cyrilzakka/clinical-trials huggingface dataset:
Negative Postprandial Effect on Endothelium After a Not-healthy Meal in Type 2 Diabetes as Affected by Training

The purpose of this study is to examine whether exercise reduces the postprandial effects of an unhealthy meal on heart function and endothelial function.

Both healthy people and type 2 diabetes subjects will during three days either carry out two different sessions of exercise training or not before ingesting an unhealthy meal high in saturated fat and fast carbohydrates. The two different exercise training modes used are high intensity interval training (HIIT) and moderate intensity training (MIT) Hypothesis: Exercise training in advance of an unhealthy meal will improve endothelial- and cardiac function in healthy and type 2 diabetes individuals. HIIT will reduce the negative postprandial effects on the endothelium more than MIT.


Eligibility Criteria:
Inclusion Criteria:

* healthy or type 2 diabetes

Exclusion Criteria:

* type 2 diabetes more than 10 years
* unstable angina
* myocardial infarction
* overt cardiovascular disease.
* severe valvular disease.
* overt lung disease.
* orthopedical- /neurological restrictions
* severe disease related to diabetes type 2 (neuropathy, micro-or macroalbuminuria, retinopathy)
* body mass index \>35
* severe eating disorders.
* personality disturbances.
* planned surgery during the project period.
* patients who achieve greater than the current exercise guidelines for type 2 diabetes (210 min/week) before the start of the study.
* uncontrolled hypertension
* kidney failure
* cardiomyopathy
* smoking
* patients who probably not will be able to complete the study
* alcohol or drug abuse
Efficacy and Tolerability of an Innovative Formulation of BAK-free Latanoprost

This study evaluates the efficacy and tolerability of a new formulation of latanoprost without Benzalkonium Chloride (BAK-free). Patients with open-angle glaucoma who were using BAK-containing latanoprost ophthalmic solution for ≥6 months, switched to BAK-free latanoprost ophthalmic emulsion.

Latanoprost is a prostaglandin F2alfa analogue that increases the uveoscleral outflow of aqueous humor, resulting in a intraocular pressure (IOP) reduction. Benzalkonium chloride (BAK) is usually employed in formulations of prostaglandin analogues due to its dual action of preservative and adjuvant in the formulation. However, this preservative has known toxic effects on the ocular surface, causing ocular dryness and discomfort on long-term use. Benzalkonium Chloride-free (BAK-free)Latanoprost is a new formulation approved for the use in patients with primary open angle glaucoma /ocular hypertension. In this study, patients that were using BAK-containing latanoprost for ≥6 months, switched to a new formulation of BAK-free latanoprost ophthalmic emulsion to evaluate its hypotensive action and quantify the changes in ocular surface parameters.

Eligibility Criteria:
Inclusion Criteria:

* Men and women aged ≥ 18 years
* Diagnosed with primary open-angle glaucoma or pseudoexfoliative glaucoma.
* Receiving containing-BAK latanoprost as monotherapy for at least 6 months
* Pachymetry between 520 and 580 microns
* Informed consent given

Exclusion Criteria:

* History of allergic hypersensitivity or poor tolerance to latanoprost or any components of the formula
* Angle closure glaucoma or secondary glaucoma
* History of recent previous glaucoma surgery or trabeculoplasty (less than 1 year of surgery)
* History of cataract surgery during the last 6 months
* History of uveitis or intraocular inflammation
* Corneal alteration
* Pregnant patients, who wish to conceive or who are in the nursing period.
Transversus Abdominis Plane Blocks for Patients Undergoing Robotic Gynecologic Oncology Surgery

This study is a single-center, randomized, placebo-controlled, double-blind clinical trial. The purpose of this study is to evaluate the impact of pre-operative transverses abdominis plane (TAP) blocks on post-operative analgesia in patients undergoing robotic surgery for gynecologic cancers.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing robotic-assisted surgery under the care of the Division of Gynecologic Oncology at UWHC.
* Patients must be ≥18 years old.
* Patients must be English speaking.
* Patients must have the ability to understand visual and verbal pain scales.
* ASA physical status 1-3.

