cyrilzakka/clinical-trials huggingface dataset:
Efficacy/Safety Study to Confirm Iberogast's Efficacy in Patients With Irritable Bowel Syndrome Diagnosed on ROME III Criteria Compared to Placebo

The study shall prove whether treatment of irritable bowel syndrome with Iberogast is superior to placebo regarding the main criterium "pain"


Eligibility Criteria:
Inclusion Criteria:

* Patients of either sex aged \>18 years
* Patients meeting the Rome III irritable bowel syndrome (IBS) diagnostic criteria. IBS is defined as recurrent abdominal pain or discomfort at least 3 days/month in last 3 months (onset at least 6 months ago) associated with two or more of the following:

  * Improvement with defecation
  * Onset associated with a change in frequency of stool
  * Onset associated with a change in form (appearance) of stool
* History of pain intensity with an average of worst abdominal pain in past 24 hours score of \> 30 on a daily measured VAS (visual analogue scale) during screening phase

Exclusion Criteria:

* Intake of STW5 within the last 5 years
* Concomitant treatment during the study (including screening phase) with any medication that could influence the gastrointestinal function
* Regular intake of nonsteroidal antiphlogistic drugs incl. COX-2-inhibitors (exception: acetylsalicylic acid for cardiovascular prevention up to 100 mg daily)
* Patients with known hypersensitivity to any component of the trial drugs
* History of eating disorders
* Patients with a history of diseases with abdominal symptoms that can resemble IBS
* Presence of any other acute or chronic gastrointestinal disorder
* History of abdominal surgery (cholecystectomy and appendectomy can be tolerated when performed at least one year previously)
* Known intolerance to azo dyes E 110 and E 151
Maintenance Treatment With Liposomal Doxorubicin (Caelyx) in Metastatic Breast Cancer Patients

This is a randomized, prospective and multicenter phase IV clinical trial, which has been designed as a phase III study. One hundred fifty-four women (77 per treatment arm) will be recruited in the study.

The main variable is time to disease progression. All patients must be treated with first line of induction chemotherapy, consisting of doxorubicin 75 mg/m2, day 1 every 3 weeks, and docetaxel, 100 mg/m2, day 1 every 3 weeks. Both drugs must be administered sequentially. Patients previously treated with anthracyclines must receive 2 courses of doxorubicin and 4 courses of docetaxel. Otherwise, patients will receive 3 courses of doxorubicin followed by 3 courses of docetaxel.

Patients with complete response, partial response or stable disease are eligible for 2001-01 study.

The investigators assume that maintenance treatment with Caelyx will increase mean time to progression from 10, 46 months (observation) to 17, 43 months. Expected difference in mean time to progression is 6, 97 months (Hazard ratio = 0.6). With an alpha error of 0.01 (unilateral) and power of 80%, 77 patients per arm are needed, 154 patients in total.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent.
* Patients with metastatic breast cancer who have responded to a first line induction chemotherapy treatment.
* Age: at least 18 years old.
* Performance status Eastern Cooperative Oncology Group (ECOG) scale 0, 1, 2.
* Normal cardiac function, confirmed by left ventricular ejection fraction (LVEF).
* Hematology: leucocytes \>= 4 x 10\^9/l; neutrophils \>= 2.0 x 10\^9/l; platelets \>= 100 x 10\^9/l; hemoglobin \<= 10 g/dl.
* Hepatic function: total bilirubin \< 1 upper limit of normal (UNL); aspartate aminotransferase (ASAT) (SGOT) and alanine aminotransferase (ALAT) (SGPT) \< 2.5 UNL; alkaline phosphatase \< 5 UNL. Patients with ASAT (SGOT) and ALAT (SGPT) \> 1.5 UNL and alkaline phosphatase \> 2.5 UNL are not eligible.
* Renal function: creatinine \< 175 mmol/l (2 mg/dl); creatinine clearance \> 45 ml/min.

