cyrilzakka/clinical-trials huggingface dataset:
Virtual Reality in Wide-Awake Hand Surgery

The vast majority of hand surgery performed at the Royal London Hospital is carried out with patients wide-awake. This is either using local or regional (brachial block) anaesthesia. A high proportion of patients find the process stressful and intimidating, which can lead to intraoperative anxiety and increased requirements for anaesthetic dosages. Most of the hand surgery lists are primarily performed by trainees under consultant supervision: conscious, aware, and anxious patients can hinder the degree of training that can take place intra-operatively. Trainees requesting for assistance can further contribute to patient anxiety levels. Virtual Reality (VR) is a relatively new technology that allows total immersion in audio-visual entertainment. Early research work has demonstrated a positive effect of VR at reducing patient anxiety and analgesia requirements during invasive procedures. The investigators hope to conduct a research study whereby adult patients undergoing wide-awake hand surgery under the care of the Department of Plastic Surgery at the Royal London Hospital are given a VR headset (the Oculus Quest 2) and headphones to wear during their operation. The investigators aim to compare their levels of perceived pain, discomfort, anxiety, relaxation and satisfaction with the intraoperative experience to patients who undergo the same operation without VR, i.e. under the conditions of standard care. The investigators will also look at the patients' additional anaesthetic requirements during the operation and physiological markers of anxiety, like heart rate and blood pressure. The operating surgeon will be given the opportunity to answer questions regarding their levels of comfort performing the operation, communicating with their assistant surgeon and calling for help if required. The investigators believe the use of VR will have a positive effect on the patient experience and will improve training opportunities for junior surgeons.


Eligibility Criteria:
Inclusion Criteria:

1. Written, informed consent provided prior to the occurrence of any study procedures;
2. Aged 18 years or above;
3. Undergoing a planned day-case operation involving the upper limb for any indication, under either local or regional anaesthesia.

Exclusion Criteria:

1. Suffer from claustrophobia, seizures or vertigo;
2. Have an active infection or open wound on the face;
3. Require droplet or airborne infection precautions;
4. Have eyesight or hearing problems that would impair the audio-visual experience of using VR (e.g. if the patient plans to wear hearing aids or eyeglasses during the operation);
5. Have a pacemaker or any other implanted medical device;
6. Are allergic to any materials on the VR headset or headphones (e.g. the VR headset facial interface foam).
A Study To Investigate The Effect Of PD-217,014 On Abdominal Pain/Discomfort In Patients With IBS.

The purpose of this study is to determine the effectiveness of PD-217,014 in the treatment of abdominal pain/discomfort associated with irritable bowel disease.


Eligibility Criteria:
Inclusion Criteria:

* Males and females having Irritable bowel syndrome as defined by the Rome II criteria.
* Patients must have had normal examination of colon anatomy within the last 5 years

Exclusion Criteria:

* Patient with an organic gastrointestinal disease.
* Patients with poor renal function.
* Patients with severe constipation.
A Study of LY3305677 in Participants With Type 2 Diabetes

The main purpose of this study is to learn more about the safety and side effects of LY3305677 when it is given as an injection just under the skin to participants with type 2 diabetes. The study will last about 20 weeks for each participant, not including screening.


Eligibility Criteria:
Inclusion Criteria:

* Have Type II diabetes
* Body mass index (BMI) of 25-40 kilograms per square meter (kg/m²), inclusive
* Have a body weight of \<150 kilograms (kg)
* Have clinical lab test results within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator; however, should have serum magnesium and potassium levels, along with lactate dehydrogenase, CK values within the normal range at screening and Day -2.

Exclusion Criteria:

* Have Type 1 diabetes or latent autoimmune diabetes in adults
* Have uncontrolled diabetes defined as an episode of ketoacidosis or hyperosmolar state requiring hospitalization for 6 months prior to screening
* Have had an episode of severe hypoglycemia, defined by the occurrence of neuroglycopenic symptoms requiring the assistance of another person for recovery, within 6 months prior to Visit 1
* Have an abnormal 12-lead electrocardiogram (ECG) at screening and/or Day -2 that, in the opinion of the investigator, increases the risks associated with participating in the study or may confound ECG data analysis
* Have poorly controlled hypertension at screening; or a change in antihypertensive medication within 30 days of screening
* Have an estimated glomerular filtration rate \<45 milliliters per minute per 1.73 meters squared of body surface area (mL/min/1.73 m²)
Can Ultrasound Detect Diabetic Peripheral Neuropathy?

