cyrilzakka/clinical-trials huggingface dataset:
Chidamide Combined With Cyclophosphamide, Prednisone, Thalidomide in Treatment of Fragile Patients With Relapse/Refratory Peripheral T Cell Lymphoma

The purpose of this study is to investigate efficacy and safety of Chidamide Combined With Cyclophosphamide,Prednisone,Thalidomide in Treatment of Fragile Patients With Relapse/Refratory Peripheral T Cell Lymphoma :a Phase II,Single-arm,Open-label, Muti-center Study

Chidamide is a new histone deacetylase inhibitor and shows anti-tumor activity in Relapse/Refratory Peripheral T Cell Lymphoma.Cyclophosphamide,Prednisone,Thalidomide(CPT) is an oral combination regimen for lymphoma patients who can not stand the standard chemotherapy. The investigators therefore design this open-label,phase II, single-arm trial to investigate the efficacy of Chidamide Combined With CPT in treatment of fragile Patients With Relapse/Refratory Peripheral T Cell Lymphoma

Primary Outcome Measures:

• overall response rate

Secondary Outcome Measures:

* duration of response
* progression free survival
* overall survival Enrollment:45 Study Start Date: August 2016 Primary Completion Date: March 2018

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed Peripheral T Cell Lymphoma,exclude NK/T cell lymphoma
2. Relapse or refractory to at least one prior therapy(chemotherapy or stem cell transplantation)
3. can not
4. age between 18 and 75, both gender
5. ECOG PS 0-1
6. Peripheral ANC \>1.5\*109/L; platelet \>70\*109/L; Hb≥ 90g/L
7. Anticipated survival ≥ 3 months
8. No chemotherapy ,radiotherapy and stem cell transplantation within 4 weeks before inclusion
9. Sign in informed consent form, adherence to the study visit schedule and other protocol requirements

Exclusion Criteria:

1. Pregnant women or women in suckling period or with Potentia Generand but not willing to take contraceptives
2. New York Heart Association class III or IV cardiac failure; or history of following disease in past 6 months: acute coronary syndrome, acute heart failure, severe ventricular arrhythmia
3. Poor hepatic function, defined as total bilirubin more than 1.5 fold of upper normal level, ALT, AST more than 2 fold of upper normal level or more than 5fold of upper normal level with hepatic involvement;Poor renal function, defined as serum creatinine more than 1.5 fold of upper normal level
4. CNS or meningeal involvement
5. intervention on myelosuppression within7 days before inclusion
6. patients with active bleeding
7. Major surgery within three weeks before inclusion
8. Positive HIV, syphilis,HCV, or HBV virus load(HBV DNA)\> 1×105 copies/ml;
9. Any psychological conditions which may disturb consent.
10. In any conditions which investigator considered ineligible
11. Known sensitivity or allergy to investigational Product.
Biomarkers in Exhaled Breath From Asthmatic Patients

This study will look for a relationship between asthma and factors released from the lungs in exhaled breath. If a relationship can be established, the identified factors may be used as biomarkers to predict episodes of increased asthma symptoms so that medications can be given to prevent the onset of an asthma attack.

Healthy volunteers and people who have had asthma for at least 1 year may be eligible for this study. Candidates must be between 18 and 75 years of age.

Participants undergo blood tests and breathing tests. For the latter, participants breathe into a machine before and after inhaling an asthma medication called albuterol. The machine measures the volume of air the subject can breathe out. Participants also provide a sample of exhaled breath by breathing normally for up to 30 minutes while wearing a mask devised for the procedure. Pulse rate, oxygen saturation and wheezing are monitored during the breath collection.

Asthma is a major public health problem that is associated with significant morbidity and mortality. Patients at increased risk for asthma decompensations include those with severe asthma that is refractory to therapy, as well as patients with poorly controlled disease due to inadequate treatment. The aim of this exploratory specimen procurement protocol is to develop a non-invasive method for the detection of asthma-specific biomarkers in exhaled breath condensates (EBC) utilizing a novel collection device that was engineered at the Johns Hopkins University Applied Physics Laboratory. Biomarkers in EBC will be identified by mass spectroscopy. We propose that the identification of biomarkers in EBC that correlate with airway inflammation and disease activity may be used to guide therapy and prevent exacerbations in asthmatic patients.

