cyrilzakka/clinical-trials huggingface dataset:
Study of Vitamin D and Effect on Heart Disease and Insulin Resistance

The purpose of this study is to evaluate how Vitamin D affects endothelial function, inflammation, lipids, insulin resistance, vitamin D levels, and parathyroid hormone (PTH).

Randomized placebo controlled trial of vitamin D supplementation in HIV infected subjects with vitamin D deficiency

Eligibility Criteria:
Inclusion Criteria:

* HIV infected
* HIV-RNA \< 400 copies/ml at study entry and for 12 wks. prior
* 25-hydroxyvitamin D level \<20
* On a stable anti-retroviral (ARV) regimen for at least 12 weeks prior to study entry

Exclusion Criteria:

* Pregnancy or Breast Feeding
* Diabetes
* Creatinine Clearance \<50
* Any active infectious or inflammatory condition
* aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>2.5 within 6 months prior to study entry
Hypoxia-guided Radiotherapy With Cisplatin-etoposide in Stage I-III : Small Cell Lung Cancer(SCLC)

Since radiation dose escalation to a large volume of tumour inevitably will induce higher toxicity than is currently the case, efforts must be made to limit the volume of tissue irradiated. Moreover, the irradiation of larger tumour volumes leads to a lower achievable tumour dose when keeping the normal tissue doses constant. Central is thus the question whether it would be possible to limit the volume of tumour to be boosted by selectively escalating the radiation dose to specific disease sites which are theoretically more prone to relapse.

Hypoxic imaging with PET scans seems attractive for this purpose as hypoxia is associated with resistance for radiotherapy and approximately 70 % of SCLC are severely hypoxic at diagnosis\[2\].

We hypothesize that it might be possible to use a selective boost in these patients to tumor areas which are still hypoxic at the end of the standard chemo-radiotherapy to a dose of 45 Gy in 30 fractions in 3 weeks.

This way all SCLC (small cell lung cancer) patients can receive a safe, but higher dose of radiotherapy to the whole tumor volume, while the most resistant areas receive the highest possible dose.

This is a hypothesis generating trial designed to deliver at least the current standard treatment to malignant tissue while defining patient selection criteria for future study.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed stage I-III small cell lung cancer. WHO performance status 0-2
* Absolute neutrophil count at least 1800/µl and platelets at least 100000/µl and hemoglobin at least 6.2 mmol/l.
* Adequate renal function: calculated creatinine clearance at least 40 ml/min
* Adequate hepatic function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for the institution; ALT, AST, and alkaline phosphatase ≤ 2.5 x ULN for the institution (in case of liver metastases ≤ 5 x ULN for the institution)
* No previous platinum chemotherapy or topo-isomerase-inhibitors for SCLC.
* Lung function: FEV1 at least 30 % and DLCO at least 30 % of the age predicted value
* No history of prior chest radiotherapy
* Life expectancy more than 6 months
* Willing and able to comply with the study prescriptions
* 18 years or older
* Not pregnant or breast feeding and willing to take adequate contraceptive measures during the study
* Ability to give and having given written informed consent before patient registration
* No mixed pathology, e.g. non-small cell plus small cell cancer
* No recent (\< 3 months) severe cardiac disease (NYHA class \>1) (congestive heart failure, infarction)
* No uncontrolled infectious disease
* No other active malignancy
* No major surgery (excluding diagnostic procedures like e.g. mediastinoscopy) in previous 4 weeks
* No treatment with investigational drugs in 4 weeks prior to or during this study

Exclusion Criteria:

* The opposite of the above
Comparison of Delta Pulse Pressure and Delta Down Before and After Sternotomy

Delta Pulse Pressure and Delta Down have been validated in surgery upon closed chest. This study aim to evaluate the influence of sternotomy on the value of Delta Pulse Pressure and Delta Down.


Eligibility Criteria:
Inclusion Criteria:

* All patients scheduled for open chest surgery.

Exclusion Criteria:

* Age \< 18 years
* Patients with arrhythmia
Integrating Sex and Gender Into CPD for Depression/Diabetes

People with type 2 diabetes are twice as likely to experience depression as nondiabetic individuals, and depression in turn increases the risk of diabetes. Clinical care for patients for either condition usually fails to consider the impact of sex and gender on tests, diagnosis and treatment, and evidence on these impacts is limited. The investigators aim to assess the impact of a continuing professional education activity (CPD) on diabetes and depression that includes considerations of sex and gender on the clinical behaviours of French-speaking healthcare professionals in Canada.

