cyrilzakka/clinical-trials huggingface dataset:
Mindfulness-Based Stress Reduction Techniques and Yoga for Treatment of Urinary Urge Incontinence (MBSR-Yoga)

Many women experience the accidental loss of urine called urge incontinence or overactive bladder (OAB) incontinence. Women describe this as a sudden, strong desire to pass urine which results in leakage before reaching the toilet. The current usual treatments for urge incontinence include behavioral treatment, physical therapy, and medicines. Although these treatments have been found to be effective in research studies, they are less effective over time in general practice. Because medicines have side effects, many women stop them. The purpose of this study is to explore different treatments that may provide another option for women with urge incontinence that might be effective. This is an initial study to see if these treatments are at least as effective as the usual treatments.

Hypothesis: Does Mind Based Stress Reduction(MBSR)(meditation practices)reduce urinary urge incontinence episodes?


Eligibility Criteria:
Inclusion Criteria:

1. Females at least 18 years of age
2. Five or more urge urinary incontinence episodes on a three-day voiding diary. Urge incontinence episodes will be determined based on voiding diary and subject indication of coincident urge symptoms, allowing self-characterization of incontinence type.
3. Urge predominant (urge \>50% of total incontinent episodes) urinary incontinence based on self-reported characterization of incontinent episodes on diary.
4. Request for treatment for urge urinary incontinence.
5. Subject is able to complete all study related items and interviews.

Exclusion Criteria:

1. Any current or recent (past 4 weeks) anticholinergic medication use. Patient may discontinue medication and after 4 weeks may be eligible for study.
2. Past non-pharmacologic treatment for urge incontinence such as supervised behavioral therapy, supervised or unsupervised physical therapy, supervised biofeedback, and transvaginal electrical stimulation.
3. Current symptomatic urinary tract infection that has not resolved prior start of MBSR group.
4. Symptoms of pelvic organ prolapse screened by PFDI (Pelvic Floor Disorder Inventory question #3) "Do you have a bulge or something falling out that you can see or feel in the vaginal area?"
5. Previous or currently implanted neuromodulation (sacral or tibial).
6. Surgically altered detrusor muscle, such as augmentation cystoplasty.
7. Women with known neurologic disease believed to potentially affect urinary function (Multiple sclerosis, spinal cord injuries, myasthenia gravis, Charcot-Marie-Tooth disease).
8. In the opinion of the investigator, inability to understand diary instructions and complete 3-day voiding diary.
9. Subject has been previously diagnosed with interstitial cystitis or chronic pelvic pain syndrome.
10. Currently pregnant or within 6 months postpartum (pregnancy is not excluded for safety reasons but for quality of data)
A Study of Basal Insulin Analog and Insulin Analog Mid Mixture in Chinese Participants With Type 2 Diabetes Mellitus

The purpose of this study is to compare the effectiveness of basal insulin analog and insulin analog mid mixture in Chinese participants with type 2 diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

* have type 2 diabetes as defined by World Health Organization (WHO) criteria
* are taking oral anti-hyperglycemic medications (OAMs) and are judged as OAM failure by the investigator
* most recent HbA1c value ≥7.5% within 12 weeks of study entry
* in the opinion of the investigator, require to initiate premix analog or basal insulin analog treatment
* willing to start with insulin treatment

Exclusion Criteria:

* have a diagnosis of type 1 diabetes
* have received any type of insulin within 24 months of study entry (except for intermittent use of insulin of less than 1 month each time)
* have serious preexisting medical or other conditions that, in the judgment of the investigator, would preclude participation in this study
* are pregnant or breastfeeding, or intend to become pregnant during the course of the study
* are currently enrolled or have participated, within the last 30 days in any other clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible
Specimen Banking From Patients With Lung Cancer

The primary objective of the protocol is to develop a comprehensive specimen banking program from patients with lung cancer for future translation research, which will enable the investigators to detect lung cancer earlier, develop better therapies and explore screening and prevention strategies.

