cyrilzakka/clinical-trials huggingface dataset:
Bundled Intervention Integrating Mental Health Services in Nepal

Globally, access to mental healthcare is often non-existent in rural, resource-deprived communities despite the pervasive need for services, particularly in post-conflict and post-disaster settings. We are developing and piloting will develop and pilot a culturally appropriate training model for non-specialist providers (NSPs) to deliver high-quality mental health care over a period of 24 months in a primary care hospital in a rural district in Nepal. We will employ a mixed methods framework to evaluate change in skills, knowledge, and attitude in NSP's, identify key mechanisms for continuum of mental healthcare delivery, and efficacy and cost-effectiveness in care delivery through a government hospital, clinics, and a network of community health workers. This integrated approach will introduce a bundled intervention that includes: both an on-site care coordinator and off-site psychiatric supervisors based in Nepal's capital, Kathmandu, weekly case conferences, and surveys of NSP's and clinical supervisors every six months during the study period. To learn about the acceptability, feasibility and challenges in the program we will also conduct Focus Group Discussions among the PCPs. In the last one year of the research in Achham District we have seen increase in knowledge efficacy and skills among the NSPs and also improved mental health care services at Bayalpata Hospital. Our experience in Achham motivated us to develop a similar program for Charikot Primary Health Center in Dolakha District. Outcomes of this study will focus on efficacy of this model to appropriately identify, counsel, and treat patients with depression, psychosis, and post-traumatic stress disorder (PTSD) through an integrated rural mental healthcare delivery intervention as a model for rural healthcare delivery.


Eligibility Criteria:
Inclusion Criteria:

* Primary Care Provider (MBBS-level physician or Health Assistant)
* Current staff at healthcare facility in Achham, Bajura, or Doti Districts.

Exclusion Criteria:

* N/A
Rehabilitation and Recovery for Persons with Esophageal or Gastric Cancer

This study aims to develop and evaluate a model for systematic and evidence-based cancer rehabilitation for people with esophageal and gastric cancer to provide conditions for a better quality of life and fewer cancer-related symptoms.

Sweden has had a National Cancer Rehabilitation Programme since 2014. This emphasises that all people with cancer have the right to individualised rehabilitation and that the contact nurse has an important role to play in identifying needs and ensuring evidence-based interventions throughout the cancer process to promote rehabilitation. The needs for optimised rehabilitation vary according to several parameters such as the person's personal circumstances and preferences, social support and type of cancer disease.

Despite this and a growing number evidence within this area cancer rehabilitation is often not integrated in clinical care. The current cancer care focuses on medical and treatment related interventions. It is a challenge for health services to find models to identify and meet the increased need for cancer rehabilitation in a systematic and structured way throughout the cancer process, based on the specific needs of each individual. This study aims to develop and evaluate a model for systematic and evidence-based cancer rehabilitation for people with esophageal and gastric cancer to provide conditions for a better quality of life and fewer cancer-related symptoms.

Eligibility Criteria:
Inclusion Criteria:

* over 18 years of age
* esophageal or gastric cancer
* living in Southern Sweden (Skåne)
* are planned to undergo curative surgerytreatment at Skåne University Hospital.

Exclusion Criteria:

* unable to communicate in the Swedish language
* suffering from a cognitive impairment that poses a barrier for participating in the study.
Antiangiogenic Peptide Vaccine Therapy in Treating Patient With Hepatocellular Carcinoma

The purpose of this study is to assess toxicities of angiogenic peptide vaccine therapy in treating HLA-A\*2402 restricted patients with advanced hepatocellular carcinoma.

It has been required to develop new treatment modalities for patients with advanced heptatocellular carcinoma. Immunotherapy is one of the encouraging modalities for patients. We have to assess its toxicities, clinical response and immune responsiveness.

