cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety Evaluation of IBI188 in Combination With Demethylating Agents in Treatment of Patients With Acute Myeloid Leukemia

The study is to evaluate safety, tolerability and composite CR of IBI188 plus Demethylating Agents in acute myeloid leukemia


Eligibility Criteria:
Inclusion Criteria:

1. AML patients diagnosed according to WHO AML diagnostic criteria in 2016 (except M3-type and BCR-ABL positive AML).
2. Relapsed// refractory AML( ≥18 ys) or newly diagnosed elderly AML unfit for intensive chemotherapy( ≥60 ys).
3. Age ≥18 years old, gender not limited.
4. ECOG score of 0-2.
5. Adequate organ function.

Exclusion Criteria:

1. Acute promyelocytic leukemia, myeloid sarcoma, acute heterozygous leukemia, CMML(accelerated phase and blast phase).
2. A history of myeloproliferative diseases (including myelofibrosis, primary thrombocytosis, and true red) Cytosis, chronic myelocytic leukemia) or acute myeloid white blood with BCR-ABL1 translocation Patients.
3. Major surgery and vaccine treatment within 4 weeks.
4. Uncontrolled concurrent diseases.
5. Pregnant or breastfeeding female subjects.
New Diagnosed Type 2 Diabetes - Online Education

To determine the effect of online education given to individuals with newly diagnosed type 2 diabetes on metabolic control, self-care and health literacy. A randomized controlled trial. This study was conducted with 95 new diagnosed diabetes patients in the Endocrine Polyclinic of a university hospital. Personal Information Form, Diabetes Self-Care Activities Scale and Health Literacy Scale were used to evaluate the data. SPSS 21 program was used in the analysis of the data and a p\<0.05 level was considered significant.

Participants were randomized into both groups (intervention and control). The Consolidated Standard of Reporting Trials-CONSORT 2010-guidelines were used to conduct a randomized controlled trial. Sample size was estimated using the G\*POWER software tool, based on 80% power and 95% confidence interval. A minimum of 45 individuals in each group were needed to determine the difference in the mean of the measurements (10% more calculated for the probability of sample loss). Between the data collection dates, 248 patients were reached and invited to participate in this study. 78 patients did not meet the inclusion criteria and 70 patients refused to participate. A total of 100 eligible patients were randomized; 50 were assigned to the intervention group and 50 to the control group. After reaching the targeted number, data collection forms were filled in. The participants were then randomly randomized into control and intervention groups in the computer program. Until the randomization was made, it was not known in which groups the individuals were. Randomization was performed after the target number was reached. The first diabetes self-management training was given to all patients by diabetes education nurses face-to-face in the outpatient clinic.

After the study objectives were stated and informed consent was obtained from the study participants, face-to-face interviews by trained interviewers were used to complete the questionnaires. The interviews lasted 20-25 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Having a diagnosis of Type 2 diabetes mellitus for at most one year
* Be between the ages of 18-65
* Being on oral antidiabetic and/or insulin therapy
* Have a smart phone
* Volunteer to participate in the study
* Hearing that interferes with communication
* Sensory loss such as speech
* Psychiatric problem

Exclusion Criteria:

* Illiterate
* Have a physical, cognitive or mental disability to answer questions
* Individuals with type 2 DM who did not volunteer to participate in the study
Efficacy of the Triangle Operation on Clinical Outcomes in Patients With Pancreatic Cancer

We aimed to analyze postoperative short-and long-terms clinical outcomes after the Triangle procedure in patients with Pancreatic head, periampullary and duodenal cancer.

After laparotomy and exploration of the abdominal cavity to rule out peritoneal or hepatic metastases, the initial steps of the operation were to determine if there was true arterial tumor infiltration, along the Celiac Artery, Hepatic Artery or Superior Mesenteric Artery. To clarify this, an "arteryfirst" maneuver was performed. The strategy depended on the results of preoperative imaging defining the site of the most likely tumor infiltration. The SMA was approached from a left-sided infracolic approach if tumors of the body or tail of the pancreas were suspected to infiltrate the artery from this direction or from a posterior approach in respective situations. Once the arterial level of suspected attachment/encasement was reached, a frozen section was performed to confirm or exclude viable tumor tissue at this site. In case of remaining viable tumor, most patients will not qualify for further surgical therapy at this point. In contrast, if frozen section confirms fibrous tissue without viable tumor, this offers the possibility to perform a radical but artery-sparing procedure, All other surgical steps are carried out as usual during partial pancreatoduodenectomy (PD), distal (DP) or total pancreatectomy. Anatomic TRIANGLE bordered by the SMA, CA and PV confirming the complete removal of all soft tissue usually contained within these borders.