Exclusion Criteria:

* Pregnant or lactating patients.
* Previous cardiac dysfunction grade II or higher as per New York Heart Association, along with congestive cardiac failure.
* Hypersensitivity to anthracyclines or Cremophor®.
* Clinically significant hepatic dysfunction.
* Current uncontrolled infection.
* Mental confusion and lack of orientation.
* Any circumstance precluding an adequate follow-up.
* Radiotherapy in the previous 4 weeks.
* Any other concurrent neoplasm, except for basal cell carcinoma or in situ carcinoma.
* Symptomatic metastasis in the brain.
* Previous radiotherapy radiating a third of haematopoietic centres.
* Males.
Translation of the Sydney Swallow Questionnaire and Validation of the German Version

Translation of a validated questionnaire (SSQ) from english to german and validation of the german version. The SSQ consists of 17 well-structured questions for the assessment and quantification of patient reported difficulties in swallowing function. The tool is specifically designed to evaluate important aspects of swallowing function The questions cover the symptoms related to combinations of variables like the anatomic region, type of dysfunction, and the consistency of swallowed bolus.


Eligibility Criteria:
Inclusion criteria: - patients with diagnosed dysphagia "of any causes"

* sufficient proficiency in german
* voluntary participation

Exclusion criteria: - insufficient knowledge of the german language

* cognitive limitations
* reduced general state of health
Investigating the Use of Prolia (Denosumab) in the Treatment of Acute Charcot Neuroarthropathy

Charcot neuroarthropathy (CN) is a debilitating disease primarily affecting poorly controlled diabetic patients with peripheral neuropathy. The consequences of CN include ulcerations of the foot and ankle, osteomyelitis, and severe musculoskeletal deformity. These consequences frequently lead to below-knee amputation of the affected limb.

Currently treatment options are limited, and no pharmaceutical treatment has been efficacious in the medical literature. The purpose of this pilot study is to investigate the potential of the medication denosumab for acute stage Charcot neuroarthropathy.


Eligibility Criteria:
Inclusion Criteria:

* Men or women \> 30 years old
* Subject is able and willing to comply with study procedures, and is able to give signed and dated consent
* Subject meets criteria for diagnosis of Diabetes Mellitus Type 1 or 2, active Charcot neuroarthropathy, and peripheral neuropathy
* Subjects with serum calcium or albumin-adjusted serum calcium ≥2.0 mmol/L (8.0mg/dL)

Exclusion Criteria:

* Unable to provide signed and dated consent.
* Charcot neuroarthropathy of the ipsilateral lower extremity, diagnosed over 1 month prior.
* Prior foot or ankle surgery of the ipsilateral lower extremity.
* Prior amputation at any level of either lower extremity.
* Prior foot or ankle fracture of the ipsilateral lower extremity unrelated to the current acute CN episode.
* Currently has any of the following:

  1. Infection
  2. Foot ulceration
  3. Hypocalcemia
  4. Creatinine clearance less than 30 mL/min or on dialysis
  5. Pre-existing disturbance of mineral metabolism (e.g., hypoparathyroidism unstable on therapy, thyroid or parathyroid surgery, vitamin D deficiency, malabsorption syndromes, excision of small intestine, history of diseases affecting bone metabolism) that has not been effectively corrected or treated.
* Have undergone revascularization procedures of the lower extremities.
* Female subjects who are pregnant or planning to breastfeed should not participate in this study.
* Determined to have poor oral hygiene after dental screening or are at increased risk for developing osteonecrosis of the jaw.
* History of osteonecrosis of the jaw.
* History of tooth extraction or other dental surgery within the prior 6 months.
* Invasive dental work planned in the next 2 years.
* Have a known hypersensitivity to Prolia.
* Known use of a bone active medication within the 6 months prior to enrollment.
* Liver disease, defined as AST \> 2.0x ULN, ALT \> 2.0x ULN, TBL \> 1.5x ULN.
* Malignancy within the last 5 years (except cervical carcinoma in situ or basal cell carcinoma)
Examining Patterns in the Involvement of Gastric Bypass Patients in Clinical Studies

Clinical trial participation has historically been heavily biased toward specific demographics.