Eligibility Criteria:
* INCLUSION CRITERIA - ASTHMA:

Patients will be between 18 and 75 years of age, male or female, with a diagnosis of asthma for at least one year.

Oxygen saturation on room air greater than or equal to 92 percent.

EXCLUSION CRITERIA - ASTHMA:

Diagnosis of a pulmonary disorder other than asthma (for example: chronic bronchitis, emphysema, cystic fibrosis, bronchiectasis, sarcoidosis, HIV-related lymphocytic airway inflammation).

Cigarette smoking within the past 3 months or a prior history of greater than 10 cumulative pack-years.

History of coronary artery disease.

INCLUSION CRITERIA HEALTHY VOLUNTEERS:

Research volunteers will be between 18 and 75 years of age, male or female.

Oxygen saturation on room air greater than or equal to 92 percent.

EXCLUSION CRITERIA HEALTHY VOLUNTEERS:

Same as the asthmatic exclusion criteria plus a history of asthma.

Reversible Airflow Obstruction (increase in FEV (1) by 12 percent and 200 cc after inhaled beta 2-agonist)
Electromagnetic Stimulation of the Phrenic Nerve of Intubated Patients With Obesity

Ventilator-induced diaphragmatic dysfunction is a common issue in critically ill patients. Muscle stimulation has shown to have beneficial effects in muscle groups on the extremities. A non-invasive way to stimulate the diaphragm would be the electromagnetic stimulation but it is currently unclear if that is feasible.

In this proof-of-concept trial the primary aim is to show that it is possible to induce a diaphragmatic contraction leading to an inspiration with a sufficient tidal volume via an external electromagnetic stimulation of the phrenic nerve in obese patients.

During the time of first spontaneous breathing trial 60% of mechanically ventilated patients present with diaphragmatic weakness or also know as ventilator-induced diaphragmatic dysfunction (VIDD). The damage to the diaphragm in terms of muscle atrophy has been shown as early as 12 hours after initiation of mechanical ventilation. Recently, a correlation between diaphragmatic atrophy and mortality could be established.

Induction of diaphragmatic contractions via stimulation of the phrenic nerve would be a possible method to prevent or treat VIDD. A possible modality would be the non-invasive electromagnetic stimulation but feasibility has not been established.

In this proof-of-concept trial the primary aim is to show that it is possible to induce a diaphragmatic contraction leading to an inspiration with a sufficient tidal volume via an external electromagnetic stimulation of the phrenic nerve in obese patients

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age
* American Society of Anaesthesiologists Classification I or II
* Planned anesthesia with intubation
* Adipositas Grade II-III

Exclusion Criteria:

* Chronic lung disease
* Preexisting diaphragmatic weakness
* Neurologic disease with known motor weakness
* Paralysis of the phrenic nerve
* Contraindication for any movement in the cervical vertebrae
* Conditions that limit the movement of the diaphragm e.g. ascites, increased intraabdominal pressure.
* Inability to communicate in the official language
* Infections, lesions or stricture in the neck area
* Implanted cardiac devices e.g. pace maker, defibrillator, event recorder
* Implanted medical pumps e.g. left ventricular assist device
* Metal implants in the upper body
* Preganancy
AMIC vs. MFx in the Ankle

This clinical investigation is a prospective, double blind, single-centre, randomised controlled trial comparing arthroscopic autologous matrix induced chondrogenesis (AMIC®) to microfracture alone in the treatment of osteochondral and chondral lesion in the ankle to evaluate effectiveness, performance and safety of AMIC® procedure versus microfracture (MFx).

This clinical investigation compares arthroscopic autologous matrix induced chondrogenesis (AMIC®) to microfracture alone in the treatment of osteochondral and chondral lesion in the ankle to evaluate effectiveness, performance and safety of AMIC® procedure versus microfracture (MFx). It is a prospective, double blind, single-centre, randomised controlled trial. The objective of this clinical investigation is to evaluate performance, effectiveness, and safety of AMIC® procedure versus Microfracture (MFx). The effectiveness of the treatment is measured by the difference in the walking/standing- part score taken from the Manchester Oxford Foot Questionnaire (MOX-FQ) from baseline to 12 months. The secondary endpoints concern clinical safety and performance. Patients will be randomized into two groups: Microfracture alone (MFx) or Bone Marrow Stimulation (Microfracture) with Chondro-Gide® (AMIC®). The investigational device will be assessed within its intended use.

