cyrilzakka/clinical-trials huggingface dataset:
A Study To Assess the Effects Of PF-04457845 On BOLD fMRI In Subjects With Post Traumatic Stress Disorder

The purpose of the study is to evaluate proof of mechanism of PF-04457845, using a well-established neuroimaging paradigm including behavioral tasks selected to activate neuro-circuitry relevant to Post Traumatic Stress Disorder. It is hypothesized that PF-04457845 will modulate the Blood-oxygen-level dependent Functional Magnetic Resonance Imaging signal from the relevant neuro-circuits in patients with Post Traumatic Stress Disorder.

This is a Phase II, randomized, placebo-controlled, parallel group design study in male and female subjects with moderate-to-severe Post Traumatic Stress Disorder between the ages of 18 and 60 years old. During this study, a dose of 4 mg PF-04457845 will be administered in the morning on Days 1-7. On Each subject will undergo a resting state fMRI (pre and post and day 8), a fearful vs. neutral faces fMRI task and a fear extinction fMRI paradigm. The Emotional Faces Paradigm and resting state tasks will be performed on Day 1 (prior to drug or placebo) and on Day 8. Acquisition of fear conditioning will be performed during the first imaging session on Day 1. After the first imaging session on Day 1, subjects will complete behavioral rating scales and then be dosed. Approximately six hours after dosing subjects will re-enter the scanner and perform the fear extinction paradigm. On Day 2, subjects will perform the fear extinction memory retention task within the scanner. Further physiological monitoring, including skin conductance and heart rate, will take place during the fear extinction paradigm. One safety follow-up visit will occur between Days 11-18.

Eligibility Criteria:
Inclusion Criteria:

* Men and women 18-60 years of age with a primary psychiatric diagnosis of Post Traumatic Stress Disorder

Exclusion Criteria:

* Other psychiatric illness requiring current treatment with medication.
A Study to Evaluate Long Term Safety, Tolerability, and Effectiveness of Olesoxime in Patients With Spinal Muscular Atrophy (SMA)

The purpose of this open-label, single arm study is to further evaluate long-term tolerability, safety and efficacy outcomes of olesoxime in participants with Spinal Muscular Atrophy (SMA) who previously participated in one of the following two clinical studies: TRO19622 CL E Q 1115-1 (open-label Phase Ib, multicenter, single- and multiple- dose study) or TRO19622 CL E Q 1275-1 (NCT01302600, Phase II/III, adaptive, parallel-group, double blind, randomized, placebo-controlled, multicenter, multinational study).


Eligibility Criteria:
Inclusion Criteria:

* Participation in the previous studies (TRO19622 CL E Q 1115-1 or TRO19622 CL E Q 1275-1)
* For women of childbearing potential: agreement to use an acceptable birth control method during the treatment period and for at least 28 days after the last dose of olesoxime

Exclusion Criteria:

* Female participants who are pregnant or lactating, or intending to become pregnant during the study
* Participants who, in the opinion of the investigator, are not suitable to participate in this open-label study
* Participants who have developed study drug hypersensitivity to olesoxime or one of the formulation excipients, including sesame oil
* Concomitant or previous participation in any investigational drug or device study within 90 days prior to screening
* Concomitant or previous participation in a survival motor neuron 2 (SMN2) targeting antisense oligonucleotide study within 6 months prior to screening
* History of human immunodeficiency virus infection, history of Hepatitis B infection within the past year, history of Hepatitis C infection which has not been adequately treated
* History of illicit drug or alcohol abuse within 12 months prior to screening, in the investigator's judgment
* Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the participant's safe participation in and completion of the study
* History or presence of an abnormal electrocardiogram (ECG) that is clinically significant in the investigator's opinion
Effectiveness of Nurse-led Family Intervention on Stress, Engagement With Patient's Care and Satisfaction Among Primary Caregivers of Chronic Liver Disease Patients Admitted in High Dependency Unit of ILBS, New Delhi