Eligibility Criteria:
Inclusion Criteria:

* No age restriction or Gender exclusion, all diagnosed fit patients with pancreatic head, periampullary and duodenal cancer will be included.

Exclusion Criteria:

* Unfit or inoperable patients will be excluded.
Factors Associated With an Evolution in the Quality of Life of Diabetic Patients With Chronic, Wound-free Charcot Foot

Charcot foot, characterized by progressive destructive damage to bone, soft tissue and tendons, involving joint dislocation in the ankle and foot, is a complication of diabetes that is still poorly understood by patients and caregivers. The clinical signs are non-specific and it is therefore largely underestimated due to a delay in diagnosis/lack of diagnosis.This study will be on a prospective multicenter cohort of patients with chronic Charcot's foot in France to evaluate the evolution of quality of life at 2 years, as well as predictive factors in order to better identify subjects with the worst outcome among this population.

Our hypothesis is that, in patients with chronic Charcot foot, the deterioration in quality of life over time is primarily related to loss of foot and ankle functionality, foot and ankle deformity and the presence of foot wounds/comorbidities/severe diabetic complications.

Diabetes mellitus is a chronic disease, representing a major public health problem. An estimated 537 million people have diabetes. Charcot foot, also known as neurogenic osteoarthropathy (NAO), is one of the complications of diabetes secondary to diabetic neuropathy. It is characterized by progressive destructive damage to bone, soft tissue and tendons, involving joint dislocation in the ankle and foot. Charcot foot is a complication of diabetes that is still poorly understood by patients and caregivers, with non-specific clinical signs. It is therefore largely underestimated, since it is estimated that there is a delay in diagnosis or a lack of diagnosis in approximately 25% of cases.

The objective of our study is to conduct a prospective multicenter cohort of patients with chronic Charcot's foot in France in order to evaluate the evolution of the quality of life at 2 years, as well as its predictive factors. In this way, we will be better able to identify the subjects with the worst outcome among the chronic Charcot foot population.

Our hypothesis is that the deterioration in quality of life over time in patients with chronic Charcot foot is primarily related to loss of foot and ankle functionality, foot and ankle deformity, the presence of foot wounds and/or comorbidities or severe diabetic complications.

Eligibility Criteria:
Inclusion Criteria:

* patients with Type 1 or 2 diabetes or secondary diabetes
* patient hospitalized or consulting for osteoarthropathy in its chronic stage, without wounds
* patients affiliated to or beneficiaries of a health insurance scheme.
* adult patients (≥18 years old).

Exclusion Criteria:

* patients with non-diabetic osteoarthropathy of the nerves.
* patients with acute diabetic osteoarthropathy of the nerves.
* patients with a foot ulcer
* patients who have expressed opposition to participating in the study.
* patients in an exclusion period determined by another study.
* patients under court protection, guardianship or trusteeship.
* patients for whom it is impossible to give informed information.
* pregnant, parturient, or breastfeeding patients.
Sildenafil Effects on Pulmonary Haemodynamics and Gas Exchange in Chronic Obstructive Pulmonary Disease (COPD)

Sildenafil is a phosphodiesterase-5 inhibitor that has been approved for the treatment of pulmonary arterial hypertension with orphan drug designation. Sildenafil modulates the nitric oxide (NO) pathway in the vessel wall. Since this pathway is impaired in pulmonary arteries of patients with pulmonary hypertension (PH) associated with chronic obstructive pulmonary disease (COPD), we hypothesized that sildenafil might improve pulmonary hemodynamics and increase exercise tolerance in this condition. However, in COPD sildenafil may also impair gas exchange due to the inhibition of pulmonary hypoxic vasoconstriction. The research project is aimed to evaluate these effects.

It is a prospective, randomized, double-blind study to evaluate the acute effects of a single dose of 20 or 40 mg of sildenafil on gas exchange and pulmonary hemodynamics. Subjects: 20 patients (10 in each group). Measurements: pulmonary hemodynamics, arterial blood gasses and ventilation-perfusion distributions; at rest and during sub-maximal exercise.


