cyrilzakka/clinical-trials huggingface dataset:
UK Ibrance Patient Program (IPP) Study

What are the real-world treatment patterns, patients' characteristics, clinical outcomes and healthcare resource utilisation associated with palbociclib treatment in the 3 years following initiation in United Kingdom patients with hormone receptor-positive, human epidermal growth factor 2-negative metastatic breast cancer treated as part of the IPP?

Hormone receptor positive (HR+) breast cancer (BC) represents the largest therapeutic subtype of the disease, accounting for 60 to 65% of all malignant neoplasms of the breast. Palbociclib (Ibrance®) is a small-molecule inhibitor of cyclin-dependent kinases 4 and 6 (CDK4/6) which in clinical trial settings has been shown to increase progression-free survival (PFS) for patients with HR+, human epidermal growth factor 2-negative (HER2-) metastatic breast cancer (MBC). Palbociclib first received a European Union (EU) marketing authorisation in September 2016, to be commercialised as Ibrance® by Pfizer. Palbociclib was recommended for use with an aromatase inhibitor in patients with HR+/HER2- locally advanced and MBC in the National Health Service (NHS) in England by the National Institute for Health and Care Excellence (NICE) in November 2017 and by the Scottish Medicines Consortium (SMC) in December 2017. In order to provide access to palbociclib in the United Kingdom (UK) during the NICE/SMC appraisal period, the Ibrance® Patient Program (IPP) was initiated and run by Pfizer between April 2017 until a positive NICE/SMC appraisal in November 2017 (for England and Wales) or December 2017 (for Scotland).

Pfizer are interested in the opportunity to collect data from patients who received palbociclib as part of the UK IPP, to better understand patients' characteristics in a routine care setting, treatment persistence and dose management, clinical outcomes, and healthcare resource utilisation. This study will provide real-world evidence on patients' clinical progression and experience of treatment with palbociclib in routine clinical settings in a UK context.

Research question:

What are the real-world treatment patterns, patients' characteristics, clinical outcomes and healthcare resource utilisation associated with palbociclib treatment in the 3 years following initiation in United Kingdom patients with HR+/HER2- MBC treated as part of the IPP?

Eligibility Criteria:
Inclusion criteria:

All patients meeting the following eligibility criteria will be included in the study:

* Patients enrolled into the IPP at one of the selected hospitals (see Annex 1 for IPP enrolment letter).
* Patients who received ≥1 dose of palbociclib as part of the IPP at one of the selected sites.
* For sites where data collection is performed by pH Associates, written informed consent will be required from living patients to access their medical records.
* Patient aged ≥18 years old at enrollment into the IPP
A Study of ACT-541468 in Healthy Japanese and Caucasian Subjects

So far, ACT-541468 has been studied mainly in Caucasian subjects. The present study will bridge results obtained in Caucasian subjects to those in Japanese subjects.


Eligibility Criteria:
Key Inclusion Criteria:

* Signed informed consent form;
* Healthy male and female subjects aged between 20 and 50 years (inclusive) at screening;
* Negative serum pregnancy tests at screening and negative urine pregnancy test at Day 1 for women of childbearing potential and agreement to use a reliable method of contraception for at least 90 days after last study drug intake;
* Body mass index (BMI) of 18.0 to 26.0 kg/m2 (inclusive) at screening;
* Healthy on the basis of physical examination, cardiovascular assessments and laboratory tests;
* Caucasian or Japanese ethnicity.

Japanese subjects only:

* must be of native Japanese descent (all parents/grandparents of Japanese descent);
* must not have been away from Japan for more than 10 years (at screening visit);
* lifestyle should not have changed significantly since relocation from Japan.

Key Exclusion Criteria:

* Any contraindication to the study treatments;
* History or clinical evidence of any disease or medical / surgical condition or treatment, which may put the subject at risk of participation in the study or may interfere with the absorption, distribution, metabolism or excretion of the study treatments;
* History of narcolepsy or cataplexy or modified Swiss narcolepsy scale total score \< 0;
* Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
Haloperidol vs. Risperidone in the Treatment of Aggression in Psychotic Inmates

This study examines the efficacy of haldol versus risperdal in the treatment of aggression in psychotic prison inmates. It is hypothsized that risperdal will be more effective in decreasing aggression than haldol.


