cyrilzakka/clinical-trials huggingface dataset:
Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease-Associated Pain

This trial is being conducted to compare the impact of Rotigotine and Placebo on Chronic Pain associated with Parkinson's Disease among patients with advanced stages of the disease.


Eligibility Criteria:
Inclusion Criteria:

* Patient has advanced idiopathic Parkinson's Disease associated chronic pain assessed by a Likert Pain Scale
* Patient is taking Levodopa with a stable daily dose of at least 200 mg for at least 21 days prior to start
* Hoehn and Yahr stage score of II to IV
* Mini-Mental State Examination (MMSE) score ≥ 25
* If an antidepressant drug is taken, the dose must be stable for at least 21 days

Exclusion Criteria:

* Therapy with a Dopamine Agonist within 21 days prior to start
* Discontinuation from previous Dopamine Agonist Therapy due to lack of efficacy
* Therapy with Dopamine-modulating substances 21 days prior to start
* Therapy with analgesics for the treatment for pain, unless the dose has been stable
* Chronic alcohol or drug abuse
* Medical or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the patient's ability to participate in this study
* Hypersensitivity to any components of the Investigational Medicinal Product (IMP) or comparative drugs
* Atypical Parkinson's Disease Syndrome due to drugs
* History of deep brain stimulation
* Significant skin disease that would make transdermal drug use inappropriate
* Electroconvulsive therapy within 12 weeks prior to start
* Evidence of an Impulse Control Disorder
* Previous diagnosis of severe Restless Legs Syndrome
* Chronic Migraine
* Severe Depression
* Symptomatic Orthostatic Hypotension
Factors Influencing the Racial Disparity in Sudden Infant Death Syndrome (SIDS)

The overall purpose of this investigation is to better understand factors contributing to the high incidence of prone sleep positioning in African-American infants. In addition, the investigators are interested in investigating other races and ethinicities to understand their beliefs and perceptions and determine differences socioeconomically and socioculturally within and between groups. The investigators will address the following specific aims:

(-) To compare knowledge, attitudes, and practices regarding infant sleep position in parents of higher and lower SES.

(-) To identify risk factors for non-use of recommended supine sleep position in families with higher and lower SES (-) to develop a phenomenologic understanding of the decisions made by parents of higher SES and lower SES who do nt use recommended supine sleep position, using qualitative techniques.

Epidemiologic studies have demonstrated prone position to be a major risk factor for SIDS. Studies have consistently demonstrated an increased rate of prone positioning in African American infants, but very little is known about the reasons why African American parents use the prone position more often than other racial groups. Furthermore, no studies have taken advantage of the observed socioeconomic status associated variablility in SIDS and prone sleeping within the African American community. By examing within-group differences, it is possible to move beyond comparative racial descriptions (i.e. comparisions of white and African American) to identification of potentially modifiable factors that might respond to culturally acceptable interventions within a disadvantaged group.

Eligibility Criteria:
Inclusion Criteria:

* Parents who are 18 years old wth children less than 6 months old are eligible to participate if they self-identify as African American, with parents born in the United States.

Exclusion Criteria:

* If the parent is male, not the custodial parent of the child, unable to complet the interview in English or if their child has a chronis illness that would preclude use of the supine sleep position, severe gastroesophageal reflux or recent spinal surgery.
Prone Position During ECMO in Pediatric Patients With Severe ARDS

In 2023, the second Pediatric Acute Lung Injury Consensus Conference (PALICC-2) updated the diagnostic and management guidelines for Pediatric Acute Respiratory Distress Syndrome (PARDS). The guidelines do not provide sufficient evidence-based recommendations on whether prone positioning ventilation is necessary for severe PARDS patients. However, the effectiveness of Extracorporeal Membrane Oxygenation (ECMO) in treating severe PARDS has been fluctuating around 70% according to recent data from Extracorporeal Life Support Organization (ELSO).