The cross sectional area of posterior tibial nerve (PTN) is increased in diabetic patients with distal symmetric polyneuropathy (DSPN) as compared to diabetic patients without DSPN. This study aims to evaluate whether the cross sectional area of the Posterior Tibial Nerve (PTN) as measured by ultrasound is increased in patients with distal symmetric polyneuropathy (DSPN) as compared to diabetic patients without DSPN.

Regional anesthesia is associated with a low frequency of neurologic injury that can result in permanent deficit. It is believed that patients with neuropathies might be at higher risk of injury but detailed investigation of the diabetic patient is lacking yet anesthetic practices may be altered nevertheless. This study intends to investigate the appearance and sonographic qualities, as well as electrophysiologic measures, of the posterior tibial nerve (PTN) in diabetic patients undergoing nerve conduction studies in order to compare PTN characteristics between diabetic patients with peripheral neuropathy to those without. Ultimately, we hope that ultrasound, a commonly used non-invasive tool, will be able to assist in the identification of patients at higher risk of injury from regional anesthesia

Eligibility Criteria:
Inclusion Criteria:

* Type I diabetic patients (diagnosed more than 5 years), and type II diabetic patients scheduled for routine NCS.

Exclusion Criteria:

* Non-diabetic neuropathy caused by genetic, metabolic and inflammatory diseases as well as toxic agents and drug induced (eg. chemotherapy agents)
Efficacy and Safety of An'Ningpai Expectorant in Non-CF Bronchiectasis

The objective of this study was to assess whether the long-term use of oral An'Ningpai Enteric Soft Capsuleson (300 mg, three times daily, 12 months) might reduce the incidence of exacerbations and improve the quality of life in patients with Non-CF bronchiectasis.

Mucus hypersecretion plays an essential role in bronchiectasis. It has been deduced that reducing the production of mucus or improving the clearance of sputum in the airway is the key to break down this "vicious cycle" and enhance the therapeutic efficacy for bronchiectasis.

The investgators aimed to assess whether the long-term use of oral An'Ningpai Enteric Soft Capsules (300 mg, three times daily) might reduce the rate of exacerbations and improve the quality of life in patients with bronchiectasis.

Eligibility Criteria:
Inclusion Criteria:

1) subjects older than 18 ; 2)a diagnosis of bronchiectasis was according to the 2010 British Thoracic Society guidelines; 3) with hypersecretion ：high viscous sputum symptoms (sputum traits score 2-3 points) ;4) patients had least two exacerbations in the past year and were in a state for at least 4 weeks prior to randomization

Exclusion Criteria:

1) cystic fibrosis or other etiologies (such as immunodeficiency, allergic bronchopulmonary aspergillosis, traction bronchiectasis caused by emphysema, advanced pulmonary fibrosis, etc.); 2)primary diagnosis of COPD or asthma; 3)a history of severe cardiovascular disease; 4)comorbidity with liver disease, kidney disease, malignant tumor, gastric ulcer, or intestinal malabsorption; 5)a known allergy to Eucalyptol , Limonene and Pinene Enteric Soft Capsules; 6)pregnancy or lactation (for women);7)a history of prior macrolide use of more than 1 week; 8)and poor compliance
Hashimoto - a Surgical Disease. Total Thyroidectomy Makes Antibodies Disappear and Ameliorates Symptoms

The investigators have already proven that absolute total thyroidectomy gives elimination of anti-TPO antibodies. Our hypothesis is that this elimination also eliminates the typical Hashimoto symptoms, namely: Serious tiredness, increased need of sleep, pain in musculature and joints and dryness in eyes and mouth. The prerequisite for this effect is that the total thyroidectomy is meticulously performed. There exists no other treatment that can eliminate the antibodies. The study is randomized between operation and ordinary conservative medical treatment with thyroxine control and supplementation. The symptoms in both groups are evaluated by 5 different Quality of Life schemes, internationally approved.

