cyrilzakka/clinical-trials huggingface dataset:
Effect of Cranial Stimulation and Acupuncture on Pain, Functional Capability and Cerebral Function in Osteoarthritis

The objective of this study is to evaluate the efficacy of transcranial direct current stimulation (tDCS) and electro acupuncture (EAC) compared to sham treatment in reducing pain, improving functional capacity and functioning of the neuro-immune-endocrine system in patients with chronic pain due to knee osteoarthritis.

The knee osteoarthritis has high prevalence, which tends to increase with the aging population. The limited efficacy of pharmacological interventions stimulates the search for other options, in order to increase the therapeutic success. Acupuncture is widely used for pain control in several pathologies. A modality of intramuscular stimulation to quantify the intensity of the stimulus is electro acupuncture (EAC) that the intensity of 2 Hz accelerates the release of enkephalins, endorphins and beta-endorphins. The application of electric currents to modify brain function is a very old technique. The transcranial direct current stimulation (tDCS) is based on applying transcranial direct weak current (usually above 2mA) through electrodes in a non-invasive, simple and painless. Other advantages include low cost and the possibility of a placebo reliable. The purpose of this study is to evaluate the ability to reduce pain and improve functionality in chronic pain for knee osteoarthritis with two techniques, one that promotes a bottom-up approach (EAC) and other top-down (tDCS). We will seek to analyze the efficacy of them separately and together, seeking summation of results.

Eligibility Criteria:
Inclusion Criteria:- Provision of informed consent to participate.

* Women with over 18 years old,with chronic pain because of primary osteoarthritis of the knee.
* Pain stable for at least three months. Score greater than or equal to 3 cm (0 cm = "no pain" and "worst possible pain" = 10cm) on Visual Analog Scale (VAS) for pain perception at baseline.
* No contraindications to electroacupuncture, transcranial direct current stimulation or transcranial magnetic stimulation.

Exclusion Criteria:-Clinically significant or unstable disorder, medical or psychiatric.

* Presence of neurological or rheumatic comorbidity.
* Pregnancy.
* Already having been treated with acupuncture.
* Having performed with corticosteroid infiltration in the last six weeks or are using this.
* Having performed with hyaluronic acid infiltration in the last year.
* Previous surgery on the limb to be treated or have surgical program for the next 6 months.
Safety, Tolerability And On-Body Temperature Of A Disposable Heatwrap Device For The Lower Back

The objectives of this study are to evaluate the dermal safety and on-body temperature of a disposable heatwrap product when worn while in a supine position for five consecutive days. The product will be worn on the back for approximately 8 hours per 24 hour period.

Purpose-To obtain safety , tolerability and on-body temperature of a heatwrap device for the lower back.

Eligibility Criteria:
Inclusion Criteria:

* The subject is a male or female in generally good health greater or equal to 35 years of age;
* Female subjects of child-bearing potential and those who are post-menopausal for less than 2 years must be using a medically-approved method of contraception (i.e., oral, transdermal, or implanted contraceptive hormones, cervical cap, intrauterine device, diaphragm, condom, abstinence, or surgical sterility including partner's vasectomy);
* The subject has a waist-hip circumference of between 27-47 inches inclusive.

Exclusion Criteria:

* The subject is a pregnant or lactating woman;
* The subject is diabetic;
* The subject has a history of melanoma, squamous or basal cell carcinoma in the area of application of the lower back and hip;
* The subject has any active skin disease which may contraindicate participation, including eczema, rash, broken or irritated skin, contact dermatitis and atopic dermatitis, or any skin condition that may be aggravated by heat;
* The subject has used (within the previous week) or is using any topical drug or heatwrap or electrical heat pads at the application site; or
* The subject has damaged skin in, or around the test sites which includes sunburn, uneven skin tones, tattoos, scars or other disfiguration at the application site, including an erythema grading of greater than 0 at the application site.
An Open Label Extension of a Study of Topiramate in Chronic Migraine.

The purpose of this study is to assess the long-term safety and effectiveness of topiramate for the prevention of headaches in adults with chronic migraine. Topiramate has been approved to prevent migraine headaches.