In 2018, the Randomized Evaluation of Sedation Titration for Respiratory Failure (RESTORE) study group conducted a retrospective analysis and concluded that ECMO does not significantly improve survival rates for severe PARDS. However, this retrospective study mainly focused on data from North America, with significant variations in annual ECMO support cases among different centers, which may introduce bias. With advancements in ECMO technology and materials, ECMO has become safer and easier to operate. In recent years, pediatric ECMO support technology has rapidly grown in mainland China and is increasingly being widely used domestically to rescue more children promptly.

ECMO can also serve as a salvage measure for severely ARDS children who have failed conventional mechanical ventilation treatment. When optimizing ventilator parameters (titrating positive end expiratory pressure (PEEP) levels, neuromuscular blockers, prone positioning), strict fluid management alone cannot maintain satisfactory oxygenation (P/F\<80mmHg or Oxygen Index (OI) \>40 for over 4 hours or OI \>20 for over 24 hours), initiating ECMO can achieve lung-protective ventilation strategies with ultra-low tidal volumes to minimize ventilator-associated lung injury.


Eligibility Criteria:
Inclusion Criteria:

* Severe PARDS and meets the criteria for ECMO support, has received ECMO support for less than 48 hours.
* Informed consent obtained from the child's direct/legal guardian

Exclusion Criteria:

1. Age \< 1 month or \> 18 years old.
2. ECMO initiated for more than 48 hours.
3. Children who have undergone cardiopulmonary resuscitation (CPR) for more than 10 minutes before ECMO initiation without restoration of spontaneous circulation, or children undergoing extracorporeal cardiopulmonary resuscitation (ECPR).
4. Presence of irreversible brain injury or intracranial hypertension.
5. Children with irreversible lung disease awaiting lung transplantation.
6. Children with abdominal trauma or postoperative acute respiratory distress syndrome (ARDS).
7. Children in whom percutaneous cannulation cannot be performed due to unstable hemodynamics within the first 48 hours after ECMO support initiation.
8. Other contraindications for performing percutaneous cannulation.
9. Liver failure.
10. Burn area \>20% body surface area (BSA).
Intraperitoneal Chemotherapy Alone or in Combination With Bevacizumab for Ovarian Cancer With Peritoneal Adhesion

Background: Malignant peritoneal adhesion is a common complication and prognostic factor of ovarian cancer and other primary abdominal tumors. The incidence of peritoneal adhesion in advanced primary peritoneal tumor is 32-56%, which has increased by more than 10 times in the recent decade. Malignant peritoneal adhesion is closely associated with the morbidity and mortality of malignant intestinal obstruction. The peritoneal adhesion may aggravates the abdominal symptoms and reduce quality of life. Further, the peritoneal adhesion may impede treatment of primary tumor, such as operation or chemotherapy, lead to a poor prognosis.

Objective: This study aims to treat malignant peritoneal adhesion with the combination of antiangiogenic agent and chemotherapy, evaluate the efficacy and safety of intraperitoneal antiangiogenic agent plus chemotherapy. As explosive endpoints, we will examination the expression of VEGF-A in peritoneal cavity during the treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Pathologically and radiologically confirmed stage IV or postoperative recurrence ovarian cancer.
2. Age of 18-70, Karnofsky score higher than 80.
3. No severe functional damage of major organ, normal liver and kidney function.
4. Peritoneal adhesion. (1) peritoneal adhesions diagnosed by microlaparoscopy or abdominal operations, and classification according to Nair criteria is performed. (1) must be met. (2) Peritoneal adhesion symptoms, intermittent abdominal pain, abdominal distension, nausea and vomiting, hard to pass stools or gas; (3) Peritoneal adhesion signs，abdominal distension, abdominal tenderness, reduced or absent bowel sounds; (4) B ultrasound or CT or MRI show peritoneal adhesion or adhesion-related complications.

Exclusion Criteria:

1. Complete intestinal obstruction and suitable for surgery.
2. Patients known to be allergic to bevacizumab or any of the components of the drug.
3. Other ongoing anti-tumor treatment.
4. Heart disease with significant clinical symptoms, such as: congestive heart failure, coronary heart disease with symptom, arrhythmia hardly be controlled by drugs, myocardial infarction in 6 months, or heart failure
5. Active wound infection and a history of uncontrolled psychiatric illness.

