cyrilzakka/clinical-trials huggingface dataset:
Vitamin D and Calcium Study

Vitamin D aids in the body's ability to absorb calcium, it is a vital component in bone formation and break down. Reduced levels of vitamin D can indicate a vitamin deficiency and may depress serum calcium levels. The following is a list of common causes of vitamin D deficiency: lack of dairy products, alcohol usage, elderly, lack of exposure to sunlight, individuals with reduced mobility, GI malabsorption problems, dark complexion, severe liver damage, and renal failure. Many of these factors can be found in individuals with spinal cord injury. SCI results in disuse bone loss after acute injury, which continues with duration of injury. The goal of this study is to determine the effects of vitamin D and calcium supplements on calcium metabolism and vitamin D deficiency in individuals undergoing functional electrical stimulation (FES) stand retraining (SRT).


Eligibility Criteria:
Inclusion Criteria:

* Spinal Cord Injury (paraplegia or quadriplegia)
* Vitamin D deficiency
* Absolute deficient Vitamin D \[25(OH)D\] \< 16 ng/ml
* Relative deficient Vitamin D \[25(OH)D\] \<30ng/ml - participation in the FES/SRT study at Kessler Institute for Rehabilitation

Exclusion Criteria:

* History of kidney stones
* History of bone disorders
* Currently pregnant
Study of Stapokibart Injection in Patients With Allergic Rhinitis

This study is a Randomized, Double-blind, Placebo-controlled phase II clinical study evaluating the efficacy and safety of Stapokibart injection in patients with allergic rhinitis.

Allergic rhinitis (AR) is a non infectious chronic inflammatory disease of the nasal mucosa that is mainly mediated by immunoglobulin E (IgE) in atopic individuals exposed to allergens.

Eligibility Criteria:
Inclusion Criteria:

* Able to understand the study and voluntarily sign the Informed consent form.
* Diagnosed Allergic Rhinitis according to the Criteria stated in the Chinese Guidelines for the Diagnosis and Treatment of Allergic Rhinitis (2022, Revised Edition).
* Subjects with asthma must be evaluated by the researcher as having a stable condition.
* Has a positive skin prick test (SPT) or positive antigen-specific serum immunoglobulin E (IgE).

Exclusion Criteria:

* Use of anti-interleukin 4 receptor alpha subunit (IL-4Rα) monoclonal antibody, thymic stromal lymphopoietin (TSLP) monoclonal antibody, anti-IgE monoclonal antibody, other monoclonal antibodies, or other biologics within 10 weeks or 5 half-lives (whichever is longer) prior to the screening visit.
* Use of any investigational product within 4 weeks prior to the screening visit or planning to participate in other clinical studies during this study.
* Forced expiratory volume in 1 second (FEV1) ≤ 50% of the predicted value during the screening/run-in period.
* Have acute sinusitis, nasal infection, or upper respiratory tract infection at screening or within 2 weeks prior to screening.
* Have received a live-attenuated vaccine within 12 weeks prior to randomization or planning to receive one during the study.
The Effects of Pre-operative Anxiety on Anesthetic Recovery and Post-operative Pain in Donor Nephrectomy

Kidney transplant is the most effective choice of treatment for patients with end-stage kidney failure in terms of quality of life and longevity. Today, 20-25% of kidney transplantations are implemented with living donors.

Donor nephrectomy is an operations which has the end goal of a living donor donating one of his kidneys to a patient with end-stage kidney failure (1).

Pre-operative anxiety is a condition which is characterized by a random illness, being hospitalised, anesthesia, surgery, or uneasiness or anxiety stemming from not knowing what is to be experienced. Educating and informing in the pre-operative period is the first step in mentally preparing the patient for the operation. In some studies, it has been pointed out that patients who were thoroughly informed in the pre-operative period have lower anxiety levels both in the pre-operative and post-operative periods with also less levels of pain and increased recovery rates in the latter (2).

Anesthetic recovery starts at the end of the surgical process and ends with the anesthetized patient completely regaining a wide-awake, responsive state, defensive reflex, and muscle strength.

Post-operative pain is acute pain which starts with surgical trauma and ends with tissue healing (3). Providing optimal post-operative analgesia plays an important role in the prevention of post-operative complications (1,4,5).

