cyrilzakka/clinical-trials huggingface dataset:
Oral Peptones Load in Normocalcemic and Hypercalcemic Primary Hyperparathyroidism and Healthy Subjects

The purpose of this study is to assess if subjects with hyperparathyroidism with normal serum calcium levels have different responses in the calcium regulating hormonal handling compared to a) patients with primary hyperparathyroidism and high serum calcium levels; b) healthy subjects.

The differences will be evaluated with oral peptones load and subsequent blood samples collected every 15 minutes for two hours. Ionized calcium, phosphate, gastrin and PTH levels will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

1. normocalcemic hyperparathyroidism

   * presence of high serum levels of intact PTH
   * serum ionized calcium levels in the high normality range
2. hypercalcemic hyperparathyroidism

   * presence of high serum levels of intact PTH
   * high serum ionized calcium levels

Exclusion Criteria:

1. potential causes of secondary hyperparathyroidism like renal insufficiency, liver disease, malabsorption, hypercalciuria, Paget's disease, thiazide diuretic or lithium use.
2. bone disease of any origin
The Effects of Exenatide After Gastric Restriction

The purpose of this study is to describe change in body weight in non-diabetic morbidly obese patients after laparoscopic adjustable gastric banding (LAGB) with twice daily exenatide or placebo injections.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years,
2. Have a body mass index ≥ 40 kg/m2 or ≥ 35 kg/m2 with comorbidities (1991 NIH Guidelines for Bariatric Surgery),
3. For women of childbearing age, must have a negative pregnancy test at screening, and agree to use barrier contraceptives for the duration of the study, AND
4. Are able to understand and comply with the study process, and give informed consent.

Exclusion Criteria:

1. A diagnosis of type 1 diabetes mellitus,
2. A diagnosis of type 2 diabetes mellitus (A diagnosis of T2DM will be a previous fasting plasma glucose greater than or equal to 126 mg/dL, or a random plasma glucose greater than 200 mg/dL),
3. Have experienced hypersensitivity reaction or a worsening of glycemic control on Byetta® (exenatide),
4. Patients with end stage renal disease or severe renal impairment,
5. Patients with severe gastrointestinal disease, including gastroparesis,
6. Liver function tests 2.5 standard deviations above normal values,
7. Contraindication for bariatric surgery,
8. Treatment with exenatide (Byetta) in the last three months,
9. Currently using or have used within three months before this trial: sibutramine, orlistat, or phentermine(patients must also agree to not use these medications for the duration of the study),
10. Treatment with any investigational drug in the last 30 days,
11. Active malignancy, liver of kidney failure, symptomatic coronary heart disease, or severe psychiatric disease,
12. History of malignancy other than basal cell skin carcinoma, OR
13. In the opinion of the investigator, patient is abusing alcohol and/or drugs.
Non-Interventional Study of Zoladex in Endometriosis

This is a prospective, open label NIS, which is to assess the efficacy of Zoladex in adjuvant setting after operation in moderate to severe endometriosis patients.


Eligibility Criteria:
Inclusion Criteria:

* Advanced endometriosis confirmed histologically (r-AFS score III-IV) with conservative laparoscopy or laparotomy.
* Patient who has the indication of Zoladex and has been prescribed Zoladex according to physician's judgement, irrespective of the inclusion in the study.
* Patient has been already prescribed Zoladex within 1 month after operation.

Exclusion Criteria:

* Have used hormone treatment prior to 3 months of recruitment.
* Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the study site).
* Previous enrolment in the present study.
Biomarkers of Immune-Related Toxicity

This is a single-center, correlative pilot study evaluating potential biomarkers predictive of immune-related adverse events associated with immune checkpoint inhibitor therapy.

This is a single-center, correlative pilot study evaluating potential biomarkers predictive of immune-related adverse events associated with immune checkpoint inhibitor therapy. The study includes a control population of patients receiving standard chemotherapy as a comparator. Patients will undergo blood draws at 4 time-points while on standard of care treatment. There are no study-related medications or interventions beyond blood sampling.