Several people will be invited to enroll in this study so that it may collect a variety of data about gastric bypass clinical trial experiences and identify barriers to participation as well as the causes of participants' failure or withdrawal.

The information collected from this study can be used to improve patient experience and outcomes for future patients and an opportunity to contribute to the advancement of medical knowledge and treatments for gastric bypass.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years and older
* Diagnosis of obesity or disorder of metabolism undergoing routine gastric bypass surgical intervention
* Capable of giving signed informed consent.

Exclusion Criteria:

* ECOG score of 4
* Ineligible for gastric bypass surgery
* Pregnant women or women actively seeking to become pregnant.
FDG PET/CT in Lung Cancer Staging

Prospective study of the effects of image acquisition and reconstruction parameters on accuracy of FDG PET/CT mediastinal nodal staging in NSCLC


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, at least 18 years of age
* Patients with NSCLC diagnosis who have been referred for a clinical FDG PET/CT staging scan as part of their standard of care
* Participants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures.

Exclusion Criteria:

* Inability to tolerate additional imaging time in the opinion of the investigator or treating physician.
* Only individuals (aged 18 or over) who can understand and give informed consent will be eligible to participate in this study. Individuals who are considered to be mentally disabled will not be recruited for this study. All subjects must be able to give informed consent. We will not be using specific methods to assess decisional capacity. Economically disadvantaged persons will not be vulnerable to undue influence, as this study offers no compensation and there is no additional cost associated with the additional study imaging time. All individuals will be told that their choice regarding study participation will in no way change their access to clinical care or their ability to undergo the standard clinical FDG PET/CT scan. This should negate any undue influence or coercion. Children, fetuses, neonates, or prisoners are not included in this research study
Neuronal Correlates of Altered States of Consciousness

The aim of the present study is to assess the neuronal correlates of alterations in waking consciousness pharmacologically induced by a 5-hydroxytryptamine (HT)2A receptor agonist in healthy subjects using functional magnetic resonance imaging (fMRI).

Functional neuroimaging may be useful in the diagnosis and characterization of early schizophrenia. However, little is known about how the subjectively experienced alterations in consciousness and perception are related with objective neuroimaging measures. The present study explores the association of subjective alterations and objective imaging findings and will inform us on the neuronal correlates of psychotic states and whether subjective alterations in perception translate into neuronal activation patterns that can be objectively measured in a brain scanner. Therefore, alterations in consciousness will be assessed in 20 healthy subjects using a random order 2-period (normal and altered state of consciousness) cross-over design. Alterations in consciousness will be induced by the hallucinogenic 5-hydroxytryptamine (HT)2A receptor agonist (5-HT2A) receptor agonist lysergic acid diethylamide (LSD).

Eligibility Criteria:
Inclusion Criteria:

1. Age between 25 and 65 years
2. Understanding of the German language
3. Understanding the procedures and the risks associated with the study
4. Participants must be willing to adhere to the protocol and sign the consent form
5. Participants must be willing to refrain from taking illicit psychoactive substances during the study.
6. Participants must be willing to drink only alcohol-free liquids and no xanthine-containing liquids (such as coffee, black or green tea, red bull, chocolate) after midnight of the evening before the study session, as well as during the study day.
7. Women of childbearing potential must have a negative pregnancy test at the beginning of the study and before each study session.

Exclusion Criteria:

1. Chronic or acute medical condition
2. Current or previous major psychiatric disorder
3. Psychotic disorder in first-degree relatives
4. Illicit substance use (except tetrahydrocannabinol (THC)-containing products) more than 10 times or any time within the previous month.
5. Pregnant or nursing women.
6. Participation in another clinical trial (currently or within the last 30 days)
Feasibility Study to Evaluate Therapeutic Ultrasound (TUS) to Acutely Increase the Perfusion in Peripheral Arterial Disease (PAD)

This study is evaluating whether a therapeutic ultrasound device can improve symptoms in the leg of peripheral arterial disease (PAD) patients 65 years of age and over.

