cyrilzakka/clinical-trials huggingface dataset:
Using NT-proBNP to Detect Chronic Heart Failure in Patients With Chronic Obstructive Pulmonary Disease

The aim of the present study was to evaluate if the analysis of NT-proBNP might be used as an initial step for the diagnosis of chronic heart failure in patients with COPD in primary health care, and to select patients for a further examination by echocardiography.

Patients with a confirmed diagnosis of COPD were examined regarding chronic heart failure.

1. An interview regarding symptoms: breathlessness, orthopnoea, night cough, nocturia, walking distance.
2. Physical examination: weight and height, heart and lung auscultation, blood pressure measurement after 5 minutes' rest in the sitting position and the presence of peripheral oedema.
3. Electrocardiography.
4. Natriuretic peptide- NT-proBNP (Immulite 2500, Siemens Healthcare Diagnostics AB Sweden).
5. Patients with the NT-proBNP level of \> 1200 pg/ml were referred for echocardiography to assess left ventricular function.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 65 years and older with the following diagnosis codes according to International Statistical Classification of Diseases and Related Health Problems - Tenth Revision:J44 (COPD) and J41, J42 (chronic bronchitis) registered during the period 1 January 2008-16 April 2008 according to the electronic patient record.

Exclusion Criteria:

* Impaired cognitive function and/or anticipated difficulties in carrying out spirometry due to immobility,
* psychiatric disorders or terminal illness.
The Effect of Blood Flow Restriction Training on Lower Limb Motor Function in Stroke Patients With Hemiplegia

flow restriction training combined with routine rehabilitation training can promote the recovery of lower limb muscle strength on the hemiplegic side of stroke patients, improve the lower limb motor function of patients, and further improve their daily life and walking ability. It provides a new treatment method for stroke patients with hemiplegia that leads to lower limb function loss and activity disorder, and the therapy also has the advantages of simple operation, high safety, good patient compliance and low cost, which is worthy of further clinical research and promotion.

In this work, Stroke is a disease with a high incidence, high mortality and high disability rate, and it is becoming increasingly common in young individuals. More than 50% of these patients have long-term chronic motor dysfunction due to unilateral limb dysfunction, and abnormal limb movement patterns occur due to unilateral limb weakness, abnormal muscle tone and other symptoms, which can manifest as a typical "hemiplegic gait" on walking. Motor dysfunction after stroke, including muscle strength, dystonia and abnormal gait, is the main dysfunction, which can cause cardiopulmonary function decline, thrombosis, muscle atrophy, etc., reducing the ability of daily living and quality of life of patients. Routine rehabilitation training methods for stroke patients with dysfunction include muscle strength training techniques, neurodevelopmental treatment (NDT), motor relearning programs (MRPs), constraint-induced movement therapy (CIMT), neuromuscular electrical stimulation (NMES). But it cannot achieve a good rehabilitation treatment effect. Therefore, we found through lower extremity motor function (LE-FMA), balance function (BBS), activities of daily living (MBI), patients' walking distance (6-MWT test) and the MMT assessment of muscle strength of iliopsoas, quadriceps, hamstrings and tibialis anterior muscles testing that combining blood flow restriction training on the basis of traditional rehabilitation is beneficial for patient muscle rehabilitation.

Eligibility Criteria:
Inclusion Criteria:

* The diagnosis of stroke meets the diagnostic criteria revised by the Fourth National
* Conference on Cerebrovascular Diseases
* Confirmed by cranial CT and/or MRI
* First onset, hemiplegia of one limb, clear consciousness, stable vital signs, no serious complications such as heart, lung, kidney, etc., no serious cognitive or audio-visual impairment

Exclusion Criteria:

* Uncontrolled hypertension
* Coronary artery disease
* Uncontrolled autonomic reflex abnormalities
* Severe spasms
* History of fractures or fractures
* Deep vein thrombosis
* Cognitive impairment, inability to cooperate
PET-CT in AML for Detection of Extramedullary AML Manifestations

