cyrilzakka/clinical-trials huggingface dataset:
Non-Invasive Hemoglobin Monitoring of Women Undergoing Cesarean Delivery

The purpose of this study is to determine the normal hemoglobin curve during cesarean delivery and for the first 24 hours after surgery to aid in the creation of an algorithm to detect life-threatening bleeding earlier.

Acute and life threatening blood loss is the most common cause of morbidity and mortality for pregnancy women in the US. To date, the only means we have of monitoring the amount of blood loss during a delivery is by the physician estimating the amount. This has been shown to not be very accurate and leads to confusion on when and how much a women should be transfused during a hemorrhage. New devices have been developed over the last few years to monitor blood levels in a accurate and non-invasive fashion. We aim here to use a non-invasive blood monitoring system to evaluate normal blood loss in women undergoing scheduled cesarean delivery. We hope that this will allow us to create a baseline that can be used in subsequent studies to identify women who are losing more blood than normal so that we may intervene faster and avoid unnecessary morbidity.

Eligibility Criteria:
Inclusion Criteria:

* Women undergoing scheduled cesarean delivery

Exclusion Criteria:

* Blood disorders (i.e. thalassemia, sickle cell), hypertensive disorders, obstetric risk factors for hemorrhage
The Natural History of Atopic Disease in Thai Children and Association With Atopic March

Atopic dermatitis(AD) is one of manifestation in atopic march. The prevalence of AD is increased. In 1998, the investigators found the prevalence of AD about 15 % in Thailand. AD is diagnosed by clinical as Hanifin and Rajka criteria. There are 3 group of severity defined by SCORAD(Scoring Atopic Dermatitis) : mild (\<25), moderate (25-50) and severe (\>50). The natural history of AD was mentioned in 3 groups: complete remission, persistent and intermittent. Atopic march is the progression of atopic disease that has atopic dermatitis as the first manifestation then patients will have allergic rhinitis or asthma in the future. The investigators do a retrospective study to understand the natural history of AD as well as it associate with atopic march. That might be a predictive factor of AD and atopic march

Retrospective review from out patient record. Collect the demographic data, onset of atopic march, sensitization of allergen and treatment that given to patients.

For patients who have current follow up at Allergy clinic, the current symptom was collect in that visit.

For patients who didn't have follow up visit, telephone interview was done. If they have symptom, investigators will ask them to come in for investigation and proper treatment.

Patient was recruited in this study with parental permission. The data will collect and use statistical analysis.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of AD by physician at birth-15 years old
* Diagnosed by physician by Hanifin and Rajka criteria: itching, dry skin, chronic dermatitis : at face, extensor area (infant), flexor area (children and adult), with or with out history of atopy in family
* Follow at allergy clinic once a year or can ask current symptom via telephone interview.
* Evaluate severity of the disease by SCORAD (Scoring Atopic Dermatitis )

Exclusion Criteria:

* Onset of atopic dermatitis more than 15 years old.
* Other disease: skin, cardiovascular, liver disease, endocrine, neurology, ect
* Not complete data collection in case record form in out patient record.
* Cannot be reach current symptom of patient.
Assessment of UTI Symptoms and Quality of Life According to Antibiotics Treatment in Acute Uncomplicated Cystitis

Although Cystitis includes a clinical syndrome characterized by various combinations of dysuria (painful urination), frequency, urgency, gross haematuria, lower back and/or abdominal/suprapubic discomfort with pyuria and bacteriuria. An acute uncomplicated UTI (referred to as cystitis) has been focused microorganisms and drug-resistance. There has been little research on Clinical aspects on cystitis treatment such as bothersomeness, or the impact of symptoms on patients' quality of life (QoL). The investigators want to study for Assessment of UTI Symptoms and Quality of Life According to Antibiotics Treatment(Ciprobay) in Acute Uncomplicated Cystitis in Korean Women.


Eligibility Criteria:
Inclusion Criteria:

* Female outpatients (20-65 years old)
* Acute cystitis symptoms (subject-reported) for \< 1 week prior to Visit 1.

