cyrilzakka/clinical-trials huggingface dataset:
A Study of the Safety and Efficacy of SK-0503 for Diabetic Macular Edema

This study will evaluate the safety and efficacy of intravitreal implant of dexamethasone for the treatment of diabetic edema.


Eligibility Criteria:
Inclusion Criteria:

* Diabetic macular edema
* Criteria for visual acuity and macular thickness are met

Exclusion Criteria:

* History of glaucoma
* Known steroid-responder
* Use of systemic steroids
* Use of Warfarin/Heparin
* Other protocol-defined exclusion criteria may apply
Mirena Intrauterine System Timing of Insertion: A Randomized Controlled Trial

In order to determine the timing of LNG-IUS insertion that results in a greater proportion of women using the LNG-IUS at 6-months post-partum, we will perform a randomized control trial of interval versus immediate post-placenta insertion. Women will be enrolled at 36-weeks gestation and greater. At the time of vaginal delivery, women will be randomized to receive either immediate post-placenta insertion of the LNG-IUS or routine insertion at 4-8 weeks post-partum. All patients will return at 4-6 weeks post-insertion and 6 months post-partum to confirm correct position of the LNG-IUS. The primary outcome of this sub-study is the number of LNG-IUS in the correct position at 6-months. Secondary outcomes include assessing the safety of post-placental LNG-IUS insertion and difference in acceptability and symptoms experienced by participants. This is a sub-study of the Contraceptive Choice Project, a prospective cohort study that aims to improve the use of long-acting contraception by removing financial barriers which has already enrolled over 5,000 patients. Association of this study with CHOICE offers unique advantages including infrastructure to support subject recruitment, retention and completion of follow-up as well as covering the cost of LNG-IUS devices.

We hypothesize that, despite higher expulsion rates, women randomized to receive the LNG-IUS immediately after placenta delivery will have higher rates of LNG-IUS continuation due to poor rates of follow up in the interval insertion group. This is likely to be particularly noticeable in our patient population, which is largely uninsured with poor access to healthcare. Further, typical symptoms of LNG-IUS insertion include bleeding and cramping, which may be disguised by the post-partum period. Published reports of immediate post-placenta insertion focus on expulsion rates and do not report on symptoms and satisfaction rates.


Eligibility Criteria:
Inclusion Criteria:

* 14-45 years
* Vaginal Delivery at Barnes-Jewish Hospital
* Sexually active with male partner
* No tubal ligation/hysterectomy
* Not currently using contraception
* Desire reversible contraception
* Reside in St. Louis City/County
* Requests Mirena(R) intrauterine device for contraception

Exclusion Criteria:

* Allergy to Mirena(R) system
* Cesarean delivery
* Cervical cancer, breast cancer
* Active liver disease
* Untreated cervicitis
* Uterine anomaly/fibroids preventing Mirena(R) placement
* Delivery \<36 weeks
* Chorioamnionitis
* Prolonged rupture of membranes (\>18 hours)
The Treatment and Natural History of Acromegaly

The purpose of this study is to investigate the treatment and natural history of acromegaly. We have a longstanding interest in acromegaly treatment, and a cohort that has been followed for 30 years, or more in some cases. We will continue to follow patients and recruit new patients for treatment and follow-up. Blood and pituitary tumor tissue (when available through clinical care) will be saved for future analyses related to acromegaly.

The purpose of this study is to investigate the treatment and natural history of acromegaly. We have a longstanding interest in acromegaly treatment, and a cohort that has been followed for 30 years, or more in some cases. We will continue to follow patients and recruit new patients for treatment and follow-up.

Eligibility Criteria:
* INCLUSION CRITERIA:

Patients will be enrolled who are 18 years of age or over who are referred for care.
Value of Ondansetron Medication vs Inhaled Isopropyl Therapy in the Emergency Department (VOMIITED)

This study will compare two different ways to relieve nausea and vomiting in the Emergency Department. The usual treatment for nausea/vomiting is a drug called Zofran, but new studies have suggested that smelling alcohol pads can also help to relieve nausea and vomiting.

Emergency physicians commonly use medications to alleviate nausea and vomiting. The medication Ondansetron is used in the emergency department and after surgery for this purpose. Inhaled isopropyl alcohol has been successfully used to decrease nausea and vomiting after surgery. No trial has compared inhaled isopropyl alcohol to Ondansetron in a clinical trial.

