cyrilzakka/clinical-trials huggingface dataset:
A Clinical Study to Evaluate the Efficacy and Safety of LIV-GAMMA SN Inj. in Primary Immune Thrombocytopenia (ITP)

The main purpose of this study is to assess the efficacy and safety of LIV-GAMMA SN Inj. in adult subjects with ITP. The primary objective of this study is to determine the responder rate. A response is defined as a platelet count of ≥30×10\^9/L and at least a 2 fold increase of the baseline, confirmed on at least 2 separate occasions at least 7 days apart without bleeding. The secondary objectives are to evaluate the further efficacy assessments including duration of response, and the safety of LIV-GAMMA SN Inj.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of ITP
* Mean screening platelet count of \<30×10\^9/L from 3 qualifying platelet counts performed within 14 days before the start of treatment, with no individual platelet count above 35×10\^9/L.
* No other factors inducing ITP
* Stable doses of ITP active treatment must not have modified the dose in the preceding 1 month and must maintain their prestudy dose during the study.

Exclusion Criteria:

* Known for hypersensitivity reactions to blood products, intravenous immunoglobulin (IVIg) or immunoglobulin G
* Immunoglobulin A (IgA) deficiency
* Therapy with live attenuated virus vaccines 3 months before the first administration of LIV-GAMMA SN Inj.
* Administration of other investigational product 1 month before the first administration of LIV-GAMMA SN Inj.
* Administration of Rituximab 3 months before the first administration of LIV-GAMMA SN Inj.
* Treatment with anti-coagulants, which may affect the function of platelet
* Positive HIV, HBV, HCV
* 3-fold increase of ALT or AST compared to normal upper limit
* eCFR \< 30mL/min/1.73m\^2
* History of deep vein thrombosis (DVT) or IVIg-induced thrombotic compliances
* Hemoglobin \> 10g/dL
PeerScope B System™ Clinical Protocol

The PeerScope B System™ by PeerMedical Ltd. is intended to provide visualization (via a video monitor) and therapeutic access to the lower intestinal tract. The lower intestinal tract includes, but is not restricted to the organs, tissues and subsystems: large bowel and cecum. The device is introduced rectally, as with any standard colonoscope when indications consistent with the need for the procedure are observed in the adult patient population.

The purpose of this prospective clinical study is to establish the usability of the PeerScope B System™ when used during standard colonoscopy procedure.

The study population is comprised of patients indicated for colonoscopy.

The primary endpoint is reaching the cecum of the colon with PeerScope B System™.Secondary endpoints:

1. The first secondary endpoint is the incidence of complications using the PeerMedical colonoscope.
2. The second secondary endpoint is successful therapeutic interventions as biopsies, polypectomies, APC etc.
3. The third secondary endpoint is the procedure time.
4. The fourth secondary endpoint is the subjective evaluation of the additional view angle by the physician.
5. The fifth secondary endpoint is patient satisfactory.

Founded in 2009, PeerMedical develops colonoscopes capable of wide view angle at the press of the button. The PeerScope B System™ is an endoscopic platform that enables the physician to get a wide angle view while maintaining all of the features commonly used during Gastrointestinal (GI) procedures with very limited learning curve and in service process. The current standard devices have viewing limitations. By adding this viewing functionality, PeerMedical will potentially empower physicians to improve polyps detection and cancers within the colon.

Eligibility Criteria:
Inclusion Criteria:

* Subject between the ages of 18 and 70
* The patient is undergoing colonoscopy for screening, for surveillance in follow-up of previous polypectomy or for diagnostic workup;
* Written informed consent must be available before enrollment in the trial
* For women with childbearing potential, adequate contraception

Exclusion Criteria:

* Patients with a history of colonic resection;
* Patients with inflammatory bowel disease;
* Patients with a personal history of polyposis syndrome;
* Patients with suspected chronic stricture potentially precluding complete colonoscopy;
* Patients with diverticulitis or toxic megacolon;
* Patients with a history of radiation therapy to abdomen or pelvis;
* Patients who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the patient's participation in this study.
Silver Diamine Fluoride After Minimal Caries Removal Technique in Asymptomatic Young Permanent Teeth With Deep Caries

This study is comparing between the Silver Diamine Fluoride after minimal caries removal versus glass ionomer in permanent teeth with open apex

The study will be carried on young permanent molars with open apices \& with deep caries. Incomplete caries removal and application of indirect pulp capping materials where Silver Diamine Fluoride (Group I) will be compared with glass ionomer only (group II). Then final restoration with composite resin for both groups. Children will be followed up for 9 months.