Quasi experimental study to check the effectiveness of Nurse-led family Intervention on stress, engagement with patient care and satisfaction among primary caregivers of chronic liver disease patients admitted in high depency unit ILBS, two group pre test post test design non randomisation with the Nurse-led family intervention with the sample size of 80 using purposive sampling technique and having independent variable as Nurse-led family intervention and dependent variables are stress, Engagement with patient care and satisfaction and these variables are assesed by using kingston caregivers scale(KCSS) caregiver health engagement scale (CHEW-S)and one knowledge questionnaire based on engagement and satisfaction scale

study having different inclusion and exclusion for criteria CLD patients and Caregiver sof patint's admitted in HDU inclusion criteria of primary caregivers between the age group of 18-65years understand hindi and english duration of hjospitalization should be more than 6 hours exclusion criteria is primary are givers who cannot understand hindi or english and age more than 65 years of age , craegivers of patients who are having disease other than CLD and those who are not willing to participate inclusion for criteria CLD patients decompensated CLD patients , understand hindi and english , duration of hospitalization more than 6 hours , patient is concious and in semi concious state and patient with hepatic encephlopathy

Eligibility Criteria:
Inclusion Criteria:between age group of 18-65 years

* primary caregivers of CLD patient's understand hindi and english duration of hospitalization more than 6 hours

Exclusion Criteria:

* primary caregivers who cannot understand hindi and english age more than 65 years of age caregivers of patient's who are other than CLD not willing to participate
Does Acne Rash During Adolescence Predict Skin Reaction to Cetuximab

The hypothesis of this study is that patients who suffered from acne vulgaris during adolescence are at greater risk of developing acneiform skin rash due to cetuximab.

The hypothesis of this study is that patients who suffered from acne vulgaris during adolescence are at greater risk of developing acneiform skin rash due to cetuximab

Eligibility Criteria:
Inclusion Criteria:

* Age above 18 years.
* Histology or cytology proven KRAS-WT mCRC.
* Performance status ≤3 (Eastern Cooperative Oncology Group \[ECOG\] classification)
* Life expectancy of more than 12 weeks.
* Written informed consent.
* In women of childbearing potential, appropriate contraceptive measures must be used during treatment with cetuximab and for 6 months following the last dose of cetuximab.

Exclusion Criteria:

* Past systemic immune therapy for disease other than cancer.
* Past immune or other target therapy for cancer (not including bevacizumab).
* Presence of acne or acneiform rash prior to starting treatment with cetuximab.
* Patients with treatment plan of cetuximab and capecitabine combination.
* For female patients: the patient is pregnant or lactating.
Comparative Evaluation of Intra-operative Peritoneal Lavage With Super Oxidized Solution and Normal Saline in Peritonitis Cases

Super Oxidized Solution (SOS) was used in peritonitis and results were compared by using normal saline solution in two groups. Abdominal fluid was taken to check for bacterial load after giving lavage with SOS solution and in other group normal saline. SOS is a high level disinfectant, non-flammable and no special training is required to handle it.

Aim - To investigate the efficacy of super-oxidized solution (SOS) over normal saline in peritonitis. The investigators objectives are to present the potential clinical impact of intraperitoneal lavage with solutions for early recovery of the patient by reducing the infection rate.

Methods - A double-blind random clinical trial was performed in 240 patients diagnosed as peritonitis at MMIMSR, Mullana, Ambala, India, from December 2014 - November 2015. Subjects were divided into 2 groups, i.e. 120 patients in the study group and 120 cases in the control group. Both the groups underwent peritoneal lavage ; the study group received SOS where as control group underwent normal saline lavage. The effectiveness of both the solutions were compared.

Eligibility Criteria:
Inclusion criteria:

* gastric, duodenal, ileal perforation, appendicitis
* those patients were willing to participate and the informed consent was taken

Exclusion criteria:

* evidence of enteric encephalopathy
* liver diseases
* renal diseases
* heart disease
* known allergy to any substance
* multiple trauma or organ injury
* any gynaecological etiology
Adapting Daily Activity Performance Through Strategy Training

Individuals with cognitive impairments after stroke sustain significant disability in their daily tasks, and account for a significant proportion of stroke-related healthcare costs. The proposed study examines a novel intervention, strategy training, that shows promise for helping individuals with stroke-related cognitive impairments reduce disability in daily tasks, which may lead to reductions in healthcare costs. We predict that strategy training will result in significantly greater independence 6 months after stroke compared to an attention control intervention, and that strategy training may reduce cognitive impairments.