There are studies which examine the link between pre-operative anxiety and post-operative pain (59,74,74,77,78). Patients who will undergo a donor nephrectomy constitute a specific group of patients both because they are not operated due to a health problem that they have and because the operation results with them losing an organ. There are no prospective studies about the effects of pre-operative anxiety on anesthetic recovery and post-operative pain in individuals who have undergone donor nephrectomy in literature. Because of this, we have aimed to research prospectively the effects of pre-operative anxiety on anesthetic recovery and post-operative pain in patients that were to undergo donor nephrectomy surgery.


Eligibility Criteria:
Inclusion Criteria:

* ASA I-II between 18-60 years
* Donor Nephrectomy patients

Exclusion Criteria:

* psychiatric disturbance
* medicinal allergy
Comparing the Effectiveness Between Ritonavir Boosted Atazanavir and Efavirenz for the First HIV Treatment

A selection study in treatment naive HIV patients to compare the virologic success rate of once daily antiretroviral treatment regimens at the 48th week with Epzicom(lamivudine and abacavir) plus efavirenz and Epzicom plus ritonavir boosted atazanavir. The superior regimen will be hired to the comparative study to the current first line regimen (tenofovir plus lamivudine plus efavirenz)

A selection study in treatment naive HIV patients to compare the virologic success rate of once daily antiretroviral treatment regimens at the 48th week with Epzicom(lamivudine and abacavir) plus efavirenz and Epzicom plus ritonavir boosted atazanavir. The superior regimen will be hired to the comparative study to the current first line regimen (tenofovir plus lamivudine plus efavirenz)

The primary endpoint is antiretroviral effect at the 48th week.

The secondary endpoint is;1. Evaluation of immunological effect and safety in 48 weeks. 2.Evaluation of antiretroviral effect, immunological effect and safety in 49 to 96 weeks.

Eligibility Criteria:
Inclusion Criteria:

* serological diagnosis of HIV infection
* male aged over 20 years old
* CD4 at enrollment between 100 to 300
* body weight over 40kg
* enable to obtain the written informed consent

Exclusion Criteria:

* Patients who are considered unable to complete 48 weeks of study by their physician.
* Patients who have gastrointestinal symptom which may interfere the absorption of antiretrovirals, or have swallowing problems.
* Patients who have the history of hypersensitivity with lamivudine.
* Hepatitis B carrier.
* Blood test results within 4 weeks prior to the randomization; hemoglobin less than 9g/dl, platelet less than 50,000/mm3, neutrophils less than 1000/mm3, serum total bilirubin more than 2.0mg/dl, GOT/GPT/LDH more than two times of upper normal limit, serum creatinine more than 1.2mg/dl.
* Patients who have had radiation or chemotherapy within 4 weeks prior to the randomization or will have the treatment during the study .
* Patients who have had immunomodulating agent such as systemic use of corticosteroid or interferon within 4 weeks prior to the randomization. Inhaled corticosteroid is the exception.
* Patients who have diabetes, congestive heart failure, cardiomyopathy, or other serious medical condition.
* Patients with AIDS defining illness.
* Patients with known resistant strains to efavirenz, atazanavir, ritonavir, lamivudine and abacavir prior to the study.
* Patients with acute retroviral syndrome.
* Patients with psychiatric disorder.
* Patients whose physician consider the study enrollment inappropriate.
A Study of LY2523355 in Patients With Solid Cancer

The primary objective of this study is to examine a recommended dose for subsequent phase trial(s), by the observation of the safety and toxicity profiles of LY2523355 in patients with advanced and/or metastatic cancer. The secondary objectives are to study the pharmacokinetics and antitumor effect.


Eligibility Criteria:
Inclusion Criteria:

* Histological and/or cytological evidence of solid tumors
* A diagnosis of advanced and/or metastatic solid tumors
* Patients who are refractory to standard therapy or for which no proven effective therapy exists
* Written informed consent
* Appropriate bone marrow, hepatic and renal functions
* ECOG PS =\< 1

Exclusion Criteria:

* Have serious preexisting complication
* Have active infection which requires intravenous antibiotics
* Have symptomatic central nervous system metastases
* Have current acute or chronic leukemia
* Have had an autologous or allogenic hematopoietic stem cell transplantation
* Have active multiple cancers
United Kingdom User Evaluation, MiniMed Paradigm® X54 System

The user evaluation is to assess user acceptance and the quality of training materials for the MiniMed Paradigm® X54 System (X54 System) in preparation for commercial distribution of the new system.


