cyrilzakka/clinical-trials huggingface dataset:
A Phase 1 Study of HEC88473 Injection in Healthy Subjects, Obese Subjects and T2DM Subjects

This is a single-center, randomized, double-blind, placebo-controlled, escalating single-dose and multiple-dose study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HEC88473 injection in healthy subjects, obese subjects and subjects with type 2 diabetes mellitus (T2DM).

This study is divided into two parts, Part A is an escalating single-dose study in healthy subjects and obese subjects, and Part B is an escalating multiple-dose study in subjects with T2DM.

Eligibility Criteria:
Inclusion Criteria:

Part A

1. Males or females, between 18 and 45 years of age, inclusive, at screening.
2. Body weight ≥ 50 kg for males and body weight ≥ 45 kg for females. 18≤body mass index (BMI)\<28 kg/m2 for nonobese subjects and 28≤BMI≤45 kg/m2 for obese subjects.

Part B

1. Males or females, between 18 and 65 years of age, inclusive, at screening.
2. 24 kg/m2≤BMI≤35 kg/m2.
3. Subjects diagnosed with T2DM, newly diagnosed subjects at screening, or treated with diet and exercise alone within 3 months before screening and still have poor blood glucose control, or treated with a stable dose of metformin for ≥ 3 months before screening.
4. 7.0%≤ HbA1c ≤10.5% at screening.

Exclusion Criteria:

Part A

1. Smoked more than 5 cigarettes per day within 3 months before the study.
2. Immunization with a live attenuated vaccine or coronavirus vaccination within 1 month prior to screening or planned vaccination during the course of the study.
3. Positive alcohol breath test result or positive urine drug screen.
4. Blood donation (\> 300 mL) or massive blood loss (\> 400 mL) within 3 months before screening.

Part B

1. Have type 1 diabetes mellitus.
2. Have had ≥1 episode of severe hypoglycemia within 6 months before screening, or history of recurrent hypoglycemia (history of hypoglycemia more than 3 times in 3 months).
3. Have acute or chronic hepatitis, signs and symptoms of any other liver disease other than nonalcoholic fatty liver disease (NAFLD), or alanine aminotransferase (ALT) level \>5 times the upper limit of the reference range at screening.
4. Have serum calcitonin ≥20 ng/L at screening.
5. Have a personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2; or have hereditary diseases that can easily induce MTC.
6. Fasted triglycerides \> 5.7 mmol/L at screening. If the patient is on lipid-lowering therapies, doses must be stable for 30 days prior to screening.
High Definition Transcranial Direct Current Stimulation Motor Cortex Versus Insula

Brain stimulation is a technique that can alter cortical function and thus be suitable for treating pain. This is especially when pain is chronic and associated with functional and even structural reorganization of the central nervous system. The idea of using invasive and noninvasive brain stimulation for pain relief is not new. Studies from the 1950s have investigated the brain stimulation for therapeutic use. Direct implantation of electrodes on the cerebral cortex has been carried out by Tsubokawa and colleagues in Japan. Although reported to be effective, it is invasive and involves the implantation of a foreign body into the cranium. Recent advancements in the techniques of non-invasive brain stimulation have improved and have measurable modulatory effects making this an attractive alternative for treating pain

Repetitive transcranial magnetic stimulation and transcranial direct current stimulation are currently the two main methods of non-invasive brain stimulation under investigation. Stimulation of the primary motor cortex has been reported to relieve neuropathic, musculoskeletal, visceral pain as well as headaches and migraine. Other parameters of stimulation have shown encouraging results. For example, stimulation of the secondary somatosensory cortex was also reported to relieve chronic visceral pain. However, there are numerous unanswered questions regarding these techniques.

This research project is an attempt to answer some of these questions:

1. Which pain conditions can be alleviated by non-invasive brain stimulation?
2. What are the best parameters for stimulation-

   1. method: transcranial direct current stimulation or repetitive transcranial magnetic stimulation transcranial or Alternating Current Stimulation
   2. High-Definition transcranial direct current stimulation or conventional transcranial direct current stimulation?
   3. which area to stimulate? Primary motor cortex, insula?
3. Will other forms of treatment such as pharmacotherapy, peripheral nerve stimulation or multi-disciplinary pain management enhance the effectiveness of non-invasive brain stimulation

Eligibility Criteria:
Inclusion Criteria:

* Able to give informed consent to participate in the study.
* Male and female University Undergraduate, Postgraduate and staff in the Department of Psychology.
* American society of anesthesiology scores I to II patients.