Eligibility Criteria:
Inclusion Criteria:

* primary diagnosis of acute stroke
* admission to acute inpatient rehabilitation
* impairment in higher order cognitive functions (EXIT-14 ≥ 3)

Exclusion Criteria:

* pre-stroke diagnosis of dementia in the medical record
* inability to follow two- step commands 80% of the time
* severe aphasia (BDAE ≤ 1)
* current major depressive, bipolar, or psychotic disorder
* drug or alcohol abuse within 3 months
High Dose, Absorbed Dose Adjusted 90Y-ibritumomab With Peripheral Blood Stem Cells (PBSC) Support in B-cell Lymphoma

90Y-ibritumomab given with stem cells support, based on absorbed dose escalation to the liver. Absorbed dose escalation starts at 12 Gy and is capped at 36 Gy to the liver.


Eligibility Criteria:
Inclusion Criteria:

* Written informed concent
* Age at least 18 years
* WHO Performance status 0-3
* Histologically verified B-cell lymphoma
* Diffuse large B-cell lymphoma and follicular grade III, failing an anthracycline containing regimen and patients not found suitable for a second line chemotherapy consolidated by high dose chemotherapy (HDCT) with stem cell support or radiotherapy
* Transformed B-cell lymphoma, failing first line therapy and not suitable for high dose chemotherapy (HDCT) or with a history of HDCT with stem cell support
* Follicular lymphoma grade II and I, and other indolent lymphomas must have failed second line treatment.
* One of these treatments must have contained chemotherapy and rituximab, the latter either together with chemotherapy or as maintenance.
* The lymphoma must require treatment, Mantle cell lymphoma, failing first line treatment,treatment required
* Measurable disease and the tumor burden must be acceptable according to the investigator
* Radiological studies must be performed and a unilateral bone marrow biopsy within 4 weeks before start of treatment
* Bone marrow reserve likely to give a harvest of at least 2x10 6 peripheral CD34+ stemcells or the existence of such a harvest or a corresponding central harvest
* Total bilirubin should not exceed 40 micromole/L
* A GFR as measured by Cystatin C of 50 ml/min
* HIV, Hepatitis B and C status known
* Life expectancy of at least 3 months.

Exclusion Criteria:

* Known or clinical evidence of CNS involvement
* Bone marrow involvement at harvest as measured by biopsy and flow cytometry
* Subjects with prior radiation to a field that includes over or equal 25% of their red marrow, liver or lung or to both kidneys
* Prior chemotherapy or radiotherapy within 4 weeks
* Subjects who are pregnant or nursing
* Pulmonary involvement, that is not negligible at the discretion of the investigator
* Liver involvement of lymphoma
* History of hepatitis B or C.
Effects of Masseter Manual Therapy on Temporomandibular Dysfunction

Muscles and myofascial dysfunction are more often the mechanism and source of pain in oral fascial disorders (OFD) than the TMJ. Masticatory muscles in patients with TMJ alterations are more hypertonic, less efficient and more prone to fatigue compared to age and sex matched controls. It is our opinion that Active Release Technique can be a reliable assessment and treatment tool in the resolution in cervical-cranio mandibular disorders. Our goal is to improve masticatory function through treatment of trigger points in the masseter.

Recruit 45 patients with TMD determined by questionnaire. Measure pre and post mandibular active range of motion and VAS pain scale. Treatment will include 4 visits over a two week span measuring before first treatment and after last treatment. There will be 3 treatment groups; active release technique, post isometric relaxation and a no treatment control group. We will analyze data for any change in mandibular range of motion and VAS pain scale.

Eligibility Criteria:
Inclusion Criteria:

* Difficulty and/or pain when opening mouth
* Jaw locking
* Difficulty or pain when chewing or talking
* TMJ clicking
* Jaw stiffness, tightness, or fatigue
* Pain in ear, temple or cheeks
* Frequent headaches, neckaches, toothaches
* Change in occlusion

Exclusion Criteria:

* Trauma to head, neck or jaw within last 12 months
* Recent dental extractions
* Taking prescription analgesics/muscle relaxants
* Recent cervical SMT (HVLA)
* Already under care for condition
* Sinus infection
A Cross-Sectional Survey to Evaluate Diabetes Management, Control, Complications, Psychosocial Aspects of Patients With Type 2 Diabetes in Bangladesh, Indonesia, Malaysia, Philippines, Sri Lanka and Vietnam

This study is conducted in Asia. The aim of this non-interventional study is to evaluate the current status of diabetes management, control, and complications in diabetic subjects in Vietnam.


