cyrilzakka/clinical-trials huggingface dataset:
Linerixibat Compassionate Use for Cholestatic Pruritus Adult Patients With Primary Biliary Cholangitis (PBC)

The goal of this compassionate use program is to provide a mechanism to supply linerixibat, on an individual named patient basis. This program is for treatment of individuals who have cholestatic pruritus associated with PBC who are deemed at high risk of a significant clinical event as a result of their pruritus and for whom all available pharmaceutical treatment options for cholestatic pruritus have been unsuccessful or are considered to not be appropriate.


Eligibility Criteria:
Inclusion Criteria:

* Participants with cholestatic pruritus associated to PBC identified by their healthcare provider as being at high risk of a significant clinical event as a result of their pruritus.
* Male and female \>= 18 years of age.
* Participants for whom all available pharmaceutical treatments for cholestatic pruritus in PBC have been unsuccessful or are considered to not be appropriate.
* Contraceptive/Barrier Requirements (applicable for female participants only): A female participant is eligible if she is not pregnant or breastfeeding, and at least one of the following conditions applies:

  1. Is not a woman of childbearing potential (WOCBP) OR
  2. Is a WOCBP and using an acceptable contraceptive method during the treatment with linerixibat and for at least 4 weeks after the last dose of linerixibat.

Exclusion Criteria:

* Advanced chronic liver disease (e.g. cirrhosis Child-Pugh C) or presence of hepatic decompensation (e.g. variceal bleeding, encephalopathy).
* Use of obeticholic acid or other IBAT inhibitor.
Extended Cancer Education for Longer-Term Survivors in Primary Care for Patients With Stage I-II Breast or Prostate Cancer or Stage I-III Colorectal Cancer

This study tests four different methods of educating patients about follow-up care (NCI facing forward, brochure, EXCELS website alone, EXCELS health coaching alone and EXCELS website \& health coaching combination) after cancer treatment ends. While it is known that patients need information to guide follow-up it remains unknown how to best provide this in primary care.

PRIMARY OBJECTIVES:

I. Develop the EXCELS intervention to facilitate engaged self-management of cancer follow-up for cancer survivors.

II. Evaluate the efficacy of EXCELS intervention in a small randomized controlled trial.

III. Assess/refine intervention usability and acceptability for primary care patients.

OUTLINE:

PHASE I: EXCELS intervention is developed and assessed.

PHASE II: Participants are randomized into 1 of 4 arms.

ARM I: Participants receive National Cancer Institute's Facing Forward brochure.

ARM II: Participants have untimed access to the EXCELS mobile web application.

ARM III: Participants also receive 4 calls of 15-20 minutes each over 3 months focusing on assisting survivors with addressing challenges to receiving preventive service and health care.

ARM IV: Participants have access to EXCELS website as in Arm II. Participants also receive 4 health coaching calls as in Arm III.

Patients are followed up at 6 months, 12 months and 18 months post randomization.

Eligibility Criteria:
Inclusion Criteria:

* Have been diagnosed with localized breast or prostate (stages 1-2) or colorectal cancer (stage 1-3)
* Have completed active treatment for their cancer diagnosis (excluding hormonal therapy)
* Have access to a phone for contact with health coach
* Be able to communicate in English; and be competent to consent
* Usability Testing and the randomized control trial (RCT): have access to a computer, a smartphone or an i-Pad/tablet equivalent with internet access

Exclusion Criteria:

* Patients who are required because of their disease to see primarily oncologists for follow-up will be excluded (i.e., those diagnosed with lymph node or distant metastasis, those with a new primary cancer)
Evaluation of the Effects of Teleconsultations on a Endocrinology Referral List

The aim of this study is evaluate the effects of telephone teleconsultations to primary care physicians (compared to the state's referral protocol) in the referrals waiting list for endocrinological appointments.

Rio Grande do Sul state's referral list for endocrinology evaluation in specialized care is highly overloaded. There is currently a referral protocol to select patients how should be referred. It will be evaluated if a intervention of telephone-based teleconsultations provided by the TelessaúdeRS to the primary care physicians can provide additional benefits. TelessaúdeRS is a telehealth program from the University of Rio Grande do Sul. This will be evaluated in a cluster randomized clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* Patients from counties with at least 5 endocrinology referrals waiting appointment.
* Patients referred from primary care physicians
* Patients referred because one of the protocol conditions (Diabetes Mellitus, Hypothyroidism, Hyperthyroidism, Goiter, Thyroid nodule, Obesity).

