cyrilzakka/clinical-trials huggingface dataset:
Promoting Wellbeing for Women With Depression: A Pragmatic Randomised Controlled Trial (RCT) of an Exercise Programme

The investigators want to find out if their specially designed exercise programme will be more successful at helping women with depression to feel better than a basic programme will, by measuring the effect the programme has on mood, physical health, and social wellbeing. Their specially designed exercise programme will involve physical exertion at the participants' chosen level of intensity (how hard the body has to work during exercise), and will include motivational support. By contrast, the basic exercise programme will be at an intensity recommended by national guidelines, of the type that may be prescribed by a general practitioner (GP), and will include no extra motivational support.


Eligibility Criteria:
Inclusion Criteria:

* Living with depression
* Aged 18 (age at first session of programme)
* Female
* Living in the community
* Resident within Nottinghamshire (personal address has Nottinghamshire postcode)

Exclusion Criteria:

* Women who, at the time of the study, are unable to participate on account of any injury or physical health problem that precludes their participation
* Women participating in research that may undermine the scientific basis of the study
Gua Sha for Chronic Low Back Pain in Elderly

The purpose of the study is to investigate whether Gua sha is an effective modality for relieving chronic low back pain specifically in the aged population by comparing the baseline measures of pain intensity, self-perceived disability, back range of motion, back local muscle stiffness, depression, sleeping quality, quality of life, biomarkers measurement, and analgesic intake on days 1 and 7 after a single session of Gua sha treatment. In addition, the investigators are going to compare between Gua sha and hot pack treatments for the above parameters.

Subjects will be randomized to receive firstly either one of the treatment arms, and then crossed over to receive another arm after 30 days washing out period. It is expected that Gua sha is 1) effective in reducing the intensity of chronic low back pain in the elderly; 2) effective in helping one or more outcome measures in this study and 3) more effective on relieving the low back pain than hot pack in terms of the outcome measures in this study.

Eligibility Criteria:
Inclusion Criteria:

* Age 60 or above
* Self-reported painful restriction of lumbar spine mobility for at least 3 months or self-reported low back pain on at least 5 days a week for at least 3 months
* Have pain intensity score 40 or above on a 100mm Visual Analog Scale (VAS) at baseline

Exclusion Criteria:

* Prior history of radiculopathy or spinal stenosis or spinal fusion or failed surgery syndrome
* Having radiating pain below the knee
* Received the following surgery at the region of treatment in the past 12 months laminectomy, laminotomy or discectomy
* Serious illness (e.g. malignancy)
* Having wounds or skin lesions at the region of treatment
* Having blood pressure at140/90 mmHg or above at baseline
* Having Body Mass Index (BMI) at 18.5 or lower at baseline (as calculated by the weight in kilograms divided by the square of the height in metres (kg/m2)
* Having active psychiatric disorders, significant mood disorder or dementia
Trismus Trial of Therabite vs Wooden Spatula in Head and Neck Cancer Patients

The trial will compare exercises using Therabite® versus wooden spatulas to prevent or relieve trismus in patients with stage 3 and 4 oral/oropharyngeal cancer.

Trismus is defined as a tightening of jaw opening. The negative impact of Trismus on the quality of life of head and neck cancer patients is well established. It affects eating, drinking, speaking and social function and is often as debilitating as any disfigurement resulting from treatment.

The use of jaw exercises using a Therabite appliance following treatment has been shown to reduce the level of Trismus in small studies. Many UK centres, however, use stacked wooden spatulas inserted between the incisors as a means of passive exercise. There is anecdotal evidence that suggests the use of exercises prior to treatment may help reduce the severity of the Trismus experienced by the patient.

This study will enrol 112 head and neck cancer patients allocated by chance to use either the Therabite or wooden spatula and patients will be asked to perform mouth exercises on a daily basis for 6 months.

There is a need to evaluate both the clinical effectiveness and cost-effectiveness of Therabite as opposed to wooden spatulas to determine whether they should be adopted as standard care in head and neck cancer patients.

In this pilot trial, the investigators will measure benefits of Therabite to patients, as compared to usual care with wooden spatulas. Mouth opening will be the key outcome for the study.