Myeloid Sarcoma (or granulocytic Sarcoma or Chloroma) is well defined by the WHO. However, there are currently no data about the prevalence, sites of occurence and thr prognostic value for patients with AML with this finding. Information about this condition is based on retrospective analyses since there have been no studies trying to define the role of myeloid sarcoma in AML so far. This observational trial will include adult patients with newly diagnosed and relapsed AML in order to perform 18FDG-PET-CT imaging prior to induction chemotherapy. Furthermore, a second 18FDG-PET-CT will be performed after induction chemotherapy to define the responsiveness of these tumors to chemotherapy. The primary endpoint of this study is the prevalence of 18FDG-PET-CT positive extramedullary AML manifestations (myeloid sarcoma) in patients with newly diagnosed or relapsed AML.


Eligibility Criteria:
Inclusion Criteria:

* Patients with newly diagnosed or relapsed AML
* AML FAB M0-2, M4-7
* Signed informed consent after patient information
* Male and female patients with AML age 18-80
* 18FDG-PET-CT is available within a period of 5 days after diagnosis of AML

Exclusion Criteria:

* AML FAB M3 (Promyelocytic Leukemia)
* lacking willingness to cooperate
* pregnancy or insufficient contraception
* 18FDG-PET-CT is not available within a period of 5 days after diagnosis of AML
* Medical condition of the patients requires an immediated start of chemotherapy
Mechanical Device for the Relief of Hot Flashes

Hypothesis: A mechanical device when applied to the back of the neck at the onset of a menopausal hot flash will attenuate the severity and duration of symptoms providing women with a reassuring non-hormonal intervention to improve quality of life in the menopausal transition. This pilot study will evaluate the effectiveness of this unit.

The mechanism of action of the device will not be revealed in advance.

This is a pilot study to test logistics and gather information for planning the definite trial. We will randomly allocate 40 subjects to receive either the active Menopod device (n=20) or a sham device with the mechanism disabled (n=20).

We will recruit menopausal women with moderate to severe hot flashes (as defined by FDA standards this means a minimum of 7 per day).

The two primary outcome parameters are the hot flash score which is the product of frequency x intensity (Sloan 2001), and the average duration (in minutes) of hot flash episodes over the course of one day. These outcomes will be self-recorded by subjects in a diary designed by our research team on five separate days throughout the course of the study, once during the evaluation phase and once per week over the four week treatment phase. The two summary measures will be the changes from baseline to the last record collected for hot flash scores and average durations. Delta values (assessment phase minus fourth treatment period) will be compared between the two treatment groups (active versus sham device) using t tests (IBM SPSS Statistics version 21).

Eligibility Criteria:
Inclusion Criteria:

* Age range: 40 to 65 years
* Healthy postmenopausal woman
* natural or surgical menopause
* FSH \> 30 IU/L
* Amenorrhea \> 6 months prior to study
* Minimum of 7 moderate hot flashes per day documented in diary during evaluation phase

Exclusion Criteria:

* Any therapy for hot flashes prior to or during study
* Obesity: BMI \> 35
* Alcohol abuse
* Drug abuse
* Unable to use device as per protocol
* Unable to complete required documentation
* Serious medical condition:
* coronary heart disease
* stroke
* chronic renal or hepatic disease
* diabetes
* depression or other psychiatric illness
* cancer
Early Administration of Bifidobacterium to Very Low Birth Weight Infants

To evaluate the effects of early administration of probiotics on acceleration of enteral feeding, and on growth of very low birth weight infants, newborn infants with birth weight less than 1500g are administered Bifidobacterium bifidum twice a day.


Eligibility Criteria:
Inclusion Criteria:

* Very low birth weight infant

Exclusion Criteria:

* Presence of major congenital malformations
Pain and Physical Fitness in Primary Dysmenorrhea

The aim of this study is to evaluate pain and physical fitness parameters such as balance, muscle strength, and core stabilization in primary dysmenorrhea.

Primary dysmenorrhea (PD) is a condition that occurs just before or during menstruation and is accompanied by cramp-like pain in the lower abdomen, without any pelvic pathology. Pain usually begins just before or during menstruation and ends within 12-72 hours. Most women with PD describe their menstrual pain as moderate to severe, which significantly affects their activities of daily living and school and work performance.