In a non-randomised controlled trial, the investigators are assessing the impacts of two CPD activities on depression and diabetes, one that includes considerations of sex and gender, and an identical one that omits sex and gender considerations, on French-speaking healthcare professionals' self-reported clinical behaviors regarding sex and gender considerations post-intervention and at 3 months. Data collection will occur in three distinct locations in Canada. Project development, data collection and analysis and dissemination of results will all integrate considerations of sex and gender. The process of creating a CPD activity that integrates considerations of sex and gender could be scaled up to other CPD activities in other clinical subjects and in other minority languages.


Eligibility Criteria:
Inclusion Criteria:

* French-speaking health professionals (in practice and in training).
Stabilometric and Baropodometric Evaluation After Osteopathic Scaphoid Tug Manipulation

This is a clinical, longitudinal, prospective and randomised study in which the subject will be assessed by stabilometric and baropodometric techniques on two occasions (before being subjected to the scaphoid tug manipulation for the experimental group or placebo technique in the case of the control group).


Eligibility Criteria:
Inclusion Criteria:

* Subjects with right scaphoid external rotation dysfunction

Exclusion Criteria:

* Suffering from disorders that alter balance (tension headaches, vertigo, migraines...).
* Deformities, orthopaedic injuries or sequelae in the limbs or spine that may alter postural statics (valgus-varus, lower limb operations, lower limb dysmetries, scoliosis, etc.).
* Pathologies or sequelae related to the postural sensors or disorders in the same:

  * Uncorrected visual defects.
  * Vestibular disorders.
  * Uncorrected stomatological disorders.
  * Sensory alterations in the foot sensor (Hypoaesthesia, Morton's neuroma, tarsal canal syndrome, etc.).
  * Cutaneous alterations that influence the foot pick-up (papillomas, plantar warts, ingrown toenails, etc.).
  * Ingestion of medication that alters the perception of stability.
* Having any contraindication to the scaphoid tug technique.
* Having carried out intense physical activity immediately prior to the study.
* Having received osteopathic treatment in the last month.
A Study to Assess the Efficacy and Safety of Paricalcitol in the Treatment of Chronic Kidney Disease With Secondary Hyperparathyroidism

The study is being conducted to evaluate the efficacy, and safety of Paricalcitol for secondary hyperparathyroidism with stage 3 and stage 4 chronic kidney disease in adults.


Eligibility Criteria:
Inclusion Criteria:

1. Under care of physician at least 2 months for CKD
2. Not on active Vitamin D and Calcimimetic therapy for at least 4 weeks prior
3. If taking phosphate binders, on a stable regimen at least 4 weeks prior
4. For entry into Pretreatment Phase:

   iPTH at least 120 pg/mL GFR of 15-60 mL/min and no dialysis expected for at least 6 months
5. For entry into Treatment Phase:

Average of 2 consecutive iPTH values of at least 150 pg/mL, taken at least 1 day apart (all values not less than 120 pg/mL) 2 consecutive corrected serum calcium levels between 8.0-10.0 mg/dL 2 consecutive serum phosphorus levels of not more than 5.2 mg/mL

Exclusion Criteria:

1. Subjects who had Primary hyperparathyroidism;
2. Subjects with a history of acute renal failure;
3. Subjects with chronic gastrointestinal disease or severe liver disease with clinical symptoms;
4. Subjects with a history of unstable angina, grade III or IV congestive heart failure, and/or clinically meaningful arrhythmia;
5. Subjects with serum albumin \< 30g/L, serum hemaoglobin \< 85g/L, or serum transaminase higher than 2.5 times the upper limit of nomal;
6. Subjects with a history of malignancy;
7. Subjects who plan to undergo surgery during the study period;
8. Subjects with a history active granulomatous diseases;
9. Subject with a history of alcohol abuse and drug abuse;
10. Human immunodeficiency virus antibody (HIV-Ab), hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab) or Treponema pallidum antibody (TP-Ab) are positive;
11. Subjects who are allergic to the test drug and its ingredients or excipients;
12. Subjects who combined with systemic or systemic diseases that are not suitable for clinical trials;
13. Subjects who have participated in clinical trials of other drugs or devices;
Gastrointestinal Surgery Study Group 2001