Exclusion Criteria:

* Patients from counties with more than one hundred endocrinology referrals waiting appointment.
Exogenous Ketones in Type 2 Diabetes

Exogenous ketone supplements are proposed to have glucose-lowering potential, provide an alternative fuel for the brain and to enhance cognitive function. No studies have tested whether exogenous ketones can lower blood glucose in people with type 2 diabetes. In addition, the impact of exogenous ketones on brain blood flow, cognitive function or brain-derived neurotrophic factor in humans is unknown. The purpose of this study is to determine if acutely ingesting exogenous ketones, in the form of a ketone monoester drink, can lower glucose and improve measures of brain/cognitive function in humans with type 2 diabetes. Participants will consume a ketone monoester drink or placebo with blood samples, brain blood flow, and cognitive function assessed over 180 minutes. The researchers will also test how the ketone monoester drink impacts appetite and measures of inflammation.


Eligibility Criteria:
Inclusion Criteria:

* physician-diagnosed type 2 diabetes of ≥1 year
* current hemoglobin A1C (HbA1c) of 6.5-8.0%
* treatment with lifestyle or stable (≥3 months) oral glucose-lowering medications
* blood pressure of \<160/99 mm Hg assessed according to guidelines
* non-smoking
* no prior history of cardiovascular disease or stroke
* not on hormone replacement therapy, corticosteroids, or anti-inflammatory medications
* 20-75 years old

Exclusion Criteria:

* being a competitive endurance athlete
* taking exogenous insulin or sodium glucose transporter 2 (SGLT2) inhibitors
* following a ketogenic diet, low-calorie diet, periodic fasting regimen, or consume ketogenic supplements
* being unable to travel to and from the university
* being unable to follow the controlled diet instructions
* being pregnant or planning to become pregnant during the study (if female)
* disorders of fat metabolism, chronic pancreatitis, had gastric bypass surgery and/or gallbladder disease
* being unable to read or communicate in English
Study of ISIS 681257 in Patients With Renal Impairment Compared to Healthy Patients

This is a Phase 1, Multicenter, Open-Label, Parallel Group Adaptive Pharmacokinetic Single Dose Study of ISIS 681257 Subcutaneous Injections in Male And Female Subjects with Normal and Impaired Renal Function


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old
* BMI 18.5 to 42.0 kg/m2
* No known diseases or significant findings on physical exam (normal renal only)
* eGFR \>/= 90 mL/min/1.73m2 (normal renal only)
* Clinically stable (renal impaired only)
* eGFR 30-59 mL/min/1.73m2 (renal impaired only)

Exclusion Criteria:

* Females of childbearing potential
* Conditions or disease that may interfere with study drug
* Any significant diseases
* Hypersensitivity to any drugs or similar drugs to those used in the study
* Drug dependency or abuse
* Previous exposure to other investigational drug within 28 days
* Blood donations within 28 days
Influence of a New Polycationic Disinfectant on Clostridium Difficile Incidence and Environmental Colonisation

The aim of this study is to 1) test the efficacy of PHMG-based disinfectant against C. difficile spores, 2) test whether it reduces the incidence of C. difficile associated disease (CDAD) and 3) evaluate cost.

Environmental disinfection has been proved to be efficient when controlling epidemics caused by C. difficile. In recent years its epidemiology has changed leading to increased morbidity and mortality in many countries. C. difficile infections are often difficult to treat and reinfections frequently occur. The major concern is a new strain of C. difficile, O27, which produce many times more spores than other types and spreads easily in institutions. Patients who have a C. difficile infection should be kept in contact isolation in hospitals and other institutions.

C. difficile is a spore forming bacteria which is resistant to some normally used disinfectants like alcohol and quats. Spores may remain viable for months in environment. Disinfectants currently in use, like chloramines and glutaralde-hyde, are risk both for workers and to environment because of their corrosive and irritating nature.

