cyrilzakka/clinical-trials huggingface dataset:
Feasibility Study of a Chronic Retinal Stimulator in Retinitis Pigmentosa

The objective of this study is to evaluate the safety and efficacy of the retinal stimulation system by evaluating the data after chronic implantation.

The chronic retinal stimulation system is an implantable electronic device designed to provide electrical stimulation of the retina in order to elicit visual percepts in blind subjects.

This chronic feasibility study will evaluate the ability of subjects to resolve multiple percepts and patterns under various stimulus conditions and optimize the effectiveness of electrical stimulus parameters with an initial chronic design.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed history of retinal degenerative disease in the worse seeing eye with remaining vision no better than light perception. The fellow eye can have any visual acuity but must have better vision than the eye that will have the surgery.
* History of former useful form vision in worse-seeing eye
* Acceptable ability to describe visual percepts
* Age eighteen (18) or older

Exclusion Criteria:

* History of glaucoma
* Optic neuropathy or other confirmed damage to optic nerve or visual cortical damage
* Presence of communicable disease/infection
* Pregnancy
* History of claustrophobia
* Inconsistent flash detection thresholds
* Any other diseases that can effect the function of the retina
* Subjects with a Beck Depression Inventory Interpretation score of \>30 and subsequent diagnosis of depression by a psychiatrist.
* Corneal degeneration
Characterization of Circulating Tumor Cells (CTC-s) in Patients With Locally Advanced or Metastatic Stage IV Breast Cancer

The purpose of this study is to identify tumor cells in the bloodstream (Circulating Tumor Cells, CTC's) from patient's with locally advanced or metastatic (stage IV) breast cancer. Analyzing the tumor is helpful in guiding therapy; however, research has suggested that the number of tumor cells found in the bloodstream (CTC's) signifies more aggressive behavior and increased difficulty in eliminating the cancer. This research will help to develop better ways to treat breast cancer which could be tailored to a patient and may be adjusted to a patient's individual needs.

Up to 60 mL of blood will be collected from each patient at up to 6 time points. Samples will be delivered to the Bruce Laboratory (Palo Alto Research Center) for immunolabeling and FAST scanning. The FAST scanning will utilize CK+, CD45-and DAPI+ labeling as well as cell morphology confirmed by collaborating pathologists to select for CTC with the technology allowing for assessment of up to four additional protein expressions on the surface of CTC's. Additional samples at the proposed time points will be placed on ice and sent over to the Wang Laboratory for the purpose of extracting RNA/microRNA and proteins from CTC's for profiling and further analysis. Benefits are only to society, not the individual. Knowledge obtained from applying the two technologies may help with better selection of therapy, early detection of progression, possibly better diagnosis and development of targeted therapeutic agents in the future.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be \> 18 years old.
* Patients are being treated for breast cancer at City of Hope (COH).
Endomina Diverticulum

Esophageal diverticulum is a rare disease. Majority comes form the pharyngo-esophageal junction (70 % Zenker's Diverticulum), 10% are mediothoracic and 20% epiphrenic. Zenker's diverticulum is well treated with endoscopy (efficacy around 80%, complications around 5%) (1). For medio or epihrenic diverticulum, the classic treatment is surgery (diverticulectomy with or without anti-reflux surgery) but is associated with 33% morbidity and 9% mortality (2). Recently another technique involving magnet was described (3). Five patients were treated with success.

Considering the surgical risk, other techniques need to be evaluated. Using the Endomina device, sutures can be apposed between the foot of the diverticulum and the esophageal lumen. If necessary the bridge between the diverticulum and the esophagus can be cut with needle knife as described in Zenker's diverticulum treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Symptomatic medio or epiphrenic diverticulum.
2. Age between 18-80 years;
3. Must be able to comply with all study requirements for the duration of the study as outlined in the protocol. This includes complying with the visit schedule as well as study specific procedures such as: clinical assessment, endoscopy, radiography, as well as laboratory investigations;
4. Must be able to understand and be willing to provide written informed consent;
5. Must live within 75 km of the treatment site;

