness in the month prior to screening

Exclusion Criteria:

* Current treatment for, or recent history (within 2 years) of, a sleeping disorder including excessive snoring, obstructive sleep apnea or a chronic painful condition that interferes with the subject's sleep
* Currently taking or expected to take any of the following during trial: amphetamines, benzodiazepines, cocaine, marijuana, methaqualone, methadone, opiates, propoxyphene, barbiturates, and phencyclidine during their participation in the trial
Polydatin Injectable (HW6) for Shock Treatment

HW6 can prolong animal's survival time and increase the survival rate. HW6 enhances cardiac function, improves microcirculation, and increases blood pressure and pulse pressure, and improves blood perfusion of important organs; HW6's anti-shock activity comes from a combined multiple target pharmacological effects.

Based on a completed phase II trial conducted in China, HW6 can effectively treatment shock patient.

This is a phase II clinical study to further evaluate the efficacy and safety of Polydatin Injectable 100mg/5mL/via (HW6) in the treatment of shock in the United States. Patients with traumatic/hemorrhagic shock or septic shock admitted to the emergency room or ICU with systolic blood pressure \< 90mmHg, or is on vasopressor(s) for systolic blood pressure stabilization, regardless the types of completed, on-going, or projected Standard of Care or surgery will be recruited to participant in the trial. A total of 120 patients with traumatic/hemorrhagic shock and 120 patients with septic shock will be enrolled. For each type of shock, sixty patients each will be in test group and control group. Both adult males and females aged 18-80 years are eligible. The primary clinical endpoint is the time length (TL) between the start of HW6 administration to the onset of the first treatment success, that is: the systolic blood pressure is stabilized at ≥90mmHg and MAP≥65mmHg for 1 hour without the use of vasopressors. Several secondary endpoints and biomarkers will be measured.

Efficacy data will be compared using group t-test or Wilcoxon log-rank test between treatment groups and placebo groups. Safety data will also be reported accordingly.


Eligibility Criteria:
Inclusion Criteria:

* Adult males or females aged 18-80 years.
* Patients with traumatic/hemorrhagic shock or septic shock admitted to the emergency room or ICU with systolic blood pressure \< 90mmHg, or is on vasopressor(s) for systolic blood pressure stabilization, regardless the types of completed, ongoing, or projected Standard of Care or surgery.
* Patients (or its relative) who have signed Informed Consent Form to voluntarily participate in this clinical study.

Exclusion Criteria:

* Has known allergic constitution or history of alcohol or drug allergy. or
* Complicating acute cardiac failure, acute renal failure, acute liver failure or disseminated intravascular coagulation (DIC). or
* Pregnant or lactating women. or
* Complicating moderate to severe craniocerebral injury. or
* Has known previous severe chronic disease(s) in liver, kidney, carvascualr system or central nervous system. or
A Virtual Heart Failure Optimization Program for Guideline Directed Medical Therapy and Cardiac Rehabilitation

The goal of this study is to test the impact of a virtual heart failure optimization program on uptake of guideline directed medical therapy, participation in cardiac rehabilitation \& impact on echocardiographic parameters.

This is a single center, prospective pre-post cohort study testing a virtual, multi-disciplinary heart failure optimization program for up-titration of guideline directed medical therapy. This nurse and kinesiologist-led program will start and up-titrate patients on GDMT and offer virtual cardiac rehabilitation over a 3-month period.

The investigators hypothesize that this program could safely achieve higher rates of maximally tolerated ARNI, Beta-blocker, MRA and SGLT2i rates, as well as participation in cardiac rehabilitation among HFrEF patient participants. The investigators hypothesize that participation will lead to improved Left Ventricular Ejection Fraction on Echocardiogram.

Eligibility Criteria:
Inclusion Criteria:

* HFrEF (ejection fraction less than 40%) with New York Heart Association (NYHA) class II or III symptoms
* Adults (\>18 years of age), capable of providing informed consent, English-proficient and with access to a telephone

Exclusion Criteria:

* Patients who are pregnant
* Patients who who are incarcerated
* Cardiac Transplant Patients
* Patients with Left Ventricular Assist Devices
EU/LA Pearl Index Study - Transdermal Contraceptive Patch

The aim of the present study is to prove efficacy and safety of a new contraceptive patch.


Eligibility Criteria:
Inclusion Criteria:

* Requiring contraception
* Normal cervical smear
* Smokers not older than 30 years
* History of regular cyclic menstrual periods

Exclusion Criteria:

* Pregnancy or lactation
* Obesity (BMI\> 30 kg/m2
* Significant skin reaction to transdermal preparations or sensitivity to surgical / medical tape
* Any disease that may worsen under hormonal treatment (cardiovascular, liver, metabolic)
* Use of other contraceptive methods than study medication
Study of ONO-4538 in Non-Squamous Non-Small Cell Lung Cancer (TASUKI-52)

