cyrilzakka/clinical-trials huggingface dataset:
Multicenter Real-World Study of Hyperthermia in Skin/Mucosal HPV Infection of Special Population

Hyperthermia refers to treating diseases with temperatures beyond normal body temperature (39-45℃), and moxibustion therapy of traditional Chinese medicine belongs to the category of hyperthermia. It has been reported at home and abroad that the local temperature of 44℃ can effectively mobilize the body's immunity and remove HPV infection lesions, such as condyloma acuminatum and verruca vulgaris. Our research group conducted randomized controlled experiments on patients with viral warts in the early clinical practice, and the cure rate of the hyperthermia group reached 45-55%, which was superior to the traditional method in the aspects of no trauma, low recurrence rate, easy to tolerate and so on. Our research group's preliminary research on hyperthermia of viral warts has been included in the British Medical Association's guidelines for viral warts therapy. The equipment our research group developed has been obtained the medical device registration certificate, and is in the process of national promotion. Hyperthermia is to mobilize systemic immunity through local warm heat, the preliminary clinical study of the research group shows that the therapeutic effect of hyperthermia is usually "all or none": "all" that is, after hyperthermia, all viral warts are removed, including non-treatment lesions;"None" means that some patients with viral warts do not respond to hyperthermia. Cellular immunity plays a very important role in the removal of warts. At present, some special clinical patients such as pregnant women, children, patients with autoimmune diseases, diabetes, immunosuppressants after organ transplantation and other patients with skin/mucosal HPV infection, their warts show more extensive proliferation or a longer and repeated course of disease, treatment resistance, etc. It has increased the difficulty of clinical treatment, and the specific mechanism is still unclear. Therefore, for these special populations, how to further enhance the therapeutic effect of hyperthermia is the top priority of current research.

In view of the above findings, this research group intends to study the efficacy and safety of hyperthermia in the treatment of viral warts in the special population (pregnant women, children, patients with autoimmune diseases, diabetes, and immunosuppressants after organ transplantation, etc.) in a multicenter real-world study of skin/mucosal HPV infection in the special population.


Eligibility Criteria:
Inclusion Criteria:

1. Pregnant women with viral warts
2. Diagnosis of AIDS with viral warts
3. Autoimmune disease patients with viral warts
4. Diabetic patients with viral warts
5. Patients with viral warts who are currently being treated with immunosuppressants
6. Children with viral warts
7. The subject or legal guardian is able to understand and sign the informed consent/consent to participate in the study

Exclusion Criteria:

1. The subject suffers from tumor or other serious disease and cannot complete this clinical study
2. Timely treatment and follow-up cannot be guaranteed due to personal or other objective reasons
Effects of Non-invasive Ventilation on Respiratory Mechanics and NRD in Patients With Stable COPD

Chronic obstructive pulmonary disease (COPD) is a chronic respiratory disease characterized by persistent respiratory symptoms and airflow limitation. Pervasive dynamic pulmonary hyperinflation (DPH) and intrinsic positive end-expiratory pressure (PEEPi) can increase inspiratory threshold load and respiratory effort, leading to abnormal changes in respiratory mechanics and neural respiratory drive (NRD). Non-invasive positive pressure ventilation (NPPV) is not only widely used in respiratory failure, but also is one of the important lung rehabilitation strategies. Several studies have reported that the use of biphasic positive airway pressure (BIPAP) mode for NPPV can improve ventilation, reduce NRD, improve NRD coupling, significantly reduce inspiratory muscle load and relieve symptoms. However, relatively few studies are reported that the NPPV is used in COPD patients without non-respiratory failure. Therefore, we suppose that for stable COPD patients without respiratory failure, early intervention with NPPV may reduce DPH, eliminate the adverse effects of PEEPi, reduce the respiratory muscle load, improve the respiratory physiological characteristics, and delay the progression of the disease. Therefore, the purpose of this study is to observe the influence of different levels of BIPAP ventilation on respiratory mechanics and NRD in patients with stable COPD, and to explore whether BiPAP ventilation can be used as a pulmonary rehabilitation method for early intervention of COPD and provide a theoretical basis for subsequent clinical trials.