Exclusion Criteria:

* Known allergy to local anesthetics.
* Immunocompromised.
* Known history of opioid dependence, as available within the medical record and standard of care pre-operative work-up.
* Known history of chronic pain disorders.
* Pregnancy or lactation.
* Patient is a prisoner or incarcerated.
* Significant liver disease that would inhibit prescription of opioids.
St. John's Wort Photodynamic Therapy

The investigators aimed to evaluated the efficacy and safety of SJW-PDT compared to indole-3-acetic acid (IAA)-PDT in the treatment of acne. The investigators also investigated the skin rejuvenating effects of SJW-PDT.


Eligibility Criteria:
Inclusion Criteria:

* patients with mild to moderate facial acne
* between 25 and 60 years old

Exclusion Criteria:

* history of oral retinoid treatment with the past 6 months
* history of oral antibiotics, topical acne treatment, or skin rejuvenation treatment such as lasers and chemical peeling within the month before the start of the study
Rectal Misoprostol Versus Sublingual Misoprostol Prior to Myomectomy

the aim of the study is To compare the effectiveness of rectally administered prostaglandin E1 synthetic analogue (misoprostol) 400 microgram versus sublingually administered misoprostol before myomectomy to decrease blood loss during and after the operation.


Eligibility Criteria:
Inclusion Criteria:

* Patients presenting for abdominal myomectomy with documented uterine fibroids on pelvic imaging
* Age ≥ 18 years and ≤ 50 years
* Pre-operative hemoglobin \>8 g/dl
* Ability to understand and the willingness to sign a written informed consent.
* Admissible medical/surgical history
* Five or less symptomatic uterine myomas
* All myomas are subserous or intramural.
* Uterine size less than 24 weeks pregnancy

Exclusion Criteria:

* Patients who have had a prior abdominal myomectomy
* Post-menopausal women
* Patients with known bleeding/clotting disorders
* Patients with a history of gynecologic malignancy
* Hypertension.
* Cardiac and Pulmonary diseases.
* Obesity (body mass index \> 30 kg/m2).
* History of allergic reactions attributed to misoprostol
* Cases that will require intraoperative conversion of myomectomy to hysterectomy.
Serial Phlebotomy in Voluntary Blood Donors

Blood donation has been proposed to be associated with reduced risk of cardiovascular disease, but the effects of phlebotomy on vascular function in human subjects have not been well characterized. A prospective randomized double-blind study was undertaken to determine the effects of iron loss and red blood cell loss induced by serial phlebotomy on vascular endothelial function in the brachial artery.

84 Fe-replete, non-anemic subjects were randomly assigned to one of three experimental serial phlebotomy procedures designed to induce Fe loss or RBC loss. Brachial artery reactivity (BAR, %) in response to transient oxidative stress induced by oral methionine was measured with high-resolution duplex ultrasound imaging before and after study phlebotomy procedures.

Eligibility Criteria:
Inclusion Criteria:

* hemoglobin levels \>13.5 g/dl for men, or \>12.5 g/dl for women
* serum ferritin 50-400 ng/ml

Exclusion Criteria:

* known intolerance of phlebotomy procedures
* major trauma or surgical procedures in the last 2 years
* menstrual or other uterine bleeding in the last 2 years
* chronic oral anticoagulation or dual antiplatelet therapy
* chronic non-steroidal anti-inflammatory drug use
* known history of hemochromatosis or other disorder of hematopoiesis or Fe metabolism
* chronic oral Fe supplementation other than Fe-containing multivitamins
* history of active cancer in the past 2 years
* known history of chronic inflammatory disease
* uncontrolled hypertension
* electrocardiographic evidence of prior myocardial infarction
* diabetes mellitus
* fasting glucose \>100 mg/dL
* body mass index \>40 kg/m2
* any tobacco use in the past 6 months
Phase II Two-step Radioimmunotherapy Clinical Study in Medullary Thyroid Carcinoma