Eligibility Criteria:
Inclusion Criteria:

1. Metastatic solid tumor cancer of any primary site, with the exception of lymphoma
2. ≥18 years of age
3. Life expectancy \>6 months
4. Starting new regimen of ipilimumab, nivolumab, pembrolizumab or atezolizumab as a single agent or in combination according to standard of care or through compassionate use granted by the pharmaceutical company (immune checkpoint inhibitor arm only) OR Starting new regimen of standard cytotoxic chemotherapy (control arm only)
5. Provision to sign and date the consent form
6. Stated willingness to comply with all study procedures and be available for the duration of the study

Exclusion Criteria:

1. Prior immune checkpoint inhibitor therapy with anti-CTLA4, anti-PD1 or anti-PD-L1 targeting agent
2. Known autoimmune disease
3. Known acute or chronic infection, including viral infections such as Hepatitis B, C, and HIV
4. Chronic treatment with immune suppressive medications, including steroids, at the time of study enrollment
5. Concomitant treatment with a monoclonal antibody in addition to cytotoxic chemotherapy (i.e. bevacizumab, cetuximab, trastuzumab) (control arm only)
6. Known pregnancy or lactation
Asymptomatic Intracranial Atherosclerotic Disease in Pakistanis

The incidence of stroke has increased by 100% in the last four decades in developing countries like Pakistan. Intracranial atherosclerotic disease (ICAD) is the most frequent causative subtype of ischemic stroke in the world including Pakistan. ICAD is progressive narrowing of the arteries at the base of the brain due to atherosclerosis. After a stroke from ICAD, recurrence rate is highest in any sub-type of stroke, up to 28% with limited therapeutic options. Therefore, it is imperative to delineate the determinants of asymptomatic ICAD prior to stroke. Investigators hypothesized that there is at least a 20% difference in the proportion of clinical, life-style (dietary, physical activity, obesity, smoking and stress/depression), and socio-economic predictors of asymptomatic ICAD than those with no ICAD.

Stroke is a major emerging cause of adult disability and the 3rd leading non-communicable cause of mortality in the world . With half of the world's population living in Asia, stroke epidemiology and its risk factor determination is important globally. The changes in population demographics and continuing industrialization in Asia have also led to a change in the epidemiology of stroke sub-types . Among the ischemic stroke sub-types, Intracranial Atherosclerotic disease is now emerging as the most prevalent vascular cause of stroke with high prevalence in Asian, African and Hispanic individuals .

Patients with ICAD are at a significant risk for recurrent stroke, with a risk as high as 25% in the first two years . Rate of recurrent stroke also varies by the location of the affected artery. Risk factor management is extremely important for the primary and secondary prevention of stroke in Asia as it is in Western countries. With the changing demographics and relatively fewer cost effective treatment modalities available, particularly for resource poor countries like Pakistan, it is imperative to delineate the clinical as well as lifestyle risk factors at an earlier asymptomatic stage to prevent future life-threatening consequences.

Therefore the primary objective of this study is to determine the clinical, lifestyle, dietary and psycho-social determinants of asymptomatic Intracranial Atherosclerotic disease (ICAD) and its other associated Brain MRI findings namely brain volume reduction, silent brain infarcts, and peri-ventricular hyper intensities in clinically normal adults with ICAD on MRI Brain.

Eligibility Criteria:
Inclusion Criteria:

* Adult Pakistani men and women ≥ 18years getting MRI brain for any indication other than stroke.
* Permanent residents of Pakistan for at least 1 year.
* No prior history of stroke which was confirmed by screening with Questionnaire for verifying stroke free status (QVSFS).
* Able to give written informed consent.

Exclusion Criteria:

* QVSFS +ve.
* Severe disability, life expectancy less than 6 months at enrollment.
* Patients in whom MRI prolongation for 5 minutes can be harmful for the patient (Anesthesia, claustrophobia, sedation etc.).
* Any clear contraindications to MRI, like pacemakers, metallic valves
Self-Care for Lymphedema in Patients With Breast Cancer

RATIONALE: Identifying why patients don't do self care for lymphedema may help doctors plan better at-home self-care treatment.