Polyhexamethyleneguanidine(PHMG) is a new disinfectant which is effective against microbes including bacteria and bacterial spores, viruses and fungi, safe to people handling it and friendly to environment and surfaces. It has been tested in the laboratory of Helsinki University according to many EN-standards to disinfectants. It can be used as a hand disinfectant, instrument disinfectant and surface disinfectant.

PHMG was introduced in three wards for hand hygiene and environmental disinfection in CDAD patients' rooms. The rooms for showers and toilets were coated with biocide coating (PHMG) as well as bed frames in investigational wards. Three wards were control wards and continued using alcohol based hand disinfectants and routine environmental cleaning and disinfection with quats/chloramines. After 6 month's intervention period, the incidence of CDAD cases were compared to that during the preceeding 10 months. Surveillance for environmental and HCWs´ hand contamination by C. difficile were performed by taking microbiological samples both from environmental sites and hands twice before intervention and then twice in month within intervention period.

Eligibility Criteria:
Inclusion Criteria: ( classified as a HCF-onset, HCF-associated CDAD )

* toxin or culture positive C difficile
* symptom onset more than 72 hours after admission to hospital
* symptom onset less than 4 weeks after discharge

Exclusion Criteria:

* recurrence of CDAD within 8 weeks
* symptom onset before admission to hospital or less than 72 hours after admission to hospital
A Pilot Feasibility Trial of Thyroid Hormone Replacement in Dialysis Patients

Hypothyroidism, defined by elevated thyrotropin (TSH) levels, is a common endocrine complication of chronic kidney disease that has been associated with impaired quality of life and cardiovascular complications. While levothyroxine is one of the most frequently prescribed medications in chronic kidney disease patients, little is known about its efficacy and safety in this population. This study will investigate 1) whether levothyroxine adequately lowers thyrotropin (TSH) levels to therapeutic target ranges, and 2) if thyroid hormone replacement improves quality of life and cardiovascular markers, without leading to wasting in dialysis patients.


Eligibility Criteria:
Inclusion Criteria:

* Prevalent hemodialysis patients, elevated thyrotropin level, normal free thyroxine level.

Exclusion Criteria:

* Hyperthyroidism, active treatment with thyroid hormone replacement, prior thyroid malignancy, active pregnancy, active coronary ischemia or atrial fibrillation, osteoporosis, inability to provide consent without a proxy.
Mindfulness-Based Cognitive Therapy + Safety Planning For Suicidal Behavior

The purpose of this study is to combine and adapt Mindfulness-Based Cognitive Therapy (MBCT) + Safety Planning Intervention (SPI) for individuals with suicidal behavior and to determine its feasibility, acceptability, safety and preliminary effectiveness. An exploratory aim is to collect data on the cognitive changes underlying treatment gains.

* The study is a nine-week clinical trial combining Safety Planning Intervention plus Mindfulness-Based Cognitive Therapy for patients with a recent history of suicidal thoughts or behavior and current or past depressive symptoms.
* These treatments work for depression and some preliminary data suggest they may work to prevent suicidal behavior.
* Participation includes:

  * Nine weeks of free treatment
  * Clinical assessments
  * An opportunity to offer your views on treatment and suggestions for improving the treatment in focus groups

Eligibility Criteria:
Inclusion Criteria:

* 18-65
* History of depression
* Suicidal behavior or thoughts (i.e., current suicidal thoughts at screening and history of at least one suicide attempt or suicide-related behavior (aborted or interrupted suicide attempt) or suicidal ideation with plan or method in the past 6 months)
* In active treatment (e.g., receiving psychiatric medications)

Exclusion Criteria:

* Current mania, psychosis, Obsessive-Compulsive Disorder, Traumatic Brain Damage, Organic or Acute Brain Syndrome, Mental Retardation or pervasive developmental disorder
* Requires priority treatment for an acute illness or debilitating problem such as severe primary substance dependence or anorexia nervosa
* Inability to complete psychiatric interview or group treatment due to lack of cooperation or lack of comprehension.
A Clinical Study of Enlicitide in Participants With Severe Renal Impairment (MK-0616-032)

Researchers have designed a new study medicine called enlicitide decanoate as a new way to lower the amount of low-density lipoprotein cholesterol (LDL-C) in a person's blood. Enlicitide decanoate will be called "enlicitide" from this point forward, The purpose of this study is to learn what happens to enlicitide in a person's body over time (a pharmacokinetic (PK) study). Researchers will compare what happens to enlicitide in the body when it is given to people with severe renal impairment (meaning the kidneys do not work properly) and to people who are in good health. The researchers believe that the total amount of enlicitide in a person's body measured during the 24 hours after a dose will be similar in people with severe renal impairment and in healthy people.