Exclusion Criteria:

* Acute cystitis symptoms for ≥ 1 week prior to Visit 1.
* Diabetes mellitus
* Congenital urinary tract abnormality
* Female subjects who are pregnant, nursing, or with a positive urine pregnancy test or who are intending to become pregnant during the study or within 3 months after the completion of the study.
* Hypersensitivity to the active substance (Ciprobay).
* Subjects who have vaginal discharge
* Fever ( ≥ 37.5 ºC)
* Sexually transmitted diseases.
* Documented significant renal disease (sCr \> 1.5)
* Subjects who cannot consent to this study.
* Subjects who had received antimicrobial agents in the previous 4 weeks.
* Recurrent urinary tract infection defined as treatment for UTI \> 3 times in the last year.
* Use of an indwelling catheter or an intermittent self-catheterization program.
* Neurogenic bladder.
Effectiveness and Safety of Electroacupuncture on Poststroke Urinary Incontinence

This pilot protocol is aimed to evaluate the effectiveness and safety of electroacupuncture therapy for the post-stroke patients with urinary incontinence.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female aged over 19 years old
2. Patients diagnosed with stroke (cerebral hemorrhage or infarction) by the examination of computed tomography or magnetic resonance imaging methods within 2 years
3. Twice or more of urination with 3 to 4 points of PPIUS\* at baseline OR 13 points or more of K-IPSS\*
4. Any volunteers who signed the informed consent forms

Exclusion Criteria: We will exclude any patients with

1. Once or more of post-voiding residual \> 200 ml per day
2. Clinically significant stress urinary incontinence diagnosed based on cough induction test or investigator's decision
3. Recurrent urinary tract infection defined as 4 or more treatments for urinary tract infection for the recent 1 year
4. Cognitive impairment with less than 23 points of MMSE-K\* examination
5. Acute or chronic lower urinary tract infection examined by urine culture
6. Urinary incontinence diagnosed before the stroke occurred and the symptoms have continued until now based on medical history
7. Any severe diseases in lower urinary tract based on medical history and screening examination
8. Coagulation disorders based on medical history
9. Peripheral arterial diseases, which resulted in taking medical or surgical procedures to treat them based on medical history
10. Psychiatric diseases based on medical history
11. Fear of acupuncture based on questionnaire test
12. Pregnancy based on urine test
13. Any other inappropriate reasons on which the primary or sub investigators do not let the patients participate in the trial

    * Abbreviations PPIUS; Patient Perception of Intensity of Urgency Scale K-IPSS; The Korean version of International Prostate Symptom Scale MMSE-K; The Korean version of Mini-Mental State Examination
Effect of Ventilation Tubes in Otitis-prone Children

The purpose of this study is to investigate the effects of ventilation tubes in children with recurrent ear infections. By drawing lots, young children with recurrent ear infections will be assigned to one of two groups (ventilation tubes or close follow-up), and the number of ear infections and antibiotic prescriptions in each group will be monitored. The study participants will be followed until they are 7 years old.

Children who fulfil the criteria of recurrent acute otitis media (AOM) before they are one year of age will be randomised to ventilation tube surgery or active monitoring (50% vs 50%). Due to the nature of the intervention, blinding will not be possible. Children randomised to are randomised to active monitoring and continue to have frequent recurrences will be given the opportunity to cross between groups.

Children will be followed by the study doctors every third month until the age of two years, and after this yearly. In addition to planned visits, the families will be advised to contact the study doctors whenever they suspect that their child has a new episode of AOM. Otomicroscopy and nasopharyngeal cultures will be performed at every visit; cultures from the external ear canal will be taken when applicable. It will also be noted whether there is any perforation of the tympanic membrane, whether ventilation tubes are still in place, whether there is an ongoing episode of AOM or of otitis media with effusion (OME). At each planned visit, a parental quality of life questionnaire for children with ear disease will be completed. It will be noted how many AOM episodes the child has had since the last planned visit, how many times the patient has been prescribed oral antibiotics (also for reasons other than AOM), and if the family has seen a doctor elsewhere. At each emergency visit, it will be noted if the child has AOM or not, whether the child has fever, any signs of complications to AOM, a spontaneous perforation and whether the child´s general well-being is affected.

