cyrilzakka/clinical-trials huggingface dataset:
Cell Therapy by Bone Marrow-derived Mononuclear Cells (BMC) for Large Bone Defect Repair: Phase-I Clinical Trial

In the present phase-I clinical trial we investigate safety and feasibility of an augmentation with preoperatively isolated autologous BMC cells seeded onto ß-TCP in combination with an angle stable fixation (Philos plate®) for the therapy of proximal humeral fractures.


Eligibility Criteria:
Inclusion Criteria:

* patients aged between 50. and 90. years with proximal humerus fractures
* indication for open reposition and internal stabilisation with a proximal fixed- angle plate for humerus (PHILOS, Synthes, Oberdorf, Swiss):
* 2-, 3- or 4-fragment fracture according to NEer
* dislocation of \>10 mm between fragments and/or
* angle of \> 45° between fragments and/or
* dislocation of tuberculum major \> 5 mm
* negative pregnancy test of premenopausal women
* signed informed consent for surgery and participation in the clinical trial

Exclusion Criteria:

* contraindications against administration of Investigational medicinal product (IMP) is pregnancy and nursing
* dislocation fracture
* known psychic disorder that leads to incompliance (e.g. dementia, schizophrenia, major depression)
* pathologic fractures caused by other underlying diseases
* fracture-induced nerve damage
* tumor disease with recent adjuvant therapy or treatment during the last 3 months (e.g. chemotherapy, radiotherapy), untreated tumor diseases
* known hypersensibility against components of the transplant
* participation in a clinical trial during the last 3 months prior to this study
Early Administration of Fibrinogen in Polytraumatized Patients With Hypofibrinogenemia: a Randomized Feasibility Trial

This is a randomized feasibility trial conducted with severe trauma patients. At admission patients presented hypofibrinogenemia, hypotension and tachycardia. The primary outcome was feasibility assessed by the proportion of patients receiving the allocated treatment up to 60 minutes after randomization. The treatments regards to receive or not to receive an early replacement of fibrinogen.

This is a randomized feasibility trial conducted between December 2015 and January 2017 with severe trauma patients (Index of Shock Severity \[ISS\] ≥ 15) admitted to the emergency room of a large trauma center. At admission patients presented qualitative hypofibrinogenemia (FIBTEM A5 ≤ 9 mm), hypotension (systolic blood pressure \<90 mmHg) and tachycardia (heart rate \> 100 bpm). The primary outcome was feasibility assessed by the proportion of patients receiving the allocated treatment up to 60 minutes after randomization meaning receive replacement through fibrinogen concentrate (50mg per kg of body weight) by the intervention group and not to receive an early replacement of fibrinogen by control group.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 80 years
* Severe trauma patients (Index of Shock Severity \[ISS\] ≥ 15)
* Hypotension (systolic blood pressure \< 90 mmHg)
* Tachycardia (heart rate \> 100 bpm)
* Qualitative hypofibrinogenemia (FIBTEM A5 ≤ 9 mm)

Exclusion Criteria:

* Patient or family do not agree to sign the informed consent form
* Eligible for institutional massive transfusion protocol
* Pregnant
* Previous coagulopathy disorders
* Use of anticoagulants drugs and/or platelet anti aggregation drugs (exception for aspirin)
* Previous thromboembolic disorders or events
* Cardiopulmonary arrest before hospital admission
* Patient admitted after another hospital transfer
* Time from trauma to screening above six hours
* Patients with exclusively traumatic brain injury
Study of Safety and Efficacy of an Oral Contraceptive

This is a non-comparative study. the primary objective of the study is to assess the efficacy of a low dose oral contraceptive in the prevention of pregnancy. The secondary objectives are to assess the incidence of intracyclic bleeding; and to assess the safety and tolerability of the product.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Women
* Age 18-45
* At risk for pregnancy
* History of regular cycles

Exclusion Criteria:

* Contraindications for use of hormonal contraception
* Conditions which affect the absorption or metabolism of steroid hormones
* BMI\>35
Efficacy Study for SD Device

The purpose of this study is to determine whether the SD unique device is effective in treatment of overweight and obesity.

Obesity and Overweight had become the number 1 health concern of the modern world. Over 1 Billion people worldwide are overweight or obese. Those who suffer from overweight or obesity are exposed to other severe illnesses such as: diabetes, cardiovascular disease and cancer.