In PD, functions and activities of daily living are also affected due to pain and other hormonal changes. Studies have reported that musculoskeletal problems such as decreased spinal mobility, pelvic stability and postural control are observed in women with dysmenorrhea.

The aim of this study is to evaluate pain and physical fitness parameters such as balance, muscle strength, and core stabilization during the menstruation and on a non-menstrual day of the cycle, in primary dysmenorrhea.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18-25
* Body mass index of 18-25 kg/m2
* Having a regular menstrual cycle (28±7 days)
* For the PD Group; pain level \>5 according to VAS during menstruation
* For the Control Group; having a VAS score of 5 or less

Exclusion Criteria:

* Having given birth before
* Using an intrauterine device
* Having a health problem that causes chronic pain
* Having a diagnosis of neurological, orthopedic, vestibular, rheumatological disorder
* Being diagnosed with a gynecological or pelvic disorder such as endometriosis, ovarian cyst
* Having a history of abdominal or gynecological surgery within the last year
* Being on oral contraceptive use/hormonal therapy or antidepressant treatment
* Having used painkillers 12 hours before the evaluation
* Participating in a regular exercise program
A Study of IBI351 in Combination With Cetuximab in Subjects With KRAS G12C Mutated Metastatic Colorectal Cancer

Phase 1b consists of combined dose escalation phase and dose expansion phase. Phase 3 study will compare efficacy and safety of IBI351 combined with cetuximab versus chemotherapy in treatment of KRAS G12C-mutated metastatic colorectal cancer

A Phase 1b study of the safety, tolerability and preliminary efficacy of IBI351 combined with cetuximab in the treatment of KRAS G12C mutant metastatic colorectal cancer will be conducted based on recommended dose of IBI351, which consists of combined dose escalation phase and dose expansion phase. After confirming the efficacy and safety of IBI351 combined with cetuximab in Phase Ib, an open-label Phase 3 study of the efficacy and safety of IBI351 combined with cetuximab versus oxaliplatin-based mFOLFOX6 regimen or irinotecan-based FOLFIRI with or without bevacizumab in treatment of KRAS G12C-mutated metastatic colorectal cancer will be conducted.

Eligibility Criteria:
Inclusion Criteria:

1. male or female subjects, ≥ 18 years and ≤ 75 years
2. have documentation of KRAS G12C mutation
3. at least one measurable lesion per RECISTv1.1
4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
5. life expectancy of \>12 weeks, in the opinion of the investigator

Exclusion Criteria:

1. history of deep venous thrombosis or any other serious thromboembolism within 3 months prior to enrollment..
2. history of radiation-induced pneumonitis, idiopathic pneumonia, active pneumonia, pulmonary fibrosis, diffuse pulmonary interstitial disease, or organizing pneumonia.
3. surgical procedures (excluding needle biopsy) performed within 28 days prior to enrollment that may affect the dosing or study assessments in this study.
4. received therapeutic or palliative radiation therapy within 14 days prior to enrollment
5. pregnant or lactating women
Determination of Optimal Mask Ventilation Mode in Pediatrics Using Real-time Ultrasonography

The peak inspiratory pressure during face mask ventilation for general anesthesia is closely correlated with gastric insufflation. High pressure increases the amount of air in stomach and low pressure could decrease the tidal volume, therefore ideal pressure means the pressure guarantee adequate ventilation with minimal gastric insufflation.

The aim of this study is finding the proper pressure and mode of face mask ventilation in pediatric patients.


Eligibility Criteria:
Inclusion Criteria:

* The ASA class I,II and 1-5 years pediatric patients need general anesthesia

Exclusion Criteria:

* Oropharyngeal or facial pathology accompanied
* Obese (BMI \> 30 kg/m2)
* GI tract obstruction
Study of the Safety and Efficacy of Dichloroacetate (DCA) in Glioblastoma and Other Recurrent Brain Tumors

The purpose of this study is to evaluate the safety and tolerability of oral Dichloroacetate (DCA) in the treatment of recurrent malignant brain tumors (RMBTs). RMBTs are defined as either: 1) malignant tumors, originating in the brain, that have recurred at least once or 2) malignant tumors originating elsewhere in the body that have spread to the brain at least once. Otherwise, there are no limitations to the number of prior recurrences. There are no limitations to the number or types of prior therapies.