Eligibility Criteria:
Inclusion Criteria:

* COPD (FEV1/FVC\<0.7)
* Age 40-75
* Pulmonary hypertension (Vmax TI\>=2.8m/sec)

Exclusion Criteria:

* Treatment with CYP3A4 inhibitors, nitrates, PDE-5 inhibitors
* Coronary disease
* Ischemic optical neuritis
An Open Label Extension Study of STX209 in Subjects With Fragile X Syndrome

Study 22001, "A Double-Blind, Placebo-Controlled, Flexible-Dose Evaluation of the Efficacy, Safety, and Tolerability of STX209 in the Treatment of Irritability in Subjects with Fragile X Syndrome" currently is evaluating the efficacy of STX209 (R-baclofen) for management of typical problem behaviors, such as irritability and aggression, in subjects with FXS. This study (22002) will enter subjects who complete Study 22001 into a long-term, open-label study.The open-label extension protocol will provide necessary data on the long-term safety and tolerability of STX209 among subjects with FXS who receive treatment under conditions more closely reflective of their general medical care.


Eligibility Criteria:
Inclusion Criteria:

* Have completed all scheduled visits in protocol 22001 and have shown they can adequately follow the protocol, with sufficient medical justification to continue on open-label treatment with STX209, as assessed by the principal investigator

Exclusion Criteria:

* Subjects with a medical condition that might interfere with the conduct of the study, confound interpretation of the study results, or endanger their own well-being.
* The occurrence or continuation of any adverse event or condition during study 22001 that, in the opinion of the Investigator, should exclude the subject from participating in this open-label extension.
PET Imaging of Ovarian Carcinoma With 18F-FSPG

This clinical trial studies positron emission tomography (PET) imaging utilizing 18F-FSPG \[(S)-4-(3-\[18F\]Fluoropropyl)-L-glutamic acid\], a glutamic acid derivative, to image patients with ovarian cancer before undergoing surgery or transplant. Diagnostic procedures, such as 18F-FSPG PET, may help find and diagnose ovarian cancer and find out how far the disease has spread.


Eligibility Criteria:
Inclusion Criteria:

* Have a presumed diagnosis of advanced stage epithelial ovarian, fallopian tube, or peritoneal.

  * Pelvic mass and/or omental caking with Ca-125:CEA ratio 25:1.

    * Adequate performance status, ECOG 0, 1, 2.
* Adequate organ function:

  * PCV \> 30 (with or without transfusion)
  * WBC: 3000 - 10,000 The lower level of normal for total WBCs is 4,000, but the NCI considers levels of 3,000- 4,000 as mild suppression for drug trials, specifically not requiring treatment.
  * Platelet count \> 150, 000 and \< 1,000,000
  * Cr \< 1.5
  * LFTS \< 1.5 x ULN
* Have undergone or have agreed to undergo standard of care CT of the chest, abdomen, and pelvis. 18F-FSPG PET imaging will be performed as investigational studies.
* No prior treatment for ovarian cancer
* have undergone or agree to undergo standard of care imaging for ovarian cancer with CT chest, abdomen, and pelvis.

Exclusion Criteria:

* Have non-invasive or non-epithelial ovarian cancer on pathological confirmation.
* Pregnant and breastfeeding
* Poorly controlled diabetes mellitus (fasting blood glucose level \> 200 mg/dL).
* Other poorly controlled medical conditions that in the opinion of the surgeon, make them not a candidate for primary cytoreductive surgery.
* CT of chest, abdomen, pelvis demonstrates:

  * Any disease in the thoracic cavity \> 1 cm.
  * Any suprarenal lymphadenopathy \> 1 cm.
  * Liver metastases \> 1 cm.
  * Disease in the porta hepatis or gallbladder fossa \> 1 cm.
  * Pleural effusion \> 50% volume of the chest cavity on chest x-ray.
  * Omental extension to the stomach, spleen, or lesser sac.