PURPOSE: This research study is looking at self-care practices for lymphedema in patients with breast cancer.

OBJECTIVES:

Primary

* To systematically identify and describe the barriers to completing recommended at home self-care of lymphedema in patients with breast cancer.
* To identify patient recalled instructions as to at home self-care practices for lymphedema as told to them by healthcare professionals and others.
* To identify the current at home self-care practices of breast cancer survivors with treatment treated lymphedema.

Secondary

* To examine the relationship between at home self-care activities and symptoms in breast cancer survivors with lymphedema.
* To examine the relationship between at home self-care activities and quality of life in breast cancer survivors with lymphedema.
* To identify patient-perceived benefits to at home self-care.

OUTLINE: Patients complete questionnaires about their breast cancer diagnosis and treatment history, lymphedema history and problems, and years of education and income. Patients also complete surveys about home self-care practices for lymphedema and any benefits, burdens, or barriers of at home care.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* History of breast cancer
* Lymphedema in one or both arms that occurred during or after breast cancer treatment
* Must have received prior lymphedema treatment by a healthcare professional

  * Patients with self-reported arm swelling subsequent to breast cancer treatment that has not been treated by a healthcare professional are not eligible
* Hormone receptor status not specified

PATIENT CHARACTERISTICS:

* Menopausal status not specified
* English speaking

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Effect of Walking to the Operating Room on Preoperative Anxiety

The operating room environment can be a source of anxiety for the patient, including in the context of outpatient surgery for which anxiolytic medication is rarely used. This anxiety-induced effect can be reinforced by the patient's lack of active participation.

Some studies have already shown the feasibility of patient walking to the operating room (OR) and advantages this approach(Kojima and Ina 2002; Lack 2016; Nagraj et al. 2006).

Moreover, recovery room complications and pain have also been shown to be greater after varicose vein surgery in patients with significant preoperative anxiety (Scavee et al. 2016).

Therefore, the investigators decided to test the effects of walking to OR for patients admitted for outpatient surgery for varicose vein surgery.


Eligibility Criteria:
Inclusion Criteria:

* Outpatient minimal invasive laser therapy for venous insufficiency

Exclusion Criteria:

* Inpatient surgery
* Invasive surgery
* Need for premedication
* Use of walking aid
* Non-French speaking patient
* Patient refusal
Study of Postoperative Concurrent Chemo-radiation With Capecitabine in Elderly Rectal Cancer Patients

The purpose of this study is to seek the proper dose of capecitabine in post-operative concurrent chemotherapy for stage II/III elderly rectal cancer patients receiving radical surgery, and evaluate the toleration of this modality in such patients.

For those "younger" locally advanced (stage II/III) rectal cancer patients (usually means patients less than 70), it is suggested that after radical surgery, patients should receive concurrent chemo-radiation. Capecitabine is a widely used chemotherapy medicine under such condition. Based on experience, the investigators think this modality can also be tolerated by patients over 70, and will increase local control rate as which has been proved in younger ones. As the first step to test this hypothesis, we designed this phase I study to seek the proper dose of capecitabine, a widely used oral chemotherapy medicine, in postoperative concurrent chemo-radiation for stage II/III rectal cancer patients over 70, and to evaluate the safety of this modality in this group of patients.

Eligibility Criteria:
Inclusion Criteria:

* rectal adenocarcinoma, pathological stage II/III(T3-4 or N+, UICC 2002), radical surgery received.
* interval between surgery and enrollment no less than two week and no more than 3 months.
* KPS status no less than 70; life expectancy no less than 6 months.
* without life-threatening complications, such as severe hypertension, coronary heart disease, cerebral vascular disease, uncontrolled diabetes, etc.
* without severe drug allergy history.
* hemoglobin \>= 100g/L, white blood cell \>= 3.5\*10E9/L, neutrophil \>= 1.5\*10E9/L, platelet \>= 100\*10E9/L.
* Creatin \<= 1.5\* ULN(upper limit of normal), Total bilirubin \<= 2.5 ULN, AST and AST \<= 2.5\* ULN, AKP \<= 2.5\*ULN
* do not receive chemotherapy before six months from enrollment.
* no previously pelvic irradiation history
* informed consent signed

