cyrilzakka/clinical-trials huggingface dataset:
Randomized Trial of Mosapride Versus Placebo in the Treatment of Constipation-Predominant Irritable Bowel Syndrome

The purpose of this study is to determine whether Mosapride, an agent which acts on serotonin receptors in the gastrointestinal tract, is effective in the treatment of constipation-predominant irritable bowel syndrome (C-IBS).


Eligibility Criteria:
Inclusion Criteria:

* Rome III Criteria for IBS:

Patients must have recurrent abdominal pain or discomfort at least 3 days per month during the previous 3 months that is associated with 2 or more of the following:

* Relieved by defecation
* Onset associated with a change in stool frequency
* Onset associated with a change in stool form or appearance

In addition, patients have to experience at least two of the following symptoms for at least 25% of the time \[11\]:

* Altered stool frequency (\< 3 bowel movements per week)
* Altered stool form (lumpy/hard i.e. Bristol type I-III \[see appendix 1\])
* Altered stool passage (straining, urgency, or a feeling of incomplete evacuation)
* Passage of mucus, bloating, or a feeling of abdominal distension

Exclusion Criteria:

* Previous allergy to mosapride
* Nocturnal Symptoms (pain in the middle of the night, or other nocturnal symptoms which suggest an organic disease)
* Age \< 18 years
* History of bloody stools or melena
* Diarrhea (\>3 bowel movements per day)
* Constitutional symptoms (fever, weight loss)
* Severe constipation (\< 1 bm/week)
* Pregnancy or lactation
* Patients with history of cardiac arrhythmias
* QT prolongation on baseline ECG
* Chronic laxative use and dependence
* Patients with previous history of congenital heart disease
* Patients with previous history of hypokalemia or hyperkalemia
* Patients taking the following classes of drugs: HIV antivirals, macrolides, anti-arrhythmics, and azole drugs.
CBM in the Context of Exposure for Acrophobia

The proposed study will apply a one-session exposure treatment combined with CBM training modifying interpretational processing biases versus a sham training in acrophobic individuals. The main aim is to advance our understanding of the mechanisms underlying exposure treatment.

The present study will apply a one-session exposure treatment followed by a computerized interpretational training (CBM) or sham training in acrophobic individuals. By doing so, it aims to better understand the mechanisms underlying exposure, i.e., the role of cognitive change. Specifically, this study aims to enhance changes in disorder-relevant cognitive processing post-exposure, compared to a sham training. Further, we hope to improve both therapy outcomes and the generalization of therapeutic effects.

Eligibility Criteria:
Inclusion criteria:

1. Informed consent
2. Sufficient German language skills to complete the experimental tasks and questionnaires
3. Aged between 18 and 65 years
4. Current primary diagnosis of acrophobia as defined by DSM-5 (based on DIPS)
5. Lives within reasonable travelling distance of the research center

Exclusion criteria:

1. Currently in psychotherapeutic treatment
2. Impaired therapy capability (as judged by researcher/clinician)
3. Current diagnosis of substance use disorder (via DIPS)
4. Current or past diagnosis of psychotic disorder or bipolar disorder (via DIPS)
5. Acute suicidality (via DIPS)
6. Diagnosis of chronical physical or neurological diseases (self-reported by participant)
7. Personality Disorder (via DIPS or via clinical judgement)
8. Attention-deficit hyperactivity disorder (self-reported by participant or via DIPS)
9. Intellectual disability (self-reported by participant or via clinical judgment)
10. Women: pregnancy or breast feeding (self-reported by participant)
11. Intake of medication that could impede the effects of exposure therapy or CBM training (e.g., Lorazepam)
A Study to Determine the Safety, Drug Levels and Drug Effects of BMS-986196 and Food and Formulation Effects on Relative Absorption Healthy Participants

The purpose of this study is to characterize the safety, tolerability, drug levels and drug effects of BMS-986196 in healthy participants. In addition, an evaluation of food and formulation effects on BMS-986196 absorption will be performed.