The aims of the study are as follows: 1) to continue to unravel the complex biology of lung cancer 2) to identify early detection and prognostic markers to guide therapeutic decision 3) to define markers of response and/or resistance to drug therapy, and 4) to identify new therapeutic and prevention targets.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects who are undergoing further testing for the diagnosis or treatment of lung cancer.
2. Oral and written informed consent

Exclusion Criteria:

1. Any individual who does not give oral and written consent for participation
Colorectal Cancer Screening in a Community Health Setting

This randomized controlled pilot study at the Health Annex, Family Practice \& Counseling Network (FPCN), a community clinic in Southwest Philadelphia, aimed at providing data on the feasibility of a mailed FIT approach to CRC screening in a community health setting, and how patients respond to text messaging and behavioral economic engagement incentives.

This is a single-center RCT at the Family Practice \& Counseling Network (FPCN), a community clinic in Southwest Philadelphia with 320 eligible subjects between the ages of 50-74 randomized to two study arms:

1. text messaging outreach (text)
2. text messaging outreach with lottery for 1/5 chance to win a financial incentive (text + lottery).

Findings will provide data on the feasibility of this mailed FIT approach in a community health setting, and how patients respond to text messaging and behavioral economic engagement incentives.

Eligibility Criteria:
Inclusion Criteria:

1. Between 50 and 74 years old
2. Has active medical insurance
3. Has had had at least one visit at Health Annex in the prior 12 months (at time of chart review)
4. Due for CRC screening (no colonoscopy in last 10 years, sigmoidoscopy in last 5 years, or stool testing in last 1 year)
5. Asymptomatic for CRC

Exclusion Criteria:

1. Has had prior colonoscopy within 10 years, sigmoidoscopy within 5 years, and FOBT/FIT within twelve months of the chart review (we will exclude patients who self-report undergoing any of the above procedures)
2. Has a history of CRC
3. Has a history of other GI cancer
4. Has history of confirmed Inflammatory Bowel Disease (IBD) (e.g. Crohns disease, ulcerative colitis)
5. Has a history of colon polyps
6. Has had a colectomy
7. Has a first-degree relative that has been diagnosed with CRC
8. Has been diagnosed with Lynch Syndrome (i.e. HNPCC)
9. Has been diagnosed with Familial Adenomatous Polyposis (FAP).
10. Has iron deficiency anemia
11. Has recent history of lower GI bleeding
12. Has metastatic (Stage IV) blood or solid tumor cancer
13. Has end stage renal disease
14. Has had congestive heart failure
15. Has dementia
16. Has liver cirrhosis
17. Has any other condition that, in the opinion of the investigator, excludes the patient from participating in this study
18. Does not use a mobile phone enabled to send and receive text messages
Study to Evaluate the Effects of Single Ascending Oral Doses of ACD856 on Safety, Tolerability and Pharmacokinetics

The SAD design of the study is based on the aim to study safety, tolerability and PK of selected doses of ACD856 in a limited number of healthy volunteers. ACD856 will be administered orally.


Eligibility Criteria:
Inclusion Criteria:

* Signed and dated informed consent prior to any study-mandated procedure.´
* Willing and able to comply with study requirements.
* Healthy males and healthy women of non-childbearing potential aged ≥18 and \<65 years at screening.
* BMI ≥18.0 and ≤30.0 kg/m2 at screening.
* Males and females of non-childbearing potential may be included in the study. Male subjects must be willing to use condom or be vasectomized or practice sexual abstinence to prevent pregnancy and drug exposure of a partner and refrain from donating sperm from the date of dosing until 3 months after dosing with the IMP.
* Clinically acceptable medical history, physical findings, vital signs, ECG and laboratory values at the time of screening, as judged by the Investigator.

Exclusion Criteria:

* Planned treatment or treatment with another investigational drug within 3 months prior to randomization.
* Positive screen for drugs of abuse or a positive alcohol result at screening or admission to the clinic.
* Clinically relevant findings in laboratory parameters, ECG or vital signs at screening
* Current smokers or users of nicotine products.
* History of alcohol abuse or excessive intake of alcohol.
* Presence or history of drug abuse.
* History of, or current use of, anabolic steroids.
* Excessive caffeine consumption.
* Plasma donation within one month of screening or blood donation prior to screening.
Drug Interaction Study of Sorafenib and Rapamycin in Advanced Malignancies

The goal of this study is to determine whether a significant pharmacokinetic interaction exists between rapamycin and sorafenib.