Eligibility Criteria:
Inclusion criteria:

* Signed written informed consent
* Diagnosis of symptomatic osteochondral or chondral lesion of the talus, deemed by surgeon amenable to arthroscopic treatment with debridement and microfracture
* Age of 18-65 years
* Subject is willing and able to comply with all study procedures, including visits, diagnostic procedures, the rehabilitation protocol and responding to patient questionnaire follow up

Exclusion criteria:

* Lesions smaller 1 square centimeters and greater than 4 square centimeters based on the MRI
* Malalignment which is not corrected prior to or as part of same surgery
* Established significant hindfoot arthritis
* Patients who are unable to have an MRI scan
* Chronic inflammatory arthritis or infectious arthritis
* History of autoimmune disease or immunodeficiency
* History of connective tissue disease
* Intra-articular steroid use within the 3 months prior to enrolment
* Other intra-articular injections (e.g., hyaluronic acid) within 3 months prior to enrolment
* The patient is currently being treated with radiation, chemotherapy, immunosuppression, or systemic steroid therapy with a dose equivalent to more than 5 mg prednisolone
* Pregnancy or lactation
* Enrolled in another study, involved in the study (as a researcher/investigator/sponsor), or relative of someone directly involved in the clinical investigation
* Active infection of the index ankle
* Has been prescribed medication to treat osteoporosis
* Any disorder or impairment that would interfere with evaluation of outcomes measures, such as neurological, degenerative muscular, psychiatric, or cognitive conditions
Healthy Lifestyles and Quality of Life in Women With Breast Cancer

A cross-sectional, multicenter, and observational study designed to update clinical, pathological, and lifestyle information for a cohort of approximately 1245 breast cancer patients included in the epiGEICAM-01 study.

In 2007, GEICAM started the EpiGEICAM case-control study, to investigate the association of diet and other lifestyle factors with breast cancer risk. In this study, we were able to identify two dietary patterns related with breast cancer in an opposite way. Thus, while women with high adherence to the so-called "Western" diet had an excess risk of breast cancer, high adherence to the "Mediterranean" pattern reduced the risk of breast cancer, being this effect particularly marked for triple negative tumors. Regarding physical activity, our preliminary results show a positive association between sedentarism and breast cancer risk. This project will focus on breast cancer patients included in that study in order to explore their degree of adherence to lifestyle behaviour recommendations and their association with the quality of life of these women.

Survivors will be re-surveyed to assess tobacco, alcohol, diet, obesity and health-related quality of life, using a specific questionnaire witch contains the following information:

* Sociodemographic information.
* Anthropometric data (weight, height).
* Clinical and gynecological data.
* Assessment of lifestyle habits: including tobacco consumption and diet.
* Physical activity questionnaire, with the International Physical Activity Questionnaire (IPAQ).
* Questionnaire to know the preference of patients on receiving information about their treatment in physical exercise.
* General Short Form-36 (SF36) quality of life questionnaire already used at the time of diagnosis.
* Specific Fatigue and Quality of Life Questionnaires: Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) and Functional Assessment of Cancer Therapy - Fatigue (FACT-F).
* Coping questionnaires: COPE-28 and Brief Resilience Scale (BRS).

Eligibility Criteria:
Inclusion Criteria:

* Women who participated in the case cohort in the epiGEICAM-01 clinical epidemiological study
* Capable and willing women to provide their written informed consent. If the patient has died, the biological sample and clinical data may be analyzed in those cases in which there is no express opposition from the patient or her relatives for participation in this type of study. The document of previous instructions will be consulted and, failing that, the criteria of the closest relative of the deceased will be recorded.
* Capable and willing women to complete the questionnaires provided in the study (except deceased).

Exclusion Criteria: None
Pre-Marketing Feasibility Evaluation of the UriCap-RM - Urine Collection in Hospitalized Male Patients

The study will evaluate device performance and user satisfaction in the UriCap-RM, an FDA cleared non-invasive urine collection device for men.