Phase II clinical trial assessing efficacy and toxicity of pretargeted radioimmunotherapy using anti-CEAxanti-DTPA bispecific antibody and di-DTPA-131I peptide in patients with reccurrence of medullary thyroid carcinoma (abnormal calcitonin level and biomarkers doubling time lower than 5 years)


Eligibility Criteria:
Inclusion Criteria:

* 18 -75 years
* Karnofsky ≥ 70%
* Histological diagnosis of medullary thyroid carcinoma
* Calcitonin serum level Ê 100 pg/ml and Calcitonin or CEA doubling time £ 5 years
* Normal liver and renal functions
* Granulocytes ≥ 1500/mm3 and platelets ≥ 150 000/mm3
* No immunization
* Consent form signed
A Phase 1/2 Study to Evaluate Axatilimab in Participants With Active cGVHD

This is a Phase 1/2, Open-label, Dose Escalation study to investigate axatilimab in participants with active chronic graft versus host disease (cGVHD).

This is a dose escalation and dose expansion study in participants with active cGVHD who have received at least 2 lines of prior therapy.

Eligibility Criteria:
Key Inclusion Criteria:

1. Participant must be 6 years of age or older, at the time of signing the informed consent.
2. Participants who are allogeneic hematopoietic stem cell transplant (HSCT) recipients with cGVHD requiring systemic immune suppression.
3. Participants with active cGVHD who have received at least 2 lines of therapy. Participants 18 or older with active cGVHD who have erythematous rash involving \>25% body surface area or a NIH mouth score of \>4 must have received prior ibrutinib therapy.

   a. Active cGVHD is defined as the presence of signs and symptoms of cGVHD per 2014 NIH Consensus Development Project on Criteria for Clinical trials in cGVHD.
4. Participants may have persistent active acute and cGVHD manifestations (overlap syndrome), as defined by 2014 NIH Consensus Development Project on Criteria for Clinical trials in cGVHD.
5. Karnofsky Performance Scale of ≥60 with a life expectancy of at least 3 months (if aged 16 years or older); Lansky Performance Score of ≥60 (if less than 16 years).
6. Adequate organ and bone marrow functions.
7. Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
8. Capable of giving signed informed consent which includes compliance with the study requirements and restrictions.

Key Exclusion Criteria:

1. Has acute GVHD without manifestations of cGVHD.
2. Any evidence (histologic, cytogenetic, molecular, hematologic, or mixed) of relapse of the underlying cancer or post-transplant lymphoproliferative disease at the time of screening.
3. History or other evidence of severe illness, uncontrolled infection or any other conditions that would make the participant, in the opinion of the Investigator, unsuitable for the study.
4. Known history of human immunodeficiency virus (HIV) or active hepatitis C virus (HCV) or hepatitis B virus (HBV).
5. Diagnosed with another malignancy (other than malignancy for which transplant was performed) within 3 years of enrollment, unless previously treated with curative intent and must be approved by Sponsor medical monitor (for example, completely resected basal cell or squamous cell carcinoma of the skin, resected in situ cervical malignancy, resected breast ductal carcinoma in situ, or low-risk prostate cancer after curative resection).
6. Female participants who are pregnant or breastfeeding.
7. Previous exposure to study intervention or known allergy/sensitivity to study intervention.
8. Taking agents other than a corticosteroid and one calcineurin inhibitor (CNI) for treatment of cGVHD (This does not include agents being prescribed expressly for the treatment of acute GVHD).
9. Receiving an investigational treatment within 28 days of study entry.
Observational Study of Analgesia and Cost-efficiency of Analgetic Medication Pumps (Zalviso and PCA-syringe Pump (PCA=Patient Controlled Analgesia)) After Urogenital Intervention at the Clinical Daily Routine

The observational study will check if there is a difference in the postoperative care of patients with urogenital intervention while using the standard PCA-syringe pump or using the Zalviso sufentanyl sublingual analgetic system.

The study will exactly examine, using questionaire for the patient, the medical stuff (nurses and anesthesiologist) the difference in the analgetic quality, the difference of the patients' mobility while being treated with one of the analgetic system and if there is a difference in the cost-efficiency.

We want to examine 50 Patients in each group. The studies should be finished in about one year.


