cyrilzakka/clinical-trials huggingface dataset:
Irinotecan and Capecitabine in Treating Patients With Solid Tumors

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of irinotecan and capecitabine in treating patients who have solid tumors that have not responded to previous treatment.

OBJECTIVES: I. Determine the maximum tolerated dose and toxic effects of irinotecan and oral capecitabine in patients with gastrointestinal or other solid tumors. II. Characterize the relationship at the recommended phase II dose between thymidine synthase and thymidine phosphorylase expression and tumor response and/or toxic effects in these patients.

OUTLINE: This is a dose escalation study. Patients receive oral capecitabine twice daily every twelve hours for 14 days, and IV irinotecan over 30 minutes once every 3 weeks beginning on day 1. Treatment continues for at least 2 courses in the absence of disease progression or unacceptable toxicity. The dose of capecitabine and irinotecan is escalated in cohorts of 3-6 patients until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose limiting toxicity.

PROJECTED ACCRUAL: Approximately 25-30 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed solid tumors, including but not limited to breast, gastrointestinal, and unknown primary cancer that is refractory to standard therapy or for which no standard therapy exists No known bone marrow involvement

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 OR WBC at least 3,500/mm3 AND Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL No known Gilbert's syndrome No other significant hepatic disease requiring medication Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No significant cardiac disease requiring medication Other: Not pregnant or nursing Fertile patients must use effective contraception No other significant medical condition

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 2 weeks since prior colony stimulating factor and other cytokines active on bone marrow Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks since mitomycin or nitrosoureas) No prior or concurrent irinotecan and fluorouracil therapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy No concurrent radiotherapy Surgery: Recovered from prior major surgery
Evaluation of the Clinical, Neuropsychological and Psychosocial Situation of Patient With Eating Disorders.

Eating disorders (ED) are serious mental illnesses with an excess mortality and many affects in the quality of life of patients and thier relatives. Management of ED is very difficult : the prognosis remains relatively poor both in terms of remission rate and quality of life. In this context, the contribution of new strategies for pathophysiological exploration and the development of therapeutic options are crucial.

In this project the investigators aim to constitute un cohort of patients from a day unit specialized in the management of ED. A prospective follow-up will be offered to patients to assess their clinical and psycho-social evolution. The overall objective is to identify which factors are prognostic of clinical improvement of the ED. We also want to better characterize patients that will migrate from diagnosis to another.

The investigators propose to assess, with a cohort of patients with ED the prognostic value of cognitive abnormalities associated with ED (cognitive flexibility and central coherence) They will recruit 370 patients suffering from a current ED (anorexia, bulimia, binge eating disorder, Eating disorder not otherwise specified).

Each patient will be reassessed every year for 3 years.

Eligibility Criteria:
Inclusion criteria:

* respond to DSM 4 criteria for ED
* Age 15 to 65 years
* Signing an informed consent.
* Affiliated to a social security scheme or being the beneficiary of such a scheme.

Exclusion criteria:

* Manifest inability of the subject to understand / perform clinical and neuropsychological evaluations and tasks
* Major protected by law (guardianship)
* Privation of liberty by judicial or administrative decision
* Pregnant or lactating women
The Effect of Psoriatic Arthritis on Female Sexual Dysfunction

Psoriasis is one of the most common immunemediated chronic inflammatory skin disorders.

Psoriasis is one of the most common immunemediated chronic inflammatory skin disorders.

Beside genetic factors, several environmental factors such as injuries, infections, stress, drugs, and immune defect take part in autoimmune pathogenesis of the disease. In addition, it has been reported that some hormones may also have a role in the pathogenesis of psoriasis, due to their effects on keratinocytes proliferation.

Studies revealed that sex hormones manifest a variety of biological and immunological effects in the skin which modulate the natural course of psoriasis.

Approximately 20-30% of patients with psoriasis may also have psoriatic arthritis, which often causes significant musculoskeletal pain that significantly impairs quality of life (QoL).

Although sexual dysfunction is a common complaint, affecting 30 to 70% of psoriasis patients, few studies have analyzed the impact of psoriasis and psoriatic arthritis on quality of sexual life.