The author proposes to prospectively investigate extension of the established antiemetic efficacy of inhaled isopropyl alcohol for undifferentiated nausea in Emergency Department patients to the 30-minute post-intervention point that has been reported to be the frequent juncture of symptom relief. By introducing prolonged intervention, and re-dosing of established benefit, into this research, the author aims to reproduce the sustained antiemetic efficacy of inhaled isopropyl alcohol for undifferentiated nausea as demonstrated for post-operative nausea and vomiting.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-65 years presenting to the emergency department complaining of current nausea with or without episodes of emesis beginning within the previous 24hrs

Exclusion Criteria:

* Patients with known allergy to isopropyl alcohol
* Patients outside of the defined age range
* Patients with an inability to inhale through the nares (including recent upper respiratory infection)
* Patients greater than 20 weeks estimated gestation
* Patients with past medical history of gastroparesis, or hemoptysis
* Patients who have taken an antiemetic medication in the past 48 hours
* Patients demonstrating hemodynamic instability with systolic blood pressure \<90 or tachycardia \>120 bpm
Low Dose Treosulfan Based Conditioning Regimen and PTCy in HSCT for Nijmegen Breakage Syndrome

The aim of the current study is to evaluate the safety and efficacy of low dose treosulfan based conditioning regimen in HSCT with post-transplant cyclophosphamide in Nijmegen breakage syndrome

Nijmegen breakage syndrome (NBS) is a DNA repair disorder. The only curative option for combine immunodeficiency in NBS is allogeneic hematopoietic stem cell transplantation (HSCT). Standard myeloablative conditioning regimens in DNA repair disorders lead to increased morbidity and mortality after HSCT. Low doses of alkylators are used to reduce toxicity rates, which, however, increase the risks of mixed chimerism and graft failure. The data of treosulfan usage in NBS are sparse. To evaluate the safety and efficacy of low dose treosulfan based conditioning regimen in NBS, treosulfan 21g/m2 in combination with fludarabine 150mg/mg, thymoglobulin (Genzyme) 5mg/kg and rituximab 100mg/m2 will be used from day -6 to -1 day, followed by stem cell infusion and post-transplant cyclophosphamide 25mg/kg/day (+3,+4 day) for GVHD prophylaxis. The primary endpoint is event-free survival, where graft failure, death, and malignancies are considered as events.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged ≥ 3 months and \< 21 years
2. Patients diagnosed with NBS eligible for an allogeneic HSCT
3. Signed written informed consent signed by a parent or legal guardian
Gemcitabine, Infusional 5 Fluorouracil and Bevacizumab in Patients With Advanced Pancreas Cancer

This is a phase II study of biweekly (every other week) bevacizumab followed by gemcitabine then infusional 5-fluorouracil in patients with stage III or IV pancreatic cancer. Patients' response will be evaluated every 8 weeks using usual CT scanning techniques. RECIST (Response Evaluation Criteria in Solid tumors) criteria will be applied to evaluate response. Tumor marker levels (Ca 19-9) will be assessed every 4 weeks, but will not be used to measure response.

Rationale: Research indicates that the vascular endothelial growth factor (VEGF), or a substance made by cells that stimulates new blood vessel formation, plays an important role in the growth and metastasis of many cancers, including pancreatic carcinoma. Both VEGF and its receptors are overexpressed in pancreatic cancer. Bevacizumab works by blocking VEGF and the growth of cancer cells in the process. The current study combines bevacizumab with two commonly used pancreatic cancer drugs, gemcitabine and infusional 5-FU. Previous studies indicate that bevacizumab combined with other anti-cancer drugs such as 5-FU improves patient survival. In addition, other research suggests that the drug administration schedule of the current study may improve patient outcomes compared to other types of administration and sequencing.

Purpose: The primary objective of this study is to assess the rate of progression free survival at 6 months in patients with advanced pancreatic cancer given gemcitabine, infusional 5-FU, and bevacizumab. Secondary objectives of this study include measuring response rates, 6 month and 1-year survival rates, and median overall survival.