Malignant brain tumors are defined as any World Health Organization grade III-IV glioma and any solid tumor metastasis (spread) to the brain. Recurrent malignant brain tumors (RMBTs) are defined as either: 1) malignant tumors, originating in the brain, that have recurred at least once or 2) malignant tumors originating elsewhere in the body that have spread to the brain at least once. They share an increasing incidence, clinical and radiographic characteristics, lack of effective therapies, tendency to recur, and poor outcome. Importantly, recurrent malignant brain tumor's shared characteristics may be usefully exploited by an emerging class of biologic agents called metabolic modulators of which Dichloroacetate (DCA) is the drug in the class most thoroughly investigated clinically. DCA's mechanism of action and tolerability have been extensively demonstrated in the treatment of chronic metabolic disorders. Furthermore, the preciseness of DCA's mechanism of action appears to target abnormal tumor cell metabolism.

Eligibility Criteria:
Inclusion Criteria:

* Subject must be able to consent for self. Subject must have either:

  1. a brain metastasis or
  2. a WHO III-IV glioma that has recurred at least once. Females of child bearing age must have (-) pregnancy test.
* Females of child bearing age must use birth control while in study.
* Adequate organ function as determined by laboratory testing.
* Absence of peripheral neuropathy of moderate or greater severity (physician determined).
* Greater than 4 weeks time from previous anti-neoplastic (anti-cancer) therapy.
* Subject must have a Karnofsky Performance Status (KPS) of greater than or equal to 60.
* Subject must have an ECOG performance status of less than or equal to 2.
* There are no limitations to the number of prior recurrences.
* There are no limitations to the number or types of prior therapies.

Exclusion Criteria:

* Medical contraindication for magnetic resonance imaging (MRI)testing.
Reducing UV Exposure to Prevent Skin Cancer: Message Development & Testing

Phase 3b of the research will be a laboratory experiment that uses an experimental and analytic design that is parallel to that used in Phase 3a, the online experiment. The primary objective of Phase 3b is to assess physiological response (i.e., eye tracking) to different message appeals of the audio-visual messages used in Phase 3a on respondents' behavioral intentions and UV-related behavioral choices post-exposure. Including time for preparation, viewing, and removal of the monitoring equipment, the message viewing session will take about 45 minutes per session.


Eligibility Criteria:
Inclusion Criteria:

* 18-49 year old non-Hispanic white (NHW) adults
* OR 18-25 year old NHW females who have tanned indoors in the past 12 months

Exclusion Criteria:

-
Evaluation of a New Sonoclot Device for Heparin Management in Cardiac Surgery

The SONOCLOT Analyzer (S1; Sienco, Inc. Boulder, CO USA, Model DP-2951) is used to perform kaolin-based activated clotting time as routine monitor of heparin therapy in patients undergoing cardiac operations. In addition, the device allows the assessment of the patient's coagulation status by a glass-bead activated test. Recently, a new SONOCLOT analyzer (S2) has been developed. As part of the routine management using S1, tests are also performed on S2. Results are entered into the cardiac surgery data base of all cardiac surgery patients and analyzed.

The SONOCLOT Analyzer (S1; Sienco, Inc. Boulder, CO USA, Model DP-2951) is used to routinely perform kaolin-based activated clotting time (kACT) as monitor of heparin therapy in patients undergoing cardiac operations on cardiopulmonary bypass.

Apart from kACT, the device allows the assessment of the patient's coagulation status by a glass-bead activated test (gbACT+, depicting also clot rate = CR and platelet function = PF). Recently, a new SONOCLOT analyzer (S2) has been developed. Although the S2 shares the technical fundamentals with the S1, the redesign of the device may result in performance changes of kACT and gbACT.

Routine management in cardiac surgery patients is guided using S1 and addition, tests are run on S2. Data are entered into the the cardiac surgery data base and S1 and S2 performance is compared by Bland-Altman analysis and % error calculation in order to establish new reference values.