Gastric cancer is one of the most common malignace worldwide, which caused a dramatically death rate, especially in east Asian, such as Japan , South Korea and China. Although the treatment of gastric cancer has a large improvement, such as radiotherapy, chemotherapy and immunotherapy, surgery is yet the mainstream method for the curable malignace without distant metastasis. As the innovation of treatment in gastric caner, laprascopic has gain its popularity owing to its equivalent oncologic outcomes, earlier oral feeding, shorten postopertative of hospital length,compared with open surgery. Depite it has several advantages, the defect of laparascopic surgery is still obvious, such as 2D surgical field, lack of inverse haptic feedback, Inflexible equipment.

D2 Lymph node dissection associated with laparascopic gastronomy is still regard as standard surgical procedure for the gastric cancer patient whose tumor stage was evaluated in advance stage. As we known that the distribution of lymph nod is accompanied with blood vessels, even for well-trained surgeon, the procedure lymph node dissection is a challenging and tough work. Computed Tomography Angiography(3D-CTA), as a emerging technology, is gradually receive the surgeon's attention for its remedy characteristic to the defect of laparascopic surgery, which can visually display the distribution and type of perigastric artery, resulting in decresing the difficulty and risk of surgery.

The aim of the study is to investigate the clinincal outcomes for the patient with BMI ≥25 kg/㎡who underwent laparascopic or robotic gastronomy using CTA to evaluate the type of perigastric artery.


Eligibility Criteria:
Inclusion Criteria:

1. Pathological diagnosis of gastric adenocarcinoma by gastroscopy
2. Age 18\~75 years old
3. BMI≥25.0kg/m2
4. Preoperative imaging staging is T1\~T4a, N0\~3, M0
5. The surgical approach is laparoscopic surgery and robotic surgery

Exclusion Criteria:

1. Patients whose tumors stage are found to be T4b or M1 during the operation, tumors are unresectable and accompanied with malignant tumors in other parts;
2. suffering from other malignant tumors, tumors of low malignant potential (giant cell tumor of bone, pseudomyxadenoma of appendix, invasive fibroma) in the past;
3. Patients who have serious other system diseases and cannot tolerate surgery;
4. Patients with non-adenocarcinoma type malignant tumors in pathology after surgery;
5. Patients with residual gastric cancer;
6. Those who are allergic to iodine contrast agents;
7. Those who have received neoadjuvant therapy before surgery;
8. Pregnant patients;
9. Patients who are participating in other clinical studies trial.
Study to Evaluate the Safety and Immunogenicity of Nimenrix (Registered) in Healthy Infants, Given at 3 and 12 Months of Age

This study will evaluate the safety and immunogenicity of a single dose of Nimenrix in infants at 3 months of age, followed by a second dose at 12 months of age. Current posology allows for 2 doses of Nimenrix before 6 months of age, where the first dose is administered from 6 weeks onwards with a second dose at least 2 months later, with a booster at 12 months; and in infants from 6 months of age, a single dose at 6 months, with a booster dose at 12 months. This study will provide valuable immunogenicity and safety data for a single dose in healthy infants \<6 months of age, followed by the booster at 12 months


Eligibility Criteria:
Inclusion Criteria:

* Male or female infants born at \>36 weeks of gestation and who are 3 months of age (≥76 to ≤104 days) at the time of consent (the day of birth is considered day of life 1).
* Participants whose parent(s)/legal guardian(s) is willing and able to comply with scheduled visits, treatment plan, and other study procedures.
* Healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.
* Participants who are available for the duration of the study and whose parent(s)/legal guardian(s) can be contacted by telephone during study participation.
* Participants whose parent(s)/legal guardian(s) is capable of giving signed informed consent.