Eligibility Criteria:
Inclusion Criteria:

* Women not of childbearing potential and men, ages 18 or local age of majority to 55 years, inclusive
* Healthy male and female non-Japanese participants without clinically significant deviation from normal in medical history, physical examination, electrocardiogram (ECG), and clinical laboratory determinations
* Body mass index (BMI) of 18 to 32 kg/m2, inclusive, and total body weight ≥ 50 kg

Exclusion Criteria:

* Known or suspected autoimmune disorder, including but not limited to rheumatoid arthritis, fibromyalgia, systemic lupus erythematosus, polymyalgia rheumatica, giant cell arteritis, Behcet's disease, dermatomyositis, MS, moderate to severe asthma, any autoimmune vasculitis, autoimmune hepatitis, or any other active autoimmune disease for which a participant requires medical follow-up or medical treatment
* Any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the participant's immune status
* Presence of any factors that would predispose the participant to develop infection
* A history of bacterial or fungal meningitis within 1 year prior to screening
* A history of intracranial or intraspinal bleeding
* Known intracranial space-occupying mass, including meningioma

Other protocol-defined inclusion/exclusion criteria apply
Validation of a Novel Robot-aided Assessment of Gait Ability

The aim of this study is the validation of a novel gait assessment method implemented in the Lokomat gait trainer with respect to established clinical gait assessment methods. The walking assessment method is based on the progressive reduction of the support of the device. The outcome measures of this algorithm will be the support needed in the different gait phases (guidance force of hip and knee joints) and the support required to the body weight support system (unloading). The hypothesis is that the guidance force and the support of the device will converge to a profile individual for each subject that is representative of one's impairment in the different gait phases. The reliability of the method will be tested collecting data from two sessions of Lokomat training. The validity of the method will be tested comparing the outcome of the assessment task with established clinical walking assessment measures.


Eligibility Criteria:
Inclusion Criteria:

* individuals \>1 year post Spinal Cord Injury or able bodied persons

Exclusion Criteria:

* presence of contraindications to Lokomat training, inability or unwillingness to provide written informed consent or follow study procedures
Post-stroke Immunological Changes in Young Stroke Patients

In the present study, the investigators aim to elucidate the role of T-cells on cognitive decline in younger stroke patients, using repeated cognitive testing, brain imaging, and immunological analyses in the first 6 month after stroke. The examiners will investigate (i) the extent and duration of stroke-induced changes in T cell function within the peripheral blood of patients; and (ii) post-stroke cognitive functions.

Demands from society on stroke patients of younger age are in most cases higher than for elderly stroke patients, because of occupational obligations and often their role as a caregiver for a young family. For example, return to their former workplace may be impossible even if cognitive deficits, e.g., in the memory domain, are only "minor" according to standardized tests. Thus, cognitive function after stroke is of utmost importance for activities of daily life and quality of life in young stroke patients. In order to prevent or at least reduce post-stroke cognitive decline, the mechanisms underlying the decline need to be further elucidated, to eventually develop new preventive and therapeutic approaches.

T-cell activation is associated with destruction of brain tissue. In neurodegenerative diseases that primarily impair cognitive functions, e. g., Alzheimers Disease, T-cells were identified as important mediators of disease pathology. Activation of cells of the adaptive immune system, most importantly T-cells, has been also investigated in experimental stroke. Here, these cells significantly contribute to secondary brain tissue damage. Stroke is associated with massive changes of the central and peripheral immune response. The investigators and other groups demonstrated that despite an overall lymphopenia, T-cells are functionally intact and pro-inflammatorily polarized, for at least two weeks post-stroke. Depletion of T cells has been shown to reduce infarct volume and to improve outcome in mice post-experimental stroke.

Eligibility Criteria:
Inclusion criteria

* Acute stroke that occurred within the last 72 hours as defined by acute neurological deficit in combination with an acute ischaemic infarct as documented by either a "Diffusion weighted imaging" (DWI)-positive lesion on MR imaging or a new lesion on a CT scan; only cortical/subcortical infarcts will be included
* Age \> 18; ≤ 55
* Provision of written informed consent or through a surrogate as appropriate
* Willingness to participate in follow-up
* National Institute of Health Stroke Scale Score (NIHSS) ≥ 4
* German as first language (neuropsychological tests and cut-offs developed for native speakers)

Exclusion criteria

* Patients are excluded if they are not able to give informed consent due to severe cognitive deficits
* Signs of infection on admission (C-reactive protein ≥ 50 mg/L)
* Patients receiving immunosuppressive drugs or diagnosed with a malignancy or severe neurological diseases other than stroke (e.g., neurodegenerative movement disorders, motoneuron diseases)
FIRMAGON® Intensive Drug Monitoring

To evaluate the safety profile of FIRMAGON® (to fulfill the regulatory authority's requirement of Intensive Drug Monitoring in Chinese participants with prostate cancer need androgen deprivation therapy \[ADT\] treated with FIRMAGON®).