The patients with COPD will be admitted in one intervention groups. Before using BiPAP ventilation, we will measure the relevant parameters of lung volume, respiratory flow, diaphragm electromyogram, neural respiratory drive mechanical and other baseline index. Then incremental pressure support will be applied to investigate the effects of different levels of BIPAP ventilation on respiratory mechanics and neural respiratory drive.

Eligibility Criteria:
Inclusion Criteria:

* Patients with pulmonary function test of forced expiratory volume at one second (FEV1)/forced vital capacity(FVC) \< 70% after inhalation of bronchial dilation agent. Patients in a clinically stable state.

Exclusion Criteria:

* Patients they had other respiratory diseases, or evidence of pneumothorax or mediastinal emphysema and pacemaker installed. Patients with acute cardiovascular event and severe cor pulmonale. Patients with poor compliance. An Other causes of diaphragmatic dysfunction.
A Registry for Participants With Cirrhosis Who Achieve a Sustained Virologic Response Following Treatment With a Sofosbuvir-Based Regimen Without Interferon for Chronic Hepatitis C Infection

The primary objective of this registry study is to assess the durability of sustained virologic response (SVR) and clinical progression or regression of liver disease including the incidence of hepatocellular carcinoma following SVR in participants with cirrhosis after treatment with a sofosbuvir-based regimen for HCV infection.


Eligibility Criteria:
Key Inclusion Criteria:

* Willing and able to provide written informed consent
* Have either previously participated in a Gilead-sponsored HCV study and received a sofosbuvir-containing regimen without interferon OR at pre-selected sites only, have received an all-oral SOF-based regimen outside a clinical study. These individuals must have documentation of the regimen, start and end of treatment dates (month and year), and of having achieved SVR12.
* Have achieved SVR either in a Gilead-sponsored study, as defined in the treatment protocol OR for individuals who enroll after receiving an all-oral SOF-based regimen outside a clinical study, SVR will be defined as HCV RNA \< lower limit of quantification (LLOQ) approximately 12 weeks following last dose of treatment.
* Have liver cirrhosis, as defined in the treatment protocol, and have not had a liver transplant after receiving a SOF-containing regimen OR individuals who enroll after receiving an all-oral SOF-based regimen outside a clinical study, will have had cirrhosis confirmed prior to initiation of HCV treatment.

Key Exclusion Criteria:

* Individuals planning to initiate a new course of HCV therapy, including approved products and any investigational agents, during the course of this Registry
* History of clinically-significant illness or any other major medical disorder that may interfere with the follow-up, assessments, or compliance with the protocol

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Effect of Soy on HDL-C Function, Central Blood Pressure, and Arterial Stiffness

The purpose of the proposed pilot study is to evaluate the effects of a soy protein isolate with naturally occurring isoflavones on the properties of HDL-C (total HDL-C, HDL particle size and HDL function), central blood pressure, and indices of arterial stiffness.

The investigators propose to conduct a randomized three-period, crossover study to evaluate the effect of soy protein supplementation on HDL function. To ensure that there are no effects of treatment order on outcome measures, subjects will be randomized to a treatment sequence. Healthy males and females (n = 20; 35 to 60 years of age) with systolic blood pressure greater than 120 mm Hg and/or diastolic blood pressure greater than 80 mm Hg will be recruited for this study. Subjects will undergo 3 treatment periods in random order. These treatment periods will include: A) 25 g/d soy protein powder; B) 50 g/d soy protein powder; C) 0 g/d protein powder (control). Each treatment will be provided for 6 weeks separated by a 2-week break between treatment periods. All subjects will be encouraged to maintain body weight and physical activity levels during the study.