Exclusion Criteria:

* Previous anaphylactic reaction to any vaccine or vaccine-related component.
* Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
* History of microbiologically proven disease caused by N meningitidis or Neisseria gonorrhoeae.
* Significant neurological disorder or history of seizure (including simple febrile seizure).
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
* Family history of congenital or hereditary immunodeficiency.
* Other medical or psychiatric condition, including recent or active suicidal ideation/behavior, or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
* Major known congenital malformation or serious chronic disorder.
* Previous vaccination with any meningococcal vaccine containing groups A, C, W, or Y.
An Efficacy and Safety Study of Elagolix (NBI-56418) in Women With Endometriosis

This study is designed to see how elagolix works compared to placebo in women with endometriosis and to see the effect, if any, on bone mineral density.

This is a Phase II, multicenter, randomized, double-blind, placebo-controlled parallel-group study to assess the efficacy and safety of elagolix at two dose levels administered once daily for up to 6 months. Participants will be randomized (1:1:1) to one of the following treatment groups for the first 12 weeks of dosing: 150 mg elagolix once daily (QD); 250 mg elagolix QD or placebo QD. Following 12 weeks of dosing, participants will continue in the study for an additional 12 weeks; participants randomized to elagolix will continue to receive their assigned dose and participants randomized to placebo will be re-randomized to receive one of the two doses of elagolix for 12 weeks in a double-blind fashion. Six weeks after the last dose of study drug at the end of Week 24, a follow-up visit will be performed (end of Week 30).

Eligibility Criteria:
Inclusion Criteria:

* Be female, aged 18 to 49 years, inclusive
* Have moderate to severe pelvic pain due to endometriosis
* Have been surgically (laparoscopy) diagnosed with endometriosis within the last 8 years and have recurrent or persistent endometriosis symptoms
* Have regular menstrual cycle
* Have a body mass index (BMI) of 18 to 36 kg/m², inclusive
* Agree to use two forms of non-hormonal contraception during the study

Exclusion Criteria:

* Are currently receiving gonadotropin-releasing hormone (GnRH) agonist or GnRH antagonist or have received any of these agents within 6 months of the start of screening
* Are currently receiving subcutaneous medroxyprogesterone acetate (DMPA-SC) or intramuscular medroxyprogesterone acetate (DMPA-IM) or have received any of these agents within 3 months of the start of screening
* Are currently using hormonal contraception or other forms of hormonal therapy or received such treatment within the last month
* Have had surgery for endometriosis within the last month
* Have had a hysterectomy or bilateral oophorectomy
* Are using systemic steroids on a chronic or regular basis within 3 months
* Have uterine fibroids ≥ 3 cm in diameter
* Have pelvic pain that is not caused by endometriosis
* Have unstable medical condition or chronic disease
* Have been pregnant within the last six months
* Currently breast feeding
Can NAVA Mode Reduce Mechanical Ventilation Day in Patients With COPD ?

Background： Neurally Adjusted Ventilatory Assist (NAVA) mode is a new mode of ventilator, using electronic potential of diaphragm to adjust tidal volume. At the same time, this mode can trigger and cycle-off inspiratory time by high sensitivity of electronic potential of diaphragm, increase patient-ventilator synchrony, reduce sedative drug, improve oxygenation, shorten mechanical ventilation day and reduce the rate of diaphragm atrophy. It can improve survival rate and hospital day of patients. Both the animal and human experiment have the effect of lung and diaphragm protection Effect： The results of this trial are expected to obtain electronic potential of diaphragm in patients with obstructive pulmonary disease. Reviewing the current literature, few related literatures have such data presentation. This trial hopes to evaluate whether the use of NAVA can reduce mechanical ventilation day by analyzing electronic potential of diaphragm in patients with obstructive pulmonary disease.

Investigators expect that participants with obstructive pulmonary disease using NAVA mode will have significantly less mechanical ventilation day than using conventional mode


Eligibility Criteria:
Inclusion Criteria:

1. Obstructive pulmonary diseases include chronic obstructive pulmonary disease (COPD), asthma (Asthma), cystic fibrosis (cystic fibrosis), bronchiectasis (bronchiectasis), bronchiolitis or other diseases that cause airway stenosis, etc.
2. Other patients with obstructive pulmonary disease assessed by the clinical team
3. Consent signed by the principal or legal representative
4. Age \> 20 years old and \< 99 years old

Exclusion Criteria:

1. Those who cannot place a nasogastric tube due to medical conditions
2. Pregnant women
3. Those who have received gas cutting
4. Patients with phrenic nerve palsy
5. Neuromuscular disease
6. Intubation due to cardiac arrest
Observational Study Describing Conditions for Intensification of Insulin Therapy in Type 2 Diabetes

This study is conducted in Europe. The aim of this observational study is to determine diabetes control improvement, during the third month of follow-up after insulin intensification to at least 3 daily insulin injections, in assessing the proportion of uncontrolled fasting and postprandial glycaemia values recorded on a diary.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes patients
* Treatment with two insulin daily injections and needing insulin intensification regimen to at least three daily injections
* HbA1c greater than or equal to 8.0%

Exclusion Criteria:

* Patients not performing glycaemia self-measurements
* Secondary diabetes
* Requirement of or use of an insulin pump
* Treatment with corticoids
Current Awareness, Perspective and Knowledge on Social Egg Freezing

Hong Kong's fertility preservation service is underutilized and limited, with low awareness among clinicians and young adults. Traditional Chinese culture may lead to social stigma, preventing discussion of fertility issues. A survey aims to explore awareness, knowledge, and acceptance of oocyte cryopreservation, enabling resource allocation for a culturally acceptable public education program and a dedicated referral system to improve oocyte cryopreservation services.

Hong Kong's fertility preservation service is underutilized and limited, with low awareness among clinicians and young adults. Traditional Chinese culture may lead to social stigma, preventing discussion of fertility issues. A survey aims to explore awareness, knowledge, and acceptance of oocyte cryopreservation, enabling resource allocation for a culturally acceptable public education program and a dedicated referral system to improve oocyte cryopreservation services.

The questionnaire will be in paper form and as an online survey. Potential participants will be provided with the study aim and respondent rights. Once verbal informed consent is obtained, participants will be asked to fill in the self-administered questionnaire. For the online survey, implied consent from the participants will be adopted when they complete the questionnaire on the webpage and return it to us.

In order to reach the 2 target groups, convenient sampling will be used. Questionnaires will be distributed to the patients who have undergone or will seek fertility preservation services in PWH. For the general public, they will be recruited online via an invitation link.

Eligibility Criteria:
Inclusion Criteria:

* People with aged from 18-60 years old

Exclusion Criteria:

* Patients unable to provide consent/assent (i.e. significant psychiatric problems/cognitive delay)
Randomized, Placebo-controlled Multicenter Trial of Lithium Plus Treatment as Usual (TAU) for Acute Suicidal Ideation and Behavior in Patients With Suicidal Major Depressive Episode

The primary hypothesis of this confirmatory study is that lithium therapy will acutely decrease suicidal ideation and/or suicidal behaviour in inpatients with a major depressive episode (MDE, unipolar and bipolar disorder according to DSM IV criteria). The specific aim is to test the hypothesis that lithium plus treatment as usual (TAU), compared to placebo plus TAU, results in a significantly greater decrease in suicidal ideation and/or behaviour over 5 weeks in inpatients with MDE.

The study will consist of 254 adult patients, hospitalized for a major depressive episode with suicidal ideation and/or behaviour who will be randomized to two groups of each 127 participants. All study participants will receive treatment as usual in the hospital, including (psycho)pharmacological treatment and, if needed, psychotherapy plus a 5-week course of lithium or placebo. Rating scales will be used daily resp. weekly to measure suicidal ideation and/or behaviour, depression, anxiety, mixed/manic features and impulsiveness. Experienced clinicians will rate suicidal ideation and/or behaviour as well as depression twice a week and anxiety, mixed/manic features and impulsiveness once a week.

Eligibility Criteria:
Inclusion Criteria:

* Major depressive episode; inpatient at screening visit; suicidal ideation/behaviour present defined by a clinical rating of 8 on the Sheehan Suicidality Tracking Scale (S-STS) and a rating of ≥20 on the Montgomery Asberg Depression Scale (MADRS) at both screening and baseline visits; both gender, age 18 years.

Exclusion Criteria:

* Contraindication for and history of lithium treatment within the past 6 months; patient unable to tolerate lithium treatment in the past; comorbid borderline/antisocial personality disorder, currently active substance dependency; patients with acute or unstable severe medical conditions, patients unable to understand the informed consent or involuntary inpatients, positive toxicology screen (illegal drugs), pregnancy and lactation