At the ages of 4 and 7 years and, if a hearing impairment is suspected on any other occasion, hearing tests will be performed.

Eligibility Criteria:
Inclusion Criteria: At inclusion, children should be under 1 year of age and fulfil the internationally accepted definition of recurrent AOM, ie have had 3 episodes of AOM during the last 6 months, or 4 during the last 12 months.

-

Exclusion Criteria: chromosomal aberrations, cleft palate or severe immune deficiency

-
Erbium Laser for Treatment of Vaginal Looseness and Sexual Dysfunction.

Patients with a primary complaint of vaginal looseness and sexual dysfunction, visiting a sexual dysfunction clinic at a tertiary medical center will undergo randomization to either a series of 3 laser treatments or 3 sham treatments, and the effect of these treatments will be measured by several validated questionaires and by means of gynecological examination.

Patients suffering from vaginal looseness and sexual dysfunction, as a primary sexual dysfunction complaint will be recruited, sign an informed consent and will receive a thorough explanation regarding the side effects and possible beneficial affects the laser treatments may bestow.

Patients will undergo randomization to either a series of 3 laser treatments or 3 sham treatments, and the effect of these treatments will be measured by several validated questionaires and by means of gynecological examination.

Follow up after treatment cessation will be for 12 months post-treatment.

Eligibility Criteria:
Inclusion Criteria:

* Premenopausal women.
* Women with vaginal looseness and sexual dysfunction as a primary complaint.

Exclusion Criteria:

* Vaginal bleeding of unknown source.
* Repeated vaginal infections.
* Known or suspected cervical pre-malignant neoplasia.
* Previous treatment with vaginal laser or other forms of energy-based treatment modalities.
* Pregnancy.
* Current pelvic inflammatory disease or urinary tract infection.
* Vaginal surgery during the year preceding study participation.
* Treatment with systemic or vaginal hormone replacement therapy.
* Current pelvic floor physiotherapy.
Knee Osteoarthritis and IPACK

Interspace between the Popliteal Artery and Capsule of the posterior Knee (IPACK) block involves ultrasound-guided local anesthetic infiltration of the space between the popliteal artery and the posterior knee joint capsule.

The purpose of the study; To investigate the effectiveness of this block applied to knee osteoarthritis in clinical practice.

In this study, patients who underwent IPACK block by the practitioner; Demographic data, medications used, block success, block characteristics and block-related complications will be recorded observationally. Before and after the block procedure, patients' pain was measured with the Numeric Rating Scale (NRS) at 1st and 3rd months, their disability levels were measured with The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire and Short Form-12 (Short Form). Quality of life will be measured with the -SF-12) survey.


Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from grade 3 and 4 knee osteoarthritis

Exclusion Criteria:

* Patients who have had previous knee surgery
* Patients who have had any knee injection in the last 3 months
* Malignancy
* Inflammatory disease
* Infectious disease (local or general)
Transcranial Alternating Current Stimulation (tACS) for the Recovery of Phonological Short-Term Memory in Patients With Aphasia After Stroke

This study will assess the effects of transcranial alternating current stimulation (tACS) on language recovery after stroke.

Aphasia is a debilitating disorder, typically resulting from damage to the left hemisphere, that can impair a range of communication abilities, including language production and comprehension, reading, and writing. Approximately 180,000 new cases of aphasia are identified per year, and approximately 1 million or 1 in 250 are living with aphasia in the United States. Treatments are limited and provide modest benefits at best. The current emphasis in aphasia rehabilitation is to formulate intensive speech and language therapies and augment therapeutic benefits, potentially with brain stimulation concurrent with therapies.

The current study will investigate the efficacy of high-definition tACS (HD-tACS) to help restore neural oscillatory activity in stroke survivors with aphasia. TACS differs from trancranial direct current stimulation (tDCS), a widely used brain stimulation paradigm, in that sinusoidal or alternating currents are delivered rather than direct currents. TACS is shown to manipulate ongoing oscillatory brain activity and also to modulate synchronization (or connectivity) between targeted brain areas. This feature of tACS is quite attractive, given the new body of evidence suggesting that language impairments stem from diminished brain connectivity and ensuing disruptions in the language network due to stroke.