Exclusion Criteria:

1. Achalasia and any other esophageal motility disorders.
2. Severe esophagitis
3. Gastro-duodenal ulcer
4. Severe renal, hepatic, pulmonary disease or cancer;
5. GI stenosis or obstruction;
6. Pregnancy, breastfeeding or willing to become pregnant in the coming 18 months;
7. Anticoagulant therapy;
8. Currently participating in other study
Effect of Bariatric Surgery on Gut Hormones Production and Cure of Type 2 Diabetes Mellitus

Type 2 diabetes mellitus (T2DM) is a relevant public health problem and obesity has been associated as the major risk factor. Roux-en-Y gastric bypass is an effective method to treat severe obesity, and its metabolic benefits can lead to early and complete remission of T2DM, even before a considerable weight loss. We have hypothesized that intestinal anatomic changes may change intestinal genes expression related to glycemic control. The knowledge of mechanisms mediating the glycemic control after Roux-en-Y gastric bypass and it site of action in bowel may eventually help to develop alternative, less invasive and safer surgery for the treatment of T2DM, as well as drug development for the newly targets identified.


Eligibility Criteria:
Inclusion Criteria:

Type 2 diabetes mellitus (T2DM) diagnosis Duration of T2DM \>5 years Use of oral antidiabetic agents Body Mass Index \>40 kg/m2 Candidates to Roux-en-Y gastric bypass

Exclusion Criteria:

Type 1 diabetes mellitus or non-diabetics Use of insulin Thyroid diseases Candidate to other surgery technique Body Mass Index \<40 kg/m2 Presence of bacterium H. Pylori
Role Of Colposcopy In Evaluation Of Suspicious Cervix

do colposcopy and cervical punch biopsy then compare between findings

The aim of this study is to correlate colposcopy and histopathological findings in early screening of suspicious cervix and cervical cancer. And to do a colposcopic evaluation of all cervical lesions and the early detection of all cervical precancer and invasive lesions of the cervix in symptomatic women.

Eligibility Criteria:
Inclusion Criteria:

* Age from 30 to 64 years old.
* Women with symptoms such as white discharge, post-coital bleeding, and intermenstrual bleeding.
* Women with the clinically unhealthy cervix (erosion, bleeding on touch, simple leukoplakia, keratinization)
* Women with Pap smear showing dysplasia

Exclusion Criteria:

* Pregnant women
* Women having active vaginal bleeding.
* Any past treatment for cervical lesions.
* Women having frank growth of cervix.
* Women who underwent a hysterectomy.
The Relationship of Critical Shoulder Angle With Proprioception and Disability

With this study it will determined that the effect of critical shoulder angle which will be obtained from the MRI images of patients with Subacromial Impingement Syndrome on proprioception and disability level.

Critical shoulder angle (CSA) is defined as the intersection angle between two lines which are drawn from inferior border of glenoid cavity to superior border of glenoid cavity and from inferior border of glenoid cavity to inferolateral border of acromion. Higher CSA is accepted a predisposing factor for degenerative shoulder diseases. Increase in CSA means more shear forces reflects on shoulder joint which also causes overload on the RC tendon. Increase of degeneration in shoulder joint may cause decreased proprioception. As a result of degeneration, the level of disability will be increased. At the end of this study, the relationship among critical shoulder angle, proprioception and disability could be more clearly interpreted.

Eligibility Criteria:
Inclusion Criteria:

* Being between 25-70 years of age.
* Being Level I-II Subacromial Impingement
* Having shoulder pain for 3 months.

Exclusion Criteria:

* Having a shoulder operation before.
* Having Cardiovascular, Rheumatological or Neurological Disease
* Having Cervical Spine Disease
* Having Physiotherapy Treatment in last 6 months.
* Having a trauma, fracture, total Rotator Cuff rupture, Frozen Shoulder on shoulder joint
Transdiagnostic Internet-delivered Intervention for Adolescents With Anxiety and Depression

The goal of this clinical trial is to test the efficacy of a transdiagnostic Internet-delivered interventions for Romanian adolescents with anxiety and/ or depression. The main questions it aims to answer are:

* What is the clinical efficacy of the Internet-delivered intervention?
* How accurate is the prediction model in predicting who will respond to treatment? Participants will undergo non-invasive fMRI to measure variability in brain signal as a proxy of the neural systems' adaptability before receiving the intervention, then they will be allocated either to the Internet-delivered intervention or control group.