Only few drugs and surgeries are currently available as approved treatments for those who wish to reduce weight.

The purpose of this study is to determine whether the SD unique medical device, is effective in treatment of overweight and obesity.

Eligibility Criteria:
Inclusion Criteria:

* BMI 30-41.99
* AGE 18-65 years

Exclusion Criteria:

* Pregnant Women,
* Type I and II diabetes,
* People with disfunctioning of thyroid gland
* Hypertension
Accuracy of Coplanar Template Assistance for Pelvic and Groin Areas Biopsy

In recent years, template guidance has been applied and developed in the field of puncture related operations, such as template-assisted radioactive seed implantation. With the guidance of template, needle pathway of seed implantation, biopsy and fiducial marker implantation can be precisely planned

, which is conducive to accurate proceeding. Templates can be divided into coplanar templates and non-coplanar templates. The digital coplanar template coordinate puncture system has been developed in China and has been applied in clinical practice. In our previous studies, coplanar template assisted CT-guided radioactive seed implantation has good clinical feasibility for percutaneous biopsy of small pulmonary nodules. However, the accuracy of coplanar template assistance for abdominal tumor puncture are lacking in prospective studies. The study aims to prospectively observe the accuracy and safety of coplanar template assisted CT-guided Pelvic and Groin Areas biopsy.


Eligibility Criteria:
Inclusion Criteria:

1. Ages 18 to 90
2. Single or multiple Pelvic and Groin Areas mass (solid, partially solid)
3. Without taking drugs affecting coagulation and/or platelet aggregation are used; If used, the drug has been discontinued for a sufficient period of time (e.g. 1 week)

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4. KPS\>60 points, no serious or uncontrolled underlying diseases, clinical evaluation patients can tolerate puncture
5. Planned biopsy with applicable puncture path
6. With informed consent.

Exclusion Criteria:

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Visceral Sensitivity in IBD (Irritable Bowel Disease) and IBS (Irritable Bowel Syndrome)

Aim:

More insight in pathogenesis of IBS and IBD. Samples are collected in context of an European research project.

Methods:

Sample collection in healthy subjects, IBD and IBS patients:

* biopsy of rectum and colon descendens
* blood sample collection
* collection of sample of nasal mucosa
* feces collection
* questionnaires
* rectal barostat sensitivity measurement
* transit measurement of colon
* MR scan of brain

Eligibility Criteria:
Inclusion Criteria:

For group 1: IBS

1. Irritable Bowel Syndrome (IBS) (ROME III criteria)
2. No obvious organic explanation for the IBS symptoms
3. Medication which affects the gastrointestinal motility or perception should be stopped at least 24 hours before the study

Group 2: active ulcerative colitis 1. diagnosis of ulcerative colitis (Confirmed by at least one sigmoidoscopy) 3. Medication which affects the gastrointestinal motility or perception should be stopped at least 24 hours before the study

Group 3: ulcerative colitis in remission (3a: with IBS symptoms, 3b: without IBS symptoms)

1. diagnosis of ulcerative colitis (Confirmed by at least one sigmoidoscopy)
2. remission is confirmed by at least one sigmoidoscopy
3. Medication which affects the gastrointestinal motility or perception should be stopped at least 24 hours before the study

   Only for group 3a:
4. Rome III criteria for IBS

Group 4: Healthy controls No abdominal (pain) complaints.

Group 5: active Crohn's disease

1. diagnosis of Crohn's disease (Confirmed by at least one sigmoidoscopy) 3. Medication which affects the gastrointestinal motility or perception should be stopped at least 24 hours before the study

Group 6: Crohn's disease in remission (6a: with IBS symptoms, 6b: without IBS symptoms)

1. diagnosis of Crohn's disease (Confirmed by at least one sigmoidoscopy)
2. remission is confirmed by at least one sigmoidoscopy
3. Medication which affects the gastrointestinal motility or perception should be stopped at least 24 hours before the study

Exclusion Criteria:

For all groups:

1. co-morbidity: severe kidney- and/or liver disease or thyroid abnormalities and impaired clotting
2. Abdominal chirurgy (except for an uncomplicated appendectomy)
A Study to Evaluate the Long-term Safety of Repeated QUTENZA Administration for Treatment of Pain Caused by Nerve Damage in Diabetic Patients

The purpose of the study is to assess the safety of repeated applications of QUTENZA in reducing pain intensity in subjects who have peripheral neuropathic pain due to diabetes.