Exclusion Criteria:

* other cancer history, except curable non-melanoma skin cancer or cervix in-situ carcinoma
* allergy history to thymidine phosphorylase
* previous pelvic irradiation history
* receiving adjuvant chemotherapy in six months before enrollment
* active infection existed
* severe complication, such as acute myocardial infarction in 6 months, uncontrolled diabetes ( Plasma glucose concentrations in any time of a day≥11.1mmol/L）, severe cardiac arrhythmia， etc.
* life expectancy less than 6 months
* estimated cannot finish treatment
* attend other clinical trials in four weeks before enrollment
* receive other anti-cancer treatment currently
* other conditions which regarded illegal by censors with full reasons. for example, some conditions may conflict from the protocol.
Clostridium Difficile Vaccine Safety, Tolerability, and Immunogenicity Study in Japanese Adults

The first-in-Japanese study B5091010 has been designed to evaluate the safety, tolerability, and immunogenicity of 2 antigen dose levels of C difficile vaccine when administered as one of two 3-dose regimens to healthy Japanese adults aged 65 to 85 years.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy male and female adults
2. Aged 65 to 85 years

Exclusion Criteria:

1. Proven or suspected prior episode of Clostridium difficile associated diarrhea
2. Unstable chronic medical condition
3. Disease requiring significant change in therapy or hospitalization for worsening disease within 8 weeks before receipt of study vaccine
4. Serious chronic medical disorders
5. Bleeding diathesis or condition associated with prolonged bleeding time that may contraindicate intramuscular injection
6. Any contraindication to vaccination or vaccine components, including previous anaphylactic reaction to any vaccine or vaccine-related components
7. Subjects with congenital or acquired immunodeficiency disorders
8. Subjects with rheumatologic disorders or other illnesses requiring chronic treatment with known immunosuppressant medications
9. Active or treated leukemia or lymphoma or bone marrow disorder
10. Residence in a nursing home or other long-term care facility, or requirement for semiskilled nursing care or assisted living
11. Abnormality in screening hematology and/or blood chemistry laboratory values
A Study of the Combination of Ibrutinib Plus Venetoclax Versus Chlorambucil Plus Obinutuzumab for the First-line Treatment of Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

The purpose of this study is to assess progression-free survival (PFS) from treatment with ibrutinib plus venetoclax (I+VEN) compared with obinutuzumab plus chlorambucil (G-Clb) as assessed by an Independent Review Committee (IRC).


Eligibility Criteria:
Inclusion Criteria:

* Adult participants who are: (a) greater than or equal to (\>=) 65 years old or, (b) 18 to 64 years old and have at least 1 of the following:

  1. Cumulative Illness Rating Scale (CIRS) score \> 6
  2. Creatinine clearance (CrCl) estimated less than (\<) 70 milliliter per minute (mL/min) using Cockcroft-Gault equation
* Diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that meets International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria
* Measurable nodal disease (by computed tomography \[CT\]), defined as at least one lymph node \> 1.5 centimeter (cm) in longest diameter
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Grade less than or equal to (\<=) 2
* Active CLL/SLL requiring treatment per the iwCLL criteria

Exclusion Criteria:

* Prior anti-leukemic therapy for CLL or SLL
* Presence of deletion of the short arm of chromosome 17 (del17p) or known TP53 mutation detected at a threshold of \>10 percent (%) variable allele frequency (VAF)
* Major surgery within 4 weeks of first dose of study treatment
* Known bleeding disorders (example, von Willebrand's disease or hemophilia)
* Central nervous system (CNS) involvement or suspected Richter's syndrome
Assessing and Understanding Freezing of Gait at Home: FOG@Home

Freezing of gait, (FOG) is an unpredictable, abrupt, short phenomenon that severely affects Parkinson's disease (PD) patients' gait and quality of life. The common measure tools are self-questioners that present the subjective feelings and the FOG provoking tests that used in clinic for evoking FOG and getting the estimated duration and the phenotype of the expressed phenomenon. The objective of this study is to investigate the FOG phenomenon using video cameras at patients' home with combination of wearable-axivity sensors and smart soles with a goal of objective assessment and quantification of freezing of gait severity in unsupervised daily-living environment of the PD patients.

