cyrilzakka/clinical-trials huggingface dataset:
SELINE: Second-Line Iressa Phase IV Study in NSCLC Patients

The purpose of this study is to evaluate ORR (Objective Response Rate) of gefitinib as a second-line therapy for NSCLC patients based on RECIST (Response Evaluation Criteria in Solid Tumors Group) and check up ORR difference by EGFR mutation, gender, smoking history, and type of tumor.


Eligibility Criteria:
Inclusion Criteria:

* Pathological Diagnosis of local advanced/metastatic Non Small Cell Lung Carcinoma
* Previously failed the first-line chemotherapy
* Patient who can provide sample for EGFR mutation test

Exclusion Criteria:

* Central Nervous System metastasis or spinal cord compression that has not yet been definitively treated with surgery and/or radiation
* Any evidence of clinically active interstitial lung disease
Biomarkers of Diabetic Retinopathy Progression

The purpose of this study is to validate a predictive model of diabetic retinopathy progression in patients with diabetes mellitus type 2 patients to clinically significant macular edema (CSME) needing treatment either photocoagulation or intravitreal injections (ITV) using non-invasive techniques.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus
* Age over 35 years-old
* Non-proliferative diabetic retinopathy (Levels 20 to 35, according the ETDRS criteria)
* Best Corrected Visual Acuity \> 20/25 on the ETDRS chart
* Informed Consent

Exclusion Criteria:

* Previous laser therapy
* Other retinal vascular disease
* Glaucoma
* Recent intraocular surgery (in the last 6 months)
* Inadequate ocular media and/ or pupil dilatation that do not permit good quality fundus photography (e.g. cataract)
* HbA1C \> 11 % at the Screening
* Subject that has a condition or that is in a situation which may put him/her at significant risk, may confound the study results or may interfere significantly with his/ her participation in the study.
Single Incision Laparoscopic Cholecystectomy

The investigators aim to investigate the safety, feasibility and short-term outcomes of Single Incision Laparoscopic Cholecystectomy.

The investigators hypothesize that Single Incision Laparoscopic Cholecystectomy is safe and feasible.

Laparoscopic cholecystectomy is the standard approach for the treatment of gallbladder disease. Laparoscopic cholecystectomy is now performed as an outpatient procedure and it commonly requires the use of 4 separate small incisions. Single incision or single access trans-umbilical surgery may provide less pain, scarring and may improve patient's overall satisfaction.

In this phase I trial we aim to evaluate the safety, feasibility and short-term outcomes of Single Incision Laparoscopic Cholecystectomy for the treatment of symptomatic cholelithiasis (gallstones).

Eligibility Criteria:
Inclusion Criteria:

* Adults male and female(\>18 years old)
* Capable of giving informed consent
* Ultrasound proven cholelithiasis
* Symptomatic cholelithiasis
* Elective cholecystectomy

Exclusion Criteria:

* Pregnancy
* Contraindications for general anesthesia
* Morbid obesity
* Multiple previous abdominal surgeries
* Uncontrolled medical conditions
* Acute cholecystitis
A Study to Compare Methodologies for Assessing Glucose-Dependent Insulin Secretion (0000-104)(COMPLETED)

This study will compare graded glucose infusion (GGI) to the hyperglycemic clamp (HGC) for assessment of glucose-dependent insulin secretion (GDIS) using exenatide as a probe.


Eligibility Criteria:
Inclusion Criteria:

* Subject has a Body Mass Index (BMI) of less than or equal to 26 kg/m2 at screening
* Subject is judged to be in good health
* Subject has been a nonsmoker for at least 3 months
* Subject is willing to avoid strenuous physical activity for the duration of the study

Exclusion Criteria:

* Subject has a history of high blood pressure requiring treatment
* Subject has a history of diabetes or a family history of diabetes mellitus
* Subject is unable to discontinue all prescription and non-prescription drugs for duration of study
* Subject consumes more than 3 alcoholic beverages per day
* Subject consumes more than 6 servings of caffeinated beverages per day (1 serving = 120mg caffeine)
* Subject has had major surgery or has donated or loss 1 unit of blood within 4 weeks of screening
* Subject has multiple and/or severe allergies to foods or drugs
* Subject is a regular user of illegal drugs
* Subject is unwilling or unable to consume the standardized meals during the study and/or is on a carbohydrate restricted diet
Study to Evaluate the Efficacy and Safety of Tocilizumab Versus Corticosteroids in Hospitalised COVID-19 Patients With High Risk of Progression