Treatment: Study participants will be given bevacizumab, gemcitabine, and 5-FU. These drugs will be administered through intravenous infusions in that order every other week on days 1 and 15. Treatments will be given in 28-day cycles. Participants will therefore receive study drugs during weeks 1 and 3, and then receive no study drugs during weeks 2 and 4. Imaging exams will be performed every 8 weeks to assess disease size. Several other tests will be given throughout the study to closely monitor patients. Tumor level markers will be assessed every 4 weeks, but will not be used to measure response. Study treatments will be discontinued due to disease growth or severe adverse effects.

Eligibility Criteria:
Inclusion Criteria:

* Males or females age \>=18 years.
* Established histological confirmation of adenocarcinoma of the pancreas.
* Stage III and stage IV will be allowed.

Exclusion Criteria:

* No prior chemotherapy or radiotherapy allowed except for that given as part of an adjuvant regimen if \>4 weeks have elapsed since the end of therapy. Any prior treatment with antibodies to VEGF.
* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to starting the study.
* Pregnant or lactating women.
A Study of Evorpacept (ALX148) With Enfortumab Vedotin for Subjects With Urothelial Carcinoma (ASPEN-07)

AT148007 is a Phase 1, open-label, multicenter, safety, pharmacokinetic, pharmacodynamic study of ALX148 in combination with enfortumab vedotin and/or other anticancer therapies in subjects with urothelial carcinoma.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed, unresectable locally advanced or metastatic urothelial carcinoma.
2. Must have received prior treatment with an immune checkpoint inhibitor (CPI).
3. Subjects must have received prior treatment with platinum-containing chemotherapy.
4. Subjects must have had progression or recurrence of urothelial cancer.
5. Subjects must have measurable disease according to RECIST (Version 1.1).
6. Adequate bone marrow function.
7. Adequate renal function.
8. Adequate liver function.
9. Adequate Eastern Cooperative Oncology Group (ECOG) performance status.

Exclusion Criteria:

1. Preexisting sensory or motor neuropathy Grade ≥2.
2. Presence of symptomatic or uncontrolled central nervous system (CNS) metastases.
3. Prior treatment with enfortumab vedotin or other monomethylauristatin (MMAE)-based antibody-drug conjugate (ADCs)
4. Prior treatment with any anti-CD47 or anti-signal regulatory protein-α (SIRPα) agent.
5. Known active keratitis or corneal ulcerations. Subjects with superficial punctate keratitis are allowed if the disorder is being adequately treated.
6. History of uncontrolled diabetes mellitus within 3 months of the first dose of study drug.
Remote Monitoring in Parkinson's Disease

The goal of this observational study is to learn about the usefulness of physical activity measures and tremor detection using wearable devices and smartphone video to detect and evaluate disease burden in people with Parkinson's disease.

Participants will wear an activity tracker at home and complete a short research visit where they will make a video using a smartphone of themselves performing a fine motor task. They will wear the activity tracker for two weeks at home.

For all groups (there is no control group):

At enrollment, the participants will complete a baseline survey that records participant sex, years since the diagnosis of Parkinson's disease, current use of levodopa medication, and whether levodopa was taken today.

Next, a research nurse from neurology will complete the Unified Parkinson's Disease Rating Scale (UPDRS) assessment. As part of this assessment, the researchers will make a video recording of Part 3 (the motor assessment) as a gold standard for comparison with the participant-recorded videos.

Next, the participant will complete the PDQ-39 (Parkinson's disease questionnaire), a 39 item questionnaire about the quality of life.

After completing the PDQ-39, the researchers will provide the participant with a camera, small tripod, and a set of written directions about how to perform the UPDRS motor assessment. The goal with this task is to simulate a home recording session to uncover any issues and create preliminary data for validation of the home recording compared to the gold standard collected by the study team. The recordings will then be converted to x, y, z landmarks using MediaPipe, running on UIowa hardware.

After completing the video, the participant will complete a short survey about ease of making the video recording.

After completing the baseline assessments, the research team will provide the participant with a Fitbit Inspire 3 activity tracker watch, configure the tracker to sync with their phone, and provide an overview of use.

The participant will wear the activity tracker for 24 hours a day for the next 14 days except for if the device needs charging and when bathing.

At 14 days, the research team will send participants a link to complete a web-based exit survey about their experience with the activity tracker during the study.