Eligibility Criteria:
Inclusion criteria:

1. Patients free from any systematic diseases.
2. Young permanent molars with incompletely formed roots having deep carious lesions according to clinical and radiographic examination and at risk of pulp exposure if complete caries is removed.
3. Absence of clinical pathologic signs (fistula, swelling and abnormal tooth mobility)
4. The absence of clinical symptoms of irreversible pulpitis.
5. Absence of adverse radiographic findings (interradicular or periapical radiolucencies, thickening of the periodontal space, internal and external root resorption).
6. Compliant patient/ parent.

Exclusion criteria:

1. Teeth with previous restorative treatment.
2. Unrestorable teeth.
3. Uncooperative patients.
Evaluation Research of the Nutrition Interventions in the INHP II Areas of CARE India

This study is designed to evaluate the effectiveness of CARE India's Integrated Nutrition and Health Program (INHP II) to reduce malnutrition among children 0-23 months of age.


Eligibility Criteria:
Inclusion Criteria:

* Mothers with a child 0-23 months of age
* Children 0-23 months of age
* Currently pregnant women
* Resides in the program or control area

Exclusion Criteria:

-
Multicenter Study on Suprapubic Catheterization Versus Transurethral Catheterization in Laparoscopic Surgery for Rectal Cancer

Compared with traditional open proctectomy, laparoscopic surgery is associated with less pain, earlier recovery, and better cosmetic outcome, and its long-term oncologic outcomes have been demonstrated. However, the rate of urinary dysfunction after rectal cancer surgery was about 19-38% because of mesorectal excision. The type of drainage is unclear. Some studies show that the rates of urinary tract infection, second catheterization, and urinary symptom are lower with suprapubic catheterization (SPC) than with transurethral catheterization (TUC). Moreover，SPC allows for testing the bladder voiding without drainage removal. Furthermore，SPC using central venous catheter(CVC) is less invasive.

Currently, there is lack of randomized controlled trial(RCT) to compare SPC with TUC. Therefore, investigators perform this prospective randomized trial to compare SPC using CVC with TUC in laparoscopic surgery for rectal cancer.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years
* Pathological rectal carcinoma
* Male patients
* Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale
* ASA (American Society of Anesthesiology) score class I, II, or III
* Laparoscopic surgery for rectal cancer
* Written informed consent

Exclusion Criteria:

* Emergency surgery due to complication (obstruction or perforation) caused by rectal cancer
* Preoperative T4b according to the 7th Edition of AJCC Cancer Staging Manual
* Basic diseases of urinary system (urinary bladder stones and tumors, prostate cancer, neurogenic bladder, urethral stricture) that affect voiding function
* History of previous pelvic surgery
* Severe mental disease
Severity Factors and Needed Observation Time at ED of Patients Wih Head Injury

We know precisely which patients and when they should have an imaging test to evaluate a Head Injury (HI). But in those patients on anticoagulant and / or antiaggregant treatment we do not know the exact incidence of early and late hemorrhagic lesions, and there is no specific recommendation on how long they should remain under observation in the emergency department if no initial lesions are evident. Our goal is to try to answer these two questions.

MATERIAL: Prospective study of patients treated of HI in the Emergency Department (ED) and to whom an image test is performed (cranial CT scan). Collection of demographic, clinical, analytical, image tests, and observation time in the emergency department (from admission to medical discharge)

METHODS: Separation of subjects included in the study in 4 cohorts: patients without anticoagulant and / or antiaggregant treatment; patients with antiplatelet therapy (ASA and / or clopidogrel); patients with anticoagulant treatment with acenocoumarol and INR \<2; and patients on anticoagulant therapy with acenocoumarol and INR\> = 2 or patients on treatment with direct thrombin inhibitors (dabigatran), or inhibitors of factor Xa (rivaroxaban, apixaban, edoxaban) or patients on treatment with low molecular weight heparins (LMWH) ) Follow-up through analysis of clinical history and telephone interview at 2, 7, 15, 30, 60 and 90 days.