Eligibility Criteria:
Inclusion Criteria:

* Are current 512/712, 515/715 or 522/722 MiniMed Paradigm Insulin Pump users, with or without CGM experience, and have at least three months experience with any one of these devices;
* Have signed an Informed Consent and are willing to comply with the user evaluation procedures;
* Have an HbA1c value less than 9.0% recorded at the time of their last test (if no HbA1c value is available within three months of enrollment, an HbA1c should be performed prior to entry to verify inclusion criteria);
* Are willing to use the Bolus Wizard feature;
* Agree to complete a diary for the duration of the study;
* Agree to complete a questionnaire at the conclusion of the study;
* Have been diagnosed with Type 1 Diabetes Mellitus by appropriate fasting or non fasting lab blood glucose values, c-peptide, insulin antibodies, prior documented DKA or good clinical picture at least six months prior to study start;
* Are 18 - 65 years of age;
* Have access to the internet and agree to upload the device per protocol

Exclusion Criteria:

* Is pregnant or planning to become pregnant during the course of the user evaluation. Pregnancy screening will be completed during the routine office visit prior to evaluation for the study. If a woman becomes pregnant during participation, she will be withdrawn;
* Suffers from a chronic debilitating condition;
* Has serious or unstable medical or psychological conditions (e.g., eating disorders, clinical depression, anxiety disorder) which, in the opinion of the Investigator, would compromise the subject's safety or successful participation in the study;
* Has impaired vision or hearing problems that could compromise the handling of the device;
* Has a history of tape allergies or skin conditions that could interfere with continued use of the system;
* Has the potential for lack of compliance or any other issue, in the opinion of the Investigator, that may preclude the subject from satisfactory participation in the study;
* Has travel plans which would make it difficult for the subject to attend on-site study visits as scheduled;
* Is currently participating in an investigational study (drug or device).
Ketamine for Opioid Use Disorder

The goal of this clinical trial is to learn if ketamine works to reduce craving for opioids in adults entering methadone treatment for opioid use disorder. The main questions it aims to answer are:

* Does ketamine reduce craving for opioids in patients with opioid use disorder?
* Does ketamine reduce symptoms of opioid withdrawal such as depression, pain, and poor sleep quality?
* Do patients who take ketamine stay in methadone treatment longer, and/or have better treatment outcomes than those given the placebo?

Researchers will compare ketamine to an active placebo (a look-alike substance that contains a drug that does not do anything to help the condition it is supposed to treat but will mimic some of the side effects of ketamine) to see if ketamine works to reduce craving for opioids in adults entering methadone treatment for opioid use disorder.

Participants will:

* Be given ketamine or a placebo 4 times over a period of 2 weeks
* Visit the clinic weekly and monthly for checkups and tests for 90 days post-intake


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 to 65 years old
2. Recent history (most recent 2 weeks prior to clinic intake) of routine use of illicit opioids, 5+ times/week
3. Fulfillment of DSM-5/ICD-10 criteria for moderate-to-severe opioid use disorder
4. Acceptance into methadone treatment for opioid use disorder within the past 14 days at the time of screening.

Exclusion Criteria:

1. Routine use of prescribed medications for OUD (5+ days/week) for longer than the 14 days leading up to clinic intake. Source: Self-report, H\&P
2. Recent prescribed or illicit benzodiazepine, ketamine, or PCP use that exceeds 5+ days/week for the last 3 months. Source: H\&P
3. Pregnant and/or breastfeeding. Source: UDS, H\&P
4. Stage 4 Hypertension, defined by a systolic blood pressure (SBP) \> 180 mmHg or a diastolic blood pressure (DBP) \> 120 mmHg. Source: H\&P
5. Clinically significant abnormal findings for which study participation is deemed unsafe. Source: H\&P
6. Severe mental illness or psychiatric disorder for which study participation is deemed unsafe (except for depression, PTSD, and substance use disorder). Source: H\&P
7. \*\*Severe hepatic impairment (baseline alkaline phosphatase or aspartate aminotransferase \> 5 times the upper limit of normal. Source: Labs