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Preventing Mother-to-child Transmission of Hepatitis B Virus With Tenofovir Alafenamide (TAF)

The purpose of this study is to evaluate the efficacy and safety of Tenofovir alafenamide (TAF) for prevention of mother-to-child transmission of hepatitis B virus among pregnant women with high level HBV DNA.

This is a single-arm multicenter, prospective, clinical study, aiming to evaluate the efficacy and safety of Tenofovir alafenamide (TAF) for prevention of mother-to-child transmission of hepatitis B virus among pregnant women with high level HBV DNA. 330 HBV-infected mothers with high level HBV DNA will be enrolled and receive Tenofovir alafenamide (TAF) for prevention of mother-to-child transmission of HBV. Demographic data, antiviral treatment history, pregnancy and labour history, co-morbidity, HBV serologic marker tests, HBV DNA tests, liver function tests, mode of delivery, neonatal characteristics (height, weight, head circumference, Apgar score and any major birth defect), breastfeeding and post vaccination serological test for infants at 7-12 months of age are collected. A mobile health application called "SHIELD" is used in this study to collect data and provide support for communication between mothers and their doctors. All laboratory test reports, questionnaires and other relevant information are uploaded into SHIELD.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant woman aged 20 to 35 years old
* 24-26 week of gestation
* HBsAg positive more than 6 months and HBeAg positive
* HBV DNA\> 200,000 IU/ml
* Informed consent is signed voluntarily by both husband and wife
* Good compliance and able to be followed up as planned

Exclusion Criteria:

* Mothers co-infected with HCV and HIV
* Evidence of decompensated cirrhosis and liver cancer
* Mothers had other organ lesions which would affect patient compliance and follow-up plan
* Mothers had history of spontaneous abortion or their children had birth defect or congenital malformation
* Mothers received antiviral therapy within 6 months
* Mothers had history of kidney injury, CCr \<50ml/min and urine protein test positive (\>300mg/L)
* Mothers had history of other chronic diseases and had to take immunomodulators, cytotoxic drugs or hormonal drugs during pregnancy
* The infants' biological fathers are infected with HBV
* Symptoms of threatened abortion during early pregnancy
* ALT \> 1×upper limit of normal (ULN), or TBIL ≥ 1×ULN or glomerular filtration rate (GFR) \< 90 ml/min, or Albumin (ALB) \< 25 g/L
* Fetal malformations detected by B-ultrasound during pregnancy
* Participating in other studies
A Phase I Study of MGCD0103 Given Three-Times Weekly In Patients With Leukemia Or Myelodysplastic Syndromes

In this study, MGCD0103, a new anticancer drug under investigation, is given three times weekly to patients with leukemia or myelodysplastic syndromes.

Phase I dose escalating study.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have a diagnosis of one of the following:

  * relapsed or refractory AML or ALL that has failed to respond to standard therapy, has progressed despite standard therapy
  * relapsed or refractory Myelodysplastic Syndromes
  * previously untreated AML or Myelodysplastic Syndromes in patients \> 60 years of age who refused or are not candidates for induction chemotherapy
* Patients with relapsed or refractory CML that has failed to respond to Imatinib therapy or standard therapy, has progressed despite standard therapy, or for which no standard therapy exists
* ECOG performance status of 0, 1, or 2
* Age ≥ 18 years
* Patients or their legal representative must be able to read, understand, and sign a written informed consent (approved by the IRB/EC) prior to study entry

Exclusion Criteria:

* Patients with a history of another cancer other than basal cell carcinoma or cervical intraepithelial neoplasia
* Pregnant or lactating women
* Patients and their partners, if either are of childbearing potential, not using adequate birth control measures throughout the study and for 90 days following the last dose of study medication
* Patients with known meningeal metastasis(es)
* Patients with active or uncontrolled infections, or with a fever \>38.5 C
* Patients with serious illnesses, medical conditions, or other medical history, which would be likely to interfere with a patient's participation in the study
* Patients who have been treated with any investigational drug or anti-cancer therapy within 30 days of study start.
Effectiveness of an Interactive Educational Website for Improving the Quality of Mental Health Care for People With Schizophrenia

This study will evaluate the effectiveness of an interactive educational website in enhancing discussions about treatment issues and improving the quality of care for people with schizophrenia.