Eligibility Criteria:
Inclusion Criteria:age 18 or over, psychotic disorder diagnosed on SCID, inmate at correctional facility for at least 2 weeks -

Exclusion Criteria: active withdrawal from substances of abuse, non-psychotic individuals, pregnant women, people unable to give informed consent, patients on mood stabilizers

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VNRX-5133 SAD/MAD Safety and PK in Healthy Adult Volunteers

This is a 2-part, first-in-human dose-ranging study to evaluate the safety, tolerability and pharmacokinetics of escalating doses of VNRX-5133 administered via intravenous (IV) infusion in healthy subjects. In part 1, subjects will receive a single dose of VNRX-5133; in part 2 subjects will receive VNRX-5133 for 7 days.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults
* Males or non-pregnant, non-lactating females
* Body Mass Index (BMI) between 18.5 - 32.0, inclusive.
* Suitable veins for cannulation

Exclusion Criteria:

* Employee of site or the sponsor
* Any disease that poses an unacceptable risk to participants
* Abnormal ECG
* Abnormal labs
* Abnormal vital signs
* Current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, autoimmune, hematologic, neoplastic, or neurological disorder
* Positive serology for hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus (HIV) type 1
* Current smokers or history of smoking within 30 days
The Effect of Ganoderma on Patients With Head-and-neck Cancer

To study the effect of Ganoderma Spores Powder Capsules on the life quality and immunity status of the patients with head-and-neck cancer after complete treatment (including surgery and / or radiotherapy and/or chemotherapy)

Ganoderma is known to modulate immunity and improve health. However, the mechanism is not clear. We hypothesize that patients who have completed standard treatment with/without radiotherapy might require biological modifier such as Ganoderma to improve life quality and immunity status.

A total of 100 patients are randomized to study and control groups. In study group, Ganoderma Spores Powder Capsules are given to the patients for 6 weeks, In control group, only placebos are given during the same period. Then the patients in study and control groups are switched, Ganoderma Spores Powder Capsules and placebos are given for 6 weeks. The data pertaining to their Life quality are collected using Quality of Life Questionnaire after the first 6 weeks and the second 6 weeks. The immunity status is also studied at the same time.

Eligibility Criteria:
Inclusion Criteria:

* Patients with head-and-neck cancer after complete treatment for at least 3 months (including surgery and/or radiotherapy and/or chemotherapy)

Exclusion Criteria:

* Patients with head-and-neck cancer under treatment or within 3 months after treatment
Leptospirosis Care Bundle Study

So in management of Leptospirosis patients There really is no another approach to treatment. The importance of the problem was acknowledged by the researchers. As a result, this study was performed in order to The Leptospirosis Care Bundle has been used, and has been proved that its use can reduce the risk of acute renal failure.


Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years
* Suspicious Leptospirosis including body temperature \> 38 celcius, Severe myalgia, and exposure to reservoir hospital of flood water.
* Calf muscle tenderness
* Conjunctival suffusion
* Anuria or oliguria and/or proteinuria
* Jaundice
* Hemorrhagic manifestations (pulmonary and intestine)
* Meningeal irritation
* Nausea, vomiting, abdominal pain, diarrhea.
* Admitted in hospital

Exclusion Criteria:

* other infectious disease
* pregnancy
A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Subjects With Hidradenitis Suppurativa

Efficacy and Safety of Imsidolimab (ANB019) in Subjects with Hidradenitis Suppurativa

This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of imsidolimab in adult subjects with hidradenitis suppurativa (HS). This study also will characterize the pharmacokinetic (PK) profile of imsidolimab and explore the immune response to imsidolimab in subjects with HS.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female aged 18 to 75 years (inclusive) at the time of signing informed consent.
2. Clinically confirmed diagnosis of active HS with a disease duration of ≥ 6 months before Day 1.
3. HS lesions present in at least 2 distinct anatomical areas.
4. Total AN count ≥ 5.
5. Draining fistulas ≤ 20.
6. Stable HS for at least 6 weeks prior to Day 1 visit.

Exclusion Criteria:

1. Concomitant dermatological or medical conditions that may interfere with the Investigators' ability to evaluate the subject's response to therapy.
Endo-biliary Laser Excision of Biliary Stenoses

The biliary system normally empties into the intestines, however, some patients have biliary system narrow areas ("stenosis") that prevent the bile to drain normally. These may be related to an underlying disease or previous surgery. Patients with this problem usually require tubes to be inserted into the biliary system to drain bile into a bag outside of their body, impacting their quality of life.

The purpose of this research study is to use a laser device to try to re-open the biliary drainage system.

The current preferred minimally invasive treatment for surgically related or in-situ benign biliary stenosis (BBS) involves open surgical revision, endoscopic retrograde cholangiographic (ERCP) or percutaneous transhepatic cholangiographic (PTC) balloon angioplasty and/or stent/biliary catheter placement. Unfortunately, most patients are poor open surgical operative candidates. Although ERCP is the preferred secondary approach, anatomical restrictions often require PTC. Additionally, previously placed biliary stents/catheters have poor long term patency and require routine exchange every 3-6 months. The vast majority of surgically related BBS patients are non-operative candidates for surgical revision of their BBS, and do not have favorable anatomy for ERCP access. For patients who have failed aggressive PTC balloon angioplasty of their stenoses, treatment consists of indefinite biliary catheter exchanges every 3 months. Lifelong biliary catheter dependence severely impacts the quality of life in an otherwise healthy patient with no additional evidence of their initial disease process.