Statistical analysis of the results.

Eligibility Criteria:
Inclusion Criteria:

* HI attended at ED
* Head CT performed as recommended by clinical guides
* Contact data available (phone number)

Exclusion Criteria:

* Patients not able for follow up (foreigners or tourists or whatsoever whom are not going to stay on the country for at least 3 months)
Pilot Study to Assess Telemonitoring of Gleevec (Imatinib Mesylate) or Tasigna (Niltinib) Therapy

This study is being conducted in a population of patients with chronic phase Chronic Myeloid Leukemia (CML) to learn more about how patients follow prescribed regimens for taking oral cancer drugs.

This is a randomized, controlled pilot study to introduce eMedonline telemonitoring technology to CML patients taking Gleevec or Tasigna. eMedonline will be used to automatically collect time-dose specific medication data for individual patients, including dosing times, missed doses, adverse events and e-diary data. All data will be available to research staff for remote review via Web interface. Adverse events and non-adherence will prompt interventions including supportive care counseling.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years of age or older.
* Pathologically documented diagnosis of Chronic Phase CML (Ph+) in whom treating physician has determined that treatment with imatinib or nilotinib is appropriate
* Patients currently receiving Gleevec (imatinib) 300-600 mg daily or Tasigna (nilotinib) 300-400 mg twice daily
* Known performance status 0,1 or 2 (ECOG)
* Known adequate end organ function, defined as:

Total bilirubin \< 1.5 xULN SGOT and SGPT \<2.5 x ULN ANC \> 1.5 Platlets \> 100,000

* Patient is willing and able to use a cell phone
* Written, voluntary informed consent

Exclusion Criteria:

* Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent
Is Aminophylline More Effective Than Neostigmine/Atropine Mixture in the Treatment of Post-dural Puncture Headache

Objectives: To compare the safety and efficacy of IV aminophylline versus IV neostigmine/atropine mixture in the treatment of post-dural puncture headache (PDPH).

Background: PDPH is the most frequent complication of procedures associated with dural puncture for spinal anesthesia or following accidental dural puncture during epidural anesthesia. Since invasive treatments have known complications, pharmacologic management may be preferable.

Patients and Methods: This was a prospective, randomized, double-blind, phase four clinical trial; carried out on 60 patients presented with PDPH at our hospital. Patients were randomly allocated into two equal groups (30 patients each); group A, received IV aminophylline, and group NA, received IV neostigmine/atropine mixture.


Eligibility Criteria:
Inclusion Criteria:

* Patients with NPRS score of ≥ 5
* American Society of Anesthesiologists (ASA) physical status ≤ II
* Age from 21 to 50 years

Exclusion Criteria:

* Patients with NPRS score \< 5
* ASA physical status \> II
* Age \< 21 years or \> 50 years
* Pregnant women
* History of; chronic headache, Cluster headache, Migraine
* History of; Convulsions, Cerebrovascular accident, Previous neurological diseases
* Signs of meningismus
* Bronchial asthma
* Arrhythmia
* Hypertension
* Ischemic heart disease
* Hyperthyroidism
Efficacy and Safety Study of Ursodeoxycholic Acid to Treat Chronic Hepatitis C

This study is a 24-week multicenter, randomized, double-blind control trial with ursodeoxycholic acid (UDCA) in patients with chronic hepatitis C in Japan. The primary objectives of this study are to verify the superiority of efficacy of UDCA 600 or 900mg/day to that of 150mg/day and the safety of UDCA treatment.

This study is a 24-week multicenter, randomized, double-blind control trial with ursodeoxycholic acid (UDCA) in patients with chronic hepatitis C in Japan. The primary objectives of this study are to verify the superiority of efficacy of UDCA 600 or 900mg/day to that of 150mg/day and the safety of UDCA treatment. The primary endpoint was percent changes of serum alanine aminotransferase(ALT) levels at 24-week of administration compared to pre-administration levels and secondary endpoints, serum aspartate aminotransferase(AST) and gamma-glutamyltranspeptidase(gamma-GTP) levels. Further, changes of bile acid composition and HCV-RNA levels at 24-week of administration were examined.