   * NOTE: Due to time constraints in the study design, exclusion criterion #7 does not need to be met before the initial consent to participate. This criterion only needs to be established prior to the first esketamine/placebo session. This will allow us to enroll participants as soon as possible, giving more time and flexibility to complete the baseline/weekly assessments before the first esketamine/placebo session. Individuals that are initially enrolled and subsequently do not qualify due to severe hepatic impairment will be considered screen failures and withdrawn from the protocol.
A Study Of SU011248 Plus Paclitaxel Versus Bevacizumab Plus Paclitaxel In Patients With Advanced Breast Cancer

To compare treatment with SU011248 plus paclitaxel versus bevacizumab plus paclitaxel to determine which treatment works better against breast cancer

On May 27, 2009, the independent Data Monitoring Committee (DMC) reviewed the progress of Study A6181094. The DMC determined Study A6181094 had met pre-specified futility criteria and was unlikely to meet its primary endpoint to demonstrate a statistically significant improvement in progression-free survival (PFS) in patients treated with sunitinib plus paclitaxel versus bevacizumab plus paclitaxel. Pfizer notified clinical trial investigators involved in the study and regulatory agencies of these findings. Enrollment in this study has been stopped.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of advanced breast cancer.
* Measurable disease as per RECIST (Response Evaluation Criterion) in Solid Tumors or bone-only disease.
* ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1.

Exclusion Criteria:

* No prior treatment with cytotoxics in the advanced disease setting.
* HER2/neu positive disease unless trastuzumab was previously received or is contraindicated.
* Treatment with a taxane in the adjuvant setting unless disease free interval \>12 months after end of treatment.
Biseko Versus Albumin in Systemic Inflammatory Response Syndrome (SIRS) Patients

Morbidity and mortality in patients suffering from systemic inflammatory response syndrome (SIRS) remain high. The primary aim of the present study is to assess the efficacy of a standardized 5% serum-protein solution containing immunoglobulins on serum cytokine levels. The secondary aim is to evaluate survival of the patients.

Out of 40 patients randomised, 18 patients received albumin, 20 patients received Biseko and 2 patients died before receiving the complete study medication. During days 1-6 of the study period, serum-levels of IL-1ß were significantly lower in patients with Biseko-therapy compared to patients receiving albumin (IL-1ß-Area under the curve 65.04 ± 71.09 days.pg/ml and 111.05 ± 156.97 days.pg/ml respectively, P=0.03). No difference could be found in serum-levels of IL-6, TNF-α and TNF-R between both groups. While a statistically not significant trend towards better survival was observed in the Biseko-group on day 28, the survival rate on day 180 was significantly higher in the Biseko-group \[9/18 (50%)\] vs. albumin- group \[2/20 (10%), (P=0.008)\].

Conclusion: Data suggest that Biseko treatment was associated with significantly lower IL-1ß plasma concentrations (d1 to 6) and improved long-term survival rates.

The data provided in our study are the first to be collected in a randomized, controlled trial. Certainly, the small number of patients and the variety of diseases limit our study, however, the variety of diseases reflects the realistic large scale of morbidity in the medical intensive care unit.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 18 and 85 years fulfilling at least two of the four SIRS criteria:

  * body temperature \> 38°C or \< 36°C
  * tachycardia \> 90/min
  * tachypnea \> 20/min with spontaneous respiration
  * leucocytosis \> 12,000/mcl
  * leucopenia \< 4,000/mcl or more than 10 % immature granulocytes were included \[8,21,22\]

Exclusion Criteria:

* Patients with proven intolerance against homologous protein solutions
* Patients with known liver failure
* Pregnant patients
* Patients with absolute IgA deficiency were excluded
Examining the Effects of Mitochondrial Oxidative Stress in DCM

Double blind, randomised, placebo-controlled trial of MitoQ (mitoquinol mesylate) in 106 patients with dilated cardiomyopathy, examining the effect of reducing mitochondrial oxidative stress on myocardial energetics and myocardial function using 31-phosphorus magnetic resonance spectroscopy and cardiovascular magnetic resonance.