Schizophrenia is a disabling mental disorder that causes hallucinations and delusions in those affected by it. Research has proven that certain treatment methods are more effective in treating schizophrenia than others. However, not everyone with schizophrenia responds to treatment in the same way, and not all physicians use the same treatment methods. Educating individuals with schizophrenia about all treatments available instead of only the treatments they are receiving may improve the quality of care and lead to better correlation between treatment and quality standards. This study will evaluate the effectiveness of an interactive educational website in enhancing discussions about treatment issues and improving the congruence between expected quality of treatment and treatment received among people with schizophrenia.

Participants in this open label study will be randomly assigned to either use the interactive website or read written materials and watch a video. All three sources will contain information about evidence-based treatment recommendations. Both groups will complete a brief interview before performing their assigned tasks. Upon completion of the interview, participants in the written materials/video group will be given the reading material and will watch a 20-minute video. Participants in the web-user group will sit with a laptop computer, answer questions about themselves and their treatment, receive feedback on care that may be inconsistent with current recommendations, and receive suggestions on how to discuss this with their physicians. Participants in clinical settings will be asked to allow their next clinician visit to be audiotaped to assess outcomes. A phone interview will be conducted with all participants 2 months following the intervention to assess treatment satisfaction and other outcomes. Medical records will be reviewed to collect treatment information 6 months before and after the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of schizophrenia
* Able to read and write English
* Scheduled to see a participating clinician at one of the study sites

Exclusion Criteria:

* N/A
Characterisation of Asthma in Obese Subjects

Our hypothesis:

Obese subjects with a physician's made diagnosis of asthma have a poorer asthma control than asthmatics with normal weight, less variability of peak expiratory flows (PEF) and bronchodilator response,increased induced sputum and systemic markers of inflammation and an increased prevalence of atopy.

Obese subjects have an increased incidence of co-morbidities such as rhinosinusitis, gastroesophageal reflux and sleep apnea syndrome.

This study aims to determine if, in comparison with asthmatics with a normal weight, paired for age and sex, obese subjects with asthma (all not using anti-inflammatory agents) show:

* A more uncontrolled asthma, increased health care use and poorer quality of life
* A reduced response to bronchodilators and diurnal variability of expiratory flows
* More marked airway inflammation and evidences of a systemic inflammatory response
* An increased prevalence of co-morbidities which can influence the report of respiratory symptoms or the severity of the disease, such as esophageal reflux symptoms, upper airway disease (rhinitis) and sleep apnea syndrome or other sleep disorder.

Questionnaires on respiratory symptoms, health care use, quality of life, medication and asthma control will be administered and a thoracic examination performed.

Spirometry and bronchodilator response, blood tests for inflammatory parameters, pH measurements in exhaled air condensate and sputum induction will be performed. Peak expiratory flows will be measured and recorded on a diary card during one week.

On the second visit, measures of lung volumes and a methacholine challenge will be performed.

Eligibility Criteria:
Inclusion Criteria:

* aged 18 and over.
* in good health apart from asthma or obesity as determined by history and physical examination (no other condition which could influence the proposed tests).
* All will be non smokers or ex- smokers for more than six months with a smoking history of no more than 10 pack- years (i.e., one pack per day or its equivalent for 10 years.)
* Subjects will have a physician's made diagnosis of asthma and have received a bronchodilator prescription in the last year.

Exclusion Criteria:

* Use of asthma medications other than bronchodilators
* Subjects who are, in the opinion of the investigator, mentally or legally
* incapacitated thus preventing informed consent from being obtained.
* Subjects having a co-existing illness that precludes them from the trial.
* Pregnancy or lactation
Multi-center Clinical Research of Acupuncture Treatment of Knee Osteoarthritis

Knee osteoarthritis (KOA) is a major public health problem among the elderly and is associated with considerable disability. A recent analysis of data indicated that about 35% of women and men aged 60 years and above had radiographic knee OA.Despite the high prevalence rate of OA, the treatment of OA is far from satisfactory. Acupuncture may be a promising treatment option for knee OA due to the effectiveness of the pain relief and the rarity of adverse effects. In order to get some more reliable data to confirm acupuncture effectiveness on KOA, a long-term follow up interventional study will be started to confirm the effects of long term for acupuncture treatment.

