cyrilzakka/clinical-trials huggingface dataset:
Study to Evaluate the Safety and Efficacy of Gefitinib, in Subjects With EFGR Amplification Refractory Solid Tumors

This study is a single-arm,phase II study of gefitinib in patient with epidermal growth factor receptor amplification Refractory solid tumors.

Gefitinib 250 mg will be administered orally daily.

To investigate the efficacy and safety of gefitinib in patient with epidermal growth factor receptor amplification Refractory solid tumors.


Eligibility Criteria:
Inclusion Criteria:

1. Provision of fully informed consent prior to any study specific procedures.
2. Patients must be ≥20 years of age.
3. Patient with Epidermal growth factor receptor amplification Refractory Solid Tumors and/or specific sensitivity to Gefitinib by Avatar scan that has recurred or progressed following standard therapy, or that has not responded to standard therapy, or for which there is no standard therapy.

   (EGFR amplification by cancer scan + EGFR IHC overexpression +2 or +3)
4. ECOG performance status 0-2.
5. Have measurable or evaluated disease based on RECIST1.1. as determined by investigator.
6. Adequate Organ Function Laboratory Values

   * Absolute neutrophil count ≥ 1.5 x 109/L, Hemoglobin ≥ 9g/dL, Platelets ≥ 100 x 109/L
   * bilirubin ≤ 1.5 x upper limit of normal AST/ALT ≤ 2.5 x upper limit of normal (5.0 X upper limit of normal , for subjects with liver metastases)
   * creatinine ≤1.5 x UNL
7. Patients of child-bearing potential should be using adequate contraceptive measures (two forms of highly reliable methods) should not be breast feeding and must have a negative pregnancy test prior to start of dosing.
8. Adequate heart function.

Exclusion Criteria:

1. Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≤5 years.
2. Has known active central nervous system (CNS) metastases.
3. Has an active infection requiring systemic therapy.
4. Pregnancy or breast feeding
5. Patients with cardiac problem.
6. KRAS mutation (codon 12 or 13) or BRAF mutation (V600)
7. Any previous treatment with Gefitinib
8. Patients with a risk factor of interstitial lung disease
Recovery of Short-term Renal Function in Post-transplant Patients Living Donor

Objectives: To describe and analyze the perioperative and functional evolution of short-term renal graft in patients with kidney transplantation from a live donor, comparing three surgical techniques for obtaining kidney graft: open nephrectomy, laparoscopic hand-assisted nephrectomy, and pure laparoscopic nephrectomy.

Analytical cross-sectional study that will compare the three renal graft procurement techniques: open nephrectomy, laparoscopic hand-assisted nephrectomy, and pure laparoscopic nephrectomy. The investigators will analyze serum creatinine values on days 1, 5 and 28 post renal transplantation. The operative, medical and surgical morbidity will also be evaluated, considering the bleeding in the donor, times of ischemia and the need for JJ catheter placement in the recipient.

Eligibility Criteria:
Inclusion Criteria:

* Patients with terminal chronic kidney disease who will receive a kidney transplant in the transplant service of the National Medical Center of the West of living donor related to the means of obtaining the kidney graft by laparoscopic hand assisted or pure laparoscopic surgery.

Exclusion Criteria:

* Patients who for some reason can not find your complete medical record.
* Patients obtained a kidney graft from a brain death donor.
Effect of Pterygium Excision on Intraocular Lens Power Calculation for Subsequent Cataract Operation

Pterygium is known to induce with-the-rule astigmatism. Excision of pterygium will steepen the cornea and reduce corneal astigmatism. We postulate that the alteration of keratometry reading will indirectly affect the IOL power calculation in cases with concurrent pterygium and cataract. Concurrent pterygium and cataract is common in Hong Kong and other tropical regions. The effect of pterygium excision on intraocular lens power calculation is investigated.


Eligibility Criteria:
Inclusion Criteria:

* All cases with concomitant cataract and primary pterygium, which are indicated for surgery.