30 PD subjects, referred by the Movement Disorders Centre would be enrolled in the study according to eligibility criteria. By prior arrangement, the researchers will arrive to the participant's home. After explanation and consent process, the participant would sign the consent form. At that point, the patient would be assessed, before the execution of the experimental protocol. Hoehn and Yahr staging (H\&Y), Unified Parkinson's Disease Rating Scale (UPDRS) and common cognitive tests would be applied. Then, the participant would be ask to put the motion sensors (accelerometers) and place the cameras in strategic places in the house, where he expect to see most freezing of gait events while walking around the house (no bedrooms and bathrooms). After activating the systems, the researchers would go, leaving the video system and the sensors for 7 days (depending on the amount of received data) in the patient house.

Eligibility Criteria:
Inclusion criteria:

Clinical diagnosis of Parkinson's disease (PD) according to the UK PD Society Brain Bank criteria; Modified Hoehn \& Yahr Stage I to IV in the ON-state; Ability to walk 5 minutes while unassisted by another person; Mini-Mental State Examination (MMSE) score of \>= 21 or \> 16 on the 26-item MMSE screening; Self-reported freezing of gait (FOG) severity of at least 1 FOG episode per day, based on Characterizing of Freezing of Gait Questionnaire, irrespective of FOG occurring ON- or OFF-medication.

Exclusion criteria:

Acute musculoskeletal or other neurological or cardiovascular conditions affecting gait or any other medical condition which, in the opinion of the investigator, may prevent completing the protocol; The occurrence of any of the following within 3 months prior to informed consent: orthopedic surgery of the lower extremity, myocardial infarction, hospitalization for unstable angina, coronary artery bypass graft, percutaneous coronary intervention, implantation of a cardiac resynchronization therapy device, implantation of deep brain stimulation; Substance abuse, major depressive disorder or clinical apathy that affects daily walking activity or may interfere with the patient's compliance; Inability to walk without a rollator indoors; Absence of clinically observed FOG during the FOG-provoking assessment.
Drug-drug Interaction Study(CKD-501, Amlodipine)

The purpose of this study is to assess the pharmacokinetic drug interaction between CKD-501 and amlodipine after oral administration in healthy male volunteers.

Volunteers doses three times over the period of CKD-501 0.5mg or Amlodipine 10mg alone/co-administrate, repeated doses are 10 days.

Eligibility Criteria:
Inclusion Criteria:

* Between 20 aged and 45 years old in healthy males
* Body weight ≥ 55kg and 18.5 ≤ IBW \< 25
* Agreement with written informed consent

Exclusion Criteria:

* Subject has a history affects the ADME of drug
* Hypersensitivity reactions to drugs or clinically significant hypersensitivity reactions in the history of party
* Inadequate subject by medical examination(medical history, physical examination, ECG, laboratory test)
* AST,ALT \> UNL \* 1.25 or Total bilirubin \> UNL \* 1.5
* Estimated GFR(MDRD) \< 80
* SBP \>150 mmHg, SBP \< 100 mmHg or DBP \> 100 mmHg, DBP \< 60 mmHg or Pulse \> 100 per/min, Pulse \< 50 per/min
* Substance abuse, or a history of drug abuse showed a positive for the party
* Continued to be taking caffeine (caffeine \> 5 cup/day), drinking (alcohol \> 210 g/week) or cannot stop drinking or severe heavy smoker(cigarette \> 10 cigarettes per day)during clinical trials
* Medication with drug-mediated induction/inhibition metabolic enzyme within 30 days or with may affect the clinical trial
* Medication within 2 weeks in the first professional medical, medicine, OTC, vitamins taking
* Subject takes grapefruit within 1 month
* Previously participated in other trial within 60 days
* Previously donate whole blood within 60 days or component blood within 30 days
* An impossible one who participates in clinical trial by investigator's decision including laboratory test result