To the best of investigators' knowledge, this is the first clinical trial conducted with adolescents diagnosed with anxiety/and or depressive disorders that tests the accuracy of a prediction model based on fMRI to investigate participants' response to a transdiagnostic Internet-delivered intervention.

Eligibility Criteria:
Inclusion Criteria:

* elevated symptoms of anxiety or depression/ internalizing problems (T score\> 60) at intake (based on Youth self-report completed by adolescents)
* primary diagnosis of an anxiety/depressive disorder based on DSM-5 criteria according to ADIS-5-C/P interview
* age 13-17
* able to read and understand Romanian language
* Currently unmedicated or on stable and adequate doses of medication for at least 6 weeks before treatment onset
* Internet access

Exclusion Criteria:

* severe mental disorder (psychosis, severe depression, bipolar disorder, based on clinical interview)
* any condition that interferes with the protocol implementation (e.g., physical illness or sensory impairment that interferes with behavioral tasks such as exposure, behavioral activation, unavailable for the next 3 months),
* active suicidal ideation (assessed by child psychiatrist during clinical interview) in the last month
* currently following CBT/ psychotherapy for anxiety/depression, in the last 6 months
* fMRI incompatible (based on safety questionnaire)
* Being diagnosed with an intellectual disability, pervasive developmental disorder, an alcohol and/or substance dependence disorder, reading disabilities (based on clinical interview).
* Current treatment with benzodiazepines
Acceptability and Feasibility of a Simplified Medical Abortion Service Delivery in Western Ukraine

The study will examine how a simplified outpatient medical abortion procedure using mifepristone and misoprostol, with the option to take mifepristone at a place of woman's choosing, works in Ukraine. The investigators intend to demonstrate the efficacy of oral administration of 200 mg mifepristone and buccal administration of 800 mcg misoprostol with gestations through 70 days, as well as the acceptability of this method.


Eligibility Criteria:
Inclusion Criteria:

* Have an intrauterine pregnancy consistent with gestational age less than 71 days;
* Be able to understand and willing to sign a consent form;
* Be eligible for medical abortion according to the clinician's assessment;
* Be able to return to the clinic and able to contact study staff or emergency medical services, if needed;
* Be willing to provide an address and/or telephone number for purposes of follow-up;
* Agree to comply with the study procedures and visit schedule.

Exclusion Criteria:

* Confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass;
* Chronic renal failure;
* Concurrent long-term corticosteroid therapy;
* History of allergy to mifepristone, or misoprostol or another prostaglandin;
* History of hemorrhagic disorders or concurrent anticoagulant therapy;
* History of inherited porphyrias;
* Intrauterine device in place (must be removed before mifepristone is administered).
Antihelminthic Therapy Combined With Antimony in the Treatment of Cutaneous Leishmaniasis

The purpose of this project is to investigate the efficacy of early, empiric anti-helminthic therapy combined with standard pentavalent antimony in the treatment of subjects co-infected with helminths and cutaneous leishmaniasis caused by L. brasiliensis. The study hypothesis is that early intervention with antihelminthic therapy will improve response rates to antimony in subjects with cutaneous leishmaniasis.