A potential long-term therapy to alleviate BBS that has not been explored is the use of laser excision of the fibrotic tissue responsible for these stenoses. Therapeutic applications of lasers in medicine is not a novel concept. Its use has been well documented in the urologic tract to ablate tissue (benign prostatic hypertrophy) and renal stones. Recent laser therapeutic use in the biliary tract to dissolve gallstones has been described. The laser excision of BBS has potential to provide long term alleviation of BBS. The primary endpoint of this feasibility study is to assess the safety and initial efficacy of BBS laser excision.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with diagnosed benign biliary stenosis
* Initial total serum bilirubin \> 1.9 mg/dL
* Subjects currently having an internal/external percutaneous biliary drain
* Subjects that have failed at least 3 separate biliary stenosis balloon angioplasties and are deemed non-surgical candidates by the transplant and/or pancreaticobiliary surgical services at the University of Florida
Postoperative Pain Control After Kidney Surgery : a Comparison of Intrathecal Morphine Plus PCA and PCA Only

postoperative pain after kidney surgery is very high. We always use PCA for postopertive pain. But almost patients still had severe pain. We try to use spinal morphine before operation aims to reduce pain.


Eligibility Criteria:
Inclusion Criteria:

* kidney surgery who less than 60 years old.
* no underlying disease
* ASA less than 3

Exclusion Criteria:

* refuse spinal morphine
* history of morphine allery
Relative Bioavailability Study of Ribavirin 200 Capsules and Rebetol 200 mg Capsules in Females Under Fasting Conditions

The purpose of this study is to demonstrate the relative bioavailability of Ribavirin 200 capsules and Rebetol 200 mg capsules in females under fasting conditions.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.
Detection of Choroidal Nevus Cells in Vitrectomy Fluid

The purpose of this study is to determine if the investigators can detect the presence of choroidal nevi cells in the vitreous fluid of humans, as this may improve the diagnosis and classification of choroidal nevi and melanomas in the future.

Approximately 7% of the population has a choroidal nevus, or "freckle," in the back of the eye. Like a nevus on the skin, there is potential for malignant change to a melanoma. Dermatologists have the ability to quickly and easily biopsy suspicious skin lesions while ophthalmologists currently have no way of determining the malignant potential of choroidal nevi other than a fine needle aspiration (which is invasive and has the potential complications of bleeding and retinal detachment). This study's sole aim is to see if choroidal nevi cells are present in the inside fluid of the eye. The investigators plan to analyze the fluid of the eye, which is routinely removed during retina surgery, to detect any nevus cells. If the investigators are able to detect these cells, then future studies may allow us to better classify choroidal nevi for potential malignant change.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a choroidal nevus who are undergoing routine vitrectomy surgery for another indication (such as epiretinal membrane or macular hole repair).

Exclusion Criteria:

* Patients without a choroidal nevus
* Children under the age of 18
* Pregnant and nursing females
Organochlorine Concentration in Adipose Tissue and Pancreatic Adenocarcinoma

Pancreatic adenocarcinoma represents more than 90% of pancreatic neoplasms. Around 14000 new cases of pancreatic adenocarcinoma are being diagnosed each year in France and about 8.6% in Grand Est region. National incidence has doubled for men and tripled for women between 1982 and 2012. Pancreatic adenocarcinoma is the deadliest digestive cancer, with only 7 to 8% all stages 5-year survival. It will become the second deadliest in Europe, behind bronchopulmonary cancer.

Several risk factors have been identified such as diabetes, tobacco, chronic pancreatitis or obesity. However, a mismatch exists between incidence forecasts and actual risk factors knowledge. Several hypothesis plead for an environnemental cause.

Plant protection products oncogenetic effects are known and have been proved to be responsible for tumors, including haematological malignancies. Its role in pancreatic carcinogenesis is still poorly studied and show heterogeneous results. They do not allow to conclude for causality. Organochlorines is a specific subset of plant protection product that store in lipids during lifetime.

The aim is to study association between organochlorine concentration in adipose tissue with pancreatic adenocarcinoma.

Unicentric prospective case control study comparing organochlorine levels including patients diagnosed with a pancreatic adenocarcinoma undergoing a surgery allowing to collect an adipose tissue sample (10g).

Controls are adults with no pancreatic cancer (excluded by a 6 months old computed tomography excluding the probability of a pancreatic neoplasm), paired with cases upon age and body mass index, with a scheduled surgical procedure allowing to collect an adipose tissue sample without extending procedure length.