Eligibility Criteria:
Inclusion Criteria:

* People with type 2 diabetes mellitus (DM) who are being treated, with any of the non-pharmacological or pharmacological options, at a particular centre for at least 1 year and who have visited the centre within the last 3-6 months
* Patients willing to sign informed consent form

Exclusion Criteria:

* Previous participation in this study
* Unable to comply with protocol requirements
* Confirmed or suspected pregnancy
Long Term Treatment of End Stage Renal Disease Patients With Lanthanum Carbonate (Fosrenol)

Patients who have been treated with Fosrenol for a minimum of 12 consecutive weeks and are receiving dialysis will be followed for 5 years to compare mortality, bone fractures and incidence of selected morbidities to patients with no lanthanum exposure and to patients being treated for hyperphosphatemia with any marketed product.


Eligibility Criteria:
Inclusion Criteria: Test Group

* Signed informed consent
* Patient must have ESRD and be receiving dialysis
* Prior treatment with Fosrenol for a minimum of 12 consecutive weeks
* Primary payer of healthcare must be Medicare (patient must supply Medicare Claim Number)
* Patient must be 18 years of age or older

Exclusion Criteria: Test Group

* Patients that do not meet inclusion criteria
Effectiveness of the Application(APP) on Individualized Antithrombotic Therapy

Develop an exemplary anti-thrombotic therapy network data platform and a intelligent terminal application(APP), establish an new pattern used in long-time anti-thrombotic management based on dynamic risk evaluation, and promoted and verified by 10 thousands large sample's cohort study.

1.1.Develop and optimize antithrombotic therapy network data platform and thrombotic risk evaluate the intelligent terminal APP, establish a new pattern based on dynamic risk evaluation and event-triggered response, settle the conundrum in clinical practice about antithrombotic therapy such as poor compliance, lag and unreasonable in drug adjustment.

1.2.Settle the technical problem that intelligent terminal APP code isn't compatible with most tablet PCs and smartphones.

1.3.Impel the data platform to render and integrate with the daily medical system, enhance its accuracy, compatibility, privacy, and quality standard.

1.4.Promote the new pattern of anti-thrombotic management by large sample's cohort study, increase the patients' compliance, reduce the readmission rate and adverse event rate of heart and cerebral vessels.

Eligibility Criteria:
Inclusion Criteria:

* age≥18 years;
* clinical confirmed coronary heart disease. Including definite history of myocardial infarction, stable angina with exercise electrocardiography test(treadmill exercise) positive, unstable angina with electrocardiogram(ECG) ischemic changes or troponin positive, coronary angiography(CAG) hints at least one coronary artery stenoses over 50%, post-operative of percutaneous coronary intervention(PCI) or coronary artery bypass grafting(CABG);
* Be receiving anti-thrombotic therapy;
* Be voluntary to participate in the study., and sign informed consent form.

Exclusion Criteria:

* inability to obtain consent from participants;
* unable to record the medical data through terminal applications(APP)
Pelvic CT with Agatston Calcium Score for Peyronie Disease

The purpose of this study is to find out how including a CT exam of the penis can help urologists make treatment decisions for patients with calcified Peyronie's disease.

Peyronie disease (PD) affects up to 10% of men with fibrosing penile plaques causing penile pain and progressing to deformity. Calcified plaque develops in up to 20% of these patients, excluding them from medical therapy with collagenase injection and often requiring more extensive surgery for treatment. PDDU identifies plaque distribution and characteristics while the Doppler exam evaluates for any underlying erectile dysfunction. Calcification can make PDDU difficult to identify the full extent of plaque since the shadow caused by calcification may prevent accurate measurement and over or underestimate the plaque size. In addition, the ultrasound exam is operator dependent and requires injection of an agent to induce erection. Since current clinical practice excludes men with any degree of calcification presumed on physical examination or demonstrated on PDDU from receiving injection therapy they may be triaged to surgical management instead. A prior study found the presence of calcifications at ultrasound had odd ratio 1.75 of patient progressing to surgical management, while fibrosis without calcification did not have increased odds of surgical management. Noncontrast pelvis CT provides three dimensional detail of calcified plaque including parts of the penis that are difficult to image with PDDU, and calcification does not have artifact on CT. By adding non-contrast pelvis CT with Agatston calcium scoring to PDDU and clinical parameters of penile deformity, patients may be better stratified into the appropriate treatment pathway.