The purpose of study is to compare the efficacy and safety of ONO-4538 in combination with carboplatin, paclitaxel, and bevacizumab (ONO-4538 group) to placebo in combination with carboplatin, paclitaxel, and bevacizumab (placebo group) in chemotherapy-naïve subjects with stage IIIB/IV or recurrent non-squamous non-small cell lung cancer unsuitable for radical radiation in a multicenter, randomized, double-blind study.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with histologically- or cytologically-confirmed non-squamous non-small cell lung cancer
* Subjects who received a diagnosis of stage IIIB/IV or recurrent non-squamous non-small cell lung cancer unsuitable for radical radiation according to the UICC-TNM Classification (7th edition) with no prior systemic anticancer therapy
* Subjects with at least one measurable lesion by radiographic tumor assessments per RECIST 1.1 criteria
* Subjects who are able to provide tumor tissue specimens.
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1

Exclusion Criteria:

* Subjects with known EGFR mutations, including deletions in exon 19 and exon 21 (L858R) substitution mutations.
* Subjects with known ALK translocations.
* Complication or history of severe hypersensitivity reactions to antibody products or platinum-containing compounds
* Subjects with autoimmune disease or known chronic or recurrent autoimmune disease.
* Subjects with multiple cancer.
Safely Reduce Cystoscopic Evaluations for Hematuria Patients

The SeARCH-trial assess the clinical impact of a molecular urine test as a 'urine-first' strategy in the diagnostic workup of patients presenting with microscopic hematuria.

Microscopic hematuria (MH) can be a sign of an underlying disease, including malignancy of the urinary tract, and is reason for referral to a urology clinic. The current standard diagnostic workup for MH patients includes visual inspection of the bladder by cystoscopy and upper tract imaging to rule out the presence of a tumor in the urinary tract. However, the a priori risk of cancer in patients with MH is only 2-5%. Consequently, 95% of MH patients unnecessarily undergo invasive procedures, which are: I) uncomfortable and stressful for patients, II) has a significant impact on limited available (financial) resources and III) a CT scan is accompanied by exposure to ionizing radiation.

Previously we developed a molecular urine assay to detect urinary tract cancer in hematuria patients that had robust diagnostic performance; a negative predictive value \>99%, sensitivity, and specificity \>90%. The SeARCH-trial evaluates the clinical impact of a urine assay as a 'urine-first' strategy, meaning that only patients with an abnormal urine test results undergo invasive diagnostics. In this multicenter stepped-wedge cluster randomized trial we compare clinical outcomes by using a 'urine-first' strategy to 'care-as-usual', which is a cystoscopy and upper tract imaging in all patients presenting with MH. In addition, we assess patients' preferences, patients reported outcome measurements, and healthcare costs to show that a 'urine-first' strategy improves patients' quality of life and results in a more appropriate use of limited available resources.

Eligibility Criteria:
Inclusion Criteria:

* Microscopically confirmed microscopic hematuria of voided urine defined as ≥3 erythrocytes per high power field
* Male patients ≥40 years
* Female patients ≥50 years

Exclusion Criteria:

* History of urothelial bladder- or urinary tract cancer
* Presence of macroscopic (visible) hematuria
* Woman who is or may be pregnant
Clinical Outcomes After Bowel Resection in Patients Receiving Alvimopan Versus Patients Not Receiving Alvimopan in the Premier Perspective Database

Alvimopan is the first and currently the only FDA-approved therapy for acceleration of the time to upper and lower gastrointestinal (GI) recovery following partial large or small bowel resection surgery with primary anastomosis.

The primary objective of this retrospective observational trial is to assess postoperative morbidity and mortality as reported during the index hospitalization for bowel resection and 15/30-day readmissions of alvimopan vs. non-alvimopan matched patients in the combined Premier/Care Science database(a large medical claims database).


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years at discharge
* Medical claim with an ICD-9-CM procedure code for a primary procedure (identified at position 1 or 2 involving large or small segmental bowel resection with primary anastomosis
* Discharged within the study dates
* Surgery at a participating Premier/Care Sciences hospital

Exclusion Criteria:

* Had a diverting ostomy without a primary anastomosis during the index hospitalization
* Had a trauma diagnosis
* Had bowel resections performed on more than 1 day during index hospitalization (this includes cases where a bowel resection and intestinal anastomosis were performed on different days during the index hospitalization)
* Had an excluded non-bowel resection surgical code (i.e., code for a major non-BR surgical procedure \[eg., nephroureterectomy, total joint replacement\] in position 1 or 2
Development and Validation of a Deep Learning System for Nasopharyngeal Carcinoma Using Endoscopic Images

Develop a deep learning algorithm via nasal endoscopic images from eight NPC treatment centerto detect and screen nasopharyngeal carcinoma(NPC).

Nasopharyngeal carcinoma (NPC) is an epithelial cancer derived from nasopharyngeal mucosa. Nasal endoscopy is the conventional examination for NPC screening. It is a major challenge for inexperienced endoscopists to accurately distinguish NPC and other benign dieseases. In this study, we collcet multi-center endoscopic images and train a deep learning model to detect NPC and indicate tumor location. Then, the model perfomance will be compared with endoscopists and be tested prospectively with external dataset.

Eligibility Criteria:
Inclusion Criteria:

* The quality of endoscopic images should clinical acceptable.
* Patients were diagnosed with biopsy(NPC, benign hyperplasia). Control corhort(normal nasopharynx) don't require bispsy result.

Exclusion Criteria:

* images with spots from lens flares or stains, and overexposure were excluded from further analysis.
* image can not expose most part of lesion clearly.