Eligibility Criteria:
Inclusion criteria

1. idiopathic or familial DCM
2. LVEF ≤45% on 2 imaging studies of any modality ≥3 months apart (may include CMR scan at baseline visit)
3. on guideline therapy for ≥3 months as determined by usual clinicians
4. sinus rhythm on 12-lead electrocardiogram
5. plasma NT-pro-BNP \>250ng/L for those \>65 years and \>100ng/L for those aged ≤65 years within the last 6 months (may include sample at baseline visit)

Exclusion criteria

1. current persistent atrial fibrillation
2. contraindication to CMR
3. estimated glomerular filtration rate (eGFR) \<30mls/min
4. current or planned pregnancy or current breast-feeding
5. clear environmental trigger such as excess alcohol intake, cardiotoxic chemotherapy or peripartum presentation
6. fibrosis burden \>25% on CMR
7. current cancer (other than non-melanoma skin cancers)
8. current use of CoQ10
9. current participation in another randomised controlled trial
A Screening Study To Assess The Cognition Status in Healthy Volunteers

This multi-center screening study will conduct a cognition assessment to collect reference data for comparison to patients with depression in healthy volunteers. Data will be collected for 6 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers, 18 to 65 years of age, inclusive
* Healthy volunteers with a stable chronic disease that is not associated with cognitive deficits (e.g. asthma) and does not require any treatment known to affect cognition have to be discussed with the medical monitor before enrollment
* A body mass index between 18 to 30 kg/m2 inclusive
* Able to participate and willing to give written informed consent and to comply with the study restrictions
* At least second generation resident in the country of origin

Exclusion Criteria:

* Current or past history of a psychiatric disorder
* Family history of psychiatric disorders
* Suspicion or evidence of regular consumption of drugs of abuse or a positive drug test at the screening visit
* Acute or chronic disorder which is not stable or may affect cognition or needs treatment affecting cognition
* Change of smoking behavior or smoking cessation therapy within 30 days before screening visit
* Positive result on hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) 1 and 2
* Systolic blood pressure greater than 140 or less than 90 mm Hg, and diastolic blood pressure greater than 100 or less than 50 mm Hg
* Resting Pulse Rate greater than 100 or less than 45 beats per minute
* Clinically significant abnormalities in laboratory test results or in ECG assessment at screening visit
* Participation in an investigational drug study within 1 month prior to baseline
Aortic Occlusion for Resuscitation in Trauma and Acute Care Surgery

Aortic occlusion (AO) for trauma has traditionally been accomplished by supra-diaphragmatic clamping of the descending thoracic aorta via emergent thoracotomy or as an initial step during laparotomy.

An evolution in endovascular technologies, however, has provided additional means by which to achieve AO. Expanding experience with the utilization of balloon occlusion in the setting of abdominal aortic rupture due to chronic vascular disease has demonstrated the potential of these new technologies. Discussion of the employment of endovascular AO in the realm of trauma has led to the description of this approach and the demonstration of its effectiveness in animal models of severe hemorrhage.

The purpose of the present study is to prospectively examine the modern utilization of AO in the acute resuscitation of trauma and acute care surgery patients in shock.

Eligibility Criteria:
Inclusion Criteria:

* All adult (age ≥ 18 years) trauma and acute care surgery patients treated with resuscitative AO (via open or endovascular means) in the acute phases after injury
* Transient or refractory hypotension (systolic blood pressure \<90mmHg) with a positive abdominal focused abdominal sonography in trauma (FAST) scan, severe pelvic fracture(s), or neither with persistent hypotension without obvious source
* Chest x-ray without evidence of thoracic aortic injury
* Subject treatment includes internal aortic cross-clamp or would have likely benefited from an internal aortic cross-clamp

Exclusion Criteria:

* Subject \< 18 years of age
* Prisoner
* Evidence of cardiac, thoracic aortic, or great vessel injury identified in primary survey, FAST scan, and/or x-rays
* Any open/exsanguinating upper extremity wound