Migraine headaches can be disabling and can interfere with work and a person's quality of life. Preventing these headaches before they start is the best option. Topiramate, an anti-seizure medication, has been shown to help prevent migraine headaches from occurring. This is an open-label study that is an extension of a previous study (CAPSS-276) of Topiramate in chronic migraine. It includes patients who completed the previous study or who stopped the study early after taking study drug for at least 4 weeks of maintenance treatment due to lack of efficacy. The current study will involve a 4-week Blinded Transition Phase during which patients will be titrated up to a daily topiramate dose of 100 milligrams (or the maximum tolerated dose, whichever is less). Then there will be a 12-week Open-Label Maintenance Phase during which the topiramate dose may be adjusted according to effectiveness and tolerance, but not to exceed a daily dose of 400 milligrams. After this period, patients will be tapered off topiramate (Taper/Exit Phase). The length of the taper/exit phase may vary based on the dose the patient was taking during the open label maintenance phase. While on topiramate, patients will record daily entries in their headache records. Patients will also be asked questions to help assess their quality of life. Both patients and doctors will be asked questions at the end of the study about their impressions of change with respect to the patient's migraine headaches. Patients will also have physical and neurological examinations and laboratory tests performed during the study. The objective of this study is to evaluate the long-term safety and effectiveness of topiramate for the prevention of chronic migraine headaches. Topiramate oral tablets, 25 milligrams per tablet, will be given in the morning and evening to a dose not to exceed 400 milligrams per day or to the maximum tolerated dose, whichever is less

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of chronic migraine
* successfully finished double-blind portion of the CAPSS-276 study or discontinued the study after a minimum of 4 weeks maintenance treatment due to lack of effect of study drug
* in generally good health
* able to take medicine orally
* if female, using birth control.

Exclusion Criteria:

* Cannot have a more painful condition than the headache pain
* cannot be taking any other medications not allowed by the study protocol
* no abnormal liver tests
* not compliant with study medication during the CAPSS-276 study
* cannot be pregnant or breast-feeding.
Different Protocols in Ovarian Stimulation in Intracytoplasmic Sperm Injection Cycles

During assisted reproduction technology treatments like in vitro fertilization, some patients give a poor ovarian response to controlled ovarian hyperstimulation. The European Society of Human Reproduction and Embryology consensus defined poor response to ovarian stimulation during in vitro fertilization with Bologna criteria.

Bologna criteria: At least two of the following three features must be present:

(i) Advanced maternal age (≥40 years). (ii) Previous Poor responders (≤3 oocytes with a conventional stimulation protocol).

(iii) An abnormal ovarian reserve test Most controlled ovarian hyperstimulation regimens currently used for expected poor responders are based on using a high daily dose (300- 450 IU/day) of exogenous gonadotropins. Giving a high gonadotropin dose obviously increases the cost of in vitro fertilization, a consequence that would be acceptable if paralleled by an improvement in in vitro fertilization outcome. Unfortunately, however, the available data suggest that increasing the daily gonadotropins dose may increase the number of retrieved oocytes, but not the final success rate of in vitro fertilization.


Eligibility Criteria:
Inclusion Criteria:

* Advanced maternal age (≥40 years) .
* Previous Poor responders (≤3 oocytes with a conventional stimulation protocol).
* An abnormal ovarian reserve tests

Exclusion Criteria:

* Hyper or Normal responders patients.
* Endocrine or metabolic diseases like hyperprolactinoma, hypothyroidism,...etc
* Patients with a severe male factor abnormality. 4-Patients with systemic disease such as chronic renal disease, chronic liver disease, etc
Clinical Of Chocolate Balloon Dilatation Versus Plain Balloon Dilatation to Treat Arteriosclerosis Occlusive Disease of Lower Extremity

This is a Prospective randomized controlled study to evaluate the difference of safety，effectiveness between chocolate balloon and plain balloon dilatation in treatment of infrapopliteal artery lesions.

Prospective randomized controlled study to evaluate the difference of safety，effectiveness between chocolate balloon and plain balloon dilatation in treatment of infrapopliteal artery lesions. Patients with femoral-popliteal artery lesions in our department were randomly assigned to the chocolate balloon group and plain balloon dilatation group. Compare the ischemic improvement rate (limb salvage rate, postoperative patency rate) and the complications rate of two different treatments.