Study Design

This study is a multi-center, single-arm, non-interventional, prospective study among Chinese participants with prostate cancer in need of ADT, receiving treatment with FIRMAGON®. This program provided the minimum 6 doses and maximum 12 doses of FIRMAGON® to enrolled participants during one-year follow-up. Participants who met the inclusion criteria would or were accepting at least 6 self-financed doses of treatment in a hospital. Participants should return to the hospital for medical assessment every three months. The prescription of 6 (3 doses × 2 times) self-financed doses will be given by doctors after assessment, and the direct-to-participant pharmacy will distribute FIRMAGON® to eligible participants (participants should bring the prescriptions and the last FIRMAGON® boxes to get other doses). All enrolled participants were followed up to collect safety information for one year from the 1st dose unless withdrawal of Informed Consent Form, discontinuation for 2 months, lost to follow-up, death, or termination due to other reasons, whichever came first.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with prostate cancer and in need of ADT
* Decision made to prescribe FIRMAGON® prior to enrollment
* Willingness and ability to provide written informed consent
* The participants are taking the marketed drug FIRMAGON®

Exclusion Criteria:

* Not signed informed consent
* Any participants who are unsuitable to participate in this study because of any other reasons will not be qualified to participate in this study.
Photon/Proton Radiation Therapy for Carcinoma of the Nasopharynx

The purpose of this study is to collect outcomes information to see what effects photon/proton beam radiation has on nasopharynx cancer.

Data collection will be obtained from the patient's medical records including initial evaluation, pathology report, dosimetry information, radiotherapy completion records and follow-up.

Eligibility Criteria:
Inclusion Criteria:

\* Nasopharynx cancer.

Exclusion Criteria:

* Evidence of distant metastasis.
* Previous radiation for head and neck cancer.
The Nuvigil and Provigil Pregnancy Registry

The primary objective of the Nuvigil/Provigil Pregnancy Registry is to characterize the pregnancy and fetal outcomes associated with Nuvigil and Provigil exposure during pregnancy.

Both the prospective and the retrospective data are captured.

Eligibility Criteria:
Inclusion Criteria:

* Reported exposure to brand or generic formulations of Nuvigil (armodafinil) and/or Provigil (modafinil) within 6 weeks prior to becoming pregnant, or during pregnancy
* Patients who provide oral or written informed consent.
* Infant up to 1 year of age born to a female with maternal exposure to armodafinil and/or modafinil within 6 weeks prior to becoming pregnant or during pregnancy.
* Able and willing to provide healthcare professional and secondary contact information, and for the patient herself to be contacted periodically by Registry staff.

Exclusion Criteria:

* Patients who refuse to provide oral or written informed consent.
* Patients not exposed to armodafinil or modafinil within 6 weeks prior to becoming pregnant or during pregnancy.
* Infants whose mother was not exposed to armodafinil or modafinil within 6 weeks prior to becoming pregnant or during pregnancy.
LIVE-C-Free: Early and Late Treatment of Hepatitis C With Sofosbuvir/Ledipasvir in Liver Transplant Recipients

The predominant remaining questions for post-transplant treatment of Hepatitis C virus (HCV) in the DAA (direct acting anti-virals) era are whether a ribavirin-free regimen is possible and whether pre-emptive treatment is now a potential option to prevent long-term damage to the allograft.

Our aim is to provide answers to these primary questions with our multicenter, prospective, randomized, open-label intent-to-treat phase IV study

This is a multicenter, prospective, randomized, open-label phase IV study.

