cyrilzakka/clinical-trials huggingface dataset:
Biospecimens for Identification of Diseases of the Pancreas.

This proposed project is designed to collect data and specimens from patients/subjects presenting to the University of Michigan with a disease affecting the pancreas (or specific control populations). This protocol is focused on collecting data, blood samples, and tissue on subjects with pancreatic diseases, including pancreatic cancer, pancreatic cysts, pancreatitis, diabetic controls, jaundice/biliary obstruction controls, and otherwise healthy controls.

We are collecting up to 50 mls of blood for research purposes only. Plasma, serum and buffy coat are collected and stored according to strict SOPs.

The recently funded GI SPORE, here at the University of Michigan, is focused on pancreatic and colon diseases. This protocol is focused on collecting data, blood samples, and tissue on subjects with pancreatic diseases, including pancreatic cancer, pancreatic cysts, pancreatitis, diabetic controls, jaundice/biliary obstruction controls, and otherwise healthy controls. A SPORE is an NCI-funded, Specialized Program in Research Excellence, with specific requirements. Those requirements include 4 projects with a clinical and a basic science Co-PI and several COREs, including a biospecimen core. Each project that has a human subjects component will require a separate protocol and IRB submission when those projects are to begin.

The specific populations we are recruiting are determined by the aims of project 2 and by the need to create a repository as part of the biospecimen core (please see the grant for details on the aims of these 2 projects).

A specially designed database is being built for this study to handle the data aspects. Our collaborators at Dartmouth College have significant experience in managing data as they have been our partners for our work in the EDRN (PI Brenner). Case report forms and other data collection tools have been developed and are being used to populate the database. All of the actual data will be completely deidentified per HIPAA regulations.

We intend to model the data and specimen collection on the model used by our work with the NCI-EDRN. This includes a customized database, the use of kits with pre-labled, bar-coded aliquots, and standardized data collection forms (CRFs).

Eligibility Criteria:
Inclusion Criteria:

Overall Inclusion (all subjects must meet these criteria to be enrolled)

* Adults 18 years of age or older
* Able to physically tolerate removal of 50 ml of blood
* Willing to sign informed consent.

Exclusion Criteria:Overall Exclusion (for all subjects)

* Pregnant or lactating
* Known HIV/AIDS or Hepatitis C
* Prepped for colonoscopy at the time of blood collection
* Unable to understand English
* Receiving chemotherapy or radiation at time of enrollment
* Any cancer within 5 years of enrollment except any of the following:

  * Squamous cell carcinoma of the skin or Basal cell carcinoma of the skin
  * Carcinoma in situ of the cervix, Stages Ia or Ib invasive squamous cell carcinoma of the cervix treated by surgery only. (Excluded if had pelvic radiation)
  * Stage Ia Grade 1 adenocarcinoma of the endometrium treated with surgery
IBI376 in Patients With Relapsed or Refractory Follicular Lymphoma/Marginal Zone Lymphoma

A Phase 2, Multicenter, Open-Label Study of IBI376, a PI3Kδ Inhibitor, in Patients with Relapsed or Refractory Follicular Lymphoma/Marginal Zone Lymphoma

Patients will be recruited for 2 cohorts. Cohort A will recruit 58 RRFL subjects, and Cohort B will recruit 62 RRMZL subjects.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 years or older.
2. Histologically confirmed, relapsed or refractory, follicular B-cell non-Hodgkin lymphoma (NHL) (FL) Grade 1, 2, and 3a or MZL.
3. Ineligible for hematopoietic stem cell transplant.
4. Definition of RRFL or RRMZL: Subjects should have received 2 or more prior therapies for FL/MZL included at least one regimen containing Rituximab. Subjects should be refractory to Rituximab or experienced disease progression after achieved remission or disease progression within 6 months since last therapy.
5. Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined as the presence of ≥ 1 lesion that measures \> 1.5 cm in the longest dimension and ≥ 1.0 cm in the longest perpendicular dimension as assessed by computed tomography (CT) or magnetic resonance imaging (MRI).
6. Subjects must be willing to undergo an incisional, excisional, or core needle lymph node or tissue biopsy or provide a lymph node or tissue biopsy from the most recent available archival tissue.
7. ECOG performance status 0 to 2.
8. Life expectancy ≥ 12 weeks.
9. Adequate hematologic, hepatic, and renal function.
10. Willingness to avoid pregnancy or fathering children.