Eligibility Criteria:
Inclusion criteria： 1.all patients signed an informed consent form; 2.digital subtraction angiography (DSA) revealed femoropopliteal artery stenosis above 70% or occlusion resulting in claudication (Rutherford clinical category-Becker class II-III2-3) or critical limb ischemia (CLI) (Rutherford clinical category 4-5-Becker class IV-V) 3.with unobstructed vascular inflow; 4.with at least a vessel runoff; 5. good compliance and regular follow-up.

Exclusion criteria: 1. Acute or subacute lower limb ischemia caused by acute intraluminal thrombus within the target lesion.; 2. Severe calcified lesions （grade 4 in the PACSS scale）; 3. In-stent restenosis lesion or surgical arterial bypass grafting; 4. Severe renal insufficiency: creatinine level greater than 2.5 mg/dL; 5. Platelet count below 100,000/μL or with antiplatelet / anticoagulation contraindications; 6. Immunologic diseases or malignant diseases; 7. Ongoing active infection; 8. Decompensated congestive heart failure or acute coronary syndrome; 9. Refuse to sign the informed consent Unwillingness to comply with follow-up suggestions.
Study to Evaluate the Efficacy and Safety of M518101 in Subjects With Plaque Psoriasis

This study is to evaluate the efficacy and safety of M518101 in subjects with plaque psoriasis.


Eligibility Criteria:
Inclusion Criteria:

* Who are able and willing to give signed informed consent
* Who are male or females aged 18 years or older with plaque psoriasis confirmed by the Investigator.
* Who have up to 20% of body surface area (BSA) afflicted with plaques
* Who are neither pregnant nor breast-feeding, nor plan to become pregnant during the study.

Exclusion Criteria:

* Who have a history of allergy to vitamin D3 derivative preparations or a history of relevant drug hypersensitivity.
* Who are pregnant or lactating.
* Who have any renal or hepatic insufficiency, or clinically significant cardiac, renal or hepatic disease.
* Who are not deemed eligible as determined by medical history, physical examination or clinical laboratory safety tests.
* Who have clinically relevant history or presence of any disease or surgical history other than psoriasis which is likely to affect the conduct of the study.
* Whose serum calcium levels exceed the upper limit of reference range
* Who have used any investigational medicinal product and/or participated in any clinical study within 60 days of randomization.
* Who have been treated with systemic therapy within 30days of randomization.
* Who have treated with biologics within 5 half-lives of the biologics before the day of randomization
* Who have been treated with topical therapy within 14days before the day of randomization.
Establishment and Clinical Transformation of ADC Drug Efficacy Evaluation System for Breast Cancer Based on Molecular Imaging

The objective of the study is to construct a noninvasive approach 68Ga-TTP PET/CT to detect the TROP2 expression of tumor lesions in patients with breast tumors and evaluate the efficacy of ADC drug therapy.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-75 years old, male or female, ECOG score 0 or 1 points (see the table in Annex 2 for the score table);
2. Blood routine and liver and kidney function meet the following criteria: Blood routine: WBC ≥ 4.0×109 L or neutrophil ≥1.5×109 /L, PLT ≥ 100×109/L, Hb≥ 90 g/L; PT or APTT ≤ 1.5 ULN; Liver and kidney function: T-Bil ≤ 1.5×ULT(upper limit of normal), ALT and AST≤ 2.5 ULN or ≤ 5×ULT(subjects with liver metastasis), ALP ≤ 2.5 ULN(ALP ≤ 4.5 ULN if there is bone metastasis or liver metastasis); BUN ≤ 1.5×ULT, SCr ≤ 1.5×ULT;
3. Patients with confirmed or suspected breast cancer;
4. Expected survival ≥12 weeks;
5. Good follow-up compliance;
6. Women of childbearing age (15 to 49 years old) must undergo a pregnancy test within 7 days before the start of the test and the result is negative; Fertile men and women must consent to the use of effective contraception to ensure pregnancy during the study period and within 3 months of the examination;
7. Subject patients can fully understand and voluntarily participate in this experiment, and sign informed consent.