    * Extension to the pelvic sidewall (this criteria may also be assessed on physical examination.
    * involvement of the root of the mesentery.
* Decline procedures that might be necessary for optimal primary cytoreduction (i.e. colostomy or splenectomy).
Effects of Anaesthesia on Inflammatory Markers

undertake confidently both open and laparoscopic cholecystectomy. Major types of body injuries surgical or accidental; evoke a temporary, yet predictable systemic inflammatory response caused by hormonal, immunological and metabolic mediators. This inflammatory response is essential for tissue repair and has evolved to maximize the organisms' healing potential. In healthy individuals the inflammatory response to major surgery is well balanced consisting of pro- and anti-inflammatory mediators. The severity of injury, the occurrence of surgical complications and its accompanying level of stress may hinder the balance of the inflammatory response6.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients aging 18 - 55 years old
* Patients scheduled for abdominal surgeries
* Patients with American Society of Anesthesiologists (ASA) I, II physical status

Exclusion Criteria:

* Patients' refusal.
* Critically ill patients.
* Patients who have contraindications to regional anesthesia.
Percutaneous Endoscopic Biliary Exploration in Complex Biliary Stone Disease

Patients with complex biliary stone disease are challenging to treat. The investigator present their experience in using urological interventions to treat challenging biliary stones.

Methods:

Fifteen patients with biliary calculi underwent 21 interventions using either extracorporeal shock wave lithotripsy (ESWL), percutaneous transhepatic choledochoscopy, percutaneous transcystic choledochoscopy, or a combination of these.

The investigator conducted a retrospective review to investigate the outcomes of urological treatments for biliary calculi from January 1, 1999, to August 31, 2016, focusing on percutaneous endoscopic methods and/or ESWL. The primary outcomes of interest were symptom- and stone-free rates, length of hospital stay, and complications. Our institutional ethics review board approved the study (IRB-2018-01-119). Due to the retrospective nature of the study, the need for informed consent was waived. One endourologist evaluated all patients preoperatively.

Urological intervention techniques The three different approaches used (ESWL, PTHC, and PTCC) are described below.

Eligibility Criteria:
Inclusion Criteria:

* complete records

Exclusion Criteria:

* lost follow up
Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Crohn's Disease

The goal of this study is to test whether adalimumab can induce clinical remission in subjects with active Crohn's disease who have been initially treated with infliximab and either lost response or discontinued its use as a result of intolerance to the drug.


Eligibility Criteria:
Inclusion Criteria:

* Males and females between the ages of 18 and 75 who are diagnosed with mild to moderate Crohn's disease (defined by a CDAI \[Crohn's Disease Activity Index\] score of 220 and 450)
* Normal lab parameters
* Are willing to give informed consent
* Have previously used and either were intolerant to or lost response to infliximab

Exclusion Criteria:

* History of certain types of cancer
* Diagnosis of ulcerative colitis
* Pregnant female or breast feeding subjects
* Known obstructive strictures
* Surgical bowel resection in the past 6 months
* History of listeria, human immunodeficiency virus (HIV), central nervous system demyelinating disease or untreated TB (tuberculosis)
* History of poorly controlled medical conditions
* Specific doses and durations of Crohn's medications
* Subjects that have previously used infliximab and have never clinically responded unless primary non-response was due to a treatment limiting reaction to infliximab
Laboratory Diagnosis of of Rickettsial and Rickettsia-like Diseases

The low confirmed rickettsioses cases rate may indicate the presence of rickettsiosis other than scrub typhus, murine typhus, and Q fever. The clinical presentation of rickettsiosis is variable and atypical that laboratory confirmation is necessary. This project is aimed to set up the laboratory to diagnose rickettsial and rickettsial like disease, which could help in develop rapid diagnostic kits, epidemiologic surveillance and prognostic factor.


Eligibility Criteria:
Inclusion Criteria:

* Rickettsioses reported cases
Low Dose St John's Wort for Depression

This observational study observes the routine use of low-dose St John's Wort herbal mother tincture in patients with major depression. It measures intensity of depression at the beginning of St Johns Wort and after 6 weeks and evaluates tolerability and compliance.