Patients will be divided into 3 groups of approximately equal size. In the first group, patients will receive a QUTENZA patch applied for 30 minutes to the feet; in the second group, patients will receive a QUTENZA patch applied for 60 minutes to the feet. In both these groups patients will also continue to receive their normal treatment (Standard of Care (SOC)) for their peripheral neuropathic pain (PNP) and may receive further QUTENZA patch applications in the same way during the study. The third group will not receive a QUTENZA patch but will continue to receive their normal treatment for their neuropathic pain (SOC). Subjects will be involved in the study for up to 15 months and will have to visit the clinic at least 9 times.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of painful, distal, symmetrical, sensorimotor polyneuropathy which is due to diabetes
* Stable glycemic control for at least 6 months prior to screening visit
* Average Numeric Pain Rating Scale (NPRS) score over the last 24 hours of \>4 at the screening and the baseline visit

Exclusion Criteria:

* Primary pain associated with PDPN in the ankles or above
* Pain that could not be clearly differentiated from, or conditions that might interfere with, the assessment of PDPN
* Significant pain (moderate or above) of an etiology other than PDPN, that may interfere with judging PDPN-related pain
* Female subjects of childbearing potential must have a negative serum or urine pregnancy test at enrollment and must agree to maintain highly effective birth control during the study.
* Hypersensitivity to capsaicin (i.e., chili peppers or over-the-counter \[OTC\] capsaicin products), any QUTENZA excipients, Eutectic Mixture of Local Anesthetics( EMLA) ingredients or adhesives
Establishment of a Tumor Bank for Blood Samples

Establishment of a tumor bank, consisting of blood samples of tumor patients and healthy people as controls. The blood samples will be collected systematically together with the corresponding clinical data. The biological samples, the clinical date together with prospective experimental date constitute the entity of the tumor bank.

Recent progress in diagnosis and therapy of cancer diseases can be ascribed mainly to translational research. The relevance of "translational oncology" will only increase in the future -"From bench to bedside" - the swift implementation of new science research results in clinical studies in order to expedite progress in clinical cancer therapy for the benefit of the patient.

Its almost a matter of course in the medical science today to collect biological samples together with clinical information thereby creating the foundation for future excellent fundamental research.

The aim of this tumor bank is to consist of biological samples (together with a tissue bank - see EK 260/2003) and isolates of tumor patients and healthy people as controls. The biological samples, the clinical date together with prospective experimental date constitute the entity of the tumor bank. The content of the tumor bank can provide essential material for current and future research (e.g. analyses of prognostic or predictive tumor markers; genetically analysis (polymorphism, mutation, hypermethylation; verification and characterisation of disseminated tumor cells).

Eligibility Criteria:
Inclusion Criteria:

* Male/Female
* Age 18 to 90 years max.
* Just one current known malignant disease or
* Just one current inflammatory disease

Exclusion Criteria:

* Inflammatory disease and malignant disease
* multiple malignancies
* multiple diseases
* underage
A Randomized, Single Center Pilot Study Comparing Hyaluronic Acid to Vaginal Estrogen for Treatment of Genitourinary Syndrome of Menopause

Non-hormonal alternatives for the treatment of genitourinary syndrome of menopause (GSM) are needed. In this proposed trial, patients who are diagnosed with GSM will be randomized to receive either a hyaluronic acid (HLA) vaginal insert or vaginal estrogen topical cream for 12 weeks. There will be a baseline visit and an 12 week follow up visit, at which points the patient will undergo a detailed history and physical examination including a pelvic exam, vaginal pH sampling, vaginal cell sample for microscopic analysis, and will fill out a vulvovaginal symptom questionnaire (VSQ). These study arms will be analyzed to assess the efficacy of HLA as compared to the gold standard of vaginal estrogen to treat GSM symptoms.