Exclusion Criteria:

1 . Known histological transformation from indolent NHL to diffuse large B-cell lymphoma.

2. History of central nervous system lymphoma (either primary or metastatic).

3. Prior treatment with idelalisib, other selective PI3Kδ inhibitors, or a pan-PI3K inhibitor.

4. Prior treatment with a Bruton's tyrosine kinase inhibitor (eg, ibrutinib).

5. Allogeneic stem cell transplant within the last 6 months, or autologous stem cell transplant within the last 3 months before the date of study treatment administration.

6. Active graft-versus-host disease. 7. Subjects positive for hepatitis B surface antigen or hepatitis B core antibody will be eligible if they are negative for HBV-DNA. Subjects positive for anti-HCV antibody will be eligible if they are negative for HCV-RNA.
Prospective Study on Embolization of Intracranial Aneurysms With Pipeline™ Embolization Device

The purpose of this study is to assess the safety and effectiveness of the Pipeline™ device in the treatment of unruptured, wide-neck intracranial aneurysms.


Eligibility Criteria:
Inclusion Criteria:

1. Subject has provided written informed consent using the IRB/EC-approved consent form and agrees to comply with protocol requirements.
2. Age 22-80 years.
3. Subject has a target intracranial aneurysm (IA) located in the:

   1. Internal carotid artery (up to the carotid terminus) OR
   2. Vertebral artery segment up to and including the posterior inferior cerebellar artery
4. Subject has a target IA that is ≤ 12 mm.
5. Subject has a target IA that has a parent vessel with diameter 1.5-5.0 mm distal/proximal to the target IA.
6. Subject has a target IA with an aneurysm neck ≥ 4mm or a dome to neck ratio ≤ 1.5.
7. Subject has a pre-procedure PRU value between 60-200.

Exclusion Criteria:

1. Subject has received an intracranial implant (e.g. coils) in the area of the target IA within the past 12 weeks.
2. Subarachnoid hemorrhage in the past 30 days.
3. Subject with anatomy not appropriate for endovascular treatment due to severe intracranial vessel tortuosity or stenosis determined from baseline or pre-procedure imaging, or a history of intracranial vasospasm not responsive to medical therapy.
4. Major surgery in the last 30 days.
5. History of irreversible bleeding disorder and/or subject presents with signs of active bleeding.
6. Any known contraindication to treatment with the Pipeline™ device, including:

   1. Stent is in place in the parent artery at the target IA location
   2. Contraindication to dual antiplatelet therapy
   3. Relative contraindication to angiography (e.g., serum creatinine \>2.5 mg/dL, allergy to contrast that cannot be medically controlled).
   4. Known severe allergy to platinum or cobalt/chromium alloys.
   5. Evidence of active infection at the time of treatment (e.g., fever with temperature \>38°C and/or WBC \>1.5 109/L).
7. The Investigator determines that the health of the subject or the validity of the study outcomes (e.g., high risk of neurologic events, worsening of clinical condition in the last 30 days) may be compromised by the subject's enrollment.
8. Pregnant or breast-feeding women or women who wish to become pregnant during the length of study participation.
9. Participating in another clinical trial during the follow-up period that could confound the treatment or outcomes of this investigation.
Drug Interaction Study of ZYN002 Transdermal Gel and Probe Substrates

This study is an open-label drug-drug interaction (DDI) study of ZYN002 transdermal gel and multiple drugs.

This study is a Phase 1, open-label, 2-part, fixed-sequence, 3-period DDI study to evaluate the effect of ZYN002 transdermal gel on the pharmacokinetics (PK) of probe substrates and their metabolites. In addition, this study is designed to evaluate the safety and tolerability of ZYN002 transdermal gel after multiple-dose topical application to healthy adult participants.

Part 1 - DDI with probe substrates for cytochrome P450 (CYP)3A4, CYP2C19, CYP2C9, CYP2D6, CYP1A2 administered as single oral doses followed by the staggered dosing of probe substrates for CYP2C8 and for CYP2B6 administered as single oral doses.

