cyrilzakka/clinical-trials huggingface dataset:
Clinical Study on the Treatment of Breast Hyperplasia With Kou Sha Therapy Based on Real World

In this study, epidemiological prospective real-world cohort study design was adopted. The Third Affiliated Hospital of Beijing University of Chinese Medicine and the First Hospital of Handan City, Hebei Province were selected. From the same time appointed before the study, all breast hyperplasia participants who met the admission criteria choosing Kou Sha therapy or routine treatment of western medicine were selected in the sample hospitals.The first 30 participants were included in the planned Kou Sha therapy group while the first 30 participants were included in the control group.Taking the change of the total score of breast pain (McGill Pain Questionnaire Short Form score+breast pain score) as the main curative effect index, and taking McGill pain questionnaire score, breast color ultrasound score, palpation lump score, quality of life, anxiety and depression symptoms, sleep and so on as the secondary curative effect indexes to observe the clinical effect of the method of Kou Sha therapy on breast hyperplasia. The research period is from March 2024 to May 2024.

Investigators adopte a real-world prospective cohort study design to investigate the efficacy and safety of the Kou Sha therapy in the treatment of breast hyperplasia.Kou sha on the key points of breast diseases can dredge the mammary veins, and scraping on the back of the liver, gall bladder, spleen, and stomach can loosen the liver and diarrhea, dredge the internal organs and meridians, regulate emotions, and facilitate the recovery of breast hyperplasia.

Eligibility Criteria:
Inclusion Criteria:

* It meets the diagnostic criteria of breast hyperplasia, and the course of disease is more than 3 months;
* Female, aged between 18 and 50, with regular menstrual cycle and period, with menstrual cycle of (28±7) d;
* Mild and moderate breast pain, with BI-RADS grade below 4;
* Informed consent, voluntary subjects and signed informed consent.

Exclusion Criteria:

With one of the following circumstances cannot be included in this experimental study:

* Patients with breast malignant tumor, inflammatory disease and other breast diseases;
* Patients with serious primary diseases such as cardiovascular and cerebrovascular diseases, liver, kidney and hematopoietic system are psychotics;
* prepare for women during pregnancy, pregnancy, lactation, menopause, severe menstrual cycle disorder or functional uterine bleeding;
* Severe diabetes, skin trauma or obvious inflammation, redness and ulceration of the skin;
* Diseases with severe bleeding tendency, such as thrombocytopenia, leukemia and allergic purpura;
* Those who are using Chinese and western medicines (including topical medicines, acupuncture, etc.) for the treatment of breast hyperplasia within one month before this treatment or now, and have not used hormonal drugs within half a year;
* Participants in other clinical trials within 3 months.
Combined Oral Vitamin D and UVB Versus UVB Alone in Treatment of Psoriasis Vulgaris

To compare the results of vitamin D plus UVB in treatment of psoriasis vulgaris with the results of UVB alone to study the relation between serum vitamin D and PASI score before and after treatment.

Psoriasis is a chronic immune-mediated inflammatory skin disease, with a prevalence of about 2%-3% in the general population. The primary manifestation of psoriasis most commonly manifests on the skin, although inflammatory processes can occur also in other organs .

Vitamin D, also known as the sunshine vitamin, has long been known to be a hormone that regulates calcium-phosphorous homeostasis and safeguards the integrity of the skeletal system . The epidermis is the natural source of vitamin D synthesis by the action of ultraviolet light (UV) B of the sun or other UVB source . On the other hand, evidence is accumulating that vitamin D might represent a key modulator of immune and inflammation mechanisms . Recently, a role for vitamin D in the pathogenesis of different skin diseases, including psoriasis, has been reported.

Psoriasis lesions are characterized by hyper-proliferation with incomplete differentiation of epidermal keratinocytes and decreased keratinocyte apoptosis, associated with inflammatory cellular infiltrate in both dermis and epidermis . Psoriasis Area and Severity Index (PASI) score is currently the preferred method for the assessment of the disease severity and extent .