The study hypothesis is that elimination of anti-TPO antibodies ameliorates the typical Hashimoto symptoms like tiredness,increased need of sleep, pain in musculature and joints and dryness in eyes and mouth. It is necessary that the total thyroidectomy is meticulously performed. We have proven the effect on the antibodies, and we have also proven that the operation procedure can be performed without more complications like recurrent nerve damage and hypocalcemia. Neutrality is secured by randomization done by a neutral institution, laryngoscopy by neutral doctors and instructions filling out the QoL-schemes performed by non-biased study nurses.

The study runs for at least 18 months with controls every 6 months. Blood samples are taken and international approved QoL-schemes are filled in. In addition to the randomised main group a side group of patients fulfilling 2 of the 3 inclusion criteria are followed in parallel in order to elucidate the spontaneous development of the disease and showing critical values of antibodies making the symptoms turn up.

Eligibility Criteria:
Inclusion Criteria:

1. Patients referred due to typical symptoms, believed to be related to Hashimoto´s disease, but not relieved by thyroxin substitution. Optimal thyroid substitution treatment is already provided.
2. Anti-TPO\>1000
3. Hypothyroidism with a need for thyroxin supplementation
4. Written informed consent by the patient - information particularly emphasising and quantifying the risk of complications (e.g. recurrent laryngeal nerve palsy). The patient should be informed by a medical endocrinologist as well as a surgeon.

Exclusion Criteria:

1. Patients \<18 years of age.
2. Pregnancy.
3. Unable to comprehend information adequately to give informed consent.
4. General anaesthesiological contraindications.
5. An unexpected finding of cancer in the surgical group is not a reason for exclusion per se, but this group should be analyzed separately. It is expected that any different loading in Quality of life would bias the medically treated group.
Effects of Indacaterol in Symptomatic COPD Patients With Low Risk of Exacerbations

This study compared the efficacy of indacaterol versus placebo in COPD patients classified as GOLD 2014 Patient Group B.

This was a 2-arm parallel group study that recruited COPD patients classified by GOLD Patient Gorup B. On successful completion of run-in period, patients were randomized in the ratio 1:1 to receive prn salbutamol plus:

1. Indacaterol 150ug or
2. Placebo for indacaterol all once daily (od) for 26 weeks. The primary objective (trough FEV1) was assessed after 12 weeks.


Eligibility Criteria:
Inclusion criteria

1. Male or female adults aged ≥40 years, who have provided their consent and signed an Informed Consent Form. Written informed consent must be obtained before any assessment is performed.
2. Patients diagnosed with COPD at 40 years of age or older.
3. Patients with smoking history of at least 10 pack years, both current and ex-smokers are eligible. (Ten pack years is defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years, etc)
4. Patients with stable COPD in Patient Group B according to GOLD 2014.

Exclusion criteria

1. Use of other investigational drugs within 5 half-lives of enrollment, or \[within 30 days /until the expected PD effect has returned to baseline\], whichever is longer.
2. History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.
3. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
4. Patients who have had 2 or more COPD exacerbations that required treatment with antibiotics, systemic steroids (oral or intravenous) or 1 or more exacerbation resulting in hospitalization in the 12 months prior to Visit 1.
5. Patients who have COPD exacerbation or infection 6 weeks prior to Visit 1.
6. Patients who develop a moderate or severe COPD exacerbation during the period between Visit 1 and Visit 2.
7. Patients with a history of asthma.
DiaBetter Together for Young Adults with Type 1 Diabetes

DiaBetter Together is a strengths-based peer support intervention delivered to young adults (age 17-25) by trained Peer Mentors (age 20-35) during the transition between pediatric and adult diabetes care. The aims of this proposed randomized controlled trial are to evaluate the impact of the intervention on glycemic control (primary), time to first adult care visit, adherence, and psychosocial outcomes (secondary) in young adults with T1D after 12 months.