Eligibility Criteria:
Inclusion Criteria:

* Unresectable or treatment-resistant patients with Hepatocellular carcinoma
* Measurable disease by CT scan
* ECOG performance status 0-2
* Life expectancy \> 3 months
* Laboratory values as follows: 2,000/mm3 \< WBC \<15,000/mm3, Platelet counts \> 75,000/mm3, Total Bilirubin \< 1.5 mg/dl, Asparate transaminase \< 150IU/L, Alanine transaminase \< 150 IU/L, Creatinine \< 3.0mg/dl
* HLA-A\*2402
* Able and willing to give valid written informed consent

Exclusion Criteria:

* Pregnancy (women of childbearing potential: Refusal or inability to use effective means of contraception)
* Brest-feeder
* Active or uncontrolled infection
* Steroids or immunosuppressing agent dependent status
* Active or uncontrolled other malignancy
* Serious or uncured wound
* Decision of unsuitableness by principal investigator or physician-in charge
Antibiotic Strategy and Asymptomatic Bacteriuria in the Context of Intra-vesical Botulinum Toxin A Injections.

The study aims to demonstrate that the "thrifty antibiotic strategy" applied to MS or SCI patients with asymptomatic bacteriuria prior to BoNTA intravesical injections does not increase the rate of symptomatic post-injection UTIs compared to the current peri-operative antibiotic strategy.

Patients included in the study will be randomized in two balanced-parallel groups, 4 days (+/- 2 days) before intra-vesical BoNTA injections.

Group 1: Experimental group: "Sparing antibiotic strategy" No antibiotic therapy will be administered during the peri-operative period.

Group 2: Control group: Recommendations - Peri-operative antibiotic strategy An antibiotic therapy will be administered during the peri-operative period. The antibiotic will be selected according to the type of bacteria isolated and the antibiotic susceptibility testing, and started two days before and pursued until two days following intra-vesical BoNTA injections.

The main objective is to demonstrate the non-inferiority of "antibiotic saving strategy" compared to peri-operative antibiotic strategy (current recommendations) for occurrence of symptomatic UTI after intra-vesical BoNTA injections in the management of asymptomatic bacteriuria (AB) among multiple sclerosis (MS) and spinal cord injured (SCI) patients undergoing clean intermittent self-catheterization (CISC).


Eligibility Criteria:
Inclusion Criteria:

* MS or SCI (traumatic or non-traumatic)
* Refractory OAB and/or DO (failure, intolerance or contra-indication to anti-muscarinic therapy)
* Treated with intra-vesical botulinum toxin A injections having proved efficacy
* CISC as the exclusive bladder management
* AB on pre-operative urine analysis (performed 10 days (+/- 2 days) before intra-vesical BoNTA injections)
* Exclusion of morphologic urinary tract abnormalities considered as a risk factor for recurrent symptomatic UTI.

Exclusion Criteria:

* Having already participated to the study
* Augmentation cystoplasty
* Bladder compliance disorders (\<20 mL/cmH2O)
* Ongoing cyclic antibiotic therapy
* Ongoing corticosteroid therapy
* Modification of immunosuppressive or immunomodulatory therapy in the 3 months before inclusion (MS patients)
* Antibiotic therapy in the month before inclusion
* Surgical procedure in the 3 months before and the 6 weeks following inclusion
* Symptomatic UTI at the time of inclusion
* Associated neurologic disease
* Pregnancy or breast feeding
* Individuals especially in need of protection
* No informed consent
* Patients incapable to follow the trial, e.g. because of language problems, psychiatric disorders, dementia and so on
* Immunocompromised patients
Study of the Influence of POLD Manual Therapy in Fibromyalgia

This clinical research aims to study the effects of the introduction of POLD manual therapy within the protocol of fibromyalgia

This research project aims to generate scientific evidence on the clinical results obtained in the treatment of fibromyalgia, which usually presents with pain and long-term disability, by applying a special form of manual physiotherapy called "POLD concept". This therapy is based on a passive, oscillatory mobilization, performed at a resonance frequency and applied throughout the time of the therapeutic session, on the vertebrae and the muscles of the back, without interruption. It is carried out on the initiative of the research team in "pain treatment", of the physiotherapy school of the University of Lleida, in collaboration with the Omphis Foundation and the clinical service of the Unity of Fibromyalgia of GSS (Hospital Universitarios de Santa María, Lleida)

Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed with Fibromyalgia
2. Patients over 25 years old and up to 65 years old, regardless of whether they are women or men.
3. Patients who present pain with a minimum value of 5 on the numerical pain scale from 0 to 10, at the time of beginning the study.
4. Presence of these symptoms in a long period (more than 6 months)