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed, written informed consent
* Aged 18 years and older
* Able to read and write English sufficiently to be able to complete questionnaires
* Stage 3/4 oral and oropharyngeal cancer patients undergoing:

Primary chemoradiotherapy or Surgical free flap plus post operative radiotherapy or post operative chemoradiotherapy

* All patients will receive 60-70 Gy in 30-35 fractions over 6 to 7 weeks to the region of the pterygoid muscles.
* All patients will have at least some trismus as indicated by subjective tightening in the jaw.

Exclusion Criteria:

* \<12mm mouth opening (cannot use Therabite)
* Anatomically unable to use Therabite for example patients who may only be partially dentate and to use the Therabite would place extreme stress on the existing teeth
* Cognitive impairment as judged by the clinicians
* International patients treated who will not have routine UK follow up.
* Previous surgery or RT to the head and neck prior to this diagnosis
* Any patient who has no subjective tightening of the jaw.
Persistence of Biological Treatment and Inhibitors of Jak Kinases in Patients With Rheumatoid Arthritis.

One-center observational study aimed at determining the survival of patients with rheumatoid arthritis treated with targeted synthetic disease-modifying drugs (FAMEsd) and biologic disease-modifying drugs (FAMEb).

These patients will be administered a series of medications and a follow-up will be carried out to analyze their evolution.

One-center observational study aimed at determining the survival of patients with rheumatoid arthritis treated with targeted synthetic disease-modifying drugs (FAMEsd) and biologic disease-modifying drugs (FAMEb).

The drugs to be administered to patients are:

* JAK-type kinase inhibitors.
* Monoclonal antibodies against TNF.
* Soluble receptor against TNF.
* Biosimilar FAMEb.
* Rituximab.
* Abatacept.
* Drugs that block IL6.

A follow-up will be carried out at 12, 24, 48, 60, 72 and 84 months from the start of treatment, to analyze how the patient's health improves.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥18 years.
* With a diagnosis of Adult Rheumatoid Arthritis according to the 2010 ACR / EULAR criteria.
* Who have received at least one of the doses of the study drugs.
* In follow-up in the consultations of the UGC of Rheumatology of the HUVM.
* With at least two complete evaluations (baseline and final) of clinical variables.

Exclusion Criteria:

* Patients where the medical records lack sufficient baseline and final variables to perform the analysis.
* Patients in whom more than 50% of the variables to be collected are missing in the data collection.
A Multifactorial Exercise Program to Reduce Falls in People With Parkinson Disease

The primary objective of this study is to investigate the effects of a theoretically driven, highly challenging exercise program (balance and strengthening exercises) in reducing fall rate, improving balance and reducing fear of falling in persons with Parkinson's disease.

In this pilot, randomized, cross-over study, 32 participants with Parkinson disease will be randomly assigned to either an early start (immediately following enrollment) or late start (3 months after enrollment) multifactorial exercise program which will meet 2 times per week for 1.5 hours over 3 months. The exercise program will consist of balance and strengthening exercises which will be individualized depending on the ability of each participant. Fall rate, balance, walking ability, fear of falling, mood, anxiety, and quality of life will be measured prior to the start, at 3 months and 6 months after enrollment. Subjects will be enrolled for 6-7 months.


Eligibility Criteria:
Inclusion Criteria:

* have a diagnosis of idiopathic Parkinson's disease (using UK Brain Bank Criteria)
* have a Hoehn \& Yahr stage of 2-4 during the "ON" state
* Mini mental status score \> 26
* be 40 years of age or older, so as to represent the typical age range of PD
* be on a stable dose of Parkinson's medications for at least 2 weeks prior to study onset and during the 3 month study period.
* have experienced at least one fall in the past 3 months and greater or equal to 2 falls in the past one-year (A fall was defined as an unexpected event where the person inadvertently came to rest on the ground or other lower level not due to a major intrinsic or extrinsic event)
* able to walk without physical assistance or an assistive device for at least 5 continuous minutes
* able to understand, communicate with and be understood by recruitment personnel
* able to attend the exercise program twice per week at Sargent College
* be interested in participating and provide informed consent

Exclusion Criteria:

* have a diagnosis of atypical Parkinsonism
* have a Hoehn \& Yahr stage of 1 or 5
* have had previous surgical management of PD (i.e., deep brain stimulation surgery; pallidotomy)
* serious co-morbidities that may interfere with ability to participate in an exercise program (i.e., musculoskeletal, cardiovascular, and neurological (other than Parkinson's))
* be pregnant
Study Assessing Effects of JZP-110 on Driving Performance in the Treatment of Excessive Sleepiness in Narcolepsy

This trial is a randomized, double-blind, placebo-controlled, crossover study to evaluate the effect of JZP-110 on driving performance in subjects with excessive sleepiness due to narcolepsy.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female, age 21 to 65 years inclusive
2. Diagnosis of narcolepsy per International Classification of Sleep Disorders (ICSD-3) or Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5)
3. BMI 18 to \<40 kg/m2
4. Willing and able to provide written informed consent

Exclusion Criteria:

1. Female subjects who are pregnant, nursing, or lactating
2. Moderate or severe sleep apnea
3. Any other clinically relevant medical, behavioral, or psychiatric disorder other than narcolepsy that is associated with excessive sleepiness
4. History or presence of bipolar disorder, bipolar related disorders, schizophrenia, schizophrenia spectrum disorders, or other psychotic disorders according to DSM-5 criteria
5. History or presence of any unstable medical condition, behavioral or psychiatric disorder (including active suicidal ideation), or surgical history that could affect the safety of the subject or interfere with study efficacy and/or safety assessments per the judgment of the investigator
6. History of bariatric surgery within the past year or a history of any gastric bypass procedure
7. Presence or history of significant cardiovascular disease
8. Unable to washout or refrain from taking any over-the-counter (OTC) or prescription medications that could affect sleep-wake function
Study to Assess the Effects and Safety of ZGN-1061 in Overweight and Obese Participants With Type 2 Diabetes

The purpose of this study is to evaluate the efficacy and safety of the study drug ZGN-1061 in participants with type 2 diabetes.

Participants will be enrolled in 1 of 2 groups. Approximately 120 participants will receive 0.05, 0.3, or 0.9 mg of ZGN-1061 or placebo (Group 1). An additional 40 participants will receive 0.9 or 1.8 mg of ZGN-1061 or placebo (Group 2).

Eligibility Criteria:
Inclusion Criteria:

Subjects must meet the following criteria to participate in this study:

* Be between the ages of 18 and 70 years, inclusive.
* Overweight or obese with a body mass index of at least 27 kg/m².
* Have type 2 diabetes with HbA1c between 7% and 11%.
* For subjects taking approved antidiabetes medications, the doses must be stable as determined by the study doctor.
* For subjects who have had weight-loss surgery (example: gastric banding), the procedure must have occurred at least 1 year ago, and be verified with documentation or by a health professional associated with the surgery.

Exclusion Criteria:

Subjects cannot participate in this research study if they meet any of the following:

* Have taken another study drug or study device within the past 6 months.
* Are taking certain prescribed medications including narcotics or opiates.
* Consistent recent use of insulin.
* Have had recent major surgery or prolonged bed rest, or planning or likely to undergo any surgery during the research study.
* Have a history of bleeding disorders or risk factors for excessive blood clotting.
* Have difficulty giving blood.
* Have a history of drug and/or alcohol abuse.
Drug Interaction Study With Atazanavir Administered With and Without Ritonavir and a Cytochrome P450 Substrate Rosiglitazone

The purpose of this clinical research study is to assess the effect of Atazanavir 400 mg QD and Atazanavir/Ritonavir 300/100 mg QD at steady state on the single dose pharmacokinetics of RGZ in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female subjects between the ages 18 to 50 years old with a BMI 18 to 32 kg/m2
Pyrotinib Combined With Trastuzumab for Maintenance Therapy After First-line TH (P) Therapy for HER2+ABC

A single-arm, multicenter, real-world observational study of pyrotinib combined with trastuzumab for maintenance therapy after first-line TH (P) therapy for HER2+ABC

In this study, after at least 4 cycles of taxoid chemotherapy combined with trastuzumab ± pertuzumab, the evaluation result reached SD, CR or PR, and capecitabine combined with pyrotinib + trastuzumab was given successively in the later period (capecitabine was used for 4-6 cycles; Single-arm, multicenter, real-world observational studies using endocrine therapy + pyrrotinib + trastuzumab in patients with HR+, and maintenance therapy after first-line TH (P) therapy for CNS events (if non-CNS recurrent, progressive events occur and the investigator decides to change the follow-up regimen). To evaluate the effect of pyrrotinib combined with trastuzumab in maintaining treatment phase delay/reduction of brain metastases after first-line TH (P) therapy for advanced breast cancer with HER-2 positivity, the incidence of first progression of brain metastases was used as the primary endpoint.