Eligibility Criteria:
Inclusion Criteria:

1. Postmenopausal status as defined by amenorrhea for \>12 months or history of bilateral salpingo-oophrectomy or if the patient has had a hysterectomy and menopausal symptoms for \>1 year or FSH \> 40
2. Symptoms of GSM
3. Negative Pap smear as per ASCCP guidelines
4. Capable of giving informed consent
5. Ambulatory
6. Capable and willing to follow all study-relation procedures

Exclusion Criteria:

1. Use of any HRT (systemic or local) or raloxifene within six weeks of proposed start date
2. History of estrogen-sensitive tumor
3. Undiagnosed vaginal bleeding in the past 12 months
4. History of thromboembolic event
5. Currently have or have had liver problem
6. Bleeding disorder
7. Impaired mental status
8. Prior pelvic irradiation
9. Active vaginal infection
10. Any medical reason the investigator deems incompatible with treatment with vaginal estrogen
Efficacy-safety Study of Sublingual Immunotherapy With Depigmented-polymerized Pollen Extracts to Treat Rhinoconjunctivitis

As the principal objective of this study is to evaluate the efficacy and safety of the treatment measuring the changes in a symptom score, the patient will be asked to fill in a patient diary. This diary will evaluate the week before the patient comes back to receive the treatment. Nose (sneeze, blockage and running), eye (itching, redness and swelling) and chest (breathlessness, wheeze, chest tightness), are scored on a scale from The patient will be instructed to daily assess each one of the symptoms, recording them on an individual symptoms follow-up diary.

The study drug is a sublingual immunotherapy (vaccine) with allergenic extract of grass pollen (Lolium perenne (50%) + Cynodon dactylon (50%)). Sublingual immunotherapy has been available on the European market to treat patients with allergic rhinoconjunctivitis (itching, sneezing, stuffy nose, runny nose) for many years. In this study it will be used as drops under the tongue. At the beginning of the study, you will be given a card that documents that you are taking part. Please carry this with you at all times, in case treatment is necessary at another location. The drops will be given at two doses. The drops are held under the tongue for 2 minutes prior to swallowing.Sublingual Immunotherapy has been shown to be safe and effective in reducing the symptoms of allergic rhinoconjunctivitis (nasal allergy and allergy of the eyes).

Eligibility Criteria:
Inclusion Criteria:

* Clinical history of allergic rhinoconjunctivitis and/or asthma due to hypersensitivity to grass mix Lolium perenne and Cynodon dactylon.
* Male or female subjects between 18 and 50 years old
* Positive skin tests to Lolium perenne and Cynodon dactylon: the wheal produced by the skin test by means of the prick-test technique must be equal or superior to the wheal produced by the positive control of prick test (histamine 10 mg/ml).
* Presence of specific IgE to Lolium perenne and Cynodon dactylon (CAP greater than 17.5K u/L).
* Female subjects must not be sexually active or must be following a medially accepted contraceptive method.
* Pregnancy test negative

Exclusion Criteria:

* Treatment with ß-blocking agents
* Patients suffering from some pathology in which the adrenaline is contraindicated (hyperthyroidism, HTA, cardiopathy, etc.)
* Autoimmune disease (thyroiditis, lupus, etc.)
* Conditions in which the patient can not offer full co-operation, compliance or those with significant psychiatric disturbance.
* Intolerance to aspirin.
* Pregnant women or with pregnancy risk and breast-feeding women
Soft Drink, Milk and Obesity in Chilean Children

The primary aim of this randomized controlled trial is to evaluate the effects of replacing habitual consumption of sugar-sweetened soft drinks with milk over 16 weeks.