Eligibility Criteria:
Inclusion Criteria:

* The study will focuses on the relationship between the FSD and PsA;
* The healthy controls will derive from a population within the same geographic area and ethnic background as PsA;
* Used the same questionnaires/instruments of FSFI to diagnose FSD

Exclusion Criteria:

* pregnancy,
* breastfeeding
* being sexually inactive
* having a partner with sexual dysfunction,
* refusing to participate, or
* being unable to read
* Females with any sexual transmitted disease
Arimidex: Compliance and Arthralgias in Clinical Therapy (COMPACT)

Patients are eligible for inclusion in this NIS if they have taken anastrozole either upfront or following two to three years of tamoxifen treatment ("switch") for at least three and not more than six months prior to offering an individual participation in this program. Treatment should follow local therapy guidelines and standard practice. Treatment decisions for patients participating in this study including assessments or supportive therapy during follow-up visits will also follow guidelines and remain independent of the program.

The patient population will include postmenopausal women with hormone-receptor positive primary breast cancer scheduled for adjuvant upfront endocrine treatment with anastrozole or following two to three years of tamoxifen treatment ("switch") according to the current SmPC (Appendix C). Patients will have taken anastrozole for at least three months and not more than six months before the start of the study.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women aged 18 years or older; Postmenopause is defined as Natural menopause with menses \>1 year ago or Serum FSH (\> 20 IU/ l), and E2 levels in the postmenopausal range or patients who had bilateral oophorectomy
* Histologically / cytologically confirmed primary diagnosis of early breast cancer (M0) with hormone sensitive tumour (ER+ve and/or PgR+ve)
* Patients, who underwent breast cancer surgery and, if appl. radiation therapy and/or neo/adjuvant chemotherapy and have taken adjuvant endocrine treatment with anastrozole (upfront or following two to three years of tamoxifen) min 3 max 6 months
* In case of a previous therapy with tamoxifen (switch-therapy), duration of tamoxifen treatment for at least two and up to three years.

Exclusion Criteria:

* Patients with severe renal function disorders (Creatinine clearance \< 20 ml/min or Patients with moderate or severe disorders of hepatic function
* Concomitant treatment with drugs known to affect sex hormonal status and tamoxifen
* Patients with ductal carcinoma in situ (DCIS) without primary diagnosis of early breast cancer (M0)
* Evidence of any significant clinical disorder or laboratory finding which in the opinion of the investigator, makes it undesirable for the patient to participate in the program
Qubic Stim Cardiac Stimulator in China

106 subjects selected from 3 study sites in China are with indications for intracardiac electrophysiological examination. The trial is to prove the clinical effectiveness and safety of Qubic Stim Cardiac Stimulator in Chinese population.

The trial is a multicenter, prospective and single-arm study. 106 appropriate subjects were selected from 3 study sites in China in accordance with the inclusion and exclusion criteria. The subjects consent to participate in the trial and sign the informed consent. The subjects who meet the inclusion and exclusion criteria will receive the intracardiac electrophysiological examination, during which the subjects will be subject to diagnostic electrical stimulation by the Qubic Stim Cardiac Stimulator. The subjects will also receive the clinical follow-up visit after cardiac electrical stimulation until they are discharged from the hospital. The clinical effectiveness and safety of Qubic Stim Cardiac Stimulator in Chinese population were proved by observing the data collected in this study.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Subjects who are willing to participate and sign the informed consent form, and are able to finish the follow-up at the study site.
3. Subjects with an indication of the intracardiac electrophysiological examination(fit one of the following):

   * Paroxysmal supraventricular tachycardia: atrioventricular reentrant tachycardia or atrioventricular node reentrant tachycardia or atrial tachycardia.
   * Ventricular arrhythmia: Premature ventricular contraction or ventricular tachycardia.
   * Atrial fibrillation.
   * Atrial flutter.