Eligibility Criteria:
Inclusion Criteria:

1. Subject must have a clinical diagnosis to apply the conservative medication for chronic hepatitis C.
2. Serum alanine aminotransferase levels measured at 4-week before the initiation of treatment must be over 61 IU/mL.
3. Subject's age must be 20 years or older.

Exclusion Criteria:

1. Subject who received a treatment of antiviral agents (interferon) within 20 weeks before the start of 8-week observation period
2. Subject who received a treatment of corticosteroids, immunosuppressive drugs, glycyrrhizic acid, cholestyramine or other drugs which could interfere with hepatic function during 8-week observation period.
3. Subject with decompensated cirrhosis
4. Subject infecting with other hepatic virus
5. Subject receiving a treatment for autoimmune disease, alcohol or drug-induced hepatic disorder, neoplasia, hepato-cholangiolar disease, fulminant hepatitis or peptic ulcer
6. Subject who require hospitalization for complications of the heart, kidney or pancreas
7. Pregnancy
8. Alcoholics
9. Alcohol intake more than 27 ml/day
10. Subject who involved in other clinical trial within 4 weeks before the start of observation period
11. Subject with a history of sensitivity to ursodeoxycholic acid or bile acid-products
A Phase 2 Study of the Safety and Efficacy of a Tofimilast in Adult Patients With Chronic Obstructive Pulmonary Disease

This an initial proof of concept, phase to study to assess the safety and efficacy of tofimilast for the chronic maintenance treatment of adults with Chronic Obstructive Pulmonary Disease


Eligibility Criteria:
Inclusion Criteria:

* Moderate-severe COPD (GOLD 2003 definition)
* Smoking history of at least 10 pack-years

Exclusion Criteria:

* Any significant co-morbid disease, particularly cardiovascular
* Use of any maintenance therapy except short acting bronchodilators
Diagnostic and Therapeutic Applications of Microarrays in Lung Transplantation

Objective: To evaluate the potential impact of molecular phenotyping of transbronchial biopsies in lung transplant recipients with allograft dysfunction, and the potential for developing a safer endobronchial mucosal biopsy format.

The current standard for biopsy-based diagnoses of dysfunction of lung transplants is the International Society of Heart and Lung Transplantation (ISHLT) classification applied to transbronchial biopsies, which represents an arbitrary international consensus. Recent data-driven approaches using molecular and conventional technologies indicate that this system produces frequently incorrect diagnoses with potential harm to patients due to inappropriate treatment. especially in relationship to the correct diagnosis of chronic lung allograft dysfunction is a pressing need. To address this unmet need and improve diagnostics in the area of organ transplantation, the Alberta Transplant Applied Genomics Centre (ATAGC, University of Alberta) has developed a new diagnostic system - the Molecular Microscope® Diagnostic System (MMDx) that interprets biopsies in terms of their molecular phenotype. The MMDx, developed first in kidney transplant biopsies with thoroughly established phenotypes, will now be adapted to lung transplant transbronchial biopsies (TBBs). Microarray analysis of lung allograft biopsy specimens will be compared to conventional allograft phenotyping, including clinical, physiologic, radiographic and histological assessment. The present study will use the MMDx™ system to assess and report TBBs, and validate and refine this system in 300 unselected prospectively collected lung TBBs. A subset of the study will examine the third bifurcation mucosal endobronchial biopsies (3BMBs) paired with TBBs from 50 patients to see if the safer 3BMBs can substitute for the TBB to be used by MMDx™. Due to a considerable interest and support from participating Centers, the study is further extended and collected 1094 TBBs and 930 3BMBs from 930 patients. This this is the extension of the INTERLUNG study - INTERLUNGEX.

Eligibility Criteria:
Inclusion Criteria:

* All lung transplant recipients undergoing a biopsy as determined by their surgeon or physician.