Eligibility Criteria:
Inclusion Criteria:

* Patients after urological interventions with no indication of an periduralanästesia
* Patients compliant for a PCA system, and complied with the analysis of their data

Exclusion Criteria:

* F03 dementia
* F10.2 dependence syndrome alcohol
* F11.2 dependence syndrome opioids
* F12.2 dependence syndrome cannabinoids
* F13.2 dependence syndrome sedatives and hypnotics
* F14.2 dependence syndrome cocaine
* F15.2 dependence syndrome coffin
* F.16.2 dependence syndrome hallucinogens
* F22 schizophrenia
* F41.1 generalized anxiety disorder
Study to Evaluate the Efficacy of COVID19-0001-USR in Patients With Mild/or Moderate COVID-19 Infection in Outpatient

Determine the efficacy and safety of COVID19-0001-USR in the treatment of SARS-COV-2 infection in mild to moderate manifestations administered via nebulization/inhalation.

This is an interventional, randomized controlled, double-blind study (i.e., active and passive control), 1 intervention group will be randomized with COVID 19-001-USR, and a control group to receive a placebo intervention to assess efficacy, tolerance, and decrease viral load and clinical manifestation on patients infected with SARS-COV-2. This will be a self-administered study drug 3 times a day for 7 days

Eligibility Criteria:
Inclusion Criteria:

* Provide written consent before being included in the essay.
* Positive cases of COVID-19 (based on polymerase chain reaction or positive antigen test for SARS-CoV-2),
* Being diagnosed with mild to moderate SARS-COV-2 disease (COVID19)
* Symptomatic or asymptomatic patient, with good clinical appearance, Sat O2 at rest \> 94% with room air, and without desaturation with ambulation, and without tachypnea,
* Respiratory rate \< 20.
* Suspected cases of COVID-19, based on 3 criteria:

  * Fever \> 38 Degrees Celsius
  * O2 saturation ≤94
* Abnormal laboratory indicators, any of them:

  * Lymphopenia \<1500 cells/m3
  * C reactive protein \>2 mg/L
  * Ferritin \>300g/L

Exclusion Criteria:

* Existing decompensated conditions such as Diabetes Mellitus, Hypertension, Coronary Insufficiency, Coronary Artery Disease, Chronic Obstructive Pulmonary Disease (or any chronic or severe lung disease), Chronic Kidney Disease, Cancer, Immunosuppression, Mood Change
* Respiratory Frequency \> 20 / min, Pulse \> 120 bpm, systolic \< 90 mmHg, diastolic \< 60 mmHg
* The patient seems toxic and distressed, or, O2 at rest \<93% in ambient air, or desaturation when ambulating
* Being diagnosed with severe SARS-COV-2 disease (COVID19)
* Patients with low oxygen saturation levels, need for ICU entry, need or likelihood of invasive mechanical ventilation
* Patients requiring bronchodilator treatment
* Patients with a known history of asthma and/or lung disease
* Patients with severe decompensated Chronic Obstructive Pulmonary Disease
* Patients who are unable to give consent or who are unable to follow up on the test group will be excluded
Cognitive Outcomes After Brain Substructure-informed Radiation Planning in Pediatric Patients

The goal of this trial is to determine whether it is possible to minimize radiation dose to parts of the brain that are important for thinking and learning in children who require radiation to treat their tumor, and if this will help reduce neurocognitive (thinking and learning) impairments in these patients.

Patients with newly diagnosed brain or head and neck tumors who are having radiation therapy will have neurocognitive testing and MRI imaging (both research and for regular care) done as part of their participation in the study.

Survivors of childhood brain tumors who completed radiation therapy at least two years before joining the study, and have not had a recurrence, will have neurocognitive testing and research MRIs completed.

Healthy children will also be enrolled and have research MRIs done.

The researchers will use the radiation plan to determine how much radiation was delivered to different parts of the brain. The investigators will use the MRIs to determine how the normal brain is changing after treatment; and how this compares to patients who had standard radiation treatment or who never had a brain tumor. The neurocognitive testing will be compared among different groups to see how different treatment plans affect performance on neurocognitive tests.