Exclusion Criteria:

1. Severe abnormal liver and kidney function;
2. Pregnant, pregnant and lactating women;
3. Can not lie flat for half an hour;
4. Unable to obtain informed consent;
5. Suffering from claustrophobia or other mental illness;
6. People who are known to be allergic to the investigational drug or its excipients in the investigational therapy;
7. Other conditions deemed unsuitable for participation in the trial by the investigator.
Study to Compare the Efficacy and Safety of Two CC-5013 Dose Regimens in Subjects With Metastatic Malignant Melanoma

Subjects are randomized to one of two treatment arms. All subjects are screened for eligibility within 28 days prior to randomization. The study consists of a treatment phase and a follow-up phase. Subjects will be treated in repeating 4 week cycles.


Eligibility Criteria:
* Understand and voluntarily sign an informed consent form.
* Able to adhere to the study visit schedule and other protocol requirements.
* Metastatic malignant melanoma now stage IV, relapsed or refractory to standard metastatic therapy.
* Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days of starting study drug.
* Patients with active brain disease, or newly diagnosed brain metastases, within 4 weeks prior to the start of study treatment are excluded.
Pandemic Influenza Plasmid DNA Vaccines (Needle-Free)

The trial will enroll up to 47 subjects. Qualified normal healthy volunteers will be enrolled in the study to receive the vaccine or placebo vaccine. Subjects will receive 2 vaccinations with the Biojector® 2000, and will be followed for 6 months to evaluate the safety of and the immune system's response to the vaccine. The safety and immune system's response will be studied throughout the trial.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 45 years of age
* Able to provide informed consent and be followed for 6 months

Exclusion Criteria:

* No immunomodulatory therapy within the past 6 months
* No evidence of immunodeficiency or pregnancy
* No laboratory or evidence of clinically significant medical disease
* No history of previous pDNA immunization
* No influenza immunization within the past 30 days
* No blood donations within 30 days of screening visit
* No history of bleeding disorder
* No use of aspirin and/or anticoagulants within 2 weeks of the administration of the investigational vaccines
Evaluation of Circadian Variation of EEG Using BIS Monitor in ICU Patients

The investigators propose to evaluate circadian variation of EEG using BIS (bispectral index) monitor in ICU patients in three different groups: non-sedated, only sedated and sedated and curarized. BIS monitor values as SR (suppression rate), SEF (Spectral edge frequency), bispectral index and EMG (electromyography) during 24 hours in admitted patients except acute neurological disease.


Eligibility Criteria:
Inclusion Criteria:

* Admitted in the ICU
* Over 18 years old

Exclusion Criteria:

* Acute neurological disease
A Trial to Assess the Pharmacokinetics, Safety and Tolerability of Semaglutide in Healthy Chinese Subjects

The main purpose of the trial is to assess the pharmacokinetics of semaglutide (i.e. the way the drug is distributed in the body over a period of time) following once-weekly administration of semaglutide in healthy Chinese subjects. Different dose levels (0.5 and 1.0 mg) will be investigated in this trial. Participants will be administered semaglutide or placebo once-weekly by subcutaneous injection (under the skin fold of the abdominal wall) using a pen injector with a very small, thin needle by the trial doctor at the trial site for 13 weeks. The trial consists of 23 visits in total, including visit for screening and safety tests, visit for dose administration and blood sample collection. The total time of participation will be approximately 18-22 weeks depending on participant's individual visit schedule.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female Chinese subjects
* Age between 18 to 55 years (both inclusive) at the time of signing informed consent
* Body mass index (BMI) between 20 and 24.9 kg/sqm (both inclusive)
* Body weight greater than or equal to 54.0 kg

Exclusion Criteria:

* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential not using an adequate contraceptive method throughout the trial including follow-up period. Adequate contraceptive measures are sterilisation, intrauterine device (IUD), oral contraceptives or barrier methods
* Any clinically significant disease history, in the opinion of the investigator, or systemic or organ disease including: pulmonary, gastrointestinal, hepatic, neurologic, renal, genitourinary and endocrine, dermatologic or hematologic diseases
* Use of prescription or non-prescription systemic products (including routine or non-routine vitamins or herbal products) or topical medicinal products (except paracetamol and oral contraceptives) within 3 weeks (or within 5 half-lives of the medicinal product, whichever is longest) prior to Visit 2 (randomisation)
* Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
* History of pancreatitis (acute or chronic)
* Calcitonin greater than or equal to 50 ng/L
* Blood donation, surgery or trauma with significant blood loss (400 mL) within the last 12 weeks prior to screening
Characterization of the Early Sex Hormone Milieu Post Injury and Relationship With Resuscitation Requirements and Coagulopathy

Traumatic injury is a major public health problem with an immense societal cost. Despite improvements in trauma management, patients continue to suffer significant morbidity and mortality. Evidence suggests that males and females tolerate severe injury differently with a greater protection afforded to females. Determining the mechanisms responsible for these sex-based outcome differences after injury, focusing specifically on the early sex-hormone environment post-injury, may allow those at highest risk for poor outcome to be predicted and promote interventions that can improve outcomes for all injured patients. The goal of this study is to determine if the early sex hormone environment soon after injury has effects on the intensity of the immune response, resuscitation and blood transfusion requirements, and important clinical outcomes including mortality, organ failure and infection, following significant injury.


Eligibility Criteria:
Inclusion Criteria:

Injury, ICU admission

Exclusion Criteria:

Isolated TBI, Admission beyond 6 hours
Evaluation of Three New Strategies to Fight Obesity in Families

Context: Endeavours to reduce overweight by calorie-restriction diets are often neither sufficient nor sustained. The growing obesity epidemic demands additional measures to enhance and sustain weight loss.

Objective: To evaluate three alternative weight-loss measures on top of a calorie-restriction diet.

Design, Setting, and Participants: Six-month randomized and controlled trial using a three-factorial design. The participants were 110 families with 142 obese parents and their 119 obese children.

Intervention: All families kept to a calorie-restriction diet and were assigned at random to one or more of three additional weight-loss strategies: (1) a diet on top of calorie-restriction with preference for carbohydrates having a low glycemic index (dual diet), (2) financial incentive, and (3) continuous telemetric control of weight and physical activity (telemonitoring). The design made it possible to determine the effect of each single measure: financial incentive vs. no financial incentive (54 vs.56 families), calorie-restriction vs. dual diet (53 vs. 57 fami-lies) and telemonitoring vs. no telemonitoring (19 vs. 91 families). The design also allowed an assessment of the effects of combinations of the additional measures, each adapted for possible effects of the other factors.

Main Outcome In the parents the outcome variable at 6 months was the relative weight loss. In children, be-cause of their body growth, the outcome variable was the age-adjusted BMI standard deviation score (BMI-SDS). Analysis was done by three-factorial ANOVA and by a one-factorial ANOVA with the included Dunnett test as a post-hoc comparison, to distinguish between the effects of the different combinations of the additional strategies.

Eligibility Criteria:
Inclusion Criteria:

* BMI \> 30 kg/m2

Exclusion Criteria:

* disease of kidney or liver
INSPIRE Trial for Abdominal Infections

The INSPIRE Abdominal Infection Trial is a cluster-randomized controlled trial of HCA Healthcare hospitals comparing routine empiric antibiotic stewardship practices with real-time, precision medicine computerized physician order entry (CPOE) smart prompts providing the probability that a non-critically ill adult admitted with abdominal infection is infected with a resistant pathogen.

Note: enrolled "subjects" represent 102 individual HCA Healthcare hospitals that have been randomized into 92 clusters. Hospitals were grouped into the same randomization cluster if they shared campuses or antibiotic stewardship staff.


Eligibility Criteria:
Facility Inclusion Criteria:

1. HCA Healthcare hospitals admitting adults for abdominal infection
2. Facility use of MEDITECH as their electronic health record system

Facility Exclusion Criteria:

-

Note: unit of randomization is the hospital, however the computerized physician order entry (CPOE) alert intervention will calculate risk estimates for adults age \>=18 admitted to non-intensive care unit wards and who are ordered to receive extended-spectrum antibiotics for abdominal infection.