Part 2 - DDI with valproate (valproic acid \[VPA\]), a probe substrate for β-oxidation and glucuronidation.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female adults, 18-55 years of age, inclusive, at the time of Screening.
2. Judged by the Investigator to be in generally good health at Screening based upon the results of a medical history, physical examination, 12-lead ECG, and clinical laboratory test results. Laboratory results outside of the reference range, but acceptable, must be documented as not clinically significant (NCS) at the discretion of the Investigator.
3. Participants must have a body mass index between 18 and 30 kg/m² at the time of Screening.
4. Females of childbearing potential must have a negative pregnancy test result at the Screening Visit and on Day -1 before admission to the CRU. Females who are not of childbearing potential are defined as being postmenopausal for \>=12 months or having a history of hysterectomy and/or bilateral oophorectomy and/or bilateral tubal ligation.

Exclusion Criteria:

1. A) Females who are pregnant, nursing or planning to become pregnant or females of childbearing potential, who are unwilling to use medically acceptable method of contraception or B) Males with a female partner who is pregnant, nursing, or planning to become pregnant or a female partner of childbearing potential who is unwilling to use a medically acceptable method of contraception.
2. Are homozygous for CYP2C19\*2 or heterozygous carriers of CYP2C19\*2/CYP2C19\*3 or CYP2C9\*2/CYP2C9\*3 or CYP2D6\*2/CYP2D6\*3 haplotypes categorized as poor metabolizers.
3. Has consumed alcohol 48 hours prior to Day 1 or during the study.
4. Has eaten any food or drink/beverage containing, grapefruit or grapefruit juice, apple, cranberry, Seville orange or orange juice, vegetables from the mustard family (e.g., kale, spinach, broccoli, watercress, collard greens, kohlrabi, brussels sprouts, parsley, mustard greens, endive, red cabbage, asparagus, or mustard), and chargrilled meats within one week prior to study start (Day -1).
Teen Health Choices & Wellness

The goal of this observational study is to learn more about changes in health, wellness, and substance-use behaviors as teenagers get older. Participants, ages 13 to 16, will be asked to use a smartphone application developed for this research study. Participants will also come to Brown University or meet via video conference to answer questions about specific behaviors, choices, and feelings that may change over time.


Eligibility Criteria:
Inclusion Criteria:

1. be age 13 to 16 years
2. engage in a target health behavior on at least one recent occasion
3. speak, read, and understand English or Spanish
4. live in or near Rhode Island

Exclusion Criteria:

1. lifetime history of moderate or severe substance use disorder or treatment, excluding nicotine use disorder
2. current psychotic symptoms or active suicidality (i.e., intent in the past 30 days)
Low Dose Aspirin in the Prevention of Preeclampsia in China

Preeclampsia is one of the three leading causes of maternal morbidity and mortality all over the world. The use of low dose aspirin has been mentioned in several studies with promising results. The investigators decided to evaluate the use of low dose aspirin in Chinese pregnant women, starting between 12+ and 20 weeks of pregnancy, based on clinical characteristics aiming to reduce the incidence of preeclampsia.

Detailed Description:

The investigators will conduct a randomized control trial to estimate the efficacy of low dose aspirin in preventing preeclampsia in Chinese pregnant women who are evaluated with risk factors. The investigators will also obtain biological specimen including maternal blood, cord blood, placenta specimen and etc. for basic science studies.

Rationale for Design:There is a lack of evidences or guideline of aspirin using in preventing PE for Chinese women. The investigators will conduct a randomized control trial, which is the 'gold standard' of research design, hoping to answer the question.

Eligibility Criteria:
Inclusion Criteria:

1. Gestational age between 12+ and 20 weeks of pregnancy
2. High risk of preeclampsia, based in clinical risk factors as:

   2.1 if they have one or more of the following risk factors： Preeclampsia in a previous pregnancy ,Diabetes Mellitus(Type 1 or 2),Chronic Hypertension .

   2.2 if they have two or more of the following risk factors: Pre-pregnancy Body Mass Index ≥28kg/m2, Elderly pregnancy(age ≥35 years), Mother or sisters with preeclampsia in a previous pregnancy, Primiparity or Famliy history (Mother or sister that developed preeclampsia in a previous pregnancy）.
3. Signed informed consent.

Exclusion Criteria:

1. Allergy to aspirin
2. Asthma
3. Peptic ulcers
4. Severe heart, liver, renal disease who can not burden the experiment
5. Rheumatic immune disease
6. Mental disease
7. Alcohol and drug abuse
8. Being in another drug experiment within 3 months
9. Difficult to follow-up
Impact of Increasing Levothyroxine Dose in Ramadan for UAE Patients With Hypothyroidism

The study aims to compare the mean change in Thyroid Stimulating Hormone (TSH) levels among patients with hypothyroidism treated with an increased dose of L-thyroxine (treatment group) versus standard/regular dose of L-thyroxine (control group) during the month of Ramadan.