This study will also look at the toxicity of the combination of rapamycin and sorafenib and the antitumor activity of the combination in subjects with advanced cancers.


Eligibility Criteria:
Inclusion Criteria:

* Solid cancer for which curative measures have failed or for which there is no known superior treatment
* ECOG performance status 0-2
* Measurable or non-measurable disease
* Life expectancy of greater than 12 weeks and no anticipated need for other antineoplastic therapy in the next 4 weeks
* Age 18 years or older
* Patients must have adequate organ and marrow function as defined below:

  * ALT and AST less than or equal to 2.5 x the ULN (\< 5 x ULN for patients with liver involvement).
  * hemoglobin greater than or equal to 9 g/dL
  * absolute neutrophil count greater than or equal to 1,500/μL
  * platelets greater than or equal to 100,000/μL (greater than or equal to 35,000/μL without transfusion for patients with CLL/SLL or follicular lymphoma)
  * total bilirubin less than or equal to 1.5 x ULN
  * creatinine less than or equal to 1.5 x ULN
* Women of childbearing potential must have a negative pregnancy test within 7 days of the start of treatment.
* Ability to understand and the willingness to sign a written informed consent document
* Must not have any evidence of bleeding diathesis.

Exclusion Criteria:

* Patients who have had chemotherapy or immunotherapy within 3 weeks or radiotherapy within 14 days prior to entering the study
* Patients may not be receiving any other investigational agents or any concomitant antineoplastic therapy
* Patients with uncontrolled brain metastases.
* Concurrent illness or medication exclusions
* HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with sorafenib or rapamycin.
Safety, Pharmacokinetics, and Pharmacodynamics of NBI-98854 in Children and Adolescents With Tourette Syndrome

This is a Phase 1b, open-label, multiple-dose study of the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of NBI-98854 in a total of 36 pediatric subjects with Tourette syndrome (TS). The study will be conducted in approximately 18 male and female children (6 to 11 years of age) and approximately 18 male and female adolescents (12 to 18 years of age). Both age groups will be divided equally into 3 dosing cohorts with 6 subjects each. Ascending doses will be evaluated as part of a staggered-cohort design. Study drug will be administered in each cohort for 14 consecutive days.


Eligibility Criteria:
Inclusion Criteria:

1. Have documentation of written informed consent, or written and witnessed assent from the subject and written informed consent from the subject's parent or legal guardian.
2. Be in good general health.
3. Have a Diagnostic and Statistical Manual of Mental Disorders diagnosis of Tourette Syndrome (DSM-IV or -V).
4. Have TS symptoms that impair school, occupational, and/or social function.
5. If medications are being used to treat TS symptoms, must be on stable doses of these medications for a minimum of 30 days before baseline (Day -1), and the medication regimen is expected to remain stable throughout the study period. The use of tetrabenazine to treat TS symptoms is prohibited.
6. Subjects of childbearing potential who do not practice total abstinence must be instructed on the proper use of barrier methods of contraception and agree to use hormonal or two forms of nonhormonal contraception consistently from screening until 30 days after the last dose of study drug.
7. Adolescent subjects (12 to 18 years of age) must have a negative urine drug screen for amphetamines, barbiturates, benzodiazepine, phencyclidine, cocaine, opiates, or cannabinoids. Subjects who are on stable doses of prescribed benzodiazepines, opiates, or psychostimulants are allowed to participate in the study.
8. Adolescent subjects (12 to 18 years of age) must have a negative alcohol breath test.
9. Be willing and able to adhere to the study regimen and study procedures described in the protocol and informed consent/assent forms, including all requirements at the study center and return for the follow-up visit.