Exclusion Criteria:

* Pterygium smaller than 1mm, which is not visually significant.
* Double headed pterygium
* Pterygium obscuring visual axis that preclude keratometry or autorefraction measurements.
* Previous corneal refractive surgery that alter the keratometric power of the cornea.
* Patients with medical problems that preclude staged ocular surgery, e.g. dementia, heart disease, on warfarin.
Growth Hormone Deficiency in Adults (GHDA)

This trial is conducted in Japan. The aim of this trial is to demonstrate superiority of the effect of NN-220 compared with that of placebo as assessed by the change in percent in truncal fat (kg) from baseline to 24 weeks' treatment (end of treatment) in patients with Growth Hormone Deficiency in Adults (GHDA).


Eligibility Criteria:
Inclusion Criteria:

* Subjects with diagnosed GHD
* If the subject has a history of treatment of treatment for a tumour of pituitary or peripheral site, two years or more must have passed since completion of surgery, radiotherapy or other treatment, and recurrence of the underlying disease to be excluded
* Appropriate replacement therapy has been administered for more than 24 weeks for the treatment of other pituitary hormone deficiencies

Exclusion Criteria:

* Subject with a history of acromegaly
* Subject with diabetes mellitus
* Subject suffering from malignancy
* Several medical conditions
XERECEPT® (hCRF) for Primary Glioma Patients Requiring Dexamethasone to Treat Peritumoral Brain Edema

The purpose of this study is to examine the safety and efficacy of XERECEPT (human Corticotropin-Releasing Factor, or hCRF) compared to dexamethasone in patients with primary malignant glioma who require increased dexamethasone doses to control symptom of peritumoral brain edema.

XERECEPT is not a potential treatment for cancer, but may reduce the edema associated with tumors and as a result, decrease neurological symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of a primary malignant glioma.
* Symptomatic peritumoral brain edema requiring initiation or increase of dexamethasone treatment.
* If a patient is on dexamethasone for treatment of symptomatic peritumoral brain edema, the dose must be stable and should not exceed 24mg/dl for a minimum of 7 days prior to Baseline.
* Presence of peritumoral brain edema confirmed by MRI scan or comparable diagnostic technology obtained within 21 days of Baseline.
* Capable of self-administration of subcutaneous injections twice daily for 8 weeks or availability of assistance from caregiver.

Exclusion Criteria:

* Need for surgery, radiosurgery or radiation therapy or the introduction of new chemotherapeutic regime within 2 weeks of study treatment.
* Systemic steroid use for any other indication than peritumoral brain edema.
* Patients on dexamethasone or anticonvulsant therapy.
* Serious concomitant cardiovascular, pulmonary, renal, gastrointestinal or endocrine metabolic disease which could put the patient at unusual risk for study participation.
* Central nervous system (CNS) infection.
* Conditions that are considered contradictions for patients to receive niacin
A Study to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of Olpasiran in Participants With Various Degrees of Hepatic Impairment

The primary objective of the study is to evaluate the pharmacokinetics (PK) of a single dose of olpasiran in participants with mild, moderate, or severe hepatic impairment compared to participants with normal hepatic function.


Eligibility Criteria:
Inclusion Criteria:

* Male or female participants of nonchildbearing potential, between 18 and 75 years of age (inclusive) at the time of Screening.
* Body mass index between 18.0 and 40.0 kg/m\^2 (inclusive) at the time of Screening.

Participants with Normal Hepatic Function Only:

• In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations at Screening and Check-in as assessed by the Investigator (or designee).

Participants with Hepatic Impairment Only:

• Child-Pugh A (Group 2), B (Group 3), or C (Group 4) classification defined by both Screening (to determine participant group) and Check-in (to confirm participant group prior to dosing) clinical laboratory values and physical examination findings.

Exclusion Criteria:

* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee).
* Estimated glomerular filtration rate \< 60 mL/min/1.73m\^2 (Groups 1-3) or \< 50 mL/min/1.73m\^2 (Group 4 only) by Modification of Diet in Renal Disease formula at Screening or Check-in.
* Receiving or has received any investigational drug within the 30 days or 5 half-lives (whichever is longer) before receiving olpasiran.
* Participants who were previously exposed to olpasiran.
* Female participants with a positive pregnancy test at Screening or Check-in.