Physiologically, the active form of vitamin D and its receptor regulate the differentiation and proliferation of keratinocytes, the balance of the cutaneous immune system and the process of apoptosis.

Several studies identified an association between polymorphisms of vitamin D receptor (VDR) and psoriasis susceptibility .The 1,25(OH)D has been shown to exert anti-proliferative effects on keratinocytes .

The exact mechanism of action of NBUVB is not known. It is proposed that it acts in the following ways: (1) Cellular DNA is converted to pyrimidine dimers which interfere with cell cycle progression, (2) alteration in cytokine production, NBUVB phototherapy as the second-line treatment for psoriasis, recommended when the topical therapy fails, is contraindicated or impractical. UVB radia- tions of wavelength 311 nm may result in the clearance of disease symptoms after just 5-8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* : patients from 10 to 60 diagnosed to have psoriasis vulgaris

Exclusion Criteria:

1. concomitant chronic inflammatory disease or malignancy.
2. pregnant and lactating women.
3. renal dysfunction.
Kinesio Taping With &Without Craniosacral Therapy in Pregnant Females With SIJ Dysfunction.

SIJ dysfunction adversely affects quality of life and causes functional impairment and disability. Although, K taping and craniosacral therapy were previously affective in treating SI joint dysfunction, the combined affects of these intervention have not been compared previously to K taping alone.

This study is a randomized controlled trial and have 30 pregnant women suffering from SIJH dysfunction. There is 2 groups and both have received treatment for 6 weeks. The data on pain is collected through VAS and the data on disability is collected through Oswestry Disability Index, and data on quality of life will be collected using SF-36. Measurements will be taken at the beginning of the study and at the end of the 4th week, at the completion of the study. Data will be analyzed using SPSS.

Eligibility Criteria:
Inclusion Criteria:

* age between 18-35
* pregnant females in 3rd trimester
* pregnant females with SIJ dysfunction

Exclusion Criteria:

* high risk pregnancy
* pregnant females with hypermobility syndrome
* previous pelvic history
A Study of the Safety of Rituxan in Patients With Rheumatoid Arthritis After an Inadequate Response to Previous Anti-TNF Therapy (SUNSTONE)

This is an observational study designed to follow patients with RA who have had an inadequate response to one or more anti-TNF therapies and who will receive Rituxan. Approximately 1000 patients in the United States with RA who have had an inadequate response to anti-TNF therapies and who will receive Rituxan therapy will be recruited. There is no protocol mandated treatment assignment in this study. Patients will be evaluated and treated according to their physician's standard practice and discretion.


Eligibility Criteria:
Inclusion Criteria:

* No prior use of Rituxan (except if received within 8 weeks of screening)
* Signed Informed Consent Form
* Age ≥ 18 years
* Diagnosis of RA
* Inadequate response to one or more anti-TNF therapies

Exclusion Criteria:

* Have known hypersensitivity to any component of a humanized or murine monoclonal antibody
Intravenous Versus Perineural Ondansetron for Laparoscopic Sleeve Gastrectomy

This prospective randomized non-inferiority study will be conducted to compare the analgesic anti-emetic effects of intravenous ondansetron versus perineural ondansetron in patients undergoing laparoscopic sleeve gastrectomy.