Eligibility Criteria:
1. STRATUM A

   1. Eligibility Criteria

      * aged 1 to \<26 years of age
      * tumor must be located in the brain or adjacent to the brain including but not limited to nasopharynx, paranasal sinuses and orbit
      * treatment must include radiation therapy (either proton or photon)
      * patients must not have completed radiation therapy
   2. Exclusion Criteria

      * pregnancy
      * patients who are not able to undergo neuro-cognitive testing, including children lacking English comprehension or children with premorbid neurological/neurodevelopmental disorders such as Down's syndrome or autism
2. STRATUM B

   1. Eligibility Criteria

      * diagnosed with a brain tumor at \<26 years of age
      * received radiation to the brain as part of therapy
      * time from radiation start to study enrollment is ≥ 2 years
      * there has not been disease recurrence from time of most recent radiation treatment to study enrollment
   2. Exclusion Criteria

      * patients who are not able to undergo neuro-cognitive testing, including children lacking English comprehension or children with premorbid neurological/neurodevelopmental disorders such as Down's syndrome or autism
3. STRATUM C

   1. Eligibility Criteria

      * must be aged 5 to \<26 years of age
      * must be able to complete research imaging without sedation
   2. Exclusion Criteria

      * must not have any major psychiatric, neurologic or medical diagnosis
Endocrine Outcome of Surgery for Pituitary Adenoma

Prospective and randomized compare between microsurgical and endoscopic transsphenoidal MRI assisted resection of pituitary adenomas.

The main aim of the study is to compare microsurgical and endoscopic transsphenoidal surgery and to determine endocrine outcome. Secondary extent of resection and quality of life will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Suspected symptomatic or progressively growing pituitary adenoma
* Informed consent

Exclusion Criteria:

* Prolactinoma
* No follow-up possible
* Emergency surgery without informed consent or without intraoperative MRI
MAGE-A4ᶜ¹º³²T for Multi-Tumor

This study will investigate the safety and tolerability of MAGE-A4ᶜ¹º³²T cell therapy in subjects who have the appropriate HLA-A2 tissue marker and whose urinary bladder, melanoma, head and neck, ovarian, non-small cell lung, esophageal, gastric, synovial sarcoma, or myxoid/round call liposarcoma (MRCLS) tumor has the MAGE-A4 protein expressed. This study will take a subject's T cells and give them a T cell receptor protein that recognizes and attacks the tumors. This study has a substudy component that will investigate the safety and tolerability of MAGE-A4c1032T cell therapy in combination with low dose radiation in up to 10 subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Subject is ≥18 to 75 years of age at the time of signing the study informed consent.
2. Subject has histologically confirmed diagnosis of any one of the indicated tumor types
3. Subject is HLA-A\*02 positive. (This determination will be made under screening protocol ADP-0000-001).
4. Subject's tumor shows expression of the MAGE-A4 RNA or protein. (This determination will be made under screening protocol ADP-0000-001).
5. Adequate organ function as indicated in the study protocol
6. Subject has measurable disease according to RECIST v1.1 criteria prior to lymphodepletion
7. Subject meets disease-specific requirements per protocol

7. Subject has anticipated life expectancy \> 6 months prior to leukapheresis and \>3 months prior to lymphodepletion.

Exclusion Criteria:

1. Subject does not express appropriate HLA-A genotype
2. Subject is receiving excluded therapy/treatment per protocol
3. Subject has symptomatic CNS metastases.
4. Subject has any other active malignancy besides the tumor under study within 3 years prior to Screening. Subject has uncontrolled intercurrent illness.
5. Subject has active infection with HIV, HBV, HCV or HTLV
6. Subject is pregnant or breastfeeding.

Additional Exclusion Criteria for the Radiation Substudy:

* Subject does not meet eligibility criteria for the main study (ADP-0044-001).
* Subject does not have at least one target lesion amenable to radiation.
* Certain radiation therapy within 6 months of clinical trial are an exclusion.
* Metastatic disease impinging on the spinal cord or threatening spinal cord compression.