Exclusion Criteria: the participant who has any history of:

* an adverse reaction to brain stimulation.
* a seizure
* an unexplained loss of consciousness
* a stroke
* serious head injury
* surgery to their head
* any brain related, neurological illnesses
* any illness that may have caused brain injury
* frequent or severe headaches
* metal in your head (outside the mouth) such as shrapnel, surgical clips, or fragments from welding
* any implanted medical devices such as cardiac pacemaker's or medical pumps
* taking any analgesic medications in the past 24 hours
* pregnancy
* anyone in your family has epilepsy
Role of Soy Supplementation in Prostate Cancer Development

This is a randomized study evaluating the effectiveness and direct effect a commercial soy supplement has on prostate cancer and normal prostate tissue. Patient will be randomized it either receive placebo or a commercial soy supplement for 2-4 weeks prior to the planned surgery for treatment of their prostate cancer. Patient's blood and prostate tissue will be evaluated to determine the effects of the soy supplement on the prostate tissue.

This is a randomized study evaluating the effectiveness and direct effect a commercial soy supplement has on prostate cancer and normal prostate tissue. Patients will be randomized to either receive placebo or a commercial soy supplement for 2-4 weeks prior to the planned surgery for treatment of their prostate cancer. The specific objectives are:

1. To assess the effect of soy supplementation on endogenous hormone production levels and serum prostate specific antigens.
2. To assess the impact of soy supplementation on estrogen receptor expression(ER).
3. To determine the impact of soy isoflavones on cell cycle regulation and associated gene expression.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven prostate cancer.
* Surgical candidate for prostatectomy.
* During study period, must agree not to take new supplements.
* No concurrent chemotherapy, radiation or hormonal therapy.
* No history of prior allergy to soy based products.
* Must not have been taking soy supplements or soy isoflavones within 90 days prior to study enrollment.
* Must be able to safely be on study supplements for period of at least two weeks prior to scheduled prostatectomy.
* Must give written and informed consent in accordance with institutional and federal guidelines.

Exclusion Criteria:

During study period, must agree not to take new supplements.

* No concurrent chemotherapy, radiation or hormonal therapy.
* No history of prior allergy to soy based products.
* Must not have been taking soy supplements or soy isoflavones within 90 days prior to study enrollment.
* Must be able to safely be on study supplements for period of at least two weeks prior to scheduled
Efficacy and Safety Evaluation of a Treatment Consisting of Peg Interferon Alfa + Ribavirin + Daclatasvir in HCV Genotype 1 and 4 Treatment naïve Patients

The purpose of this study is to determine whether 24 week treatment with the Daclatasvir (DCV) in combination with Pegylated-interferon alfa 2a (pegIFNα-2a) and Ribavirin (RBV) is safe and demonstrates rate of Sustained Virologic Response at follow up week 24 (SVR24) (defined as undetectable HCV RNA at post-treatment Week 24) that are non-inferior to 48 weeks of the dual combination therapy of pegIFNα-2a/RBV in a majority of study subjects


Eligibility Criteria:
Inclusion Criteria:

* Patients chronically infected with Hepatitis C virus (HCV) GT 1 or 4
* HCV RNA viral load ≥ 10,000 IU/mL
* Naïve to prior treatment with any interferon formulation, Ribavirin (RBV) or HCV direct antiviral agent
* Patients with compensated cirrhosis are permitted

Exclusion Criteria:

* Infected with HCV other than GT 1 or 4
* Evidence of decompensated liver disease
* Documented or suspected Hepatocellular carcinoma (HCC) as evidenced by previously obtained imaging studies or liver biopsy
* Evidence of a medical condition contributing to chronic liver disease other than HCV
* History of chronic Hepatitis B virus (HBV) or Human immunodeficiency virus (HIV)
* Current or know history of cancer (except in situ carcinoma of cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to enrollment
* Laboratory values:

  1. Hemoglobin \< 12 g/dL (females) or \< 13 g/dL (males)
  2. Platelets \< 90 x 1000000000 cells/L
  3. Absolute neutrophil count (ANC) \< 1.5 × 1000000000 cells/L
  4. Total bilirubin ≥ 34 µmol/L (unless due to Gilbert's disease)
Validation of Therapeutic Effects of Cefaly on Insomnia

The study aims to examine whether the Cefaly has a therapeutic effect on insomnia patients visiting a psychiatric clinic in Korea. The study design is a single site, single-armed exploratory study. Insomnia patients received a 20-minute daily sessions of the Cefaly for 4 weeks. Primary endpoint was a reduction of scores in Pittsburgh Sleep Quality Index, Insomnia Severity Index, Epworth Sleepiness Scale, improvements in polysomnography measures, and changes in resting state networks, cortical thickness, fractional anisotropy and mean diffusivity

Insomnia is well-known for its association with adverse health outcomes. Although insomnia is usually treated with hypnotics or cognitive behavioral therapy for insomnia, the need for novel nonpharmacological treatment for insomnia is increasing emphasized due to reports of side effects and detrimental consequences of hypnotics. Trigeminal nerve electrical neuromodulation has been suggested as a potential treatment modality through its modulation of noradrenergic activity that results in promoting relaxation and reducing hyperarousal. Insomnia patients enrolled in the study will go through a 20-minute daily session of the Cefaly device(originally FDA-approved device for migraine, which electrically modulates trigeminal nerve) for 4 weeks. The objective of this study is to test whether trigeminal nerve electrical neuromodulation has a therapeutic effect, validation measures involving subjective measures(Pittsburgh Sleep Quality Index, Insomnia Severity Index, Epworth Sleepiness Scale), objective measures(Polysomnography measures) and neuroimaging(changes in resting state networks, cortical thickness, fractional anisotropy and mean diffusivity).

Eligibility Criteria:
Inclusion Criteria:

1. Patients who have adequately understood the whole study procedures within age range of 19-64 years
2. Patients with insomnia severity index (ISI) score of more than 15

Exclusion Criteria:

1. Cognitive impairment
2. Psychiatric disorders or neurological disorders.
3. Unstable medical conditions
4. Prior diagnosis of sleep disorders
5. Hypnotic prescription
6. History of brain or facial trauma within 3 months
7. Skin abrasions
8. Acrylic acid allergy
9. Electromagnetic hypersensitivity
10. Apnea hypopnea index of \>15/hour in the baseline polysomnography.
Phenotyping Genetic Risk for Type 2 Diabetes

This study tests the hypothesis that non-diabetic individuals with a high genetic risk score for type 2 diabetes have impaired glucose tolerance and insulin resistance compared to those with a low genetic risk score for type 2 diabetes.

The study team will recruit individuals based on genetic risk score for type 2 diabetes from the biobank populations who have agreed to be recontacted for future research. Each participant will undergo a frequently sampled four-hour oral glucose tolerance test and whole body DXA scan (dual-energy X-ray absorptiometry) in addition to baseline laboratory and history assessment.

Eligibility Criteria:
Inclusion Criteria:

* Age 10-70 years
* Prior participant of the UPenn Biobank or Center for Applied Genomics Biobank and agreed to be recontacted for future research.
* Adults with BMI 25kg/m2 or higher, children and adolescents with BMI 85th percentile or higher

Exclusion Criteria:

* prior diagnosis of type 1, type 2, or secondary diabetes
* use of medications that would impact glucose and insulin response such as steroids, metformin or other anti-diabetic medication
* acute illness that may impact insulin and glucose dynamics
* pregnancy
* hypothalamic obesity or related genetic disorder of metabolism
* recent systemic chemotherapy use
* gastrointestinal impairment or surgery that may impact absorption
* anemia
* major organ system illness or any underlying condition requiring regular medication or treatment that could make implementation of the protocol or interpretation of the study results difficult
* inability to comply with study protocol
Comparison of Manual Cardiopulmonary Resuscitation (CPR) Versus Automatic CPR Machine During Ambulance Transport.