Exclusion Criteria:

* Patients who declined participation or unable to give informed consent.
Bariatric Surgery Study

The current study proposes an open clinical trial to investigate the effectiveness of a social functioning intervention on bariatric surgery outcomes and depression. The treatment will be administered in a group format over 10 weekly/biweekly sessions and will take place at the University of Washington Weight Loss Management Clinic (WLMC) at the Roosevelt Clinic location. Effects of the intervention will be measured with self-report questionnaires and by self-report of behaviors outside of assessment sessions (via questionnaires and self-report of adherence to treatment). Data collection will occur at specific time points including before treatment, after treatment, and two months after treatment.

As of 2009, 344,000 bariatric procedures were performed annually . Although some studies report depressive symptoms decrease in the 6 months after bariatric surgery, there is growing body of literature suggesting there exists a subgroup of patients whose depressive symptoms worsen after surgery and the likelihood of developing depressive symptoms increases longitudinally. Depression can be an indicator of an increased risk of self-harm and additional studies have found that the risk of suicide may increase post bariatric surgery compared to obese individuals who have not undergone surgery.

Research supports that psychosocial factors contribute to successful postoperative outcomes. Functional Analytic Psychotherapy shows potential to impact social variables that may be relevant to bariatric surgery outcomes including depression. In this context, FAP aims to improve interpersonal relationships through experientially teaching skills intended to increase social connection. FAP also seeks to increase awareness, which includes the ability to view interpersonal interactions from multiple perspectives, allowing new interpersonal skills to emerge.

The present study seeks to evaluate the use of a FAP group to enhance interpersonal relating with a sample of post-bariatric surgery patients. Measures will be collected on quality of life and variables involved in interpersonal connectedness.

Eligibility Criteria:
Inclusion Criteria:

* Older than 18
* Speak English as a primary language
* Had Bariatric Surgery in the past 6-24 months (bypasses (Roux-en-Y) or sleeves)
* Yes to one or both of the first two PHQ-9 Questions
* Not pregnant
* Not traveling anywhere in the next 6 months
* No surgeries scheduled in the next 12 months

Exclusion Criteria:

• No exclusion criteria are utilized in the present study.
Eardream Data Collection in Colombia Supported by ADDF

Data collection based on this study will allow us to collect neurophysiological and cognitive data collected from in-ear EEG recordings of the Autosomal dominant alzheimer's disease population in Colombia

There is solid neurophysiological evidence indicating that abnormal brain rhythms during sleep and noradrenergic dysfunction are core components of cognitive decline and AD onset, and their related pathophysiology. Crucially, irregularities in these neurophysiological mechanisms appear to occur in an asymptomatic and pre-symptomatic stage, but their potential to identify susceptibility for triggering neurodegeneration has yet to be established.

Thus, the possibility to identify such risk biomarkers in humans will require the acquisition of large-scale data related direct or indirect measurements of these physiological signatures. A possible key source to obtain such large-scale data related to sleep and noradrenergic function is the assessment of electroencephalographic recordings through non-obtrusive, low-cost, and reliable wearable sensors, alongside the use of advanced neuro-computational algorithms that link brain function and behavioral outcomes of LC function via pupilometry measurements.

Eligibility Criteria:
Participants fulfilling all of the following inclusion criteria are eligible for the study:

Informed Consent as documented by signature mutation and non-mutation carriers of ADAD populations Patients diagnosed with MCI and AD

Diseases or lesions of the nervous system (acute or residual included neurological and psychiatric diseases, except for MCI and AD in the patient population) Clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.) Sleep disorders, known or suspected (e.g. Insomnia, sleep apnoea, restless leg syndrome, narcolepsy, etc.) mini mental state examination (MMSE) score \> 24)

Participants are not eligible if they fulfill the following exclusion criteria:

Participation in another study with investigational drug/therapy/interventions within the 30 days preceding and during the present study (start date adapted accordingly) Suspected drug- or medication abuse, or on-label sleep medication use during the time of the study Infection/disease of the auditory canal or ear drum that could worsen with EAR-DREAM application, or allergies to in-Ear electrode materials (e.g., silver) Pregnancy (not safety related, but relevant for data interpretation procedures given that pregnancy can result in sleep patterns that are different from the baseline measurements we intend to characterize) Additional non-medical exclusion criteria may be defined for certain cognitive tasks (e.g. no glasses during experiments involving pupillometry).