Exclusion Criteria:

1. Patients with a recent traumatic history.
2. Presence of an irradiation component of neurological origin to upper or lower limbs
3. Patients with neurological alterations, both central and peripheral.
4. Patients who are taking opioid-based analgesic medication.
5. Patients with severe spinal malformations.
6. That they are following any other type of treatment, whether manual or physical agents or alternative or complementary therapies.
7. That they have been treated with infiltrations or similar in a period of less than one year before beginning the study.
8. Patients with a serious psychiatric history such as schizophrenia or psychopathies.
9. Patients who have vestibular problems that do not tolerate oscillation.
10. Patients with heart failure
11. Existence of judicial process of disability
Efficacy of Exclusive Enteral Nutrition in Adult Active Crohn's Disease

Patients with Crohn's disease (CD) could develop complications such as stricture, intestinal fistula and abdominal abscess. Some CD patients had poor response to medical therapy. The efficacy of exclusive enteral nutrition (EEN) to these adult active CD patients is still unclear. The investigators aim to study the efficacy of EEN in induction of remission in adult active CD patients with complications or poor response to drugs.

Active CD patients following up in our center who had been diagnosed as complicated disease with stricture, intestinal fistula, abdominal abscess and no response to drugs, were recruited since July 2013. Patients were only offered EEN for 12 weeks without using other drugs except that patients with abscess could use antibiotic therapy with or without percutaneous drainage. The disease activity was assessed by the Crohn's disease activity index (CDAI). CDAI\<150 was taken as achieving clinical remission. Demographics and clinical variables were recorded. Nutritional (body mass index, albumin) and inflammatory (High sensitivity C-reactive protein and platelet) index were evaluated at baseline, week 4 and week 12. Some patients performed colonoscopy and/or computed tomography enterography (CTE) /resonance enterography(MRE) before and after EEN. Mucosal healing was assessed under endoscopy with SES-CD and the size of abscess was detected by CTE /MRE.

Eligibility Criteria:
Inclusion Criteria:

1. \>18 years old
2. Patients with CD was diagnosed clinically according to previously established international criteria \[9\]
3. The diagnosis of stricture, fistula and abdominal abscess was confirmed by ultrasound, CT enterography (CTE), and endoscopy. The bowel stricture should mainly cause by inflammation. Intolerance or failure to steroids or IFX was judged by medical history
4. The disease was in an active period.

Exclusion Criteria:

1. Intolerant to EEN or need emergency surgery
2. The bowel stricture should mainly cause by fibrosis
Safety and Efficacy Study of an Edible Colonoscopy Preparation

The purpose of this study is to evaluate the efficacy and safety of ECP (PEG 3350) Colon Prep Kit compared with MoviPrep split-dose as a colon-cleansing preparation for colonoscopy.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled to undergo a medically indicated colonoscopy for colorectal cancer screening or surveillance for colorectal cancer
* Females must be non-lactating and have a negative pregnancy test if of child bearing potential
* Ability and willingness of subject to participate fully in all aspects of this clinical trial
* Written informed consent

Exclusion Criteria:

* Known or suspected clinically significant intestinal stricture of any etiology
* History of diabetes mellitus, controlled with insulin
* Taking insulin by injection
* Pregnant or lactating
* Renal insufficiency, hypokalemia, hyperkalemia, chronic liver disease or arrhythmic disorder
* Chronic heart failure or recent (within 90 days of screening) acute heart failure
* Receiving warfarin, heparin, clopidogrel, Pradaxa®, Xarelto®, Effient® or other blood thinning agents
* Short bowel syndrome
* Known diagnosis of Crohn's disease or ulcerative colitis, exclusionary only if subject has a history of any bowel resection, has suspected active inflammation, has symptoms suggestive of obstruction or a known bowel stricture
* Severe psychological disease causing functional impairment limiting capacity to complete the preparation
* Impaired consciousness increasing the risk of aspiration
* Used narcotics/opiates within the 14 days prior to the colonoscopy
* Used an anti-diarrheal within the 14 days prior to the colonoscopy procedure
* Uses drugs of abuse including abused prescription medication
* Used iron supplements within 14 days of the colonoscopy procedure
* History of gastrointestinal surgery other than appendectomy or cholecystectomy
* Diagnosis of gastroparesis or ileus
* Symptoms of chronic constipation defined as fewer than 3 bowel movements per week on average over the previous 3 months
* History of a failed bowel preparation, defined as either requiring an enema the day of the colonoscopy or needing to have the colonoscopy repeated
* CTCAE grade 1 sodium, potassium or magnesium at screening
* Clinically significant abnormalities (ketones, protein, glucose) at screening urinalysis, in the opinion of the investigator
* Any known allergies to any of the ingredients or ECP Colon Prep Kit (including coconut) or the active comparator
* Unable or unwilling to consume all components of the study drug including aversions to or adverse events from flavoring
* Received any investigational therapy within 30 days of initiation of study drug
* Serious underlying disease that, in the opinion of the investigator, may interfere with the subject's ability to participate fully in the study
* Requirement to use chromoendoscopy during the procedure for the purpose of surveillance for colorectal dysplasia or cancer in subjects with inflammatory bowel disease
A Phase II Study of the Safety and Efficacy of MPSK3169A in Patients With Coronary Heart Disease or High Risk of Coronary Heart Disease