Following various disease conditions such as trauma, orthopedic surgery, and infections etc., patients may be bedridden and unable to void in a bedpan or to make their way to the toilet. Others may be incontinent of urine. In such situations an indwelling catheter is often placed to relieve patients while they are incapacitated; in many cases a catheter is placed despite lack of urinary retention. Indwelling catheters, although effective, are associated with discomfort, pain, and urinary tract infections. In other cases diapers or absorbent pads may be used, or a condom-type urine collection device. These may be associated with skin irritation and infection.

The study will evaluate the UriCap-RM non-invasive urine collection device in hospitalized men.

Eligibility Criteria:
Inclusion Criteria:

* Male ≥ 18 years old.
* Empties the bladder completely on voiding
* A clinical indication for an indwelling catheter, use of pads or diapers
* Subject has signed an informed consent form, is cooperative and willing to complete all study procedures
* Absence of localized disease at the site of device application - no discharge, itching, inflammation or skin condition - - on visual examination
* Subject has no hypersensitivity to silicon.

Exclusion Criteria:

* Known allergy to silicon
* Dysuria
* Urinary retention - Post-void residual urine more than 300cc
* Hematuria or pyuria (turbidity) on visual inspection, according to investigator judgement.
* Diagnosed with acute renal failure, according to investigator judgement.
* Serious or unstable psychological condition (e.g., eating disorders, clinical depression, anxiety, emotionally labile) which, in the opinion of the Investigator, would compromise the subject's well-being or successful participation in the study
* Participating in another clinical study.
* Financial interest in the Sponsor Company or a competitor company by subject or a family member
Community-Based Cognitive Therapy for Suicide Attempters

This study will determine the effectiveness of cognitive behavioral therapy (CBT) in preventing future suicide attempts in repeat suicide attempters.

Rates of mental health and substance use disorders are high among economically disadvantaged, ethnic minority populations. Studies have shown that CBT designed for this high-risk population is successful at reducing suicide attempts in people with suicidal thoughts or attempts. This study will implement a CBT intervention into the community and will focus on increasing compliance with psychiatric, substance abuse, and medical treatment.

Participants in this study will be randomly assigned to receive either CBT plus standard care or standard care alone. Participants who receive CBT will have ten weekly sessions of treatment. Suicidal thoughts or attempts, hopelessness, depression, health care utilization, and overall psychological and social adaptation will be assessed. Assessments will be made 1, 3, 6, 12, 18, and 24 months after study completion.

Eligibility Criteria:
Inclusion Criteria:

* Suicide attempt within 48 hours prior to being evaluated at the hospital
* English speaking
* Able to provide 2 verifiable contacts

Exclusion Criteria:

* Acute, unstable, or severe Axis III disorder or a severe Axis I disorder that may prevent safe participation in outpatient psychotherapy
Promoting Mental Health of Teachers and Caregiver Using a Personalized mHealth Toolkit in Uganda

This is a randomized controlled trial with 8 schools (4 intervention and 4 wait-list control schools) including 160 caregivers (80 teachers and 80 parents), with the aim of pilot testing the implementation process, feasibility, acceptability, usage patterns, and efficacy of the mHealth Toolkit for Wellness \& Empowering Lives of School Community (mWEL) in Uganda. The mWEL-App is a preventive intervention tool for teachers and parents as a self-help support modality. Caregivers who need support in navigating the toolkit will be supported by P-CHWs. The investigators hypothesize that: 1) relative to the control, caregivers receiving the mWEL will have better efficacy outcomes (mental health literacy, and mental health outcomes); and 2) mWEL implementation will have high acceptability, appropriateness, and feasibility.


Eligibility Criteria:
Teachers Inclusion Criteria:

* Teaching in recruited schools.
* At least 18 years old.

Parents Inclusion Criteria:

* At least 18 years old.
* Have a child aged 6-14 years.

Exclusion Criteria:

* Evidence of psychopathology or cognitive impairment severe enough to preclude giving consent, or completing the survey instruments or the focus group of the study.
* Parents/Teachers/Caregivers who are not in one of our recruited primary school
* Participants under the age of 18
* Participant who does not speak English and Luganda will not be able to participate
TB-CAPT CORE Truenat Trial

A cluster randomized controlled trial to evaluate the effect of placing Truenat platform/TB assays at primary health care clinics combined with rapid communication of results on time to treatment initiation of microbiologically confirmed TB.