The VibratoSleeve TUS will be used on to assess its acute vasodilatory and perfusion effects in subjects with early stage PAD. Each subject will receive TUS treatment multiple sessions. All post- treatment acute assessments will take place immediately following each day's treatment and no follow-up assessments will be required in this study.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 65
2. Diagnosis of PAD.
3. Claudication symptoms in Rutherford class 1,2, or 3 as determined by the investigator.

Exclusion Criteria:

1. Prior stenting in posterior tibial artery.
2. Re-vascularization procedure within 30 days prior to enrollment in the study.
3. Ulcers, cellulitis, or skin breakdown in treatment areas (posterior calf).
4. History or diagnosis of severe chronic venous insufficiency.
5. Acute limb ischemia within 30 days prior to treatment.
6. History or diagnosis of deep venous thrombosis below the knee in treatment leg.
7. Any conditions that, in the opinion of the investigator, may render the subject unable to complete the study or lead to difficulties for subject compliance with study requirements, or could confound study data.
8. Subject's enrollment in another investigational study that has not completed the required primary endpoint follow-up period.

stenting in posterior tibial artery.
Feasibility of Exercise and Spinal Cord Injury

The purpose of the study is to examine the impact of a community-based exercise intervention (CBEI) for persons with spinal cord injury (PwSCI) on physiological and psychological well-being and identify barriers and facilitators to implementation.

People with spinal cord injury (PwSCI) are at a greater risk for major health conditions and poorer health outcomes than the population without spinal cord injury. For PwSCI, habitual exercise is critical for both physiological and psychological well-being. Prior research indicates that exercise programs conducted in a controlled setting have positive effects on the physical and psychosocial fitness of PwSCI, but the efficacy and feasibility of these programs are not well understood in community-based settings. The proposed project aims to examine potential health benefits in response to the intervention and identify the barriers and facilitators to successful implementation of a CBEI in PwSCI. The long-term goal of this research is to improve health outcomes of PwSCI by identifying strategies to promote health and support exercise in the community.

The project research aims are to:

1. Estimate improvements in physical function, cardio-metabolic health, and psychological well-being of participants enrolled in a CBEI compared to an education-only group.
2. Identify barriers, facilitators, and reasons for positive determinants for PwSCI to exercise in a community-based setting.

A single-blind pilot RCT will be conducted. Forty individuals with SCI will be recruited. Each participant will be randomized into either a 12-week CBEI (n=20) or an education control group (n=20). Participants' cardiorespiratory fitness, body composition, metabolic blood chemistries and strength will be assessed pre- (T1) and post- (T2) intervention.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of SCI
* 18 years or older
* Have written physician approval to participate in the study
* Ability to use upper extremities to exercise
* Participate in \< 60 minutes of moderate-intensity exercise per week in the last month
* Understand English at a sixth-grade level or higher
* Be able to follow multi-step instructions
* Independently provide informed consent
* Willing to participate in three assessments and 36 intervention sessions

Exclusion Criteria:

* Enrollment in a structured exercise program in the past six months.
* Have had cardiovascular complications within the past year
* Currently receive medical treatment for an acute upper extremity injury
* Have a Stage IV pressure injury
* Have a cognitive impairment that does not allow them to provide consent or follow multi-step directions.
ENHANCE-Efficacy of the Presence of Right Ventricular Apical Pacing Induced Ventricular Dyssynchrony as a Guiding Parameter for Biventricular Pacing in Patients With Bradycardia and Normal Ejection Fraction

The purpose of this clinical project is to evaluate the efficacy of the presence of Right Ventricular Apical (RVA) pacing induced ventricular dyssynchrony as a guiding parameter for bi-ventricular pacing in patients with bradycardia and normal left ventricular ejection fraction (LVEF). The results of this project may provide with the evidence based medicine for guidelines expansion of using Cardiac resynchronization therapy (CRT) in patients with Heart Block and normal LVEF (LVEF \>45%).