The present study is an open-label, two-arm parallel groups, randomized controlled clinical trial that included Emirati patients with hypothyroidism who attended the Family Promotion Centre, Endocrinology Clinic, regularly. Eligible participants (n = 103) were randomly allocated to the treatment group (patients who received an increased dose of L-thyroxine, 25 mcg, n = 50) and the control group (patients who received standard/regular dose of L-thyroxine, n = 46). Both groups attended 5 visits before, during, and after Ramadan. Several tests were conducted including thyroid function, lipid profile, HbA1c, and Vitamin D.

Eligibility Criteria:
The inclusion criteria for participants will include:

1. Male and female patients with primary hypothyroidism.
2. Patients with stable TSH
3. Aged between 18 and 70 years.
4. Patients regularly fasting for at least 25- 30 days during Ramadan.
5. Emirati nationals (100% health care coverage)

Exclusion Criteria:

1. Patients with any end organ damage
2. Pregnant or Breast-feeding women
3. Thyroid cancer
4. Patients not adhering to initial thyroxine medications.
5. Those receiving proton pump inhibitory therapy, dietary fiber, bile acid sequestrates, ferrous sulfate, sucralfate, calcium carbonate, aluminum-containing antacids, phosphate binders, and raloxifene.
6. Disease interferes with thyroxine absorption, coeliac disease, inflammatory bowel disease, lactose intolerance as well as Helicobacter pylori (H. pylori) infection and atrophic gastritis,
7. Several other factors cause treatment failures such as fiber-rich food, soy protein, grapefruit, and aluminum antacids, which interfere with Thyroxine absorption. In addition to calcium carbonate and ferrous sulfate.
8. Patients were diagnosed with cardiovascular disorders, including angina, coronary artery disease, and hypertension.
Patient Education in Patients With Chronic Obstructive Pulmonary Disease (COPD) - Effect and Costs

The aim of this study is to determine the long term effect of a self-help group in a patient education program for patients with chronic obstructive pulmonary disease (COPD).

Pulmonary rehabilitation is aimed to increase the level of health of patients with COPD by increasing their self care ability. A recent updated systematic review concluded that evidence strongly supports respiratory rehabilitation as part of the spectrum of management of patients with chronic obstructive pulmonary disease (COPD). Studies of pulmonary rehabilitation programs lasting up to 18 months show that effects are mainly maintained throughout the duration of the program. The long term effect, however, is mostly studied for programs of shorter durations. Some of the studies with shorter duration have found that the achieved benefit was lost or diminished during the follow up period, while others have found that the effect has been maintained up to 18 months. Our necessity in the rehabilitative field is to find strategies to maintain benefits during time.

Eligibility Criteria:
Inclusion Criteria:

* (FEV1) lower that 75% of predicted
* the ability to participate in physical activity
* not been hospitalized the last month.

Exclusion Criteria:

* contraindications for physical activity
CPC in Adult Refractory Glaucoma

The purpose of this study is to assess the relative effectiveness and safety of diode laser cyclophotocoagulation procedure to reduce IOP and relieve pain in adult patients with refractory glaucoma.

A hospital -based, prospective interventional non comparative case series study.This study will be conducted on patients with refractory glaucoma whose ages are 18 years and older.They will be subjected to Transscleral Diode Laser Cyclophotocoagulation.

Postoperative evaluation will be scheduled for the first day postoperative, then 1 week later and then at 1st, 3rd, month postoperative.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion Criteria:

  1. Patients with refractory glaucoma aging 18 years and older.
  2. Both sexes are included.
  3. Patients Capable of giving informed consent.
  4. Pseudophkic glaucoma.
  5. Aphakic glaucoma.
  6. Silicon oil induced glaucoma.
  7. Neovascular glaucoma.
  8. Inflammatory glaucoma.

Exclusion Criteria:

1. Patients \<18 years of age.
2. Patients controlled on regular antiglaucomatous therapy.
3. Patients who cannot do regular follow up visits.
4. Diffuse scleral staphyloma at the site of CPC.
Study on All-Trans Retinoic Acid, Induction and Consolidation Therapy, and Pegfilgrastim After Consolidation Therapy in Younger Patients With Newly Diagnosed Acute Myeloid Leukemia

This trial is a study on all-trans retinoic acid in combination with induction and consolidation therapy as well as pegfilgrastim after consolidation therapy in younger patients with newly diagnosed acute myeloid leukemia (AML).