Eligibility Criteria:
Inclusion Criteria:

1. Age: 18-70 years old, female;
2. Pathological examination confirmed HER-2 positive invasive breast cancer; Her2-positive is defined as \>10% of tumor cells with an immunohistochemical (IHC) score of 3+ or in situ hybridization (ISH) results as HER2 gene amplification. A positive HER2 should be confirmed by the pathology department of the participating center of this study.) Imaging examination confirmed recurrent/metastatic breast cancer;
3. Patients with recurrence or metastasis more than 1 year after trastuzumab treatment, or newly diagnosed stage IV breast cancer;
4. ECOG score is 0-1;
5. Expected survival ≥6 months;
6. Normal function of major organs;
7. 1) Blood routine • ANC≥1.5×109/L; • PLT≥90×109/L; • Hb≥90 g/L; 2) Blood biochemistry • TBIL≤1.5×ULN; • ALT and AST≤2 x ULN; For patients with liver metastases, ALT and AST≤5× ULN; • BUN and Cr ≤ 1.5×ULN and creatinine removal rate ≥ 50 mL/min; 3) Heart color ultrasound • LVEF≥50%;
8. The researcher believes that the subject is likely to benefit;
9. Voluntarily participate in the study and sign the informed consent

Exclusion Criteria:

1. Head MRI or head CT confirms the presence of brain metastases;
2. Have multiple factors affecting oral medication (history of gastrointestinal surgery, inability to swallow, chronic diarrhea, intestinal obstruction);
3. Study patients allergic to drugs and excipients;
4. Suffering from mental illness or psychotropic substance abuse, unable to cooperate;
5. Pregnant or lactating women;
6. Participated in clinical trials within 4 weeks;
7. Participants considered unsuitable for inclusion by the researchers.
Rheohemapheresis and Lutein Supplementation in the Non-Exsudative Form of Age-Related Macular Degeneration

Age-related macular degeneration is one of the major causes of blindness in the western world. There is an exsudative and a non-exsudative form of age-related macular degeneration.Most studies concentrate on the exsudative form. In the non-exsudative form the policy is generally watch and see, but patients are at risk to develop an exsudative form. So far, the only accepted therapy to reach stable disease in the non-exsudative form is high-dose supplementation of antioxidants. Another approach to improve visual acuity in patients with non-exsudative form of macular degeneration is rheohemapheresis treatment, an extracorporeal therapy where plasma is separated from blood cells. By the use of a hollow fiber filter plasma is depleted of high molecular weight proteins and reinfused. Others report describe the supplementation of lutein (a vitamin A derivative) as possible treatment option. However, none of the studies have yet examined a combination of rheohemapheresis and lutein supplementation.

Rheohemapheresis will be performed in 5 cycles. One cycle consists of 2 rheohemapheresis treatments on day 1 and day 4. A cycle lasts for 4 weeks and will be repeated every fourth week. During each treatment \> 75% to 100% of patients total plasma volume has to be filtered.General medical reviews, ETDRS and Radner visual acuity assessment, ophthalmologic examinations, ocular imaging with OCT 3, autofluorescein imaging and infrared imaging, multifocal ERG, ocular echography, and blood examinations will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Study eye with non-exsudative AMD AREDS II - III

  * with \> 10 large soft, and / or confluent drusen within 3000 nm of the foveal centre
  * and a best corrected visual acuity of 0.06 - 1.0 using ETDRS charts (letter score of 3 to 50 letters)
  * with / without geographic atrophy less than 3 disc diameters within 3000 nm of the foveal centre ´. with / without serous pigment epithelial detachment without clearly identifiable neovascularisation
* Patients must have elevated baseline concentrations of at least one of the rheologic parameters (serum cholesterol level \> 200 mg/dL, fibrinogen level \> 390 mg/dL, or plasmaviscosity \> 1.6 mPa\*s)
* Men or women aged between 50 - 99 years.