The study will employ high-definition tACS (HD-tACS) in a parallel, double-blinded, sham-controlled design combined with language therapy targeting phonological short-term memory (STM) function in stroke survivors with aphasia. Magnetoencephalography (MEG) and fMRI BOLD data collection will occur to determine tACS parameters and to evaluate stimulation-induced neural changes, respectively. The investigators plan to recruit 120 stroke survivors with aphasia in a 2-group tACS study design.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with left hemisphere stroke/aphasia
* Consent date \>= 1 month after stroke onset
* Fluent in English
* 18 years of age or older

Exclusion Criteria:

* Severe cognitive, auditory or visual impairments that would preclude cognitive and language testing
* Presence of major untreated or unstable psychiatric disease
* A chronic medical condition that is not treated or is unstable
* The presence of cardiac stimulators or pacemakers
* Contraindications to MRI or tACS, e.g. patients with metallic implants, and/or history of skull fractures, pregnancy, skin diseases
* History of ongoing or unmanaged seizures
* History of dyslexia or other developmental learning disabilities
Targeting the Mechanisms Underlying Cutaneous Neurofibroma Formation in NF1: a Clinical Translational Approach.

The purpose of the research study is intended to use specimens (such as tissue) and medical information in the Laboratory of Musculoskeletal Oncology at the Van Andel Research Institute for laboratory research in Grand Rapids, Michigan. Small tissue samples of cutaneous neurofibromas will be collected as part of this research. The samples will help researchers learn more about cutaneous neurofibroma and help them better understand NF1. There are many different types of studies, both now and in the future, that can be done using the specimens the investigators receive. These include using the specimens and information to look for new ways to diagnose and treat Neurofibromatosis Type 1 (NF1). The specimens may be used to study how genes affect health and disease, or how genes affect the way a disease or condition responds to treatment. Some of these studies may lead to new products, such as treatments or tests for diseases. Through this study, the investigators hope to find better ways to understand and treat NF1 in the future.

Skin tumors in Neurofibromatosis Type 1 (NF1) are very common and diminish quality of life. Apart from surgery, very few treatment options exist. In comparison to other types of tumors in NF1, skin tumors receive less attention in the research world because they almost never turn into cancer. Under the microscope, skin tumors and plexiform tumors look similar, however they do not share the same growth potential, nor do they appear at the same time during development. These differences suggest that skin tumors are driven by different factors than plexiform tumors.

In this study the investigators will be harvesting CNFs from 3 groups of subjects in order to obtain a minimum of 18 tumors in three size categories: \<5mm, 5-10mm, and \>1cm. These sizes were selected based on the variable natural history of CNF progression where incipient lesions (typically \<5mm) are more numerous and demonstrate a less aggressive growth pattern, whereas the intermediate group (5-10mm) represent a transition state towards growth to larger (\>1cm) lesions. Interestingly, CNF growth tends to stall out at 3cm. The investigators plan to do experiments that identify which factors are important to CNF progression, and then find matching drugs that can shrink the tumors.

Eligibility Criteria:
Inclusion Criteria:

1. Any subject with an established diagnosis NF1 and CNFs. The diagnosis may be based on clinical criteria or genetic testing.
2. Age \>18 years.

Exclusion Criteria:

1. Adults with diminished decision-making capacity with no defined legal guardian.
2. Prisoners.
3. Pregnant women.

3) Breastfeeding mothers.
Effect of Bladder Distension on Dosimetry in Brachytherapy of Cervical Cancer

The purpose of this study is to compare, for each patient, dosimetry of organs at risk (bladder, rectum, sigmoid, small bowel) in two bladder distension procedures (emptied by a urinary catheter or filled with 120cc) during PDR 3D image-guided brachytherapy of cervical cancer.