Herbal medicine is widely used, and high-quality evidence shows their efficacy and tolerability for specific disorders. Most of the studies, however, is conducted with standardized, relatively high dosed dry extract preparations, while other preparations such as tinctures are widely used as well. The aim of this observational study ist to document real-live use of the use of a low-dose herbal medicine preparation (a mother tincture) of St John's Wort (Hypericum perforatum), to compare depression intensity at the beginning and after 6 weeks of therapy using the Hamilton Depression Scale 17, and to evaluate tolerability and compliance. Finally, the results will be compared with results of randomized controlled trials examining high dosed dry extract preparations of St John's Wort for major depression.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of mild or moderate depression according to ICD-10 or DSM-IV
* new start of CERES St John's wort mother tincture

Exclusion Criteria:

- at the same time as St John's wort mother tincture started, other antidepressive therapy
Speech Perception Training: Advanced Scoring and Feedback Methods

The purpose of the study is to assess training of visual speech (lipreading) and audiovisual (lipreading plus auditory) speech as a rehabilitation strategy for hearing loss in adults.

It is hypothesized that training that improves lipreading in older adults can carry over to untrained lipreading materials and to audiovisual speech recognition in noise. Participants receive pre- and post-training tests of speech recognition with visual-only, auditory-only, and audiovisual spoken sentences and isolated words. During pre- and post-training tests, they carry out forced choice identification of lipread consonants. Participants who are assigned to a training arm train on lipreading isolated sentences (Aim 1) or on learning via lipreading sets of isolated nonsense words (Aim 2). Depending on the outcomes of Aims 1 and 2, in Aim 3, new participants receive audiovisual training with conditions from Aims 1 and 2.

Eligibility Criteria:
Inclusion Criteria:

* Must have Mild to severe hearing loss
* Native speaker of American English
* Access to computer and the ability to use it for the testing, training, and teleconferencing
* computer display \>= 10 inches diagonal

Exclusion Criteria:

* Internet too slow for streaming
* History of brain trauma or learning disability
* Poor (corrected) vision
Quality of Life, Symptoms and Treatment Satisfaction in Adult Patients With Relapsed and/or Refractory Multiple Myeloma, Receiving Ixazomib (Ninlaro®) in Combination With Lenalidomide and Dexamethasone in a Real World Setting: Pilot Study

The purpose of this pilot study is to examine changes in patient-reported outcomes in patients with RRMM receiving triple therapy with ixazomib in combination with LenDex in a real world setting as well as to analyze clinical outcomes and safety of this treatment modality.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with confirmed diagnosis of RRMM
* At least 18 years of age at the time of treatment start
* Patients who have received at least one prior therapy and who are suitable for treatment with ixazomib in combination with LenDex
* Patients who gave informed consent
* Patients who are capable to fill out questionnaires
* Patients with expected life duration of at least 6 months

Exclusion Criteria:

* Patients currently enrolled in any other clinical trials
* Patients with contraindications to ixazomib in accordance with instruction for use.
The Effect of Paracetamol on Brain Temperature

The main objective of this study is to compare the effect of intravenous paracetamol administration on mean brain temperature (measured between H0 and H6) in patients with cerebral hyperthermia versus placebo.

The investigators will measure brain temperature using a thermistor that will be connected to the intracranial pressure transducer.


Eligibility Criteria:
Inclusion Criteria

* 18-year or older patients
* Patient hospitalized in neuro-critical care for:
* Arachnoid hemorrhage
* Intra parenchymatous hematoma
* stroke
* Acute brain Severe injury
* Post-operative complication of an act of neurosurgery or programmed neuroradiology
* Sedation and mechanical ventilation planned \> 2 days
* Monitoring of intracranial temperature and pressure by intraparenchymal sensor (Sophysa®)
* Brain temperature \> 38.5°C for more than 30 minutes

Exclusion Criteria

* Known hypersensitivity to paracetamol or mannitol (excipient with known effect)
* Severe hepatocellular insufficiency (ASAT or ALAT \> 5N, or bilirubin \> 2N)
* Pharmacological intervention (administration of corticosteroids, NSAIDs or paracetamol) or physical intervention (external cooling technique) that may influence temperature in the last 6 hours.
* Pregnant or breastfeeding women
* Previous participation in this study
Dizziness Among First Time Users of Hearing Aids

The score on the Dizziness Handicap Inventory (short version) before and after hearing aid fitting and usage will be compared


Eligibility Criteria:
Inclusion Criteria:

* Hebrew speaking
* First time users of hearing aids

Exclusion Criteria:

* Using a wheelchair
* Neurological disorders
* Spine of leg surgery in the previous 6 months