The purpose of this study is to evaluate the safety and cholesterol lowering effects of MPSK3169A when given as subcutaneous (SC) injections over a 24-week period to patients with a high risk of cardiovascular events and LDL-c levels well above goal.


Eligibility Criteria:
Inclusion Criteria:

* Use of a standard-of-care statin at a stable dose, or intolerance of statins, without use of other lipid modifying therapies
* Fasting LDL cholesterol 90-250 mg/dL on the statin regimen above

And at least one of the following:

* Coronary heart disease (CHD) with a history of myocardial infarction (MI), percutaneous coronary intervention (PCI), coronary artery bypass graft surgery (CABG), or prior coronary angiography demonstrating coronary atherosclerosis
* A CHD risk equivalent condition, including diabetes mellitus (type 1 or 2), chronic kidney disease, prior stroke, carotid disease, peripheral arterial disease, or abdominal aortic aneurism
* \>/=2 CHD risk factors (age \>/= 45 years for men or \>/= 55 years for women; smoking; hypertension; low HDL cholesterol; family history of premature CHD) and a high risk of a CV event based on risk estimation systems

Exclusion Criteria:

* Severe congestive heart failure (NYHA Class III-IV) or left ventricular ejection fraction \</= 35%
* Recent (within 3 months) MI, unstable angina, stroke, transient ischemic attack, CABG, PCI, hospital admission for heart failure, major surgery, uncontrolled cardiac arrhythmia (other than atrial fibrillation or flutter), or initiation of renal replacement therapy (dialysis)
* Fasting serum triglyceride level \>/= 400 mg/dL
* Homozygous familial hypercholesterolemia
* Poorly controlled diabetes mellitus, hypertension or thyroid disease
* Liver or muscle disease, including abnormal test results at screening
* Pregnant or lactating

The above list is not intended to contain all factors relevant to a patient's eligibility for the study.
Cardiometabolic Profiles of Boys With Klinefelter Syndrome

This study plans to learn more about how to measure the way the the body's energy system works in boys with Klinefelter syndrome, including the heart, lungs, muscles, and liver. This is important to know so that investigators understand how hormones and an extra X chromosome relate to diseases such as diabetes, extra weight gain, heart disease and liver diseases.

Klinefelter syndrome (KS) is the most common chromosomal abnormality in males and is associated with primary gonadal failure in adolescence and a high morbidity and mortality from cardiovascular-related diseases (CVD) in adulthood. Recent studies in children and adolescent boys with KS have found a high prevalence of CVD risk markers, however the underlying mechanisms have not been explored. Our central hypothesis is that pubertal boys with KS have relative testosterone deficiency resulting in abnormal energy metabolism that predisposes them to later CVD, and that exogenous testosterone will modify these abnormalities.

In this study, investigators will measure markers of cardiometabolic risk in pubertal boys with KS.

Eligibility Criteria:
Inclusion Criteria:

* Male, 47,XXY karyotype (non-mosaic)
* Age 12-17 years
* Tanner stage 3-5 pubic hair
* T naïve group only: No exogenous androgen exposure within the past 5 years
* T exposed group only: currently on topical testosterone, with duration of treatment between 1-2 years.