The prevalence of obesity has risen dramatically among children in the U.S. and throughout the world since the 1960s. Many factors are thought to have contributed to the epidemic of pediatric obesity. One factor that has received increasing attention is consumption of sugar-sweetened beverages. Feeding studies suggest physiological mechanisms by which sugar in liquid form may be less satiating than other foods. An observational study found total energy consumption to be greater among children who consume sugar-sweetened beverages compared to non-consumes. Short-term interventional studies report increasing energy intake and body weight in subjects given sugar-sweetened beverages compared to non-caloric beverages. Our preliminary data found that the risk for becoming obese increased by about 60% in middle school children for every additional serving per day of sugar-sweetened beverage consumed. The purpose of the present study is to conduct a 16-week clinical trial involving 96 children ages 8 to 10 years in Chile, a developing nation characterized as undergoing a "nutrition transition." The subjects, selected for current sugar-sweetened soft drink consumption, will be randomly assigned to intervention or control groups. The intervention group will be encouraged to substitute milk products for soft-drinks; to facilitate this dietary change, a variety of milk products will be delivered to subjects' homes on a weekly basis. Clinical endpoints include changes in dietary quality, body weight, adiposity by DEXA-scan and measures of calcium homeostasis.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, age 8 to 10 years
* Tanner Stage I
* BMI between 85th and 95th percentiles for age and gender
* Consuming at least 2 servings/day of sugar-sweetened beverages
* Willingness to consume milk instead of sugar-sweetened beverages for 16 weeks
* Able to read Spanish and accurately complete dietary assessments

Exclusion Criteria:

* Presence of a serious underlying medical condition
* Taking any medication that affects body weight
* History of lactose intolerance or milk protein allergies
* History of an eating disorder
INvestigating TELmisartin Study

This study will enroll 40 inpatients hospitalized for COVID-19 at Queens' Medical Center. Participants will be randomized 1:1 to Telmisartan (80 mg) vs placebo to be administered orally once daily x 21 days.

The study is intended to assess, in a pilot study, the effect of telmisartan in mitigating the severity of COVID-19 related disease in hospitalized patients. Data on clinical course and lab values will be passively abstracted from Queen's standard of care evaluations on COVID-19 in-patients. Participants will be monitored closely as an outpatient if/when discharged prior to day 21. The only study-specific procedure will be a blood draw of ten (10) cc to be collected for research purposes at entry and at day 4 and day 21 of study for the evaluation of the renin-angiotensin system (RAS) system and for various blood biomarkers of organ function/coagulation, inflammation, leukocyte chemotaxis, tissue remodeling/fibrosis and immune exhaustion.

Eligibility Criteria:
Inclusion Criteria:

* Able to provide written informed consent prior to initiation of any study procedures.
* Within 72 hours of initial hospitalization for acute COVID-19 disease management
* Male or non-pregnant female adult ≥18 years of age at time of enrolment.
* Able to easily swallow pills

Exclusion Criteria:

* Systolic blood pressure less than 100 mmHg
* Self-reported history of decompensated liver failure
* Pregnancy or breast feeding
* Allergy to the study medication
* Current use of ARB, ACE inhibitors, or angiotensin receptor/neprilysin inhibitors (ARNIs). Blood pressure medications in other classes will be permitted as long as the systolic BP is \>100 mmHg
* Currently receiving vasopressors for hypotension
* Prior reaction or intolerance to ARB, ACE Inhibitor or ANRI for whom study participation would not be advisable in the opinion of the study team
* Current use of and on-going need for aliskiren, lithium, digoxin, and potassium sparing diuretics such as spironolactone
* Participating in other drug clinical trials EXCEPT for other COVID-19 treatment trials which will be allowed with the permission of the Corresponding PI or Co-PI and concurrence of the treating physician/hospitalist
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 10x upper limit of normal (ULN) within 24 hours of baseline
* Absolute neutrophil count (ANC) \< 1000/mL within 24 hours of baseline
* Platelet count \< 50,000/mL within 24 hours of baseline.
* Patients with acute kidney injury (AKI) or chronic kidney disease (CKD) including individuals on hemodialysis may be enrolled based on the investigator's clinical judgement.
* Any serious medical condition/ abnormality or other issues that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study or suggests that the study is not in the patient's best interest
* In the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments
The Effect of Membrane Sweeping on the Delivery Time and the Need of Induction in Term Pregnancy

Pregnancies that extend beyond 42 weeks of gestation are at an increased risk for poor fetal and maternal outcomes. For decreasing the number of these cases, some labor induction techniques are used. The status of the cervix is an indicator for the success of the induction. In these study, investigators investigate the effect of membrane sweeping on the need of induction and the delivery time in term pregnancy.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-35 years
* Vertex presentation
* No contraindication for vaginal delivery
* No contraindication for labor induction

Exclusion Criteria:

* Active vaginal infection
* Previous uterine surgery
* Systemic disease
* Multiple pregnancy
* Fetal anomaly and suspicious fetal health status