Obesity and its associated disorders have significant implications for health, resulting in heightened productivity loss and reduced life expectancy while also negatively impacting the quality of life of patients. Surgical intervention is the most effective way to achieve sustainable weight loss in patients with obesity and to alleviate the associated comorbidities. Despite the current availability of minimally invasive bariatric surgical treatments, postoperative pain remains a significant issue. Vagal and sympathetic afferent signals originating from the gastrointestinal system stimulate the vomiting center, causing nausea and vomiting. Paragastric autonomic neural blockade (PANB) is a new method performed by injecting local anesthetic material into three to four separate points along the border between the lesser omentum and the stomach (from the esophagogastric junction to the distal antrum), the hepatoduodenal ligament, and the area covering the left gastric artery. This procedure aims to prevent visceral pain and symptoms of nausea and vomiting. Ondansetron is a serotonin receptor (5-HT3) antagonist used commonly to manage postoperative nausea and vomiting (PONV) through intravenous (IV) injection. It also has a local anesthetic effect and many studies used it as adjuvant in various regional anesthetic techniques. In this study, investigators will compare the combined antiemetic analgesic effects of IV and perineural (adjuvant to the local anesthetic bupivacaine in PANB) ondansetron. The investigators hypothesized that perineural administration of ondansetron will be non-inferior to the IV route regarding prophylaxis against PONV, and will provide superior postoperative analgesic effects by its local anesthetic enhancing action.

Eligibility Criteria:
Inclusion Criteria:

* Patients of either sex
* American Society Anesthesiologists physical (ASA) status II-III
* age between 18-65 years old
* Body mass index (BMI) \>35 kg/m2 with comorbidity or \> 40 kg/m2 -- undergoing laparoscopic sleeve gastrectomy with intraoperative surgeon performed laparoscopic paragastric autonomic neural blockade..

Exclusion Criteria:

* Allergy to experimental drugs.
* Known to have long QT, previous history of postoperative nausea and vomiting
* Abuse of alcohol, analgesia, or sedative antidepressant drugs
* Chronic pain disorders
* History of previous upper gastrointestinal system surgery, those with surgery-related complications during or after surgery.
* Liver or kidney failure
* Performance of concomitant procedures in addition to laparoscopic sleeve gastrectomy
* Anesthetic complications that may alter the postoperative management protocol.
Clinical Study of Biokinetic Model of Iodine-131 in Total(Near) Thyroidectomy Patients.

Thyroid cancer patients who have undergone total thyroidectomy, postoperative iodine 131 treatment to ablation residual thyroid tissue, is the current clinical practice. The effective half-life of the iodine 131 in the human body and in vivo exposure dose can be assessed by the in vivo kinetic model published by ICRP, but this model is based on standard healthy people and can not be corrected for patients undergoing total thyroidectomy.

In this study, the investigators will use the actual clinical data to revise the biokinetic model of iodine-131 in patients with total thyroidectomy.

Methods Patients:All patients undergoing thyroidectomy and are about to be treated with iodine 131 30mCi will be invited to join the study. Exclusion with gastrointestinal surgery.

Preparation:The patient of this study, their medication and diet and other matters needing attention, are in accordance with the original to accept iodine -131 30mCi treatment of the standard treatment.

Imaging Protocol:After oral administration of iodine 131, patients must undergo whole body scan, for 1 hour, 4 hours, 24 hours, 48 hours, 72 hours, 168 hours, respectively. Image collection will use GE Infinia Hawkeye 4 SPECT / CT with high energy general purpose collimator. The imaging parameters use the original I-131 whole body scan protocol.

Expected results:Image data is further analyzed by MATLAB software to obtain iodine 131 in the body of individual organs of the biological half-life and path strength percentage. This analysis can revise the iodine -131 biokinetic model of patients with total thyroidectomy, providing more accurate calculations and subsequent studies.

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing thyroidectomy and are about to be treated with iodine 131 30mCi will be invited to join the study.

Exclusion Criteria:

* Exclusion with gastrointestinal surgery.
A Study Comparing Cardiovascular Effects of Ticagrelor and Clopidogrel in Patients With Peripheral Artery Disease

The purpose of this study is to compare the effects of ticagrelor and clopidogrel in patients with Peripheral Artery Disease.