Compare ledipasvir/sofosbuvir + ribavirin for 12 weeks vs ledipasvir/sofosbuvir alone for 12 weeks in patients over 90 days post-liver transplant

Eligibility Criteria:
Inclusion Criteria

1. At least 18 years of age and able to give informed consent
2. History of HCV genotype 1 or 4
3. Normal EKG
4. At least 91 days post orthotopic liver transplant
5. Screening laboratory values within defined thresholds
6. Detectable HCV RNA at screening
7. Creatinine Clearance of at least 40ml/min using the Cockcroft Gault equation
8. Negative pregnancy test for female subjects within 48 hours prior to receiving study medication
9. Use of two effective contraception methods if female of childbearing potential or sexually active male unless status post bilateral tubal ligation, bilateral oophorectomy, hysterectomy, or vasectomy

Exclusion Criteria

1. Serious or active medical or psychiatric illness
2. History of significant or unstable cardiac disease
3. Stomach disorder that could interfere with the absorption of the study drug
4. Pregnant or nursing females or males with a pregnant female partner
5. Co-infected with Hepatits B (HBV) or HIV
6. Recipients of an allograft from a donor that was infected with HCV with an unknown genotype or non-genotype 1 or 4 unless the recipient is demonstrated to have only genotype 1 or 4 HCV replication post-transplant
7. Allergic to or intolerant of sofosbuvir, ledipasvir, or ribavirin
8. History of exposure to an Nonstructural protein (NS5A) inhibitor
9. Within 1 year of transplant AND history of Hepatocellular Carcinoma (HCC) with tumor burden outside of the Milan Criteria (See Appendix II) prior to transplant
10. Participated in a clinical study with an investigational drug or biologic within the last 30 days
11. Combined liver/kidney transplant
12. History of organ transplant other than liver
13. Childs Turcotte Pugh (CTP) B or C
14. Patients with fibrosing cholestatic hepatitis
15. Platelet count of ≤ 30 k/mm3
16. Hemoglobin \< 10g/dL
17. Total bilirubin \> 10mg/dL
18. Alanine aminotransferase (ALT),aspartate aminotransferase (AST), or alkaline phosphatase ≥ 10x upper limit normal
19. Serum sodium \< 125mmol/L
20. Current use of any of the Prohibited Interventions (Section 5.3.2) and un-willing to discontinue use, or use of amiodarone within 6 months of screening
Dopamine in Acute Decompensated Heart Failure (DAD-HF) Trial

The aim of this study is to compare the effects of high-dose furosemide versus low-dose furosemide combined with low-dose dopamine on diuresis, renal function, electrolyte balance, and 60-day post-discharge outcomes in patients hospitalized with acute decompensated heart failure.

Worsening renal function (WRF) and hypokalemia related to diuretic use for acute decompensated heart failure (ADHF) are common and portend poor prognosis. Low dose dopamine infusion improves renal perfusion. Whether dopamine infusion improves diuresis and/or reduces renal complication in ADHF is not known. The aim of this study is to compare the effects of high-dose furosemide (HDF, 40 mg furosemide bolus IV, followed by continuous IV infusion of 20 mg/h for a total of 8 hours) vs. low-dose furosemide combined with low-dose dopamine (LDFD, 40 mg furosemide bolus IV, followed by continuous IV infusion of 5 mg/h furosemide plus 5μg/kg/min dopamine for a total of 8 hours) on diuresis, renal function, electrolyte balance, and 60-day post-discharge outcomes in patients hospitalized with ADHF.

Eligibility Criteria:
Inclusion Criteria:

* patients with New York Heart Association (NYHA) functional class IV heart failure according to the American Heart Association (AHA) classification, namely dyspnea on minimal exertion or rest dyspnea, orthopnea, and paroxysmal nocturnal dyspnea
* signs of congestion (third heart sound or pulmonary rales on physical examination)
* pulmonary congestion on chest x-ray
* serum B-type natriuretic peptide levels \> 400 pg/ml or NT-proBNP \> 1500 pg/ml
* echocardiographic documentation of systolic or diastolic dysfunction
* all candidate patients must be:
* Age \>18 years old
* on medical therapy with an ACE-inhibitor and/or a β-blocker
* experiencing an acute decompensation of known chronic HF
* Having baseline oxygen saturation \<90% on admission arterial blood gas

Exclusion Criteria:

* the investigators will exclude patients with:

  * acute de novo HF
  * severe renal failure (serum creatinine \> 200 μmol/L or GFR \< 30 ml/min/1.73m2)
  * admission systolic blood pressure \< 90 mm Hg
  * severe valvular disease
  * known adverse reactions to furosemide or dopamine
  * HF secondary to congenital heart disease
  * a scheduled procedure with a need for IV contrast dye
  * a scheduled cardiac surgery within 6 months
Evaluation of the Vaginal Colonization of Two New Lactobacillus Strains After Oral Administration in Healthy Volunteers

Randomized study to determine whether the vaginally isolated strains of Lactobacillus gasseri and/or Lactobacillus crispatus can colonize the vagina when taken orally for 18 days. Secondary outcomes comprise evaluation of safety, tolerability, impact on vaginal microbiota and vaginal pH

Double blind, randomized, placebo-controlled biomedical research study to determine whether supplementation with the vaginally isolated strains of Lactobacillus gasseri and/or Lactobacillus crispatus can colonize the vagina. Healthy women who meet inclusion and exclusion criteria will be randomized 1.5:1.5:1 to one of the following study groups: group one will receive L.gasseri for 18 days (1 capsule/day), group two will recieve the combination of L.gasseri and L.Crispatus for 18 days (1 capsule/day) and the other will receive placebo, starting the day after menstruation is over. Main study outcome will be colonization throughout the study, which will be determined by analysis of specific strains by qPCR. Secondary outcomes comprise comprise evaluation of tolerability, impact on vaginal microbiota, vaginal pH and adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Healthy women
* Reproductive age 18-45 years

Exclusion Criteria:

* Vaginal infection or symptoms (AMSEL criteria).
* Relevant disease (immunodeficiency, cervicovaginal pathology, diabetes, estrogen-dependent tumors, inflammatory bowel disease, atrophic vaginitis, pancreatitis)
* Suffer from chronic diarrhea or constipation or short bowel syndrome,
* Having taken systemic or vaginal antibiotics or antifungals during the month prior to study entry.
* Pregnant women or willing to be during the study, lactating women.
* Having taken another probiotic during the month prior to study entry orally or vaginally. This includes food supplements or foods supplemented with probiotics such as Actimel, Activia or similar.
* Intake of immunomodulators or systemic corticosteroids.
* History of alcohol or drug abuse.
* Menopausal women.
* Use of the IUD.
* Use of spermicides or vaginal lubricants during the month prior to study entry.
* Very irregular periods or low probability of going at least 18 days without menstruation (short cycles).
* Have participated in a clinical trial during the month prior to entering the study.
* Not being able to follow or understand study procedures. This includes not being willing to maintain sexual abstinence during the 24 hours prior to each vaginal sample collection.
* Any other condition not compatible with the study according to the investigators
Effect of Cyclic Loading (Vibration) on Orthodontic Tooth Movement

To gather data indicating whether or not the OrthoAccel device speeds tooth movement in people who use orthodontics (braces).

This is a randomized, blinded study that will follow 32 patients for up to six months. Patients will have a minimum of 3 mm of extraction space that needs to be closed by moving the anterior teeth or canine distally. Patients will have standard orthodontic treatment and temporary anchorage devices for tooth movement and space closure. Half the patients will receive a functioning device and half the patients will receive a sham-device. Patients will use the device for 20 minutes daily; the device has a mouthpiece for the patient to lightly bite into plus a connected enclosure that stays outside the mouth. The enclosure provides a light vibration.

Eligibility Criteria:
Inclusion Criteria:

* Permanent dentition between the ages of 12 and 40
* Minimum of 3 mm of extraction space to be closed by distal movement of all 6 anterior teeth from canine to canine or by distal movement of the canines
* Good oral hygiene and compliance

Exclusion Criteria:

* Any compromised medical or dental condition
* Patient currently involved in any other study
* Lives significantly outside San Antonio, TX
* use of bisphosphonates
* pregnant females
Efficacy And Safety Of Macugen In Patients With Neovascular AMD In Routine Clinical Practice.

Efficacy and safety of MACUGEN in patients suffering from neovascular age-related macular degeneration in routine clinical practice at least as good as demonstrated in randomized multicenter clinical trials.

Eligible patients in routine clinical practice

Eligibility Criteria:
Inclusion Criteria:

adults with neovascular age-related macula degeneration

Exclusion Criteria:

according to SmPC