Eligibility Criteria:
Inclusion Criteria

* Diagnosis of PD
* Current patient at UIHC Movement Disorders clinic
* Owns a smartphone that is compatible with a activity tracker.

Exclusion Criteria

* Non-English speaking
* Bedridden or uses a wheelchair the majority of the time
* Prisoner status
* Inability to provide own informed consent
Prognostic Value of Confocal Endomicroscopy in Ulcerative Colitis: the CONF-UC Study

This study employs a prospective, single-center, interventional design to investigate the prognostic value of confocal endomicroscopy in assessing treatment response in ulcerative colitis (UC) patients receiving small molecules .

The study incorporates confocal endomicroscopy as an additional diagnostic modality for assessing barrier dysfunction and treatment response in UC patients. Confocal endomicroscopy enables real-time visualization of mucosal changes at a cellular level during endoscopy, potentially enhancing the detection of treatment response and mucosal healing.

Eligible patients will undergo baseline assessment, including clinical evaluation, partial Mayo score calculation, endoscopic evaluation, biopsies with histological evaluation and confocal endomicroscopy. Follow-up assessments will be conducted at 8 weeks and 6 months after initiating therapy with small molecules .

The study aims to enroll a sample size of 26 UC patients to pilot the feasibility and utility of confocal endomicroscopy in assessing barrier dysfunction and treatment response.

Eligibility Criteria:
Inclusion Criteria:

1. Established diagnosis of UC since at least 12 weeks prior to inclusion
2. Age ≥ 18 years
3. Any gender/sex
4. Active disease consistent with indication to start with Small molecules (defined as Mayo endoscopic score (MES) ≥ 1, partial Mayo score ≥ 3 (with at least rectal bleeding score of 1 and bowel movements score of 1)
5. No contraindications to endoscopy or confocal exam
6. Ability to understand and to comply with the study procedure and sign an informed consent form

Exclusion Criteria:

1. Subjects with an endoscopic Mayo sub-score at baseline \&lt;2;
2. Pregnancy
3. Subjects with any contraindication to any study procedure (included fluorescein allergy).
Health Related QOL, Depression and Lifestyle Changes in Insulin Resistant Adolescents

The purpose of this study is to assess adolescents with Insulin Resistance Syndrome for quality of life and altered health related issues.

Matched historical control study designed to examine outcomes on insulin resistant adolescents who were treated in the Insulin Resistance Syndrome Clinic at Children's Mercy Hospital in the past year. New patients will be screened at baseline, 4 and 12 months to evaluate if there is improvement in the BMI Z-score, HgA1c, lipid profile or waist circumference when depression and/or altered health related quality of life are identified and treated in this population.

Eligibility Criteria:
Inclusion Criteria:

* Patients 11-17 years of age who are seen in the Insulin Resistance Clinic for the first time
* Historical control: Patients 11-19 years of age seen in the Insulin Resistance Clinic during the prior four months

Exclusion Criteria:

* Co-morbid syndrome (Downs, Turner's, Prader Willi etc)
* Diagnosis of Type 2 Diabetes
* Taking Metformin before the initial visit
* Taking medication for or diagnosis of a psychiatric condition prior to initial visit
* Developmentally delayed
TriClip CED RWE Study

This Coverage with Evidence Development (CED) study evaluates the long-term health outcomes of patients with symptomatic, severe or greater Tricuspid Regurgitation who received a Tricuspid Transcatheter Edge-to-Edge Repair (T-TEER) procedure using the TriClip system.

The TRICARE will assess 2-year effectiveness in patients with symptomatic, severe or greater TR who undergo Tricuspid Transcatheter Edge-to-Edge Repair (T-TEER) with the TriClip system, as compared to a contemporaneous control of patients without T-TEER.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years of age at time of implant
* Patients with symptomatic, severe or greater Tricuspid Regurgitation who have received the TriClip system (treatment group) or have not undergone T-TEER (control group)

Exclusion Criteria:

* Patients with less than severe Tricuspid Regurgitation
* Patients with a prior history of surgical or transcatheter tricuspid valve replacement
* Patients with a surgical or transcatheter aortic or mitral valve intervention prior to index
Treatment of Recent Onset Low Back Pain With Periradicular Injections of Meloxicam

This randomized, double-blind, placebo control, cross-over study tested the hypothesis that periradicular injections of Meloxicam would reduce recent onset low back pain and improve physical activity compared to saline injection at 3 months follow-up evaluation

In the present study we use a well-known non steroidal anti-inflammatory drug, meloxicam, in a novel way, an IM administration near a nerve root.