Eligibility Criteria:
Inclusion Criteria:

* all consecutive cardiac surgery patients

Exclusion Criteria:

* none
Efficacy and Safety of Losartan in Pediatric Chronic Kidney Disease With Tubular Proteinuria

The investigators hypothesize that using Losartan would help decrease proteinuria in pediatric chronic kidney disease with tubular proteinuria.

Children with tubular proteinuria (urine protein to creatinine ratio \> 0.3 mg/mg) were randomly assigned in 1:1 ratio to losartan or placebo treatment for 12 weeks, then crossed over to the opposite intervention for another three months after a washout period of 2 weeks. The primary outcome is the change in urinary protein-creatinine ratio from baseline to the end of 12 weeks. Efficacy of losartan in children with CKD with tubular proteinuria was also investigated with additional retrospective review of medical record.

Eligibility Criteria:
Inclusion Criteria:

* Age: 2years or older and younger than 18 years
* estimated GFR ≥ 30mL/min/m\^2
* Mean urinary protein-creatinine ratio \> 0.3 g/g from three first-morning spot urine collections
* Renal hypoplasia/dysplasia, Reflux nephropathy, Polycystic kidney disease, Lowe syndrome, Dent disease, Tubulointerstitial nephritis, Nephronophthisis/Medullary cystic disease, Obstructive uropathy(including PUV, UPJ obstruction, UVJ obstruction)

Exclusion Criteria:

* hypertension
* under dialysis or organ transplanted
* bilateral renal artery stenosis or primary hyperaldosteronism
* pregnant or nursing
Nephroprotective Effect of Nicorandil in Type 2 Diabetes Mellitus

This study aims to evaluate the possible nephroprotective effect of nicorandil in patients with type 2 diabetes mellitus .


Eligibility Criteria:
Inclusion Criteria:

* Patients newly diagnosed with T2DM with diet control and good glycemic index ( Hb A1C\< 7 )
* Age range between 18 and 60 years old.
* Both sexes.
* Stage 1and Stage 2 CKD according to KDIGO .
* Controlled HTN .

Exclusion Criteria:

* Pregnant and lactating females.
* Patients with hypersensitivity to nicorandil.
* Other Causes of CKD or Nephropathy eg : Uncontrolled HTN , Renal Malignancy , collagen disease as Amyloidosis and some autoimmune disease as ( SLE and Rh.fever ) .
* Uncontrolled HTN and its antihypertensive medications ( ACEI , ARB ) and other antihypertensive medications .
* Patients receiving nephrotoxic drugs as aminoglycosides, non-steroidal anti inflammatory drugs and contrast media.
A Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Plaque Psoriasis

This is a multi-center, randomized, double-blind, placebo-controlled study in patients with moderate to severe plaque psoriasis.

This study will consist of a 4 week screening period, 12 week treatment period, and a 4 week follow up period for a total of 20 weeks. Each participant will be randomized to receive ESK-001 or placebo daily for 12 weeks. An open label extension study will be available for those patients who complete the study.

Eligibility Criteria:
Inclusion Criteria:

* Total body weight \>40 kg (88 lb)
* Men and woman age 18-75
* Men and Women must use highly effective methods of contraception for the entirety of the study

Exclusion Criteria:

* History of malignancy within the last 5 years
* Positive for HIV, Hepatitis B or C
* History of tuberculosis
* Diagnosis of non-plaque psoriasis
* Patients with QTcF \>450 msec (males) or \>470 msec (females) at screening
* Live vaccines
Study of Combination Therapy With SYR-322

To determine the efficacy and safety of SYR-322 (alogliptin) 25-mg, once daily (QD), in patients with diabetes when used in combination with insulin.


Eligibility Criteria:
Inclusion Criteria:

1. The subject is an outpatient.
2. The subject signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.

Exclusion Criteria:

1. The subject has any serious cardiac disease, serious cerebrovascular disorder, or any serious pancreatic or hematological disease.
2. The subject is considered ineligible for the study for any other reason by the investigator or subinvestigator.