A randomized, double-blind, parallel group, multicentre phase IIIb study to compare ticagrelor with clopidogrel treatment on the risk of cardiovascular death, myocardial infarction and ischemic stroke in patients with established Peripheral Artery Disease (EUCLID Examining Use of tiCagreLor In paD)

Eligibility Criteria:
Inclusion Criteria:

* Male and Female patients 50 years old or older Symptomatic peripheral artery disease

Exclusion Criteria:

* Patients needing dual anti-platlet drug treatment before start of study Planned revascularisation or amputation
* Patients with known bleeding disorders
* Patients with a history of intracranial bleed
* Patients considered to be at risk of bradycardic events unless already treated with a permanent pacemaker
On-Q Pump vs Epidural for Postoperative Pain Control in Children

Open abdominal and pelvic surgery or thoracotomy (open chest surgery) is frequently performed for tumor excision in children. Post-operative pain management regimens are often at the discretions of the attending surgeon and may include opiods, patient administered analgesia (PCA), epidural catheters, subcutaneous analgesia catheters or NSAIDS to control incisional pain. Currently, both epidural or subcutaneous analgesia catheters (On-Q pumps) are commonly used for children undergoing these operations, at the discretion of the surgeon. There are no studies comparing these regimens in children. The purpose of this study is to compare postoperative pain control of the two strategies.

The study design is a randomized, controlled trial to compare the effectiveness of on-q pump subcutaneous incisional analgesia to epidural analgesia for postoperative pain relief in children undergoing open abdominal, thoracic, or pelvic operations for oncologic purposes. The patient and treating team will be blinded to the pain control device. The primary outcome is additional narcotic usage for 3 post-operative days, and secondary outcomes are pain scores for 3 post-operative days, post-surgical day of ambulation, time to regular diet, infectious complications (UTI, wound infection or pneumonia), and hospital length of stay. Outcomes from both groups will be directly compared in order to determine whether one strategy provides more effective pain control with less complications than the other, or whether they are equivalent.

Eligibility Criteria:
Inclusion Criteria:

* Weight \> 5kg
* Age younger than 19 years of age
* Planned abdominal, pelvic or thoracic operation for an oncologic indication

Exclusion Criteria:

* Patients deemed inappropriate for placement of epidural by anesthesiologist
* Minimally invasive operation
* Biopsy through limited incision
* History of chronic narcotic or opioid use
* History of drug abuse
Comparison of Outreach Methods to Encourage Enrollment in Diabetes Prevention and Weight Management Programs

Individuals with prediabetes are at increased risk for developing diabetes. Higher hemoglobin A1c's (6.1-6.4%) are associated with a high risk of developing diabetes. It is known that programs such weight management classes and one-on-one counseling with registered dieticians can lead to weight loss and decrease the risk of diabetes. However, engagement of Kaiser Permanente Colorado members in these activities is low. The purpose of this study is to determine which of three outreach methods is most effective in increasing engagement in these activities.


Eligibility Criteria:
Inclusion Criteria:

* Kaiser Permanente Member
* Age 18-75
* Prediabetes
* BMI \>= 25
* A1c 6.1-6.4%
* No dietitian visit within the past 3 years

Exclusion Criteria:

- Pregnancy
ALK29-002: A Study of Baclofen Formulations in Healthy Adults

The purpose of this study is to determine the pharmacokinetics, safety, and tolerability of different baclofen formulations.


Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18 and 65 years
* Body mass index of 19 to 30 kg/m2 at screening
* If subject is female and of childbearing potential, she must agree to use an acceptable method of contraception for the duration of the study

Exclusion Criteria:

* Pregnancy and/or currently breastfeeding
* Clinical significant medical condition or observed abnormalities
* Acute gastrointestinal disorder or history of chronic gastrointestinal disease or surgery
* Participation in a clinical trial within 30 days before screening
* Known intolerance and/or hypersensitivity to baclofen or its excipients
* Use of alcohol-, caffeine-, or xanthine-containing products
* Clinically significant illness within 30 days of first study drug administration
* Dietary restrictions that conflict with required study meals
Institutional Registry of Haemorrhagic Hereditary Telangiectasia

The purpose of this study is to create an institutional and population-based registry of Haemorrhagic Hereditary Telangiectasia with a prospective survey based on epidemiological data, risk factors, diagnosis, prognosis, treatment, monitoring and survival.