Eligibility Criteria:
inclusion criteria :

Cases :

* patients diagnosed with a pancreatic adenocarcinoma, all stages allowed
* undergoing a surgery allowing to take a 10 grams adipose tissue sample

Controls :

* patients without a pancreatic neoplasm on a 6 months old CT scan before inclusion
* undergoing a surgery allowing to take a 10 grams adipose tissue sample

exclusion criteria :

Cases :

* patients diagnosed with a pancreatic adenocarcinoma developed on IPMN or cystadenoma
* patient with a known genetic predisposition increasing pancreatic adenocarcinoma risk
* histopathology proof of a mixed neuroendocrine neoplasm
* no surgery allowing to take a 10 grams adipose tissue sample

Controls :

* patients with a pancreatic neoplasm on a 6 months old CT scan before inclusion
* no surgery allowing to take a 10 grams adipose tissue sample
SpO2 Accuracy Validation of Pulse Oximetry Systems During Motion and Non-Motion Conditions

Study to evaluate the %SpO2 accuracy performance of the Nonin Medical pulse oximetry systems.

Study to evaluate the %SpO2 accuracy performance of the Nonin Medical pulse oximetry systems during motion and non-motion.

Eligibility Criteria:
Inclusion Criteria:

* The subject is male or female
* The subject is of any racial or ethnic group
* The subject is \> 30 kg (\>66 pounds) in weight (self-reported)
* The subject has at least one finger height of 0.2 - 1.0 inch (based on measurement)
* The subject is between 18 years and 45 years of age (self=reported)
* The subject shows no evidence of medical problems as indicated by satisfactory completion of the health assessment form
* The subject has given written informed consent to participate in the study
* The subject is both willing and able to comply with study procedures.

Exclusion Criteria:

* The subject has a BMI greater than 31 (based on weight and height)
* The subject has had any relevant injury at the sensor location site (self-reported)
* The subject has deformities or abnormalities that may prevent proper application of the device under test (based on examination)
* The subject is current smoker (self-reported)
* The subject has a known respiratory condition (self-reported)
* The subject has a known heart or cardiovascular condition (self-reported)
* The subject is currently pregnant (self-reported)
* The subject is actively trying to get pregnant (self-reported)
* The subject has a clotting disorder (self-reported)
* The subject has Raynaud's Disease (self-reported)
* The subject is known to have a hemoglobinopathy (self-reported)
* The subject is on blood thinners or medication with aspirin (self-reported)
* The subject has unacceptable collateral circulation from the ulnar artery (based on examination)
* The subject is unwilling or unable to provide written informed consent to participate in the study
* The subject is unwilling or unable to comply with the study procedures
* The subject has another health condition which in the opinion of the principal investigator makes him/her unsuitable for testing.
Effects of the GOLO Weight Management Program With and Without Release Supplement on Weight and Metabolic Parameters in Subjects With Obesity

This randomized, double-blind placebo-controlled study was intended to measure the effects of the GWMP with Release supplement versus GWMP with placebo supplement in a representative group of obese subjects with or without diabetes at one outpatient medical practice.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years and ≤ 80 years
2. Body mass index (BMI) ≥ 30 and ≤ 60 kg/m2
3. Have the ability to engage in at least 15 minutes of moderate physical activity such as brisk walking
4. Willing to comply with study procedures described herein

Exclusion Criteria:

1. Current diagnosis of type 1 diabetes
2. Subjects with a history of hypoglycemia
3. A history of an eating disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
4. Known allergy to any of the components in the Release supplement
5. A history of prior surgery for weight loss
6. Currently taking injectable medications to control diabetes, including insulin and GLP-1 agonists
7. Currently pregnant or breastfeeding or have had a baby within the last six weeks
8. Planning to become pregnant in the next three months. Women of child bearing potential must be willing and able to use adequate and reliable contraception throughout the study (e.g. abstinence or barrier with additional spermicidal foam or jelly, or the use of intrauterine device or hormonal contraception).
9. Uncontrolled hypertension at screening defined as Systolic blood pressure greater than 180 mmHG or Diastolic blood pressure greater than 110 mmHG
10. Current clinical diagnosis or signs and symptoms of unstable (in the opinion of the principle investigator) heart, kidney or liver disease, cancer, or chronic neurological disease.
11. Current participation in any other weight loss or weight management program
12. Currently taking weight loss medications, or medications or supplements known to be associated with significant weight loss or weight gain
13. Has any condition that, in the opinion of the investigator, would make participation in this study not in the best interest of the subject or that could prevent, limit or confound the protocol-specified assessments. Examples include: history of diabetic ketoacidosis; active chronic liver disease or cirrhosis; chronic autoimmune disease; inflammatory bowel disease, colonic ulceration, partial intestinal obstruction, subjects predisposed to intestinal obstruction; chronic intestinal diseases associated with marked disorders of digestion or absorption

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