First Induction Therapy:

* Cytarabine 100 mg/m² cont. i.v. days 1-7
* Idarubicin 12 mg/m² i.v. days 1,3,5
* Etoposide 100 mg/m² i.v. days 1-3
* ± ATRA 45 mg/m² p.o. days 6-8
* ATRA 15 mg/m² p.o. days 9-21

Second Induction Therapy:

* Cytarabine 100 mg/m² cont. i.v. days 1-7
* Idarubicin 12 mg/m² i.v. days 1 and 3
* Etoposide 100 mg/m² i.v. days 1-3
* ± ATRA 45 mg/m² p.o. days 6-8
* ATRA 15 mg/m² p.o. days 9-21

Consolidation Therapy:

cohort 1 (\<= ID 336)

* Cytarabine 3 g/m² 2x/die i.v. Tag 1,3,5
* ± ATRA 15 mg/m² p.o. Tag 6-21
* Pegfilgrastim 6 mg s.c day 10

cohort 2 (\> ID 336)

* Cytarabine 3 g/m² 2x/die i.v. Tag 1,2,3
* ± ATRA 15 mg/m² p.o. Tag 4-21
* Pegfilgrastim 6 mg s.c day 8

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed AML defined according to the World Health Organization (WHO)-classification (excluding acute promyelocytic leukemia \[APL\])
* Ages 18-60 years
* Written informed consent of each patient at study entry.
* Molecular and cytogenetical diagnostics on initial bone marrow and peripheral blood specimen at the central reference laboratories

Exclusion Criteria:

* Bleeding independent of the AML
* Acute promyelocytic leukemia
* Uncontrollable infection
* Participation in a concurrent clinical study
* Insufficiency of the kidneys (creatinine \> 1.5x upper normal serum level), of the liver (bilirubin, AST or AP \> 2x upper normal serum level), severe obstructive or restrictive ventilation disorder, heart failure New York Heart Association (NYHA) III/IV
* Severe neurological or psychiatric disorder interfering with ability to give an informed consent.
* No consent for registration, storage and processing of the individual disease-characteristics and course.
* Performance status WHO \> 2
* Pregnancy
BETTY: BEnign Prostatic Hyperplasia Transperineal Targeted Microwave therapY

This is a pilot study on applying 3D-Ultrasound-Guided Transperineal Microwave needle ablation for men with symptomatic benign prostatic hyperplasia (BPH).

This is a prospective, single centre, open-label and non-comparative trial planned on 12 patients. Patients who fit inclusion criteria would be recruited and offered microwave ablation to the enlarged prostate. The patients will be closely followed up to 6 months after treatment with serial assessment on safety and efficacy.

Eligibility Criteria:
Inclusion Criteria:

* Age over 50 years.
* Benign prostatic hyperplasia with prostate size 30-80 cc
* IPSS ≥ 14
* PSA ≤ 4 ng/mL or PSA \>4 ng/mL with no evidence of suspicious lesion on mpMRI
* Maximum urine flow rate (Qmax) ≤ 15 mL/s.
* Post-Void Residual ≤ 150 mL.
* Patient suitable for IV sedation and/or spinal anaesthesia and/or general anaesthesia and focal microwave ablation.
* Informed written consent

Exclusion Criteria:

* Significant intravesical median lobe hyperplasia.
* Suspicious lesion on mpMRI prostate
* History of prostate, bladder or urethral surgery.
* History of prostate cancer
* Presence of stones, bladder diverticulum and/or bladder tumor
* History of long-term indwelling catheter.
* Urethral stricture
* Known coagulopathy or on anticoagulant
* Presence of a pacemaker.
* Active infection
* Dysuria due to bladder dysfunction.
* Serious medical illness, including any of the following: uncontrolled congestive heart failure, uncontrolled angina, myocardial infarction, cerebrovascular event within 6 months prior to the screening visit.
* Neurological disorders that would impact bladder function (e.g., multiple sclerosis, Parkinson's disease, spinal cord injury).
* Contraindications for mpMRI exam or MR contrast
* Acute and/or chronic renal failure (GFR \<50 ml/min and serum creatinine \> 1.5 mg/d).
* Patient currently participating in another interventional clinical trial.