Exclusion Criteria:

1. Previous cases of unsuccessful radiofrequency ablation or recurrence
2. Pregnant and/or lactating women
3. Acute or severe systemic infection was present within 7 days prior to the intracardiac electrophysiological examination
4. Liver and kidney functions were obviously abnormal within 7 days prior to the intracardiac electrophysiological examination
5. Obvious bleeding tendency or blood system disease
6. Cancer and terminal disease
7. Combined with severe organic cardiovascular disease
8. Cerebral apoplexy and other cerebrovascular diseases within the past 3 months
9. Thromboembolic disease
10. Subjects who are participating in other interventional clinical trials
A Text- and Audio-based Intervention to Promote Physical Activity in Midlife

This is a randomized, controlled pilot trial (N=30) to examine the feasibility, acceptability, and preliminary efficacy of the Move with Meaning program, an 8- week, text message- and audio-based intervention to promote physical activity in midlife adults.

This is a randomized, controlled pilot trial to examine the feasibility, acceptability, and preliminary efficacy of the Move with Meaning program, an 8- week, text message- and audio-based intervention to promote physical activity in midlife adults. In Move with Meaning, participants will listen to weekly audio sessions and complete twice weekly text message sessions, in which they will set a weekly physical activity goal. The primary outcome is feasibility (measured by number of successful text message sessions sent). Secondary outcomes include acceptability and preliminary impact on physical activity, psychological health-, and physical health-related outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Midlife adults (aged 45-64 years at the time of enrollment)
* Suboptimal physical activity (\<150 minutes of moderate to vigorous physical activity, measured by accelerometer)
* Access to a phone capable of receiving text messages and listening to audio files (i.e., a smartphone)

Exclusion Criteria:

* An unrelated condition limiting physical activity
* Participation in any other programs focused on cardiac prevention or well-being
* A cognitive disturbance precluding participation or informed consent
* Current pregnancy
* Inability to speak/write fluently in English
New Combination Inhaler (FlutiForm HFA MDI 100/10 µg and 250/10 µg) Versus Fluticasone and Formoterol Administered Alone, and Placebo in Patients With Moderate to Severe Asthma

The purpose of this study is to compare the efficacy and safety of the fixed combination asthma drug FlutiForm with its two components administered alone, fluticasone propionate and formoterol fumarate, and with placebo in adult and adolescent patients with moderate to severe asthma.


Eligibility Criteria:
Ages eligible for study: 12 years and above; genders eligible for study: both; prior steroid use: steroid-requiring

Inclusion Criteria:

* History of asthma for at least 12 months.
* Documented use of inhaled corticosteroid for at least 4 weeks prior to Screening Visit Demonstrate FEV-1 of 40-80% of predicted normal values at Screening and Baseline Visit.
* Documented reversibility of 15% within 12 months of Screening visit or at Screening Visit (15% increase from pre-FEV-1 levels following albuterol inhalation or nebulized albuterol administration).
* Symptoms of Asthma during Run-in.
* Females of childbearing potential must have a negative urine pregnancy test at Screening and Baseline Visits. Females are eligible only if they are not pregnant or lactating, and are either sterile or using acceptable methods of contraception
* Must otherwise be healthy.
* Provide written informed consent. Wishes of minors must be respected.

Exclusion Criteria:

* Life-threatening asthma within past year or during Run-In Period.
* History of systemic corticosteroid medication within 3 months before Screening Visit.
* History of omalizumab use within past 6 months.
* History of leukotriene receptor antagonist use, e.g. montelukast, within past week.
* Current evidence or history of any clinically significant disease or abnormality including uncontrolled hypertension, uncontrolled coronary artery disease, congestive heart failure, myocardial infarction, or cardiac dysrhythmia.
* Upper or lower respiratory infection within 4 weeks prior to Screening visit or during Run-In Period
* Significant, non-reversible, pulmonary disease (e.g., chronic obstructive pulmonary disease \[COPD\], cystic fibrosis, bronchiectasis).
* Known Human Immunodeficiency Virus (HIV)-positive status.
* Smoking history equivalent to "10 pack years".
* Current smoking history within 12 months prior to Screening Visit.
* Current evidence or history of alcohol and/or substance abuse within 12 months prior to Screening visit.
* Patients who are confined in institution.
Biomechanical Evaluation of a Novel, Compliant Low Profile Prosthetic Foot

The investigators have developed a novel layered low-profile prosthetic foot that is able to provide enhanced compliance without sacrificing strength for individuals with transtibial amputation who have long residual limbs. It is hypothesized that the proposed prosthesis will offer similar benefits to these individuals as comparable higher profile prostheses offer users with shorter residual limbs. The primary goal of this Phase I proposal is to assess the degree to which the proposed prosthesis can provide benefits to prosthesis users in this population, along with characterizing the degree to which the novel prosthesis emulates its taller counterparts.