A cluster randomized controlled trial to evaluate the effect of placing Truenat platform/TB assays at primary health care clinics combined with rapid communication of results on time to treatment initiation of microbiologically confirmed TB.

In a setup period (survey of study centers) before randomization, the healthcare facilities (=clinics) of 4 sites will be asked to provide information about the number of TB notifications per quarter covering the period 1/2018-6/2020. From this information the foreseeable number of examined patients ("size of a clinic") will be derived, which will be used as a strata variable in randomization process.

Facilities will be randomly allocated to the standard of care (control), or Truenat platform/TB assays (intervention).

A cluster refers to a clinic. The clusters will be assigned to intervention or control arm to one of two diagnostic procedures (SOC \[smear microscopy and/or Xpert MTB/RIF Ultra off-site\] vs Truenat platform/TB assays on-site) following a restricted randomization strategy, whereby 6 to 8 strata of clusters will be established using the stratification variables site (clinics belong to a site) and size and apply balance criteria for them. The number of strata per site depends on heterogeneity of the sizes of the clinics as established in setup period and may be increased, typically 1 or 2 strata per site will be established.

The primary endpoint will be compared in an individual level analysis with strata and intervention as fixed effects and cluster as random effect.

Eligibility Criteria:
Inclusion Criteria:

* Patients with presumptive pulmonary TB, as defined by the national TB treatment guidelines in each country: patients with cough more than 1-2 weeks and/or fever, night sweats, blood-stained sputum (haemoptysis) significant weight loss, abnormalities on chest radiograph
* Adults 18 years old and above who are able and willing to consent

Exclusion Criteria:

* Circumstances that raise doubt on free, informed consent (e.g. in a mentally impaired person or a prisoner)
* Already diagnosed with TB
* Currently receiving anti-TB therapy
* Patients with symptoms which are only attributable to extra-pulmonary TB
* Patients who are seriously ill and need to be admitted to hospital
Influence of Nutrition on Lung Microbiota in Traumatic Brain Injury

Role of immunonutrition in modulating the lung microbiota of intubated TBJ patients and how this interaction may affect the infections and outcomes.

For these reasons, the aims of our study are the evaluation of the impact of immunonutrition on the lung microbiota and the relationship between lung microbiota and infection in TBJ patients in ICU.

Traumatic brain injury patients, requiring mechanical ventilation admitted to ICU will be randomly divide in two groups receiving standard nutrition or specialized formula.

Lower lavage (Bronco Alveolar Lavage: BAL) samples will be collected at admission in ICU and at day 7 for the microbiota analysis. Clinical follow-up at day 28 will be obtained

Eligibility Criteria:
Inclusion Criteria:

* adults (age \> 18 years),
* paziente with traumatic brain injury

Exclusion Criteria:

* pregnant women,
* patients with gastric content inhalation
* patients with chronic inflammatory bowel diseases
* patients underwent major abdominal surgery and/or organs/tissues transplant
* patients on corticosteroid and/or immunosuppressive therapy
Aneurysmal Subarachnoid Hemorrhage and Superior Mesenteric Artery Flow Study

The purpose of this research study is to determine if the diameter and flow of the superior mesenteric artery in patients with aneurysmal subarachnoid hemorrhage undergoing hypertensive therapy for cerebral artery vasospasm are effected enough to justify withholding enteral nutrition.

Study measurements of the diameter and Doppler flow velocity of the superior mesenteric artery (SMA) using abdominal ultrasound in order to evaluate the potential additional risk of non-occlusive mesenteric ischemia (NOMI) and non occlusive bowel necrosis (NOBN) in patients undergoing hypertensive therapy for cerebral vasospasm in Aneurysmal Subarachnoid Hemorrhage (aSAH), to justify the withholding of enteral nutrition.

Eligibility Criteria:
Inclusion Criteria:

* Patient diagnosed with aSAH

Exclusion Criteria:

* Hemodynamic instability
* Already receiving vasopressor therapy
* Non-aneurysmal SAH
* Intracranial hemorrhage of other cause
* Not anticipated to receive hypertensive therapy with vasoactive medications for cerebral vasospasm from SAH or suspected aSAH
* Unable to visualize SMA using ultrasound
* Pregnancy