This is a randomized controlled prospective study which assigned patient to receive manual CPR or automatic CPR machine use. The quality and efficacy between manual CPR and machine CPR will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Non-traumatic out-of-hospital cardiac arrest patient in Taipei distric
* Patients sent to National Taiwan University Hospital (NTUH) through Jhongsiao Emergency medical service (EMS) team

Exclusion Criteria:

* Younger than 15 years old
* Traumatic cardia arrest
* Patients not sent to NTUH by Jhongsiao EMS team
A Study to Evaluate the Efficacy of EB-PA on Muscle Mass and Strength in Occasional Gym Goers

The present study is a placebo- controlled, single-blind sequential study. Total of 40 males aged between ≥ 18 years and ≤35 years will be screened. Assuming screen failure and dropout rate in this study, a minimum of 30 participants should complete the study. The treatment duration for all the study participants will be 60 days.


Eligibility Criteria:
Inclusion Criteria:

* Males aged ≥18 to ≤ 35 years with moderate physical activity levels as per International Physical Activity Questionnaire (IPAQ-SF).
* Occasionally gym goer with a history of at least 1 month of training but not participating in the resistance-type activity for ≥3 months.
* Habitual non-veg eater
* Body mass index (BMI) 22 - 29.9 kg/ m2
* Waist Circumference 94-102 cm
* Ready to refrain from caffeinated products and intense strength/ endurance exercise for 24 hrs before the exercise lab visit.
* Fasting blood Glucose ≤ 125 mg/ dl
* Systolic Blood Pressure ≤ 129 mm Hg and Diastolic Blood Pressure ≤ 89 mm Hg
* TSH (thyroid stimulating hormone) ≥0.4 and ≤ 4.9 mIU/L

Exclusion Criteria:

* Engaged in structured weight training for more than 12 months before screening.
* Presence of chronic disease
* Changes in body weight of more than 4.5 kg (10 pounds) in the past three months
* Individuals with uncontrolled hypertension
* Known cases of Type II Diabetes mellitus
* History or presence of clinically significant renal, hepatic, endocrine, biliary, gastrointestinal, pancreatic, or neurologic disorders
* Individuals who have any other disease or condition or are using any medication that, in the investigator's judgment would put them at unacceptable risk for participation in the study or may interfere with evaluations or non-compliance with treatment or visits
* Individuals who have been part of a clinical trial within 90 days before the screening
* Individuals who have used whey or other supplements anytime in the last 3 months
Robot-assisted vs VATS Lobectomy for NSCLC

Robot-assisted thoracoscopic surgery (RATS) was widely used in thoracic surgery, the surgical safety and feasibility of RATS lobectomy for NSCLC has been confirmed. However, the oncological long-term outcomes of RATS lobectomy has not been studied by randomized controlled trial, the purpose of this study is to determine whether RATS lobectomy would be as effective as VATS lobectomy on short-term and long-term outcomes.

Video-assisted thoracoscopic surgery (VATS) lobectomy is recommended for non small cell lung cancer (NSCLC) with surgical indications in China, its oncological long-term outcomes has been widely approved. As a new form of VATS, robot-assisted thoracoscopic surgery (RATS) was widely used in thoracic surgery, the 3D vision and flexible robot arm were helpful for surgeons to perform precise operations, and RATS was reported to bring extra benefits to patients. The surgical safety and feasibility of RATS lobectomy for NSCLC has been confirmed. However, the oncological long-term outcomes of RATS lobectomy has not been studied by randomized controlled trial. so we designed this randomized controlled trial to determine whether RATS lobectomy would be as effective as VATS lobectomy on short-term and long-term outcomes.

Eligibility Criteria:
Inclusion Criteria:

1. surgical indication for lobectomy;
2. minimal invasive surgery;
3. ASA (American Society of Anesthesiologists) stage: I-III;
4. sign the informed consent. -

Exclusion Criteria:

1. benign tumor or nodule;
2. present of other malignancy;
3. preoperative chemotherapy, radiotherapy, targeted therapy. -
Incentive Spirometry in Routine Management of COPD Patients

The incentive spirometer is a device that encourages patients, with visual and other positive feedback, to maximally inflate their lungs and sustain that inflation. However, its efficacy in patients with COPD has been little documented especially in diaphragmatic function. This study tried to assess the role of incentive spirometry on Spirometric functions, Sonographic diaphragmatic function, and the scale of dyspnea in COPD patients with exacerbation and with follow-up of these parameters after 2 months.