This study will also describe the occurrence of Haemorrhagic Hereditary Telangiectasia in the population of HIBA in the Central Hospital, as well as the characteristics of clinical presentation and evolution.

Haemorrhagic Hereditary Telangiectasia is a uncommon autosomic hereditary disorder caracterizad for recurrent epistaxis,cutaneomucous telangiectasias and arteriovenous malformations in diferent organs; brain, lung, liver and gastrointestinal are more often afected . Afect one in 5000-8000 individual in worldwide. HHT may produce important morbidity like brain absces, stroke, hemoptisis and cronic ferropenic anemia.

Molecular mechanism of this disorder are complex and still no fully dilucidated. The genes mutated in HHT encode endothelial cell-expressed proteins that mediate signalling by the transforming growth factor (TGF)b superfamily. Endoglin (HHT type I) and ACVRL-1 (HHT type 2) mutations are responsible in more than 80% of the individuals. Mutation of SMAD 4 protein (MADH4)cause HHT in association with juvenile polyposis. HHT may associated with primary pulmonary hypertension en more rare cases.

There arent HHT register in Argentina and Latinamerican population. This registry may gader valious information in order to generate a better diagnosis and treatment of our population and others.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with HHT defined.
2. Followed in Unidad HHT of Hospital Italiano de Buenos Aires.

Exclusion Criteria:

1. Denied to participated in the registry or inform consent process.
Capecitabine in Treating Patients With Advanced, Persistent, or Recurrent Cervical Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of capecitabine in treating patients who have advanced, persistent, or recurrent cervical cancer.

OBJECTIVES:

* Determine the activity of capecitabine in patients with advanced, persistent, or recurrent squamous cell carcinoma of the cervix.
* Determine the toxicity profile of this drug in this patient population.

OUTLINE: This is a multicenter study.

Patients receive oral capecitabine twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 28-62 patients will be accrued for this study within 9-20 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed advanced, persistent, or recurrent squamous cell carcinoma of the cervix

  * Documented disease progression after local therapy and considered incurable
* At least 1 target lesion measurable in at least 1 dimension

  * At least 20 mm by conventional techniques, including palpation, plain x-ray, CT scan, or MRI OR at least 10 mm by spiral CT scan
  * Target lesion cannot be in a previously irradiated field

PATIENT CHARACTERISTICS:

Age:

* Any age

Performance status:

* GOG 0-2

Life expectancy:

* Not specified

Hematopoietic:

* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3

Hepatic:

* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* SGOT no greater than 2.5 times ULN
* Alkaline phosphatase no greater than 2.5 times ULN

Renal:

* Creatinine clearance at least 50 mL/min

Other:

* Not pregnant
* Negative pregnancy test
* Fertile patients must use effective contraception
* No active infection requiring antibiotics
* No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
* No neuropathy (sensory and motor) greater than grade I

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* At least 3 weeks since prior biologic therapy or immunotherapy for the malignant tumor
* No concurrent prophylactic filgrastim (G-CSF)

Chemotherapy:

* At least 3 weeks since prior chemotherapy for the malignant tumor and recovered
* No prior cytotoxic therapy (except when used as a radiosensitizer)
* No prior chemotherapy for other malignancy

Endocrine therapy:

* At least 1 week since prior hormonal therapy for the malignant tumor
* Concurrent hormone replacement therapy allowed

Radiotherapy:

* See Disease Characteristics
* At least 3 weeks since prior radiotherapy for the malignant tumor and recovered
* No prior radiotherapy for other malignancy

Surgery:

* Recovered from prior surgery

Other:

* At least 3 weeks since any other prior therapy for the malignant tumor
* No prior anticancer therapy that contraindicates study therapy
* No concurrent amifostine or other protective reagents