DiaBetter Together is a strengths based peer support intervention delivered to young adults (age 17-25) by trained Peer Mentors (age 20-35) during the transition between pediatric and adult diabetes care. The study aims to optimize transition in T1D by leveraging and building on young adults' diabetes strengths, self-management skills, and social supports. This intervention will maximize protective processes that can facilitate optimal transition by training Peer Mentors (experienced young adults with T1D who have successfully established care in an adult setting) to provide relevant information about successful transition, teach strengths-based skills for managing transition-related challenges, share personal transition-related experiences, encourage young adults to access their social support network, and serve as a positive role model. Delivery of these strengths-based intervention components through a Peer Mentor has potential to reduce isolation, increase access to relevant information, and facilitate engagement with self-management and T1D care. This intervention is a complement to existing systems of care for young adults with T1D for 12 months as they leave the pediatric setting.

Eligibility Criteria:
Young Adult Inclusion/Exclusion Criteria

Inclusion Criteria:

* has a diagnosis of type 1 diabetes of at least 1 year
* currently receiving care at a Texas Children's Hospital Diabetes Care Center location
* is between the ages of 17-25 years at enrollment
* exhibits fluency in reading/speaking English
* their endocrine provider confirmed plans to transfer to adult provider in the next 6 months

Exclusion Criteria:

* serious medical, cognitive, or mental health comorbidity that would preclude ability to provide informed consent or participate in data collection or intervention

Peer Mentor Inclusion/Exclusion Criteria

Inclusion Criteria:

* was diagnosed with type 1 diabetes before age 18
* has a diagnosis of type 1 diabetes of at least 1 years
* is between the ages of 20-35 at enrollment
* has been previously treated in pediatric care and is currently treated in adult care
* demonstrated interest and ability to effectively deliver the peer intervention \&
* exhibits fluency in reading/speaking English

Exclusion Criteria:

* serious medical, cognitive, or mental health comorbidity that would preclude ability to fulfill role or complete questionnaires.
Collagenase Chemonucleolysis vs Percutaneous Endoscopic Lumbar Discectomy (PELD) for Lumbar Disc Herniation

Lumbar disc herniation compressed the nerve cause pain, numbness, weak legs called sciatica, which seriously decrease the quality of life and work efficiency. Both collagenase chemonucleolysis(CCNL) and percutaneous endoscopic lumbar discectomy (PELD) was effective to treat lumbar disc herniation(LDH) requires surgery. whether functional clinical outcomes of CCNL vs PELD effect on LDH was superior, and no study provided convincing evidence.

Lumbar disc herniation (LDH) is a common disease with an incidence of 1%-3%, usually manifested as low back pain radiating to the lower extremities, which seriously affects patients' quality of life. Collagen hydrolysis was effective in treating LDH, it makes the protrusion smaller or disappeared, relieving or resolving the compression of nerve root by the protrusion.Percutaneous endoscopic lumbar discectomy (PELD) is a less invasive techniques to treat LDH. However, the outcomes of collagen hydrolysis vs PELD effect was still unknown.

Eligibility Criteria:
Inclusion Criteria:

* at least six weeks of excessive radiating leg pain with no tendency for any clinical improvement despite conservative therapy
* have a nerve root compression by a lumbar disc herniation proven by magnetic resonance imaging

Exclusion Criteria:

* previous surgery at the same or adjacent disc level;
* isthmic or degenerative spondylolisthesis
* pregnancy
* severe comorbid medical or psychiatric disorder (American Society of Anesthesiologists' classification \>2);
* severe caudal or cranial sequestration of disc fragments, defined as sequestration towards more than half of the adjacent vertebra;
* contraindication for surgery
Q-tip Test and Urodynamic Study

Urethral hypermobility, which can be assessed with Q-tip test, has been considered to be partly responsible for pathogenesis of women with stress urinary incontinence (SUI). Nonetheless, Q-tip test has lost favor due to patient discomfort. Thus, the purpose of this study was to search a surrogate for assessment of urethral hypermobility by correlating the Q-tip angle and the urodynamic variables in women with SUI.

All women with SUI and underwent Q-tip testing were reviewed. Patient characteristics, degree of prolapse determined by Pelvic Organ Prolapse Quantification system, Q-tip angle, the results of urodynamic studies, the Urinary Distress Inventory (UDI-6) Questionnaire and Incontinence Impact (IIQ-7) Questionnaire were reviewed from their medical records. Spearman correlation test, and univariate and multivariate backward stepwise linear regression analysis were performed as appropriate.