Leishmaniases are a group of diseases caused by a parasite and transmitted by the sand fly. There are a number of diseases associated with infection ranging from simple skin lesions to a severe, fatal form. The standard treatment of cutaneous leishmaniasis (CL) is a 20 day course of antimony which, although fairly effective, has multiple side effects and is difficult to administer. The populations that are affected by leishmaniasis are usually also affected by intestinal helminths (worms). It is unknown what effect these two diseases have on each other and the immune system. As pathology in CL is mediated by an inflammatory reaction and helminths down regulate inflammation, helminthic infection may be beneficial for leishmaniasis. However, a recent study by our research group suggested that subjects infected with both leishmania and helminths have longer healing times and are less likely to respond to antimony. Since failure of initial therapy often results in repeat courses of the drug or development of more severe disease, we propose a study to investigate the role of early treatment for co-existing helminth infections in improving response rates to antimony in subjects with CL.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with a diagnosis of CL based on the presence of typical skin lesions and a positive Montenegro skin test
* Evidence of helminthic infection by parasitological examination of first stool sample
* Males or females between 13 and 50 years of age
* Maximum of 3 ulcers with no more than 2 body regions involved
* Period of 15 to 60 days from the onset of the first ulcer
* Subject agreement to follow-up visits and therapy
* Ability to give informed consent

Exclusion Criteria:

* Pregnancy
* Breastfeeding mothers
* Presence of mucosal disease
* History of prior treatment with antimonial drugs.
* History of prior treatment with anthelminthic drugs within the last 6 months.
* History of allergy to pentavalent antimony or antihelminthic
* Presence of underlying disease which affects the immune response, such as HIV and diabetes mellitus
Study Evaluating the Equivalence of GDC-229 and Metronidazole Vaginal Gel 0.75% in the Treatment of Bacterial Vaginosis

This research study is being done to compare the safety and efficacy of GDC-229 (test drug) against the currently marketed reference drug (metronidazole 0.75% vaginal gel) and to establish that these two drugs work better than placebo in subjects with BV.


Eligibility Criteria:
Inclusion Criteria:

1. Non-pregnant female aged ≥ 18 years who is in good general health
2. Diagnosis of BV
3. Willing to refrain from using any intravaginal product (e.g., spermicide, tampon, douche, feminine deodorant spray, diaphragm, vaginal ring birth control, or condom with spermicide or insertion into the vagina of any drug or non-drug product during treatment), other than study treatment for the duration of the trial
4. Subjects of childbearing potential who have a negative urine pregnancy test at the Entry Visit (Visit 1) and agree to use an acceptable form of birth control throughout the study
5. Able to understand and willing to sign the informed consent form (ICF) and able to comply with the requirements of the protocol

Exclusion Criteria:

1. History of alcohol or substance abuse
2. Experienced a clinically significant medical event within 90 days
3. Abnormal pap or high risk human papillomavirus (HPV)
4. History or presence of clinically significant central nervous system (CNS), cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, gynecologic, dermatologic, neurologic, oncologic, or psychiatric disease
5. Pregnant, lactating, or planning to become pregnant or breastfeed during the study period
6. Primary or secondary immunodeficiency
7. Evidence of any vulvovaginitis at screening other than BV
8. History of hypersensitivity or allergy to metronidazole, parabens, other nitroimidazole derivatives, or other ingredients of the GDC 229 (metronidazole 0.75% vaginal gel), metronidazole 0.75% vaginal gel (Oceanside Pharmaceuticals), or vehicle gel
9. Participating in another clinical trial
Parenteral Antiplatelet Agents in Real-world Spanish PCI Patients

This registry will provide exploratory and descriptive information regarding contemporary practice patterns of parenteral antiplatelet therapy in the PCI (Percutaneous Coronary Intervention) setting and will investigate as well the short-term effectiveness and safety of the currently available parenteral antiplatelet agents in a cohort of "real-world" patients undergoing PCI in Spain.

The present study is an observational, multicenter, nationwide, prospective investigation in patients undergoing PCI due to any coronary syndrome (acute or chronic) and receiving parenteral antiplatelet agents, GPIs or cangrelor, as per clinical practice during the procedure.

This investigation will provide exploratory and descriptive information regarding contemporary practice patterns of parenteral antiplatelet therapy in the PCI setting and will evaluate the short-term effectiveness and safety of the currently available parenteral antiplatelet agents in a cohort of patients undergoing PCI in Spain.

Approximately 15 high-volume PCI-capable Spanish centers will participate in the present investigation with the intention to enroll circa 1.000 patients.