Participants with Normal Hepatic Function Only:

* Positive hepatitis panel. Participants whose results are compatible with prior immunization may be included.
* Alanine aminotransferase and aspartate aminotransferase elevations \> 3x upper limit of normal at Screening or Check-in.

Participants with Hepatic Impairment Only:

* Positive for hepatitis B surface antigen. Participants with positive hepatitis B core antibody may be included if hepatitis B surface antigen is negative. Participants with positive hepatitis B surface antibody may be included (consistent with prior vaccination).
* Active malignancy of any type. Participants with a history of malignancy that has been eradicated with supporting medical documentation indicating that there is no residual malignancy detected in the past 2 years will be allowed.
* Values outside the normal range for liver function tests that are not consistent with their hepatic condition, as determined by the Investigator (or designee).
Sofosbuvir Containing Regimens for the Treatment of Chronic HCV GT3 Infected Patients

The purpose of this study is to assess the safety, tolerability, and efficacy of Sofosbuvir containing regimens in treatment-naive or treatment-experienced patients with HCV genotype 3 infection.


Eligibility Criteria:
Inclusion Criteria:

* Age equal to or greater than 18 years, with chronic genotype 3 HCV infection;
* Documented HCV treatment-naïve or treatment-experienced subjects who failed previous PEG+RBV regimen;
* HCV RNA \> 10,000 IU/mL at Screening;
* Screening laboratory values within defined thresholds;
* Negative pregnancy test at baseline (females of childbearing potential only);
* Use of two effective contraception methods if female of childbearing potential or sexually active male.

Exclusion Criteria:

* Pregnant or nursing female;
* HIV infection or HBV infection (HBcAb and HBsAg positive);
* Hematologic or biochemical parameters at Screening outside the protocol-specified requirements;
* Active or recent history (≤ 1 year) of drug or alcohol abuse;
* Hepatocellular carcinoma or other malignancy (with exception of certain resolved skin cancers).
Evaluation of the Aortoseal™ for Sealing and Fixation of AAA Endovascular Grafts to Aortic Wall

The Aortoseal Endostapling System is indicated in patients undergoing, or having undergone, treatment of an abdominal aortic aneurysm (AAA) with an endovascular graft to provide enhanced fixation and apposition to the aorta.

The device may be implanted at the time of the initial endovascular graft procedure to maintain, or during a secondary procedure to restore, adequate aneurysm.

The study includes 5 years of follow-up, with visits at 30 days, 6 months, 1 year, and yearly thereafter through 5-years.

Follow-up assessments: Physical examination, X-ray, CT (with and without contrast) and assessments of any adverse events.

Eligibility Criteria:
Subjects diagnosed with a qualifying AAA suitable for elective endovascular repair with Endovascular Graft System or have a previously placed endovascular graft.
A Feasibility Study to Evaluate the Tolerability of Oph1 Compared to Restasis in Healthy Volunteers

20 healthy participants will be evaluated for tolerability and safety of a new eye drop formulation for treatment of Dry Eye Syndromes, Oph1 0.5% Cyclosporine A (CsA) compared with Restasis 0.05% CsA ophthalmic formulation.

20 healthy participants will be enrolled to the study and randomized into two groups of 10 participants each. In one group participants will be treated with Oph1 0.5% CsA ophthalmic formulation and in the other group with Restasis 0.05% CsA ophthalmic formulation. Both groups will be treated with the eye drops in the right eye only, twice a day (6-9 hours apart), for four days and once on the fifth day (total of 9 eye drops treatment for each), both groups will have 2 days of washout, and will be crossed to identical course of treatment with the other ophthalmic formulation. All eye drops treatments will be done on the medical site by one of the study staff unblinded to the treatment. The Investigator assessing the ocular signs and the participants will be blinded to study treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female aged 20-50 years, inclusive.
2. Systemically and ophthalmologically healthy subjects evaluated during the clinical history.
3. Best-corrected visual acuity (BCVA) 20/40 or better in both eyes.
4. Negative Fluorescein staining in Fluorescein Corneal staining (FCS) in both eyes.
5. Up to 0.5 Conjunctival redness in Conjunctival redness without slit lamp, in standardized lighting conditions, in both eyes.
6. IOP (\< 22mmHg), in both eyes.
7. No pathology findings in Slit-lamp biomicroscopy in both eyes.
8. Ability to comply with the requirements of the study and complete the questionnaire and a full sequence of protocol-related evaluations.
9. Ability to understand and provide written informed consent.
10. In the judgement of the investigator, the participant can safely perform study activity.