Eligibility Criteria:
Inclusion Criteria:

* Peyronie Disease with stable curvature considered for therapeutic intervention
* PDDU obtained at clinic visit
* Able to provide informed consent

Exclusion Criteria:

* Implanted penile prosthesis or implanted urethral sphincter that would prevent adequate CT images
* Acute active Peyronie disease that would not be managed with injection or surgical therapy
Evaluation of the Influence of Output on a Newly Develop Adhesive

The study investigates the impact real output has on the adhesion of adhesives.


Eligibility Criteria:
Inclusion Criteria:

1. Have given written informed consent
2. Be at least 18 years of age and have full legal capacity
3. Have had an ileostomy for more than one year
4. Have intact skin on the area used in the evaluation
5. Has an ileostomy with a diameter up to (≤) 35 mm
6. Have a peristomal area accessible for application of patches/adhesive strips (assessed by investigating scientist)

Exclusion Criteria:

1. Currently receiving or have within the past 2 month received radio- and/or chemotherapy
2. Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment.
3. Are pregnant or breastfeeding
4. Having dermatological problems in the peristomal- or abdominal area (assessed by investigating scientist)
5. Participating in other interventional clinical investigations or have previously participated in this evaluation
Clinical Characteristics Analysis and Prediction Model Establishment of Fatal Esophageal and Gastric Variceal Bleeding

The purpose of this study is to analyze the clinical characteristics of patients with fatal acute variceal bleeding (AVB) and establish a mortality risk prediction model to identify patients at high risk of death after admission, so as to guide clinical practice, further optimize the allocation of emergency resources, and further reduce the mortality of AVB patients.

How to predict adverse outcomes of acute variceal bleeding and identify high-risk patients remains unclear. Most studies related to risk factors for adverse outcomes in AVB patients took 5 days and 6 weeks as time nodes, and the main outcome indicators were the rebleeding rate and mortality rate at 5 days and 6 weeks. However, some patients admitted to hospital may suffer death within a short period of time ,the investigators will define AVB patients at high risk of death in several hours after admission as fatal acute variceal bleeding.To identify such patients and give more positive treatment can further reduce the mortality of AVB. Such risk stratification can be used to further guide the rational allocation of emergency resources, improve the efficacy of medical resources. This study intends to retrospectively collect the clinical data of AVB patients in Renmin Hospital of Wuhan University, analyze the risk factors for death after admission, establish a mortality risk prediction model, and compare and validate the new model and the scoring model to be verified.

Eligibility Criteria:
Inclusion Criteria:

1. History of cirrhosis/previous history of endoscopic varicose veins/undiagnosed liver disease but signs related to liver disease, hematemesis or melena; The diagnosis of cirrhosis is based on liver biopsy or the usual clinical and radiological criteria;
2. AVB was confirmed by endoscopy without special medical history;

Exclusion Criteria:

1. Patients who cannot obtain complete data (vital signs, medical history, laboratory tests and other data are seriously missing);
2. Patients with upper gastrointestinal bleeding have no evidence of AVB.
Improvement of Body Image Flexibility in High School Female Athletes Doing Educational About Nutrition and Body Image

Evaluation of increase in body flexibility in female high school athletes undergoing education on nutrition and body image

This study was a prospective cohort design. Female high school athletes were asked to participate in three educational sessions about nutrition, body image flexibility, and RED-S (relative energy deficiency in sport). Pre and post-tests were done with a validated tool measuring body image flexibility.

Eligibility Criteria:
Inclusion Criteria:

* identify as female
* athlete at local high school
* willing to fill out survey at beginning and end of sessions
* willing to provide consent

Exclusion Criteria:

* none