Forty COPD patients were admitted with an acute exacerbation and the patients were divided randomly into 2 equal groups: the first used the incentive spirometer together with medical treatment (according to GOLD guidelines) for 2 months and the second received only medical treatment for 2 months. All participants, on admission, underwent assessment of mMRC dyspnea scale, spirometry, arterial blood gases, and diaphragmatic ultrasound. Then, a follow-up of the participants was done after 2 months with the same parameters and a comparison between both groups was done.

Eligibility Criteria:
Inclusion Criteria:

* confirmed cases of COPD according to the criteria GOLD
* age more than 40 years

Exclusion Criteria:

* bad acoustic window by ultrasound
* other chronic respiratory diseases
* lung malignancy
* recent major surgery
* inability to complete or perform the study
* patient refusal
Transversus Abdominis Plane Block in Acute Appendicitis Pain Managment

In this study, it was aimed to investigate the analgesic efficacy of the preoperatively applied Transversus Abdominis Plane (TAP) Block in the management of acute appendicitis-related abdominal pain and post-appendectomy pain.

TAP block creates an analgesic effect by blocking both sensory skin dermotams and viscerosomatic transmission. TAP block with ultrasound was first performed by Hebbard, and the use of USG made the procedure faster and safer. TAP block has been successfully applied for analgesia in procedures such as laparoscopic colocystectomy, inguinal hernia repair, abdominal hysterectomy, prostatectomy and appendectomy. According to the surgical incision to be applied, TAP block is performed from different anatomical regions. It is also applied for pain palliation in intra-abdominal etiologies or rarely for anesthesia in surgical procedures.

The analgesic efficacy of TAP block on preoperative abdominal pain and postoperative surgical pain in acute appendicitis was investigated.

Eligibility Criteria:
Inclusion Criteria:

* Patients over the age of 18 with a diagnosis of acute appendicitis,
* with abdominal pain,
* tap block applied for perioperative pain management.

Exclusion Criteria:

* The data of patients who underwent laparoscopic appendectomy
* additional surgical procedure other than appendectomy (right hemicolectomy, etc.)
* who were diagnosed other than acute appendicitis after the surgical procedure (diverticulitis, tumor, etc.),
Clinical Study of Raloxifene and Strontium Ranelate in Postmenopausal Osteoporosis

The purpose of this study was to compare compliance and efficacy of raloxifene and strontium ranelate in a group of women with postmenopausal osteoporosis.

OBJECTIVE: To compare the performance of raloxifene and strontium rannelate in the management of women with postmenopausal osteoporosis.

DESIGN: Prospective, open label study. SETTING: University hospital menopause unit. PATIENTS: 80 women with postmenopausal osteoporosis were assigned to either raloxifene (60 mg/d) or strontium ranelate (2g/d). Participants were followed for 1 year.

MAIN OUTCOME MEASURE(S): Compliance with each regime. Secondary objectives were parameters of efficacy, including changes in bone mineral density and bone biochemical markers.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women with densitometric osteoporosis

Exclusion Criteria:

* Secondary osteoporosis
Diet and Activity Promotion Among Older Working Adults

The trial will test whether the Alive email-delivered health behavior program can improve subjects' physical activity, fruits and vegetables and saturated/trans fats and added sugars.


Eligibility Criteria:
Inclusion Criteria:

* aged 50+
* currently employed
* access to email/web

Exclusion Criteria:

* angina
Demographic Differences in Patients With Abdominal Aortic Aneurysm and Surgical Features of Treatment

The study of demographics and risk factors for abdominal aortic aneurysms, allows to individualize treatment approaches.

Determining of the results of treatment of patients who requires a late open conversion after EVAR will allow to develop the surgical approach and the selection of the optimal type of surgical treatment.

Determination of genetic polymorphisms will reduce the number of postoperative complications by predicting of possible complications in the long term period.


Eligibility Criteria:
Inclusion Criteria:

* Infrarenal Aortic Aneurysm

Exclusion Criteria:

* Other Aneurysms