All eligible patients willing to provide written informed consent were invited to participate in the study, and then randomized 1:2 to either the Control Group or Echo-guided Group. Patients randomized into the Control Group were implanted with a dual chamber pacemaker (DDDR) device (St. Jude Medical) standard therapy. Patients randomized into the Echo-guided Group were implanted with a cardiac resynchronization therapy pacemaker (CRT-P) device (St. Jude Medical), which was programmed to DDDR pacing mode (CRT-P OFF) at implant. For each Echo-guided Group patient, presence of RVA pacing induced ventricular dyssynchrony was assessed within 24-hour of implant using the standardized criteria of Doppler echocardiography. The Echocardiography Core Laboratory (Echo Core Lab) then analyzed each image and the treatment allocation of the Echo-guided Group was done within 72-hour post implant based on the Echo Core Lab outcomes:

* Patients with the presence of RVA pacing induced ventricular dyssynchrony were allocated to the CRT-P standard therapy with CRT-P turned ON
* Patients with the absence of RVA pacing induced ventricular dyssynchrony were allocated to the DDDR standard therapy with CRT-P remained OFF

Patients meeting all the inclusion criteria and not meeting any of the exclusion criteria were eligible for the study. Data was collected at the following study visits:Enrollment, Implant \& Randomization, Pre-discharge (PDH) (≤ 72 hours post implant), Month 1 follow-up visit: 30 ± 14 days post implant, Month 3 follow-up visit: 90 ± 14 days post implant, Month 6 follow-up visit: 180 ± 14 days post implant and Month 12 follow-up visit: 365 ± 14 days post implant

Eligibility Criteria:
Inclusion Criteria:

* Patient meets current indications for implantation of a DDDR pacemaker
* Patient is geographically stable and willing to comply with the required follow-up schedule
* Patient has LVEF \>45%
* Patient has atrioventricular block (IIo or above)
* Patient has adequate echocardiographic images to measure LV volumes and LVEF

Exclusion Criteria:

* Patient has permanent atrial fibrillation (AF)
* Patient has unstable angina or an acute coronary syndrome
* Patient has undergone percutaneous coronary intervention or coronary artery bypass surgery within the previous 3 months
* Patient's life expectancy is less than 1 year
* Patient is less than 18 years old
* Patient is pregnant
* Patient has received a heart transplant
Application of a Mindfulness and Self-Compassion Program in Patients With Schizophrenia. Randomized Controlled Trial.

This is a randomized clinical trial to check whether the quality of life of patients with schizophrenia improves after participation in the mindfulness and self-compassion (MSC) programme.

MAIN AIM To check whether the quality of life of patients with schizophrenia improves after participation in the mindfulness and self-compassion (MSC) programme, compared with those participating in an active control programme or those following usual treatment.

DESIGN

Randomized clinical trial, three parallel groups:

1. Experimental, which will receive the MSC together with the usual treatment (TAU).
2. Active control, which will receive an alternative programme with cognitive, behavioural and psychoeducational components (CBTG) together with the TAU.
3. Passive control, which will receive the TAU. STUDY DISORDER

Schizophrenia. DATA FROM THE INTERVENTION UNDER STUDY Program developed by Kristin Neff and Christopher Germer, after observing in diverse investigations the inverse correlation between levels of self-pity and diverse pathological clinical variables.

POPULATION UNDER STUDY Patients from Telde's Mental Health Unit who have been diagnosed with schizophrenia.

TOTAL NUMBER OF SUBJECTS 150

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of schizohrenia

Exclusion Criteria:

* Drug addict