Knee osteoarthritis (KOA) is a major public health problem among the elderly and is associated with considerable disability. A recent analysis of data from the National Health and Nutrition Examination Survey III indicated that about 35% of women and men aged 60 years and above had radiographic knee OA. Although the cause of OA can be many factors, such as previous injury, abnormal limb development and so on, its main symptom is a complex chronic pain condition. Previous studies have demonstrated central sensitization in OA patients. Despite the high prevalence rate of OA, the treatment of OA is far from satisfactory. Acupuncture could be a promising treatment option for knee OA due to the effectiveness of the pain relief and the rarity of adverse effects. In order to get some more reliable data to confirm acupuncture effectiveness on KOA, a long-term follow up interventional study with clear design, standard criteria, control group, will be started to confirm the effects of long term for acupuncture treatment.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients who have knee OA diagnosed according to the American College of Rheumatology classification criteria (with at least one osteophyte in the tibiofemoral joint and with a Kellgren-Lawrence grade of more than 2).
* Male and female patients who have had a history of moderate or greater knee pain of more than 3 months' duration and have reported moderate or greater, clinically significant, knee pain during most days of the last month before the interview.
* Male and female patients who have given their consent to participate in the study.
* Patients will be selected among those who are not on the waiting list for total knee arthroplasty by the traumatology unit of our hospital.

Exclusion Criteria:

* Patients with any of the following will be excluded from the study: a history of any secondary OA associated with any systemic arthropathy (i.e., rheumatoid arthritis or gouty arthritis);
* Any knee treatment with steroids, methotrexate, or azathioprine; recent traumatisms caused by acupunctured insertion;
* A history of bleeding disorders or any disease related to acupuncture contraindications;
* A history of any knee injection in the previous 6 months (e.g., cortisone and hyaluronic acid); a history of morphine or morphine derivative use.
Feasibility of AI-based Classification of Normal, Wheeze and Crackle Sounds From Stethoscope in Clinical Settings

Assessing the feasibility and testing the accuracy of the developed artificial intelligence algorithms for detection of wheezes and crackles in patients with lung pathologies in clinical settings on unseen local patient data acquired through three digital stethoscopes.


Eligibility Criteria:
Inclusion Criteria:

* Ages all
* Written consent provided

Exclusion Criteria:

* Subject condition unstable
* Chest wall deformity or wounds in adhesive application areas
* Written consent not provided
Effect of AN-PEP Enzyme on Gluten Digestion in Gluten Sensitive Individuals

In this trial, the effect of a low and a high dose AN-PEP will be investigated in gluten sensitive individuals. Volunteers receive a breakfast with background (0.5 g) gluten. Capsules are taken in the morning within 5 min after start of breakfast. Gastrointestinal fluid will be sampled over 3 hours to measure gluten degradation. After 5 volunteers have completed 3 test days, a blind interim analysis is performed by a third party based on which it is decided whether to proceed with the low AN-PEP dose.


Eligibility Criteria:
Inclusion Criteria:

* Male/female
* Age ≥18 but \<70 yr
* Females: Hormonal contraceptive treatment
* Self-reported gluten-sensitive individuals fulfilling the Rome III criteria while consuming gluten
* Subject has read and understood the information provided on the study and given written informed consent

Exclusion Criteria:

* Coeliac disease serology while consuming gluten (serological test for tissue transglutaminase IgA antibodies and total IgA antibodies)
* Wheat allergy (serological test for wheat protein IgE antibodies)
* Medication or medical condition that affects gastric emptying or secretion
* Females: Pregnancy or breast-feeding
* Inability to swallow the gastroduodenal feeding tube
* Any medical condition that in the opinion of the investigators may interfere with the study and may jeopardise the health status of the participant
* Any condition that in the opinion of the investigators may interfere with the study and may jeopardise the health status of the participant