Exclusion Criteria:

1. Have an unstable medical condition or chronic disease.
2. Had a medically significant illness within 30 days of screening.
3. Excessive use of tobacco and/or nicotine-containing products.
4. Have a history of substance (drug) dependence or substance or alcohol abuse.
5. Are currently pregnant or lactating.
6. Have a known history of neuroleptic malignant syndrome.
7. Have a known history of long QT syndrome or cardiac tachy-arrhythmia.
8. Have a cancer diagnosis within 3 years prior to screening, with the exception of localized skin cancer or carcinoma in situ of the cervix.
9. Have received an investigational drug within 30 days before screening or plan to use an investigational drug (other than NBI-98854) during the study.
10. Have a significant risk of suicidal or violent behavior.
Bendamustine Hydrochloride Injection for Initial Treatment of Chronic Lymphocytic Leukemia

To compare the clinical efficacy and safety of bendamustine hydrochloride versus chlorambucil for initial treatment of chronic lymphocytic leukemia

Patients will be assessed for response after three cycles of treatment. Two additional cycles are recommended for CR, PR or SD patients, up to a maximum limit of six cycles in total. Patients will be followed up every three months until disease progression or death.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have a diagnosis of CLL according to National Cancer Institute (NCI) Working Group criteria
* No prior treatment for CLL
* Binet stage B or C
* ECOG performance status ≤ 2
* Life expectancy ≥3 months
* AST and ALT ≤ 3 x ULN; Total bilirubin ≤ 2 x ULN; Creatinine clearance ≥ 40 mL/min
* Written informed consent

Exclusion Criteria:

* Patients were diagnosed with or treated for malignant tumors other than CLL (including central nervous system lymphoma) within one year prior to entering the study
* Transformation to Richter's syndrome, or prolymphocytic leukemia (PLL)
* Autoimmune hemolytic anemia requiring glucocorticoid therapy
* Autoimmune thrombocytopenia requiring glucocorticoid therapy
* Participation in any other clinical trials within 4 weeks prior to study entry
* Any of the following conditions: severe heart failure; cardiomyopathy; myocardial infarction within 6 months; severe, uncontrolled diabetes; severe, uncontrolled hypertension; active, uncontrolled infection; central nervous system dysfunction
* Patients received major surgery within 30 days prior to study entry
* Pregnant or lactating women
* Allergic to study drug or mannitol
Ondansetron Plus Dexamethasone With or Without Metoclopramide as Antiemetic Prophylaxis After Receiving Cisplatin

The objective of this study is to assess the efficacy and tolerability of metoclopramide added to standard antiemetic regimen for prophylaxis of cisplatin-induced emesis.

Ondansetron plus dexamethasone are standard emetic prophylactic agents for highly emetogenic chemotherapy. Metoclopramide is a dopamine antagonist, which may enhance efficacy of ondansetron and dexamethasone.

Eligibility Criteria:
Inclusion Criteria:

* schedule to receive first cycle of cisplatin \> 50 mg/m\^2
* pathologically or histologically confirmed solid cancer
* more than 18 years old
* creatinine clearance more than 50 ml/min
* aminotransferase less than 2 times of upper normal limit

Exclusion Criteria:

* pregnant woman
* patients with episode of vomiting within 24 hours prior to chemotherapy session
* gut obstruction
* brain metastasis
* abdominal or pelvic irradiation
* no history of allergy to study drugs
A Study to Evaluate the Effect of Fluconazole, Bupropion, or Itraconazole on the Drug Levels and Safety of BMS-986235

This study will evaluate the effect of inhibitors, at steady state, on the drug levels, safety, and tolerability of BMS-986235 when taken by healthy participants. The inhibitors to be utilized in this study are fluconazole, bupropion, and itraconazole.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index of 18.0 kg/m2 to 32.0 kg/m2, inclusive, at screening.
* Males and females must agree to follow specific methods of contraception, if applicable.
* Healthy participants, as determined by no clinically significant deviation from normal in physical examination, ECGs, and clinical laboratory determinations, and no significant findings in medical history.

Exclusion Criteria:

* Women of childbearing potential (WOCBP), women who are pregnant or breastfeeding
* Inability to tolerate oral medication
* Known previous exposure to BMS-986235.

Other protocol-defined inclusion/exclusion criteria apply
Interest of the Balance of Pro-coagulating and Profibrinolytis Activities of the Microparticles (MP) in the Prognosis of Septic Shock

Septic shock is a clinical syndrome occurring in 10 to 20% of patients admitted in ICV. Mortality associated to septic shock varies from 30 to 50%. It follows a systemic response of the organism to a severe infection, associated with a circulatory failure marker by an arterial hypotension and a vascular hyperactivity to vasoconstrictor agents.