Eligibility Criteria:
Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

* Body Mass Index (BMI) between 18 and 40 kg/m\^2, inclusive
* On a stable dose of statin therapy; no changes to dose or type of statin therapy for at least 2 months

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

* History or presence of renal artery stenosis
* Had a functioning renal transplant in the past 5 years and is taking transplant medication
* History of gastrointestinal (GI) disease which might affect food and drug absorption

Panel A: Participants with Severe Renal Impairment:

- History of any illness, other than hypercholesterolemia and Renal Impairment

Panel B: Healthy Participants:

- History of clinically significant endocrine, GI, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases, other than hypercholesterolemia
A Phase 2 Study With Panzem in Patients With Relapsed or Plateau Phase Multiple Myeloma

The purpose of the study is to determine the safety and effectiveness of providing 2-methoxyestradiol to patients with plateau phase or relapsed multiple myeloma. Information regarding trough 2ME2 levels will also be collected.


Eligibility Criteria:
Inclusion Criteria:

1. Have plateau phase (patients who have been previously treated with at least one conventional or high-dose chemotherapy who are currently off all therapy for at least 4 weeks and are considered to have stable disease) or relapsed MM. Patients in plateau phase must have M-protein concentrations that are stable for at least 4 weeks prior to registration.
2. Be at least 18 years of age.
3. Have monoclonal plasma cells in the marrow.
4. have M-protein greater than or equal to 1g/dL in the serum or 200 mg of monoclonal light chain in a 24-hour urine protein electrophoresis.
5. Have laboratory data as specified below:

   * AST and ALT \< 2.5 x upper limit of normal (ULN)
   * Alk phos \< 5.0 x ULN
   * direct bilirubin \< 2 x ULN
   * Creatinine \< 3.0 x ULN
   * ANC greater than or equal to 750 cells/mm3
   * Platelets \> 25,000/mm3
   * Hemoglobin greater than or equal to 7.0g/dL
6. Have life expectancy of at least 3 months
7. Have ECOG performance status of 0, 1, or 2
8. Women and men of child bearing potential must agree to use effective barrier contraceptive methods during study.
9. Have the ability to understand the reuirements of the study, provide written informed consent, abide to study restrictions, and agree to return for the required assessments.

Exclusion Criteria:

1. Be pregnant or nursing.
2. Have any condition that is likely to detrimentally affect regular follow up.
3. Have a history of myocardial infarction within the last 3 months, angina pectoris/angina equivalent in the last 3 months, or uncontrolled congestive heart failure.
4. Have an active infection
5. Have had major surgery within 21 days of starting 2ME2 administration
6. Have additional uncontrolled serious medical or psychiatric illness
7. have had any active cancer in addition to the MM within the last 5 years (excluding superficial skin cancer)
8. Have uncontrolled or untreated active bleeding or thrombotic disorder.
Epidemiology of Urinary Functional Disorders in Women of 40 and More

Assess prevalence of urinary functional disorders in women of 40 and more, visiting a general practitioner, occupational medicine or health examination center in Puy-de-Dôme. Study conducted for a month using a self-filled survey distributed by secretaries or nurses.

The diagnosis of urinary incontinence is clinical. Three types of urinary incontinence are described: urinary stress incontinence, urinary incontinence by overactive bladder or mixed urinary incontinence.

To standardize the medical examination and to precise the urinary incontinence type, the use of a validated questionnaire is recommended (USP), the quality of life's resounding also must be assessing, using questionnaire of quality of life valid in French (ICIQ®, CONTILIFE®...) Several medical cares exist, but patients often don't know it. Unhappily, it is still a taboo subject. In a French medical study, conducted in 1992 by 60 general practitioners, of a total of 2911 female patients, 37% said they had urinary disorders. Among them, 77% said they had symptoms during an effort, 57% had urinary urge incontinence and 35 % had spontaneous leaks. One in five women had three associated disorders.