Exclusion Criteria:

1. Have chronic systemic disease of any form known.
2. In the case of women: be pregnant, breastfeeding or planning to become pregnant within the study period or women without a history of hysterectomy, oophorectomy, who do not ensure a hormonal contraceptive method or intrauterine device during the study period.
3. Be a user of topical ophthalmic products of any kind.
4. Being a chronic drug user.
5. Be a user of contact lenses.
6. Have a history of any type of eye surgery.
7. Participating in clinical research studies 90 days prior to inclusion in the present study.
8. In the judgement of the investigator, any condition that could interfere with the intent of the study or would make participation not in the best interest of the participant.
Comparison of Ocular Findings in Patients Between Surgical and Natural Menopause

It is aimed to compare the ocular findings in patients with natural and surgical menopause.

To compare the parameters such as fundus examination, macular thickness, visual acuity and lens opacities among female patients diagnosed with menopause between the ages of 40-65.The criteria for exclusion from the study are the presence of a history of illness, drug use, smoking and alcohol use.Inclusion criteria were female patients who were in menopause and who did not use any medications. For surgical menopause, the uterus and ovaries were surgically removed at least 3 months ago.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed menopause (Natural or Surgical Menopause( At least 3 months after surgery),
* No history of illness(Diabetes,Heart disease,Kidney disease etc.)
* Not Smoking
* Did not use alcohol
* Have not use any medication
* Age between 45-65 years
* BMI between 20-25 kg/m

Exclusion Criteria:

* Smoking or Alchohol consumption
* Age before 45 and after 65 years
* Have chronic disease
* Using any medication
* Have not diagnosed Menopause
* BMI greater than 30 kg/m
Study of Difluprednate in the Treatment of Inflammation Following Ocular Surgery (ST-601A-002a)

The purpose of this phase III study is to determine the efficacy of difluprednate in the treatment of inflammation following ocular surgery.


Eligibility Criteria:
Inclusion Criteria:

* Unilateral ocular surgery in the day prior to study enrollment.
* Anterior chamber cell grade ≥ "2" on the day after surgery (Day 1).
* Aged 2 years or older on the day of consent.
* Negative urine pregnancy test on Day 1 for postmenarchal subjects; negative urine pregnancy test for premenarchal subjects at the investigator's discretion.
* Provide signed written consent prior to entering the study or signed written consent from parent or legal guardian if subject is a minor and signed assent from minor subject, if appropriate.

Presurgical Exclusion Criteria:

* Systemic administration of any corticosteroid in the 2 weeks prior to study enrollment.
* Periocular injection in the study eye of any corticosteroid solution within 4 weeks prior to instillation of the study drug, or of any corticosteroid depot within 2 months prior to instillation of the study drug.
* Instillation of any topical ocular corticosteroid or NSAID within 24 hours prior to instillation of the study drug or during the course of the study, with the exception of presurgical administration of a topical NSAID to prevent miosis.
* Any history of glaucoma or ocular hypertension in the study eye.
* History or presence of endogenous uveitis.
* Any current corneal abrasion or ulceration.
* Any confirmed or suspected active viral, bacterial, or fungal keratoconjunctival disease.
* Allergy to similar drugs, such as other corticosteroids.
* History of steroid-related IOP increase.
* Scheduled surgery on the contralateral eye during the treatment period.
* Unwilling to discontinue use of contact lenses during the study period.
* Pregnancy or lactation.
* Participation in any study of an investigational topical or systemic new drug or device within 30 days prior to screening, or at any time during the study.
* Prior participation in the study described in this protocol.
* Unable or unwilling to give signed informed consent prior to participation in any study related procedures.

Postsurgical Exclusion Criteria:

* Ocular hemorrhage which interferes with evaluation of postsurgery inflammation.
* Injection of gas into the vitreous body during surgery.
* Presence of IOP ≥24 mm Hg on Day 1 after surgery.
Doppler Ultrasonography Evaluation of Tibial Fracture Site Vascularity

The purpose of this study is to evaluate the blood supply to patients that are suffering from fracture in the tibia by UltraSound Doppler.