The mechanisms involved on one hand an activation of white blood cells inflammatory system and the vascular inflammatory system; and on the other hand on imbalance in hemostatis characterized by an activation of the coagulation and an inappropriate fibrinolysis leading to a disruption of microcirculation in the context of a disseminated intravascular coagulation (DIVC).

This inflammatory and thrombotic cellular activation is strongly associated with the phenomenon of vesiculation; leading to the production of cellular microparticles (MP) by blood cells and vascular cells.

MP are membranous vesicles, resulting in the reassortment of membrane phospholides in response to an activation of cellular apoptosis. They have been initially described as new actors of hemostatis. Indeed, the expression of phospholipid serine and tissular factor (TF) confer them a procoagulating activity, which increases in patients undergoing septic shock.

The finding of a fibriniolytic activity of the cellular MP suggests the existence of compensating mechanisms with a procoagulating activity. This confers to MP a key-role in the control of the coagulolytic balance.

Our recent researches suggest that endothelial and white blood cells MP produce in vivo plasmin.

They carry into the main circulation a fibrinolytic activity which is partially beyond the physiological inhibitors activity (PAI-1, x 2 antiplasmin). Preliminary findings show that this ability of plasmin generation is important in patients affected with septic shock.

Our hypothesis is that an increase in plasmin generation by MP compensates the risk of occurrence of microthrombosis, modulating therefore the vital prognosis of patients with septic shock.

The coagulolytic balance of MP, which is resulting of their own procoagulating and fibrinolytic activities could claim the status of new pronostic marker relevant in patients with septic shock.


Eligibility Criteria:
Inclusion Criteria:

* Patient with septic shock

Exclusion Criteria:

* age under 18 yo
* pregnant woman
* septic shock since more than 24 hours
* patient hospitalized for cardiac arrest
* immunocompromised patients
* patient in whom the stop of active therapeutic is discuss
* patient treated with an anti-coagulant at therapeutic dose
Genetic Epidemiology of Adult Onset Glioma

To establish a clinic based case control study for examination of potential risk factors for primary adult brain tumors.

Genetic epidemiology of adult glioma to establish potential risk factors for primary adult brain tumors.

Eligibility Criteria:
Inclusion Criteria:

* primary glioma of any stage
* diagnosed within 4 months
Aromatherapy and Essential Oils in Improving Insomnia and Other Symptoms in Patients With Newly Diagnosed Acute Leukemia Undergoing Chemotherapy

This randomized clinical trial studies aromatherapy and essential oils in improving insomnia and other symptoms in patients with newly diagnosed acute leukemia. Aromatherapy and essential oils may help improve insomnia and other complications caused by chemotherapy.

PRIMARY OBJECTIVES:

I. Does the addition of aromatherapy by diffusion of essential oils improve insomnia in newly diagnosed, hospitalized leukemia patients?

SECONDARY OBJECTIVES:

I. Does the addition of aromatherapy by diffusion of essential oils improve other common symptoms in newly diagnosed, hospitalized leukemia patients, including pain, nausea, lack of appetite, shortness of breath, depression, anxiety and wellbeing? II. Do newly diagnosed, hospitalized leukemia patients find the use of aromatherapy for symptom management a positive experience?

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients select between 3 scented essential oils: peppermint, lavender, or chamomile which is diffused in the hospital room from approximately 9 PM in the evening until morning during week 1 and placebo intervention using rose water during week 2.

GROUP II: Patients undergo placebo intervention using rose water during week 1 and aromatherapy and essential oils as in Group I during week 2.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are newly diagnosed with acute leukemia and hospitalized to receive their initial 4 weeks of intensive induction chemotherapy for this disease

Exclusion Criteria:

* Asthma or other reactive airway disease
* Sleep apnea
* Planned less than two week hospitalization
* Change in pain medications/sleeping medications/anxiety medications/antiemetics during the trial
* Patients who have not completed their initial steroids
* Patients who are confused and unable to give informed consent