This study aims to compare the efficacy and safety of Methylprednisolone versus Tocilizumab in improving clinical outcomes and reducing the need for ventilator support in COVID-19 patients with moderate COVID-19 disease at risk for complications of cytokine storm. Approximately 310 participants hospitalized with COVID-19 in UMMC, Hospital Sungai Buloh, Hospital Kuala Lumpur and Hospital Tuanku Jaafar will be enrolled into this study.

Eligible participants will be selected based on a set of clinical, laboratory and radiological parameters indicative of early stages of CRS and lung function decline prior to being randomized at a ratio of 1:1 to receive either Tocilizumab or Methylprednisolone. Participants will be monitored daily for clinical and laboratory parameters, and at 48 hours, switched to the alternate study arm should they manifest signs and symptoms indicative of decompensation.


Eligibility Criteria:
Inclusion Criteria:

1) Hospitalised symptomatic COVID-19 patients 2( Presence of clinical and radiological signs of progressive disease, AND laboratory evidence indicative of risk for cytokine storm complications.

All patients participating in this clinical trial must meet the following inclusion criteria:

1. Hospitalised symptomatic COVID-19 patients
2. Presence of clinical and radiological signs of progressive disease, AND laboratory evidence indicative of risk for cytokine storm complications:

   Clinical:

   Dyspnoea OR RR\>20 breaths/min AND O2 sat \<93% on RA OR increasing need for O2 supplementation to maintain O2 sat \>95% on RA

   WITH

   Radiological:

   CXR or CT indicative of pneumonia OR worsening findings over time

   AND

   Laboratory:

   CRP levels \>60 OR an increase of CRP \>20 over 12 hours WITH an increasing ferritin level OR declining lymphocyte counts
3. Age \> 18 years and able to give consent

Exclusion Criteria:

Patients will be excluded if any of the following conditions apply:

1. Known sensitivity/allergy to TCZ or other monoclonal antibodies
2. AST/ALT\>5 times UNL, platelet counts \<50,000 or neutrophil counts \<500
3. Active TB
4. Pregnant
5. Receipt of mechanical ventilation
6. Has received other immunomodulatory drugs (including TCZ) in the past for the treatment of other conditions
7. Individuals, in the opinion of the investigator, where progression to death is imminent and inevitable in the next 24 hours irrespective of treatment provision or who have signed a DNR.
8. Participating in other clinical trials (subject to approval)
9. Any serious medical condition or abnormal clinical laboratory tests which in the judgement of the investigator may compromise patient safety should he/she participate in the study.
The Comparison of Mcgrath Mac, C-MAC, and Macintosh Laryngoscope in Novice Users: a Manikin Study

The purpose of this study is to evaluate whether the McGrath MAC videolaryngoscope is superior when compared to the C-MAC videolaryngoscope and the Macintosh laryngoscope for novice users in manikin.


Eligibility Criteria:
Inclusion Criteria:

* Medical students

Exclusion Criteria:

* wrist disease excluded.
Comparison of Thrice Daily Biphasic Human Insulin With Basal Bolus Regimen in Type 2 Diabetes Mellitus Patients

It is a proven fact that Basal Bolus insulin regimen is the near- physiological regimen \& Thrice daily Biphasic Insulin Aspart is a comparable alternative for glycemic control in type 2 diabetes mellitus patients. In this study the investigators evaluated whether Biphasic Human Insulin can be used in a thrice daily regimen in place of BIAsp.

As the regimen is less expensive and one prick less than the basal-bolus regimen, it can be a good alternative for a diabetics in India.

This is a 12 week Open labelled parallel-Randomised controlled pilot study - 50 patients with type 2 Diabetes mellitus was selected after satisfying the inclusion and exclusion criteria's .Metformin and pioglitazone were continued and they are randomised into 2 groups at base line and was allotted into any of the two regimens.

