cyrilzakka/clinical-trials huggingface dataset:
Comparison of Solitaire to Embotrap to Treat Large Vessel Occlusion in Acute Ischemic Stroke (SOLTRAP Study)

The primary aim of this study is to assess if there is a difference in first pass reperfusion between the two devices. This is a randomized prospective study to assess if there is a difference in first pass reperfusion at two centers with large mechanical thrombectomy volumes. Data will also be collected on time-to treatment, outcomes and hemorrhagic complications.

The SOLTRAP Study is an investigator initiated two hospital study designed to assess the procedural success and clinical outcomes associated with mechanical thrombectomy using the Medtronic Solitaire Device and the Cerenovous Embotrap device. Both devices are FDA approved for this indication of removal of a thrombus for patients suffering from stroke secondary to a large vessel occlusion.

Data collected will include device used during the procedure, mechanical thrombectomy techniques, time from onset to imaging, imaging to puncture, and overall time from onset to reperfusion as well as quality of life at 90 days post stroke.

The study will enroll up to 418 subjects and will be conducted at Wellstar North Fulton Hospital and Wellstar Kennestone Hospital. The devices will have regulatory authorization to be on the market in the geographic location of both sites.

The duration of the Registry protocol is approximately 24 months

Eligibility Criteria:
Inclusion Criteria:

1. Subjects who experienced acute ischemic stroke (AIS), eligible for restoration of blood flow using a Solitaire or Embotrap device to remove thrombus from the neurovasculature
2. Occlusion of intracranial cerebral circulation vessel involving the M1, M2 MCA or ICA-T (Tandem occlusions will be enrolled)
3. Subject or subject's legally authorized representative (LAR) has signed the informed consent form prior to or within 72 hours post-procedure
4. Subject is willing to comply with the protocol follow-up requirements
5. The intended technique and treated technique must be one of the following techniques for the first thrombectomy pass in the neurovasculature per Instructions for Use (IFU).

Exclusion Criteria:

1.The subject can participate in another clinical trial if the study does not impact the endpoints defined in this protocol given this is a data collection trial. Patients who are unable to comply wit the 90 day follow up in person or via telephone will be excluded from the study.
18FDG-PET Imaging to Detect Changes in Airways Inflammation in Cystic Fibrosis Patients

The purpose of this study is to determine if 18Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) imaging can detect changes in airways inflammation in Cystic Fibrosis (CF) patients after treatment for a pulmonary exacerbation.

Neutrophils play a key role in the pathogenesis of CF lung disease. We know that neutrophilic inflammation is related to a decline in pulmonary function. Therefore, early anti-inflammatory intervention is an opportunity to slow this irreversible pulmonary destruction. However, the development of sensitive, non-invasive diagnostic tools of airways inflammation is essential to the study and implementation of anti-inflammatory therapies. Our current armentarium of measures of airways inflammation is limited. BAL is invasive and not clinically acceptable as a tool for the serial measurement of inflammation. Sputum samples are highly variable and not reliable.

18FDG-PET is a promising tool because it is non invasive, has been shown to quantify the amount and location of neutrophilic inflammation and has the potential to be used to track inflammation over time. Therefore, the goal of this research study is to evaluate the ability of 18FDG -PET imaging to detect changes in airways inflammation in CF patients in response to conventional treatment for a pulmonary exacerbation

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of CF as defined by two or more clinical features of CF and a documented sweat chloride \> 60mEq/L by quantitative pilocarpine iontophoresis test or a genotype showing two well characterized disease causing mutations
* Informed consent and verbal assent (as appropriate) provided by the subject's parent or legal guardian and the subject
* Ages 6-18 and able to perform reproducible spirometry
* Admission to the Hospital for Sick Children for a pulmonary exacerbation

Exclusion Criteria:

* Inability to perform reproducible spirometry
* Diagnosis of Cystic Fibrosis Related Diabetes (CFRD)
* Medical instability that would preclude the ability to perform PET imaging
* FEV1% predicted \< 40%
* The use of supplementary oxygen
* Pregnancy or breastfeeding
* Severe claustrophobia
A Study of the Clinical Application of [18F]RCCB6 and [68Ga]Ga-NOTA-RCCB6 PET/CT Imaging in the Diagnosis of CD70-expressing Multiple Tumors

The aim of this study was to establish and optimize the \[18F\]RCCB6 and \[68Ga\]Ga-NOTA-RCCB6 PET/CT imaging method, and its physiological and pathological distribution characteristics, on the basis of which the diagnostic efficacy of the above imaging agents in renal cancer (especially clear cell renal cell carcinoma) and lymphoma was evaluated.


Eligibility Criteria:
Inclusion Criteria:

1. Be between 18 and 65 years of age and of either sex.
2. Affected with renal cancer or lymphoma confirmed by puncture or surgical pathology.
3. Informed consent must be signed in writing by the subject or his/her legal guardian or caregiver.
4. Willingness and ability to cooperate with all programs of this study.