Eligibility Criteria:
Inclusion Criteria:

* low back pain from 6 months or less
* older than 18 years

Exclusion Criteria:

* not able to understand and sign the written informed consent
A Study of Recombinant Human Growth Hormone Injection（JINTOPIN AQ）for Short Children With Small for SGA

To preliminary assess the efficacy and safety of recombinant human growth hormone injection on the treatment of small for gestational age (SGA), and determine the best dose.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of small for gestational age, SGA.
* Chronological age between 2-6.5 years in girls and 2-7.5 years in boys. Both genders.
* Prepubertal stage (Tanner I).
* Without catch-up growth in two years after birth.
* Height was lower than the mean -2SD of the values of normal children of the same age and gender when participating in the study.
* A GH peak concentration \>10µg/L in a provocative test within a year before participate in the study.
* Bone age\<Chronological age+1.
* Normal glucose regulation：Fasting blood-glucose \< 5.6mmol/L and 2-hour postprandial blood glucose\< 7.8mmol/L.
* Gestational age≥Gestational age≥ 36weeks + 4days.
* Never accepted growth hormone treatment.
* The subjects and their guardians signed informed consent.

Exclusion Criteria:

* Subjects with Liver and renal insufficiency (ALT \> 2 times of upper limit of normal value, Cr\> upper limit of normal value).
* Patients with positive for antibodies to hepatitis B core (anti-HBc), hepatitis B surface antigen (HBsAg) or hepatitis B e antigen (HBeAg)。
* Known highly allergic constitution or allergic to the test drug.
* Subjects with diabetes, severe cardiopulmonary and pulmonary disease, and hematological diseases, malignant tumors, or systemic infection, immunocompromised patients and patients with psychosis.
* Subjects with other types of abnormal growth and development, such as Turner syndrome, constitutional delay of puberty, Laron syndrome, growth hormone receptor deficiency.
* Subjects who have received the treatment of Somatropin or took part in other clinical trial study within 3 months.
* Other conditions which in the opinion of the investigator preclude enrollment into the study.
Hemorrhagic Brainstem Cavernous Malformations Treatment With Sirolimus: aSingle Centre, Randomized, Placebo-controlled Pilot Trial

The aim of this pilot phase trial is to assess the safety and tolerability, and estimate the efficacy of sirolimus in reducing the incidence of ICH during high-risk periods for rebleeding, compared to placebo. This pilot trial will inform the design of a future definitive clinical trial on sirolimus treatment for CCM.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-65 years, any gender;
2. Patients who have experienced their first symptomatic BSCM ICH within the six months before randomisation;
3. Diagnosed with solitary BSCM through T2, GRE/T2\*, or SWI MR imaging;
4. ICH within or around the BSCM confirmed by CT /MR;
5. Capable of signing an informed consent form with the accompaniment and understanding of a guardian.

Exclusion Criteria:

1. Cancer history;
2. Pregnancy or lactation;
3. Sirolimus/starch allergy;
4. Modified Rankin Scale (mRS) score 5, respiratory failure or currently severe bleeding requiring life support treatment;
5. Abnormal liver and/or kidney function (transaminase levels greater than 50, creatinine greater than 110), abnormal white blood cell/platelet counts (white blood cell count below 3.5 or above 9.5 x 109/L or exceeding normal values, platelet count below 100 or above 300);
6. History of previous immunosuppressive therapy;
7. History of prior surgical intervention for CCM ;
8. History of prior cranial radiation therapy ;
9. Familial CCM or people with multiple CCM;
10. Patients with concurrent acute active infections (e.g., severe bacterial, viral, or fungal infections);
11. Uncontrolled diabetes mellitus;
12. Currently participating in another clinical trial;
13. Patient unwilling/unable to undergo MRI.
14. Co-administration of drugs affecting CYP3A4 enzymes (ketoconazole, voriconazole, itraconazole, telithromycin, clarithromycin).