1. Basal detemir + bolus aspart or
2. Thrice Daily Biphasic Human Insulin Regimen.

The two regimens were compared by the following variables:

Primary endpoint:

Glycaemic control

Secondary endpoint:

Weight gain, Hypoglycaemic episodes, Adverse effects and Cost effectiveness

It is a proven fact that Basal Bolus insulin regimen is the near- physiological regimen \& Thrice daily Biphasic Insulin Aspart is a comparable alternative for glycemic control in type 2 diabetes mellitus patients. In this study the investigators evaluated whether Biphasic Human Insulin can be used in a thrice daily regimen in place of BIAsp.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 Diabetics \>/= 18 yrs of age Diabetic for \>/= 6months
* Inadequately controlled patients treated with human premixed insulin twice daily for at least 3months along with metformin 2g/d and pio30mg/d

  * Single dose of insulin exceeding 25 units or total insulin dose is more than 0.7u/kg/day with
  * If post lunch blood glucose is not controlled
  * If HbA1c ≥7%
* No major cardiac events in the preceding 6 months.
* NYHA \<= Class II.

Exclusion Criteria:

* Deranged LFT's- AST,ALT or ALP values \>= 2 times.
* Deranged RFT Sr. Creatinine \>=1.5
* Allergy to Insulin or its products.
* Recent intake of any new medications for sugar control.
* Illiterate to the level that she/he cannot understand the study.
* Any other acute co morbid illness.
* Pregnancy.
* Decompensated heart failure/UsA/MI all within last 12month
* Untreated proliferative retinopathy/ maculopathy
* Drug or alcohol dependence
Acupuncture for Non-cyclical Breast Pain

Breast pain or mastalgia is a common and troublesome symptom for many women. Whereas cyclical breast pain related to hormonal fluctuations can frequently be treated, non-cyclical breast pain can go untreated due to its various etiologies and non-specific presentation. Acupuncture is an ancient form of Chinese medicine that has been used for centuries to treat a vast array of illnesses and conditions. Research has shown that acupuncture has a link to a release of endorphins and other chemicals in the central nervous system. Thus, it is thought to help relieve pain. To date, there has been minimal research using acupuncture for breast pain. This pilot of 30 women will seek to determine whether four acupuncture treatments over a period of two weeks will significantly lower the level of pain experienced by these participants. Additionally, we will evaluate quality of life measures.


Eligibility Criteria:
* Female
* greater than 18 years
* non-cyclical unilateral or bilateral breast pain occurring daily, Greater than or equal to 2 on the BPI (average pain question)
* pain for more than 3 months
* satisfactory (non-suspicious for malignancy) breast examination within one year of enrollment (need documentation from physician or advanced practice nurse)
* satisfactory (non-suspicious for malignancy) mammogram and/or ultrasound within one year if Greater than 35 years(need written report to verify)
* able to return for acupuncture two times a week for two weeks
* speak and understand English
* hormone replacement therapy discontinued \> 3 months
Enhanced Recovery Open Versus Laparoscopic Donor Nephrectomy

A phase III randomized trial conducted to compare recovery outcomes between laparoscopic and open donor nephrectomy within a specified enhanced recovery protocol

The MEnROL trial is a phase III randomized controlled trial of Open versus Laparoscopic donor nephrectomy within a standardized enhanced recovery program. Eligible donors were randomized in a 1:1 ratio.

Laparoscopic procedures are performed by a single surgeon (AMM) while Open donor nephrectomies (ODN) were performed by an experienced team that included the laparoscopic surgeon. ODN were performed via a supracostal incision above the 11th rib and an extra-pleural extra-peritoneal approach was adopted. Laparoscopic donor nephrectomy (LDN) was performed via a standard 4-port distribution. Control of the hilar vessels was performed using extra-large Hem-o-Lok clips (Weck- Covidien, Research Triangle Park, NC) and graft extraction was performed via a pre-prepared Pfannenstiel incision.

Donors are enrolled in our enhanced recovery program for donor nephrectomy. The program was compliant with the Enhanced Recovery After Surgery Group (ERAS) guidelines. All donors receive epidural analgesia and are maintained on non-narcotic postoperative analgesics. Criteria for hospital discharge include ambulation, adequate pain control with oral analgesics, and sustained intake of solid food.