Exclusion Criteria:

* Cognitive, psychiatric, or physical impairment resulting in inability to tolerate the study procedures
* MRI incompatible metal
* Diagnosis of type 1 or type 2 diabetes
* Hypertension greater than 140/90 mm/Hg at rest (would make exercise studies unsafe)
* Weight \> 300 lbs (limit for DEXA)
* Testosterone treatment for \<1 year or \>2 years
Effects of Dynamic Hyperinflation on the Left-ventricular Diastolic Function in Healthy Male Subjects

The aim of this study is to identify whether actively induced dynamic hyperinflation can cause left-ventricular diastolic dysfunction in healthy male subjects in order to explore the mechanisms of developing cardiac dysfunctions in patients with COPD.

Cardiovascular diseases, especially left-ventricular diastolic dysfunction, are among the most frequent reasons for morbidity and mortality in patients with chronic obstructive pulmonary disease (COPD).

Dynamic hyperinflation is one of the expected pathophysiological mechanisms in the multifactorial genesis of this left-ventricular diastolic dysfunction in patients with COPD.

The novel concept of Expiratory Stenosis Breathing (ESB) is based on the method of Metronome-Paced Tachypnea (MPT) of Cooper et al. Therefore the investigators use a metronome to indicate a specific breathing frequency (BF) and the relation of inspiration : expiration (I : E) in order to let subjects hyperinflate.

Subjects get split into two groups each hyperinflating three times for 90sec by one of the two methods before doing a cross-over and switch groups to do the same in the other group. At the end of the 90sec there is a measurement of the Inspiratory Capacity (IC) and an echocardiography in order to objectify dynamic hyperinflation respectively the change in diastolic function.

During ESB participants hyperinflate with a BF - 30/min and a I : E - 1 : 3. In addition they have to breathe through an expiratory-effective stenosis (3, 2 and 1,5mm) on the mouthpiece of the pneumotachograph to simulate the collapsing airways in COPD-patients. In contrast, during MPT subjects hyperinflate with a BF - 40/min, I : E - 1 : 1; BF - 40/min, I : E - 1 : 2; BF - 30/min, I : E - 1 : 2.

During the whole trial investigators measure Intrinsic Positive Endexpiratory Pressure (PEEPi) in order to objectify the dynamic hyperinflation more significantly.

The primary goal of this study is to assess if actively induced dynamic hyperinflation can affect diastolic function of the left ventricle.

Furthermore a correlation between the extent of dynamic hyperinflation and diastolic dysfunction should be quantified.

In addition measurement of PEEPi should validate the method of Metronome-paced Tachypnea (MPT) because the investigators hypothesize that this method does not simulate the pathophysiological circumstances in patients with COPD sufficiently.

Eligibility Criteria:
Inclusion Criteria:

* BMI \<27 kg/m2
* Lifelong nonsmoker (currently non-smoking and up to now less than 100 cigarettes)

Exclusion Criteria:

* Obstructive pulmonary diseases (asthma, COPD)
* Cardiovascular diseases (cardiac insufficiency, coronary heart diseases, hypertonia)
* Other relevant pulmonary or cardiac diseases
* Baseline E/A-ratio \<1
Molecular, Pathologic Intra Tumoral Heterogeneity in Malignant Pleural Mesothelioma

Malignant pleural mesothelioma (MPM) is a rare pleural cancer, which could be primary or secondary to an asbestos exposure. To enhance our knowledge of this rare disease, an exploration of genetic and tumor mechanism is mandatory. One of the principal difficulty is to harvest sufficient tumour pieces to perform multi-omics analysis. The goal of the SCITH-MESO study is to harvest larges pieces of tumour during a routine surgical procedure of MPM diagnosis by mean of pleural biopsies during VATS surgery. Operating samples will increase a tissue bank collection (CRB).


Eligibility Criteria:
Inclusion Criteria:

* age \>18
* suspected MPM requiring VATS biopsy after multidisciplinary oncologic board validation
* patient able to understand study objectives and able to give an informed consent
* patient affiliated to an healthcare society.

Exclusion Criteria:

* pregnancy
* mental disease, psychiatric disorder
* patient under protection regimen