Eligibility Criteria:
Inclusion Criteria:

* all women with stress urinary incontinence, who underwent both Q-tip testing and urodynamic study, and completed the Urinary Distress Inventory (UDI-6) Questionnaire and Incontinence Impact (IIQ-7) Questionnaire

Exclusion Criteria:

* women who had incomplete exam or questionnaires
Primary Paclitaxel Plus Gemcitabine in Patients With Stage II and III Breast Cancer

This is an open labeled phase II single arm trial. The patients with clinical stage II and III will undergo core-needle biopsy of breast tumor for histologic diagnosis, immunohistochemical studies for estrogen receptor (ER), progesterone receptor(PR), HER-2/neu and others. PET or ultrasound results will determine the positivity of lymph node metastasis.

Patients will be treated as follows:

PG x 4®operation®AC x 4®radiation ± tamoxifen/AI(postmenopausal)

Intravenous infusion of Paclitaxel 80 mg/m2, over 60 min, on D1 and D8 Followed by intravenous infusion of Gemcitabine 1200 mg/m2, over 30 min, on D1 and D8

The cycle repeats every 3 weeks for 4 times. Premedication includes antiemetics, dexamethasone, famotidine, pheniramine as routinely given.

After the operation, standard adjuvant chemotherapy (doxorubicin 60 mg/m2, cyclophosphamide 600 mg/m2, every 3 weeks x 4 cycles) will be given.

Eligibility Criteria:
Inclusion Criteria:

* All patients must have histologically confirmed and newly diagnosed breast cancer: node-positive stage IIA and any stage IIB, III. PET results will determine node positivity. If PET was not utilized, sonographically positive node should be confirmed cytologically by fine needle aspiration.
* No prior hormonal, chemotherapy or radiotherapy is allowed.
* No breast operation other than biopsy to make diagnosis is allowed.
* Age: 18-years and older, not pregnant pre-, and postmenopausal women with good performance status (ECOG 0-1)
* Adequate hematopoietic function: Absolute granulocyte count ³1500/mm3, platelet ³100,000/mm3, Hemoglobin ³ 10 g/mm3
* Adequate renal function: Serum creatinine £ 1.5 mg/dl
* Adequate hepatic function: total bilirubin: £ 1.5 mg/dl, AST/ALT: £ two times normal, Alkaline phosphatase: £ two times normal
* Adequate cardiac function: normal or nonspecific EKG taken within 1 mo of enrollment
* Adequate mental function to understand and sign the consent

Exclusion Criteria:

* Patients who received hormonal, chemotherapy or radiotherapy for breast cancer
* Patients who underwent surgery for breast cancer
* Patients with node-negative stage IIA breast cancer
* Patients who have history of cancer other than in situ uterine cervix cancer or nonmelanotic skin cancer
The Efficacy of Group Therapy in Ultra-Orthodox Jewish Young Men Diagnosed With Type One Diabetes

The purpose of this study is to compare the influence of an intervention program especially designed to young ultra orthodox men that were diagnosed with diabetes type one.


Eligibility Criteria:
Inclusion Criteria:

* Young Ultra-Orthodox men diagnosed with diabetes type one.

Exclusion Criteria:

* Psychiatric illness .
Study On Discopathie With Modic 1

The chronic lumbago can be associated with an active discopathie, objectified on the MRI by the presence of an inflammatory signal (Modic 1) or greasy (Modic 2) vertebral trays framing the pathological vertebral disk The treatment recommended by t consists in particular of a local infiltration of corticoids which the efficiency is variable according to the patients. The objective of this study is to estimate the efficiency of the local treatment and to highlight some of the factors associated to the advantage of the infiltration by corticoids.


Eligibility Criteria:
Inclusion Criteria:

* Patient admitted in Rhumatology service for intra-disc infiltration
* Chronic pain (\>3 monts)
* VAS \>3
* MRI stipulating MODIC 1

Exclusion Criteria:

* radiculalgy
* radicular VAS\< lumbar VAS
* pregnancy
* local infection
* corticoid allergy
* previous rachial surgery
* previous spondylodiscite
* psychiatric disorder
* MRI contraindication