In a French study conducted in 2005, it appeared that women talked to their general practitioner about urinary disorders only four or five times out of ten, and six times out of ten when they used panty liners.

The results are eloquent, but the data is not recent, and the investigators need some, to propose better cares.

This medical study will be conducted during one month. Two self-filled questionnaires will be distributed by nurses or medical secretary, working at recruited general practitioner's place, to every female patient who will be 40 years old or more, coming for themselves or accompanying somebody else (children for example). Every female patient will have to fill both questionnaires alone, anonymously, and will have to let them in a closed box, in the waiting room.

The two self-filled questionnaires are called USP and CONTILIFE. They are both validated to evaluate symptoms and quality of life.

Additional question about existence of fecal incontinence (and its type), and the reasons why patients didn't talk about it with their general practitioner spontaneously (shame, absence of information about cares, fatality...).

Prior visit of each recruited service by Julie de la Roque, to explain the goals of the study, to general practitioners, nurses and medical secretaries.

Eligibility Criteria:
Inclusion Criteria:

* female
* 40 and more
* speaking French

Exclusion Criteria:

* men
* female of less than 40
* not speaking French
* refusal
* inability to answer questions
Treatment of Upper Cluneal Nerve Entrapment Syndrome for Reduction of Low Back Pain

Superior cluneal nerve entrapment (SCN) is a painful symptomatic condition related to compression by the thoracolumbar and gluteal bands of nerve outcrop, above the iliac crest. This syndrome is not considered in the classical differential diagnosis of lumbosacral spine disorders and is almost unknown in Italy.

It is a neuropathic pain, acute, subacute, or chronic, evoked by mechanical stress at the level of the sensory territory corresponding to the superior cluneal nerve, easily found anatomically and evoked at a trigger point on the posterior iliac crest approximately 70mm from the midline and 45mm from the posterior superior iliac spine.

SCN entrapment syndrome represents a not so infrequent syndrome. It is easily framed and treatment is effective in most cases. Therefore, diagnosis and treatment of this syndrome represents an excellent option in all those patients with low back pain that cannot be otherwise framed and resolved.


Eligibility Criteria:
Inclusion Criteria:

* patients with age between 18 and 99 years
* male and female sex
* superior cluneal nerve trigger point positivity at clinical evaluation
* absence of urgent criteria for spinal surgery

Exclusion Criteria:

* patients younger than 18 years old
* patients who have not given consent to be included in the study
* patients with negative upper cluneal nerve trigger point - emergency criteria for spine surgery
* pregnant women - patients allergic to local anesthetic
* patients with language barrier
Intravenous Lidocaine Infusion Reduce Postoperative Pulmonary Complications in Patients Undergoing Minimally Invasive Esophagectomy

The goal of this double-center, double-blind, randomized controlled clinical trial is to compare the effect of intravenous lidocaine infusion on postoperative pulmonary complications in patients undergoing minimally invasive esophagectomy. The main question it aims to answer are whether intravenous lidocaine reduce postoperative pulmonary complications in patients undergoing minimally invasive esophagectomy. Participants will be given intravenous lidocaine infusion in lidocaine group or placebo in control group.


Eligibility Criteria:
Inclusion Criteria:

Patients between 18 and 85 years of age with a recent schedule for MIE are screened for this study. Patients who show clear consciousness and ASA status I - III will be included as eligible participants.

Exclusion Criteria:

The exclusion criteria are as follows: patients with severe psychiatric disorders, such as schizophrenia, depression, dementia, etc.; severe hepatic insufficiency (concentration of glutamic oxaloacetic transaminase, glutamic pyruvic transaminase or bilirubin ≥2.5 times the upper limit of normal); renal impairment (creatinine clearance \<60 mL/min); allergy to amide local anesthetics; history of seizures; presence of II/III atrioventricular block; patients with severe sinus bradycardia or sick sinus syndrome; patients with Adams-Stokes syndrome or pre-excitation syndrome; intracardiac block (e.g. complete bundle branch block, atrioventricular block); serum potassium ion concentration below 2.5 or above 5.0 mmol/L; PH\>7.55 or PH\<7.2. Patients will be discontinued if any of the following situations occur: the patient has an allergic reaction, severe cardiovascular events that cannot be managed with symptomatic treatment, and the patient is unwilling to continue the study.