The study is purely observational and no intervention will be performed in the included subjects because due to their participation in this investigation.

Patients fulfilling inclusion and exclusion criteria will be included after providing written informed consent to participate in the current investigation. Patient characteristics, procedural details and pharmacological therapies will be collected after inclusion and clinical events will be registered at two time points: 48 hours and 30 days.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Undergoing a PCI
* Use of a parenteral antiplatelet agent (GPIs or cangrelor)during the invasive procedure (PCI)

Exclusion Criteria:

* Blood dyscrasia, bleeding diathesis or active bleeding at the time of the index procedure.
* Chronic oral anticoagulation.
* Recent history of stroke, TIA (Transient Ischemic Attack)or intracranial bleeding (\<3 months prior to inclusion).
* Severe anemia (Hb\<9g/dl) or platelet count \<100x106/ml at the time of the index procedure.
* Any active neoplasm.
Efficacy and Safety of Simtuzumab (SIM) With FOLFIRI as Second Line Treatment in Colorectal Adenocarcinoma

The primary objective of this study is to compare the additive efficacy of SIM versus placebo in combination with leucovorin (folinic acid), irinotecan, and fluorouracil (FOLFIRI) as measured by improvement in progression-free survival (PFS) in participants with metastatic KRAS mutant colorectal adenocarcinoma who have progressed following a first-line oxaliplatin- and fluoropyrimidine-containing regimen.


Eligibility Criteria:
Inclusion Criteria:

* Metastatic colorectal carcinoma with KRAS mutation
* Received first line therapy and discontinued part or all of first line therapy
* Estimated life expectancy \> 3 months
* Stage IV disease
* Eastern Cooperative Oncology Group (ECOG) performance status: 0-2
* Adequate hepatic and hematologic function
* No major operations within 4 weeks prior to treatment start

Exclusion Criteria:

* More than 1 prior chemotherapy regimen for Stage 4 colorectal cancer
* Experimental medical treatment within 30 days prior to study entry
* Known or suspected cerebral metastases
* History or presence of any form of cancer, other that colorectal cancer, within the 3 years prior to enrollment
* Known dihydropyrimidine dehydrogenase-deficiency (special screening not required)
* Subjects with angina pectoris, poorly controlled ventricular arrhythmias (does not include asymptomatic, occasional premature ventricular contractions), history of clinically significant coronary heart disease or cardiomyopathy, or electrocardiogram (ECG) abnormalities consistent with ischemia
* Uncontrolled hypertension (seated systolic blood pressure \> 180 mm Hg or diastolic blood pressure \> 110 mm Hg) at screening
* Clinically active liver disease, including active hepatitis (any etiology) or cirrhosis
* Anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, retinoid therapy, hormonal therapy) within 21 days prior to randomization
* Prior irinotecan therapy for metastatic disease is not permitted
* Systemic fungal, bacterial, viral, or other infection

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Comparison of Subconjunctival 5-Fluorouracil (FU) Injection and Mitomycin C for Treatment of Early Bleb Failure

purpose : to evaluate and compare the effectiveness and complication of 5-FU injections and MMC drop in management of early bleb failure .

Design:Randomized clinical trial Methods:Patients with low injected bleb in first month after filtering or combined surgery with MMC which don't respond to high frequent topical steroids and removal of releasable sutures will be randomize to either 5-FU injection or Mitomycin drop 0.02%.For each patient slit photograph in first day of recruiting,first two weeks and first and third month will be obtained.Patients will follow for at least 3 months and IOP ,bleb configuration will check as primary outcome measures.Preoperative and postoperative data,complications,and the need for further surgical procedures will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Patients with low,injected bleb in first month after trabeculectomy or combined trabeculectomy\&phaco which not respond to high frequent topical steroids or removal of releasable sutures

Exclusion Criteria:

* Injected bleb due to complications of surgery such as button hole formation
* Injected bleb due to blebitis
* Bleb leakage
* Flat AC
* Pregnant or nursing mothers
* Injected bleb after bleb reconstruction