Eligibility Criteria:
Inclusion Criteria:

* Male and Female
* 35-60 years old,with
* Systolic blood pressure greater than 120 mm Hg
* Diastolic blood pressure greater than 80 mm Hg
* BMI within 18-39 kg/m2 ,
* non smokers with
* no inflammatory diseases and
* not taking medication for high cholesterol, blood pressure, or glucose control

Exclusion Criteria:

* Under 35 years of age or over 60 years old
* Systolic blood pressure \<120 or Diastolic blood pressure \<80
* smoker
* inflammatory disease
* BMI outside of 18-39kg/m2 range
* taking medication
* refusal to discontinue any other supplement use
DeMONSTRATE-TB Study in Ethiopia

Ending the TB epidemic by 2035 in Ethiopia would be possible if TB notification declines by an annual factor of at least 15% from the current notification rate of 132 per 100,000 population. This requires highly effective strategies to reduce TB transmission and maximize TB prevention among populations at risk of developing TB, such as Household contacts and people living with HIV.

The investigators hypothesize that community wide administration of enhanced TPT will accelerate decline in TB incidence rates when combined with an optimized currently recommended comprehensive TB prevention and care packages described below. The investigators further hypothesize that such intervention packages will be acceptable to the community, providers and policy makers, and that they will be cost-effective.

Based on the study results, a TB elimination framework in high burden TB regions and woredas in Ethiopia will be developed, and local evidence to enhance the shift toward TB elimination will be provided as input to the appropriate allocation of resources.


Eligibility Criteria:
Inclusion Criteria:

1. Adults:

   * Greater than or equal to 18 years old
   * Provides consent
   * Living in study site area (woreda)
2. Children

   * Aged 12 to 17 years
   * Living in the study site area (woreda)
   * Assent to enrollment
   * Guardian provides consent for enrollment
3. Younger children:

   * Less than 12 years old
   * Living in the study site area (woreda)
   * Consent for enrollment provided by the guardian

Exclusion Criteria:

1. Adults:

   * Does not provide consent
   * Declines to provide contact information
   * Less than 18 years
   * Living outside of the study site area
   * Declines to allow study staff to contact them by phone and in person if they miss a study visit
2. Children

   * Does not provide assent
   * Guardian does not provide consent
   * Guardian declines to provide contact information
   * Not within 12 to 17 years
   * Living outside of the study site area
   * Guardian declines to allow study staff to contact them by phone and in person if they miss a study visit
3. Younger Children

   * Guardian does not provide consent
   * Guardian declines to provide contact information
   * Not less than 12 years
   * Living outside of the study site area
   * Guardian declines to allow study staff to contact them by phone and in person if they miss a study visit
microRNAs Tool for Stratifying Stage II Colon Cancer

The investigators discover the investigators' miRNA tool can be a useful tool to predict the patients with stage II colon who can benefit from chemotherapy.Then the investigators plan to make an observation study that may validation this tool.

This is an observation study. The investigators recruit patients who agree to use their postoperative specimen for miRNA tool examination and receive the investigators' follow up.Their receiving chemotherapy or not will decided by their doctors. The investigators just see whether the stratifying tool could predict prognosis.

Eligibility Criteria:
Inclusion Criteria:

* The informed consent has been obtained from the patient.
* With confirmed diagnosis of stage II colon cancer.
* With moderate/good ECOG health rating (PS): 0-1 score.
* The patient receive no anti-cancer treatment before primary surgery.
* The patient receive radical operation for colon cancer with negative margin.

Exclusion Criteria:

* With severe comorbidities, such as cardiovascular disease, chronic obstructive pulmonary disease, diabetes mellitus, and chronic renal dysfunction.
* With bad compliance or contraindication to enrollment.
* Pregnant woman or lactating woman.
* With contraindication to receive adjuvant chemotherapy.
The Effect of Ankle Taping and Balance Exercises on Postural Stability

Both taping and balance exercises have effects on dynamic balance, so this study compared ankle taping and balance exercise on postural stability indices in healthy women. we hypothesized that both balance exercise and taping would increase stability indices but the effects of balance exercise was more greater than taping.