Exclusion Criteria:

* Study eye with exsudative AMD
* Study eye with concomitant retinal or choroidal disorder other than AMD
* Study eye with significant central lens opacities and / or conditions that limit the view of the fundus
* poor general condition
* hematocrit \< 30%
* coagulation disorders (incl. marcoumar therapy)
* significant cardiac problems ( \> NYHA II)
* history (\< 12 months) of cardiac infarction
* uncontrolled arterial hypertension
* recent history (\< 3 months) of cerebral vascular infarction
* cerebrovascular disease IV
* uncontrolled diabetes
* insufficient antecubital venous access
* lutein supplementation within the last 3 months
* weight \< 45 kg
* hemato-oncological disorder
* Patients who are unwilling to adhere to visit examination schedules
A Registry Study on Reduning（a Chinese Medicine Injection）Used in Hospitals in China

This study was advocated by Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences in January 2013.

The purpose of this study is to make a event monitoring to see whether Reduning injection is safe and the characteristic and mechanism of anaphylactic reaction used Reduning injection in hospitals in China.

It is very common that Chinese Medicine Injection used in hospitals in mainland China. However safety problems rose in recent years. There could be many uncertain factors influence Chinese Medicine Injection in clinical practice.

In order to ensure the safety of public drug use and lower drug-induced risks, a registry study for Reduning injection safety surveillance with 3000 patients will be conducted from Jan.2013 to Mar.2013.At the same time,Patients who have anaphylactic reaction are selected as the allergic group and not have anaphylactic reaction are selected as the control group.The proportion of allergic group and control group is 1:4.All the patients who are selected should draw blood.

Eligibility criteria Patients who will use Reduning injection in selected hospitals.

Eligibility Criteria:
Inclusion Criteria:

* Patients using Reduning injection from January to March 2013

Exclusion Criteria:

-
Efficacy of Intravenous Ibuprofen and Paracetamol on Postoperative Pain and Morphine Consumption in Lumbar Disc Surgery

Primary aim of this prospective, randomized, double-blind, placebo-controlled clinical trial is to compare the analgesic effects of IV ibuprofen and paracetamol on postoperative pain, and secondary aim is the effects on morphine consumption and side effects of morphine in patients who underwent lumbar disc surgery with a single level laminectomy or discectomy.

All surgical procedures are associated with acute pain and inflammation, with varying degrees of severity for patients, causing significant stress and discomfort. Effective postoperative pain management in lumbar disc surgery may reduce complications and improve postoperative care. For postoperative pain, multimodal analgesic techniques are used to provide synergistic effects through different nociceptive mechanisms.

Various analgesics are used for pain. Opioids, commonly used for postoperative pain, are the most popular drug group. Side effects such as sedation, respiratory depression, nausea-vomiting, pruritus and urinary retention that develop secondary to opioids may also be reduced by the combination of supplemental analgesics.

Adjuvant agents, including nonsteroidal anti-inflammatory drugs (NSAID), may be used in combination with opioids. These drugs not only reduce pain but also control the underlying inflammatory process. In addition, combining NSAIDs and opioids can help to reduce the side effects by minimizing administration of total opioid consumption.

Intravenous (IV) ibuprofen is the first and only IV NSAID approved in the United States for both pain and fever control in adults. It has been reported in multicenter studies that IV ibuprofen is safe and effective in postoperative pain management for abdominal hysterectomy and orthopedic surgeries.

IV paracetamol is an analgesic and antipyretic agent used as a first step drug for pain and fever control in adults and children. It has been clearly shown that IV paracetamol, with analgesic efficacy and good safety profile, reduces analgesic requirements for pain management. It provides better analgesic efficacy and reduces opioid consumption when used in combination with opioids.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists scores 1-3
* 18-85 years

Exclusion Criteria:

* American Society of Anesthesiologists scores IV,
* Under the age of 18,
* Over the age of 85,
* Peptic ulcer disease,
* Hepatic and renal dysfunction,
* Severe cardiovascular and pulmonary disease,
* Allergic history to propofol, fentanyl, rocuronium, paracetamol, ibuprofen and morphine,
* Emergency surgery,
* Refused informed consent form