Eligibility Criteria:
Inclusion Criteria:

1. Donor aged 18 years or more.
2. Donors who have the ability to understand information and materials provided.
3. Donors who didn't express a preference for either open or laparoscopic surgery.
4. Donors who are fit for both open and laparoscopic intervention
5. Donors in whom evaluation revealed left kidney with single renal artery suitable for donation.
6. Donors able to give signed written informed consent.

Exclusion Criteria:

1. Donors who had a preference for either open or laparoscopic surgery.
2. Donors in whom the right kidney was chosen for donation.
3. Donors with double renal arteries in kidneys chosen for donation.
4. Donors who didn't sign consent.
Inspiratory Resistive Loading and Diaphragm Fatigue

The aim of the study is to clarify whether specific loading of the inspiratory muscles induces contractile fatigue of the diaphragm muscle in healthy individuals and individuals with recurrent low back pain.


Eligibility Criteria:
Inclusion Criteria individuals with low back pain:

* Age: 18-35 years old
* At least 1 year of low back pain with/without referred pain in buttock/thigh
* At least 3 episodes of disabling low back pain
* At least a score of 20% on the Oswestry Disability Index
* Willingness to sign the informed consent

Inclusion Criteria healthy individuals:

* Age: 18-35 years old
* No history of low back pain
* A score of 0% on the Oswestry Disability Index
* Willingness to sign the informed consent

Exclusion Criteria:

* History of major trauma and/or major orthopedic surgery of the spine, the pelvis or the lower quadrant
* One of the following conditions: Parkinson, multiple sclerosis, stroke, history of vestibular disorder, respiratory disease, pregnancy
* Radicular symptoms
* Not Dutch-speaking
* Strong opioids
* Neck pain
* Smoking history
Faslodex International Observational Non-Interventional Study in Advanced Breast Cancer (BC)

The purpose is to collect real life data on the use of fulvestrant in normal clinical practice in Austria and document the clinical benefit of fulvestrant treatment.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women with hormone receptor-positive locally advanced or metastatic breast cancer
* Ability to read and write and complete questionnaires
* Provision of written informed consent
* Patients who already received a prescription for fulvestrant

Exclusion Criteria:

* A subject who does not fulfil all the above mentioned inclusion criteria is not allowed to participate in this NIS
Study of the Efficacy and Safety of Abametapir Lotion Administered for the Treatment of Head Lice Infestation

Purpose of this study is to evaluate the efficacy of at-home administration of a single application of abametapir lotion 0.74% w/w for the treatment of head lice.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female, aged six months of age or older.
2. Is in good general health based on medical history.
3. Has active head lice infestation at Screening as determined by a trained evaluator with the exception of the male head of household who may self-assess as being lice-free. Active head lice infestation is defined as at least three live lice for the index subject and at least one live louse for the other household members.
4. The subject and/or their caregiver is physically able and willing to apply the Investigational Product at home.
5. Belongs to a household with an eligible index subject with active head lice infestation.
6. Agrees to an examination for head lice and to all visits and procedures throughout the study.
7. Has signed an informed consent and/or assent form.

Exclusion Criteria:

1. Had treatment (over-the-counter), home remedy or prescription medication) for head lice within 14 days prior to Day 0.
2. Intends to use any other form of lice treatment from Day 0 through the Day 14 visit, unless provided as rescue therapy to this Protocol.
3. Intends to use a lice comb from the Day 0 through the Day 14 visit unless provided as rescue therapy to this Protocol.
4. Intends to cut their hair, use hair dye/bleach or have permanent wave hairstyling from Day 0 through the Day 14 visit.
5. Has a household member(s) who is infested with lice but is not willing or not eligible for enrollment.
6. Has a condition that, in the opinion of the Investigator, may increase the risk to the subject and/or the interpretation of the data.
7. Has visible skin/scalp condition(s) that are not attributable to head lice infestation, such as an erythema score that is \>2, blisters, vesicles which, in the opinion of the investigative personnel or Sponsor, will interfere with safety and/or efficacy evaluations.
8. Has eczema or atopic dermatitis of skin/scalp.
9. Has had a prior reaction to Nix® or products containing permethrin.
10. Receiving systemic or topical medication, which in the opinion of the Investigator, may compromise the integrity of the safety and/or efficacy assessments.
11. Has received an investigational agent within 30 days prior to Day 0.
12. Does not have a known household affiliation with the household members (i.e., does not stay in one household consistently, or sleeps at one place for several nights and then at another place or location).
Introduction of the ADAPT System in an Orthopedic Department

The ADAPT system by Stryker is introduced in the orthopedic department (at Aarhus University Hospital). Following the introduction of the ADAPT system all pertrochanteric fractures operated with a gamma3 nail by stryker are operated with the use of the ADAPT system. Following surgery the operating surgeon fill out a questionaire on the use of ADAPT.