The ability to control the body in the space is a complex interaction between musculoskeletal and neural systems. This set is called postural control system. Postural control involves the control of body position in space for the dual purposes of postural stability and postural orientation. Balance process is divided into four-stage by Sullivan and Markos: mobility, stability, controlled mobility, and skill. Several types of exercise have been proposed to improve proprioception. Bout and Gahery stated that balance exercises improve neuromuscular relations and reduces the proprioception errors. They believe that those who have more proprioception difficulty may benefit more from exercise therapy.Taping is another technique to enhance proprioception. Improvement in proprioception leads to better function and reduction of disability. Kinesiotaping is being used to prevent injuries and to help curing the injury. It can also improve efficiency in sport, improve lymph and venous circulation, decrease edema, stimulate the mechanoreceptors and increase awareness of subject about the ankle position, reduces the pain and improves muscle performance

Eligibility Criteria:
Inclusion Criteria:

* having no pain in ankle joint, not having sport activity in the period of this study, healthy sensory motor function in lower limb, no history of neuromuscular disease, vertigo or any uncorrected visual problems, any kind of ankle injury or lower limb surgery, taking sedative medication, cardiovascular, neurologic, and pulmonary disease, balance problems, rheumatoid disease, psychological disease, body mass index between 17 to25.

Exclusion Criteria:

* ankle pain, allergy to tape, and not completing all interventional sessions.
S-adenosylmethionine Plus Choline in Treatment of Patients With Alcoholic Liver Disease

The study will assess the effect of treatment with formulation containing S-Adenosyl methionine and choline, on patients with alcoholic liver disease.

Half of the patients included will receive named formulation once daily for 24 weeks while other half will receive placebo.

Choline and S-Adenosyl methionine are nutrients both showing hepatoprotective effects.

Choline helps liver metabolise glucose and lipids and repair cell membrane. S-Adenosyl methionine is essential for the synthesis of glutathione, a main cellular antioxidant showing its protective effect against free radicals, among others in liver tissue. Furthermore S-Adenosyl methionine is involved in regulation of hepatocyte growth, differentiation, and death. It also enables endogenous production of small amount of choline. Although human organism has capacity for production of small amount of S-Adenosyl methionine, damaged liver can not produce it or produce it insufficient amounts.

Having this in mind it can be hypothesised that administration of choline and S-Adenosyl methionine can be beneficial in patients with alcoholic liver disease.

Eligibility Criteria:
Inclusion Criteria:

* alcoholic liver disease

Exclusion Criteria:

* hepatitis B
* hepatitis C
* autoimmune hepatitis
* hemochromatosis
* Wilson's disease
* hepatocellular carcinoma
Comparison Of Efficacy Of Tazarotene 0.045% Vs Halobetasol Propionate 0.01% Lotion For Treatment of Scalp Psoriasis

Psoriasis is a serious, immune-driven illness that affects around 2% of the population and has a wide range of clinical manifestations 1-3 . Many patients have localized illness, and topical therapy can be an important part of treatment.

tazarotene is the first receptor-selective retinoid for the topical treatment of plaque psoriasis. On application, tazarotene is rapidly hydrolyzed to its main metabolite, tazarotenic acid, which binds to retinoic acid receptors (RARs) in the nucleus. Tazarotenic acid selectively binds to RARs b and g . The predominant type of RAR expressed in the human epidermis is RAR, indicating that it may be an important mediator of retinoid action in skin. .

Topical Corticosteroids is commonly used in situations of mild to moderate disease severity. However, long-term safety is still an issue, especially when utilizing stronger formulations,which come with a higher risk of local cutaneous adverse events (AEs). Telangiectasia, suppression of the hypothalamic-pituitary-adrenal (HPA) axis, and skin shrinkage are some of these negative consequences. By regulating gene transcription, tazarotene normalizes abnormal keratinocyte differentiation, reduces epidermal hyperproliferation, and decreases inflammation, the three pathogenic factors in psoriasis, thereby producing a more normal expression of skin differentiation in psoriatic lesions

Eligibility Criteria:
Inclusion Criteria:

* Patients between 30-50 years of age, either gender presenting with scalp psoriasis as per operational definition will be included in the study.