Eligibility Criteria:
Inclusion Criteria:

* Above 16 years old

Exclusion Criteria:

* Pregnancy
The Effects of Tegaserod vs. Placebo on Whole Gut Transit Time in Patients With Chronic Constipation and Dyspepsia

To demonstrate the effects of tegaserod on gastrointestinal scintigraphic orocecal transit in female patients with CC and upper GI symptoms of dyspepsia


Eligibility Criteria:
Inclusion Criteria:

* Females aged 18 to 64 years of age
* Patients must present with two or more of the following criteria for chronic constipation for at least 12 weeks prior to entering the study:

  1. Less than 3 bowel movements per week
  2. Hard or lumpy stools
  3. Straining during bowel movements
  4. Feeling of incomplete evacuation
* Patients must report overlapping symptoms consistent with dyspepsia, such as mid-upper abdominal discomfort characterized by early satiety, post-meal fullness and bloating

Exclusion Criteria:

* Patients with a recent history of, or current frequency of diarrhea occuring more than once per month off of laxatives
* Clinically significant diagnosis of pelvic outlet obstruction or pelvic floor dyssenergia as determined by the study physicians
* Patients with constipation secondary to medication use as determined by the study physician
* Patients with clinically significant abnormal TSH levels at screening
* Patients that have heartburn or abdominal pain as their predominant GI symptom
* Evidence of cathartic colon or a history of laxative abuse

  * Other protocol-defined inclusion/exclusion criteria may apply
Bioequivalence Study of 6-Mercaptopurine Under Fasting Conditions

The objective of this study was to assess the bioequivalence of a potential generic 6-mercaptopurine 50 mg tablet formulation compared with GlaxoSmithKline Purinethol® (mercaptopurine) 50-mg scored tablets following a single 50 mg oral dose administered in the fasted state.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal findings on physical examination, medical history, or clinical laboratory results.
* Must voluntarily consent.

Exclusion Criteria:

* Must not have a known history of thiopurine methyltransferase deficiency or family history.
* Must not have a history of elevated uric acid or gout.
* Must not be currently using allopurinol.
A Study to Evaluate the Efficacy and Safety of AK111 in Subjects With Moderate to Severe Plaque Psoriasis

This is a randomized, double-blind, placebo-controlled, multicenter phase III clinical study to evaluate the efficacy and safety of AK111 in the treatment of subjects with moderate to severe plaque psoriasis.

This is a randomized, double-blind, placebo-controlled, multicenter phase III clinical study to evaluate the efficacy and safety of AK111 in the treatment of subjects with moderate to severe plaque psoriasis. Subjects will be randomized to receive AK111 or placebo subcutaneously and followed up to week 56.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects aged ≥18 years old.
2. Subjects diagnosed with moderate to severe plaque psoriasis with or without psoriatic arthritis.
3. At screening and baseline, PASI score ≥ 12 , Body Surface Area(BSA) ≥ 10%, sPGA ≥ 3.
4. Suitable for systematic therapy assessed by investigators.
5. Subjects who are women of childbearing potential must have a negative pregnancy test at screening and must be practicing an adequate, medically acceptable method of birth control during the study and for at least 6 months after the last study drug administration.

Exclusion Criteria:

1. Types of psoriasis other than chronic plaque-type psoriasis.
2. Drug-induced psoriasis.
3. Evidence of active TB. Patients with evidence of latent tuberculosis may enter the trial after sufficient treatment had initiated and maintained according to protocol.
4. Positive results of confirmatory test for hepatitis B, hepatitis C, human immunodeficiency virus (HIV) or syphilis.
5. History of repeated chronic infection, had any serious infection or systemic infection within 2 months before screening.
6. Progressive or uncontrolled symptoms or signs of circulatory, respiratory, digestive, neuropsychiatric or psychological, hematological, endocrine and other systems before randomization.
7. History of malignant tumour within 5 years before screening.
8. Previous or current autoimmune diseases.
9. Allergic to any component of the investigational drug, or have had severe allergic reactions to monoclonal antibodies.