At the ortopedic department, Aarhus University Hospital pertrochanteric fractures are mostly operated with the gamma3 system by Stryker.

The ADAPT system is software based instrumentation designed for use in Gamma3 surgery. The software assists the surgeon with implant alignment, lag screw length determination, lag screw positioning and distal targeting. ADAPT is the only augmented reality instrumentation of its kind.

From March 1, 2021 it becomes mandatory for all orthopedic surgeons at the department to use the ADAPT system when operating pertrochanteric fractures with a gamma3 nail. Following surgery the operating surgeon will fill out the System Usability Scale questionaire and an additional 3 questions.

Eligibility Criteria:
Inclusion Criteria:

* Surgeons who operated patients with pertrochanteric fractures with the use of a gamma3 nail

Exclusion Criteria:

* none
Nitrate and Vitamin C on Vascular Health Oxidative Stress

The objective of this study is to examine whether the co-administration of dietary nitrate combined with vitamin C for 4 weeks in patients at risk for CVD would yield robust effects on endothelial function using blood measures and a non-invasive technique (Peripheral Artery Tonometry) compared to dietary nitrate supplementation alone.

This is a 10 week randomized, cross-over, double-blinded, placebo-controlled study. This study was designed to compare the magnitude changes in RHI (primary outcome), plasma NO metabolites (nitrate and nitrite), and plasma vitamin C, plasma oxidized LDL, and blood (secondary outcome) following treatment with inorganic nitrate and vitamin C placebo (N) and inorganic nitrate combined with vitamin C (NC). Following baseline testing, eligible subjects were randomized to receive either treatment (N) or treatment (NC) for 4 weeks (period1), and participants were then crossed over to the alternate treatment for another 4 weeks (period 2). There was a 2-week washout at crossover.

Eligibility Criteria:
Inclusion Criteria:

* Age: between 50 and 70 years
* Body mass index (BMI) of 18.5-34.9 kg/m2
* Reactive hyperemia index (RHI) of \< or equal to 2
* High cholesterol levels with LDL concentrations (\>130 mg/dL)
* Not receiving any lipid lowering therapy.
* Non-smokers

Exclusion Criteria:

* Evidence of overt atherosclerotic disease (i.e., documented medical history of coronary artery disease, peripheral artery disease, cardiovascular disease, and stroke).
* Any surgery or medical history that could confound study results, such as a history of bowel resection, rheumatoid arthritis, inflammatory bowel disease, celiac disease, diabetes, uncontrolled hypertension (systolic blood pressure \>160 mm Hg or diastolic blood pressure \>100 mm Hg), controlled hypertension on clonidine medication.
* Participants were ineligible if they had been diagnosed with the following medical conditions such as active cancer, severe anemia (Hb \< 10mg/dL), hepatic or renal disease, heart failure, or finger deformities.
* HIV-positive patients on combination antiretroviral therapy because of potential pharmacokinetic interactions with beetroot juice were excluded.
* Participants were also excluded if they reported taking any form of hormone replacement therapy (estrogens, progesterone, and testosterone), multivitamin supplements that provides \>100% of RDA, or any of the following medications that attenuate nitrate conversion to NO: proton pump inhibitors (PPI) and antibiotics.
* Participants who consumed greater than 6 drinks of alcohol (any form) per week, performed structured resistance or aerobic training for more than 1-hour four times per week, or participated in other clinical intervention within the previous 30 days were excluded from the study.
* Eligible subjects were asked to avoid using the mouthwash before and throughout the study duration. In addition, enrolled participants were advised to consume low- vitamin c diet throughout the study. They were provided at the beginning of the study with a list of high vitamin C foods/fortified foods to avoid during the study.