Exclusion Criteria:

* pustular psoriasis or had used phototherapy, photochemotherapy, or systemic psoriasis therapy within the last four weeks (or biologics within the last three months).
* Used topical treatment within 14 days prior to the baseline visit or who were diagnosed with skin conditions that would interfere with the interpretation of results were also excluded.

pregnant women, women attempting to become pregnant, lactation
Conservative Treatment vs. Volar Plating of Distal Radius Fractures

A prospective, randomized controlled single-center trial with 80 patients aged 50 years and above to compare the functional and radiological results of conservative treatment and volar fixed-angle plating in the management of distal radius fracture

Volar plating has became as a standard approach for treating unstable distal radius fractures. The incidence of surgically treated patients with distal radius fractures has increased many fold from the beginning of this millennium, owing mostly to increased number of volar platings. The most striking increase of plate fixations has occurred in older patient groups, especially in females. With volar fixed-angle plate, very near-anatomic, stable fixation with relatively low complication rate, can be achieved even in osteoporotic bone. There are only few randomized, prospective studies comparing results of volar plating and conservative treatment, comparing patients aged over 65 years. Quite little is known of the results comparing conservative treatment and volar plating in patients aged below 65 years.

Main goal of our study was to compare the functional and radiological results of conservative treatment and volar fixed-angle plating in the management of distal radius fracture in patients aged over 50 years an older.

Eligibility Criteria:
Inclusion Criteria:

* patients over 50 years-old
* primary dislocated distal radius fracture (AO/OTA 23 type A2-3 and C1-2)
* primary reduction of fracture is acceptable considering primary conservative treatment

Exclusion Criteria:

* bilateral and open fractures and fractures with neurovascular compromise
* other major concurrent fracture necessitating treatment of any kind
* patients under 50 years of age
* previous ipsilateral distal radius fracture
* inflammatory joint disease
* significant radiocarpal-joint degeneration
* patient's bad co-operation or major co-morbidity making an operation contraindicated
A Study of Pegylated Liposomal Doxorubicin and Cyclophosphamide in Her2-negative Stage I and II Breast Cancer Patients

Primary objective:

* To evaluate the disease-free survival (DFS) in the two randomized arms after therapy with LC vs. EC in chemo-naive Her2-patients with stage I or II breast cancer

Secondary objectives:

* To assess the overall survival (OS)
* To establish the safety profile by assessing the toxicities and tolerability
* To assess the quality of life (QoL)
* To evaluate survival correlation with biomarkers expression.


Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed invasive, but non-inflammatory, breast adenocarcinoma with stage I or II (if N0, T must be \>1cm) disease
* Her2-negative on fluorescence in situ hybridization (FISH) study
* performance status of ECOG 0, 1
* female, age between 20 and 70 years
* life expectancy of at least one year
* ability to understand and willingness to sign a written informed consent document

Exclusion Criteria:

* Her2 3+ over-expression on immunohistochemistry (IHC), or Her2 amplification on fluorescence in situ hybridization (FISH) study
* previous or current systemic malignancy with the exception of curatively treated non-melanoma skin cancer or cervical carcinoma in situ, unless there has been a disease-free interval of at least 5 years
* Patients who have received prior chemotherapy
* inadequate hematological function defined as absolute neutrophil count (ANC)less than 1,500/mm3, and platelets less than 100,000/mm3
* inadequate hepatic function defined as: serum bilirubin greater than 1.5 times the upper limit of normal range (ULN) alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2.5 times the ULN
* inadequate renal function defined as serum creatinine greater than 1.5 times the ULN
* left ventricular ejection fraction (LVEF) \< 50% confirmed by multiple-gated acquisition (MUGA) scan or echocardiogram
* concomitant illness that might be aggregated by chemotherapy or interfere study assessment. For examples, active, non- controlled infection (such as hepatitis B and hepatitis C, HIV, infectious tuberculosis) or other active, non-controlled disease such as congestive heart failure, ischemic heart disease, uncontrolled hypertension or arrhythmia, unstable diabetes mellitus, and active peptic ulcer
* patients who are presence of liver cirrhosis or are HBV/HCV carrier
* participation in another clinical trial with any investigational drug within 30 days prior to entry
* pregnant or breast feeding women
* fertile women of child-bearing potential unless using a reliable and appropriate contraceptive method throughout the treatment period and for three months following cessation of treatment