Eligibility Criteria:
Inclusion Criteria:

* Age \> or = 18 years old
* with a cervical cancer histologically proven (squamous cell carcinoma, adenocarcinoma and neuroendocrine cell carcinoma)
* Utero-vaginal brachytherapy indications::

  * Stage 1B1: brachytherapy before surgery
  * Stages IB2 to IIIB: after pelvic radiotherapy (45Gy/25 fractions/5 weeks) with or without concomitant chemotherapy
* Ability to provide an informed written consent form
* Patient must be affiliated to a social security system

Exclusion Criteria:

* Age \< 18 years old
* History of pelvic radiotherapy
* History of pelvic surgery
* Recent joint prothesis (\<3 months)
* Pregnant woman or being breastfeeding
* Patients deprived of liberty or under supervision
Effects of Gallopamil in Severe Asthma

Severe asthma is a difficult to treat disease, characterized by bronchial remodelling, which is an abnormal repair process that contributes to the development of poorly reversible airway narrowing. Such remodelling is now considered as one of the main prognostic factors. Gallopamil-sensitive calcium influx plays a key role in this remodelling process in vitro. The objective of this study is to compare the effects of gallopamil versus placebo on the bronchial smooth muscle remodelling in severe asthmatic patients.

Bronchial remodelling mainly involves an increased mass of bronchial smooth muscle (BSM), which is related with an increase proliferation of smooth muscle cells. Recently, using BSM cells obtained from severe asthmatics, we have demonstrated that such an increase proliferation was induced by an activation cascade (Trian, J Exp Med, 2007). It first started with a gallopamil-sensitive calcium influx which induced the activation of calcium-calmodulin kinase IV (CamK-IV). CamK-IV then enhanced mitochondrial biogenesis through the subsequent activation of various transcription factors including PGC-1α, NRF-1 and mt-TFA. BSM cell proliferation was mainly mitochondria-dependent in vitro in severe asthma whereas that of controls was virtually mitochondria-independent. However, in vivo effects of gallopamil remain to be investigated. We will thus enrol 32 severe asthmatic patients in a phase 2 randomized double blind study against placebo and evaluate the effect of gallopamil on BSM remodelling. Since inflammation also activates mitochondrial biogenesis in BSM cells, we will initially optimized asthma treatment for 3 months by both controlling co morbidities and decreasing bronchial inflammation using exhaled NO and eosinophil count within the induced sputum. We will then perform fiberoptic fibroscopy before and after 12 month treatment with gallopamil.

Eligibility Criteria:
Inclusion Criteria:

* Male or female aged more than 18 years
* Written informed consent
* Diagnosis of severe asthma according to ATS criteria

Exclusion Criteria:

* Smoker or former smoker
* Chronic viral infections (hepatitis, HIV)
* Aspergillosis
* Pregnancy
* Breastfeeding
* Contraindications to gallopamil or bronchoscopy
Combination Bisphosphonate and Anti-Angiogenesis Therapy With Pamidronate and Thalidomide

The purpose of this research is to study how helpful the combination of thalidomide and Pamidronate is in controlling multiple myeloma and to study any side effects that may be experienced.

Recently, laboratory research found that thalidomide can inhibit the formation of new blood vessels that are necessary for the growth and spread of cancer. In order to grow and increase in size, tumors require new blood vessels to supply them with the necessary blood to grow. If we can prevent these new blood vessels feeding the tumor from being formed by using thalidomide we might slow or stop the growth of the tumor. This concept is called "anti-angiogenesis". It is hoped that thalidomide will slow or stop the growth myeloma. However, it cannot be guaranteed that you will benefit if you take part in this study. The treatment you receive may even be harmful.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have a diagnosis of Multiple myeloma with poor hematopoietic reserve (platelet count \<100,000 OR inability to collect adequate PBSC to support autologous transplant (4X106 CD34+cells/kg OR WBC \<2,000)
* Patients must not be eligible for UARK 98-035
* Patients must be at least 6 weeks beyond previous chemotherapy
* All patients must be informed of the investigational nature of this study and must sign a written informed consent in accordance with UAMS Human Research Advisory Committee and federal guidelines

Exclusion Criteria:

* Prior bisphosphonate therapy within 30 days prior to study entry
* Serum creatinine \> 5 mg/dl, ascites, or serum direct bilirubin \> 2.5 mg/dl
* Prior plicamycin or calcitonin within 2 weeks of study entry
* Severe cardiac disease, unstable thyroid disease, or epilepsy