Eligibility Criteria:
Inclusion Criteria:

1. 18-89 years old
2. unilateral transtibial amputation
3. daily use of a low profile foot
4. cognitive ability to understand and willingness to provide informed consent and follow the study protocol

Exclusion Criteria:

1. unable to perform walking for 2 minutes without an assistive device
2. other health conditions which may prevent them from participating in the study
Intravesical Liposomes for Ulcerative Cystitis

The objective is to instill liposomes reconstituted with sterile water into the bladder as a compassionate use treatment in one patient with ulcerative interstitial cystitis (IC).

A physician sponsored Investigation New Drug (IN) has been acquired from the FDA for compassionate use of this non-approved treatment in one patient from Dr. Peters' private practice. Since this treatment has not been used previously in the US, we propose to evaluate the safety and efficacy of the treatment in this one patient by comparing pre and post treatment symptom changes.

Prior to treatment (visit 1) baseline measures will be assessed: vital signs,pelvic/bladder pain on a visual analog scale (VAS; "0" being none and "10" being severe), concomitant medications, Serum pregnancy test and Antiphospholipid Antibody Panel, Urine cytology, urinalysis (dipstick), and culture.

At visits 2-5 (4 treatment visits) questionnaires will be completed and vital signs, pain VAS, post void residual (measured by bladder scan or catheter), unanticipated events, and voiding history (voiding diary) will also be assessed. Additionally, cystoscopy will be done prior to the first treatment to view the bladder lining. At each treatment visit, the patients will have a solution of liposomes instilled in the bladder with a catheter, retained for 30 minutes, and be carefully monitored for at least 1 hour after the liposomes are drained.

After treatment, visits 6 and 7 (follow up) will include vital signs with VAS pain assessment, post void residual (PVR), urinalysis (dipstick), unanticipated events assessment, questionnaire completion and review of voiding diary. Visit 8 (study exit) will include the same parameters measured at follow up visits 6 and 7 with the addition of cystoscopy and Antiphospholipid Antibody Panel testing.

Eligibility Criteria:
Inclusion Criteria:

* Ulcerative IC for at least 6 months documented,
* Negative urine cytology,
* Able to independently complete self administered questionnaires and voiding diaries.

Exclusion Criteria:

* Pregnant or lactating,
* History of bleeding diathesis,
* On anticoagulant therapy,
* Active peptic ulcer disease,
* Obvious neurological impairment,
* Known allergy to liposomes.
The Role of Oxytocin-receptor Signalling in Physiological Regulation of Eating Behaviour in Individuals with Obesity

The present study evaluates appetite, glucose metabolism, gastrointestinal motility and energy expenditure in men and women with obesity (BMI 30-40 kg/m2) under oxytocin exposure compared to placebo.

In a randomised, double-blind, placebo-controlled, crossover fashion, 24 participants will complete two experimental days (A and B) including a mixed meal test and an ad libitum meal test. The procedures during the two experimental days are similar except for intravenous infusion of oxytocin on experimental day A and placebo (saline) on experimental day B, respectively. On experimental days, oxytocin or placebo infusion will be started at timepoint -60 minutes. At timepoint 0 minutes, participants will ingest a liquid mixed meal. After 190 minutes, participants are served an ad libitum meal followed by ad libitum snacks.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years
* BMI between 30 and 40 kg/m2 (both included)
* Percentage body fat (BF%) ≥25 for men and ≥32 for women (assessed by bioelectrical impedance analysis)
* Informed oral and written consent

Exclusion Criteria:

* Anaemia (haemoglobin below normal range)
* Alanine aminotransferase (ALT) \>2 times normal values
* History of hepatobiliary and/or gastrointestinal disorder(s)
* Kidney disease (serum creatinine above normal range and/or urine albumin-creatinine ratio (uACR) \>30 mg/g confirmed by two measures)
* Previous gastric or intestinal resection, cholecystectomy and/or any major intra-abdominal surgery (including bariatric surgery)
* Previous pancreatic disease and/or neoplasia
* Regular tobacco smoking and/or use of other nicotine products
* Glycated haemoglobin (HbA1c) ≥48 and/or type 1 diabetes or type 2 diabetes requiring medical treatment
* Pituitary gland disorders
* Initiation of special diets, lifestyle changes and/or weight loss \>5% of total body weight within three months prior to or during study period
* Pregnancy or breastfeeding
* Long QTc on electrocardiogram (ECG) at screening (≥0.45 seconds for men and ≥0.46 seconds for women)
* Any physical or psychological condition or ongoing medication the investigator group suspect would interfere with trial participation
COPD Patients Diagnosed With GERD,COPD Exacerbations After Treatment With High Dose PPI

The purpose of this study is to determine which COPD patients have GERD and if COPD patients with GERD treated with high dose lansoprazole for 1 year decreases the frequency of COPD exacerbations compared to the previous year without treatment.

Gastroesophageal reflux disease (GERD) is a common esophageal disorder with 40% of the US adult population experiencing symptoms monthly. Pulmonary diseases associated with GERD may include pneumonia, pulmonary fibrosis, asthma, or chronic bronchitis. The latter may be a manifestation of chronic obstructive pulmonary disease (COPD), suggesting GERD as a risk factor for acute exacerbation of COPD. Acute exacerbations of COPD are a major cause of morbidity and mortality in patients with the disease. Recent work suggests that COPD patients with a minimum of weekly reflux symptoms have an increased number of COPD exacerbations that those who are either asymptomatic or have GERD symptoms less than once a week. On this basis, we theorized that in patients with COPD, who also have gastro esophageal reflux disease are at increase risk for acute exacerbations of COPD. To test this question, we will determine which COPD patients have GERD by 24 hour pH testing, treat their GERD with esomeprazole or lansoprazole for 1 year, and compare the number of COPD exacerbations during the treatment period to the previous year.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of COPD
* forced expiratory volume/forced vital capacity ratio (FEV1/FVC) of \< 70% on pulmonary function testing
* age \> 40 years
* \>20 pack year history of smoking

Exclusion Criteria:

* presence of the following disorders: respiratory disorders other than COPD, known esophageal disease such as cancer, achalasia, stricture, active peptic ulcer disease, Zollinger-Ellison syndrome, mastocytosis, scleroderma, or current abuse of alcohol defined as greater than three alcoholic drinks per day.
Glycyrrhetinic Acid-Effect on Serum Potassium and Insulin Resistance in Dialysis Patients

Background: 18B Glycyrrhetinic acid (active compound of Licorice) decreases serum potassium via enhanced renal potassium loss in healthy individuals and thereby inducing renal sodium retention and arterial hypertension.In dialysis patients this mechanism is disturbed and compensatory intestinal potassium secretion is enhanced. 18B Glycyrrhetinic acid is an inhibitor of 11B Hydroxysteroid dehydrogenase type 1 (11b HSD1). Inhibition of 11 b HSD1 offers a novel potential therapy to lower intracellular cortisol concentrations and thereby enhance insulin sensitivity.

Hypothesis: Glycyrrhetinic acid decreases serum potassium by enhanced intestinal excretion in dialysis patients and increases insulin sensivity by inhibition of 11b HSD

Methods: double blind, 6 month cross over trial comparing oral 18b Glycyrrhetinic acid with placebo in 24 nondiabetic dialysis patients.

Endpoints: predialytic serum potassium levels, insuline sensitivity assessed by fasting glucose and fasting insulin concentrations


Eligibility Criteria:
Inclusion Criteria:

* dialysis patients (\>3 months)

Exclusion Criteria:

* diabetics
* hospital stay in the last 4 weeks