Exclusion Criteria:

* Subjects meeting any of the following criteria will be excluded from the study:

  1. Severe hepatic and renal insufficiency;
  2. Targeted therapy prior to radiotherapy or PET/CT scan. Renal function: serum creatinine less than or equal to the upper limit of the normal range;
  3. Liver function: bilirubin, AST(SGOT)/ALT(SGPT) less than or equal to the upper limit of the normal range.
  4. History of serious surgery in the last month.
  5. Those who have participated in other clinical trials during the same period.
Greater Occipital Nerve Pulsed Radiofrequency in Cervicogenic Headache

The effect of GON PRF treatment applied with USG-guided proximal technique in patients who do not respond to conservative treatments for cervicogenic headache

In our study, GON PRF will be applied to volunteers who are diagnosed with cervicogenic headache according to ICHD-3 criteria, who meet the study criteria and who report a positive effect with diagnostic GON block application. The main purpose of our study is to evaluate the clinical efficacy and safety of ultrasound-guided C2 level greater occipital nerve pulsed radiofrequency treatment in cervicogenic headache during the follow-up period. Our secondary purpose is to determine the effects of the GON PRF treatment we applied on the volunteers' analgesic drug consumption, daily life activities and sleep, how they generally perceive this treatment and whether there is a need for any additional treatment.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with cervicogenic headache according to ICHD-3 criteria
* Cranial and cervical spine imaging is available
* Number of headache days per month 5 and/or more
* Inadequate benefit from pharmacological treatments or physical therapy methods used
* Volunteer patients who can understand and approve the treatment and the informed consent form and who can comply with the treatment

Exclusion Criteria:

* History of secondary headache other than cervicogenic headache according to ICHD-3 criteria
* Cervical nerve root irritation and/or spinal stenosis symptoms and signs
* Sensory deficit findings in the greater occipital nerve dermatome
* Craniocervical defect or other anatomical abnormality in the target area or nearby the procedure
* Local or systemic infection
* Received nonpharmacological treatment within the last 3 months (physical therapy, botulinum toxin A, acupuncture, ozone, cognitive behavioral therapy, etc.)
* Pregnancy or suspected pregnancy
* Known allergy to local anesthetic drugs
* History of malignancy
* Known organic disease of the brain and spinal cord
* History of cranial/cervical surgery within the last 1 year
* Bleeding-clotting disorder or oral anticoagulant use
* Comorbid disease that may cause headache (uncontrolled hypertension, intracranial lesion, etc.)
* Compliance with treatment and treatment results diseases that may affect the evaluation (psychiatric disorder, dementia, etc.)
* Those who request re-treatment due to the emergence of contralateral pain or other types of pain during the follow-up period after treatment
* Those who do not accept treatment
Effect of SAR153191 (REGN88) With Methotrexate in Patients With Active Rheumatoid Arthritis Who Failed TNF-α Blockers

Primary Objective:

- To demonstrate that sarilumab (SAR153191/REGN88) on top of methotrexate (MTX) was superior in efficacy to placebo for the relief of signs and symptoms of rheumatoid arthritis (RA), in participants with active RA who had failed up to 2 tumor necrosis factor-alpha (TNF-α) antagonists.

Secondary Objectives:

* To assess the safety of sarilumab;
* To document the pharmacokinetic profile of sarilumab.

The duration of the study period for each participant was approximately 22 weeks; including up to 4 weeks screening period, 12-week double-blind treatment period and 6-week safety follow-up period.

Participants who completed the 12-week treatment period were offered enrollment in a separate long-term extension study (LTS11210/NCT01146652).

Eligibility Criteria:
Inclusion criteria:

* Diagnosis of rheumatoid arthritis ≥6 months duration and American College of Rheumatology (ACR) Class I-III functional status at screening and baseline visits;
* Active disease defined as:

  * At least 6 of 68 tender joints and 6 of 66 swollen joints at screening and baseline visits, and
  * hs-C-Reactive Protein (hs-CRP) \>10 g/L or Erythrocyte Sedimentation Rate (ESR) \>28 mm/hr at screening visit;
* Continuous treatment with Methotrexate for at least 12 weeks and on stable dose (minimum 10 mg/week) for at least 6 weeks prior to the screening visit;
* Participant considered as Primary TNF-α blocker nonresponder. i.e.:

  * Appropriate for previous TNF-α blocker therapy
  * Lack of adequate clinical response after at least 3 months TNF-α blocker therapy with MTX or other synthetic disease modifying anti-rheumatic drug (DMARD) co-therapy.

Exclusion criteria:

* Age \<18 years or \>75 years;
* Pregnant or breastfeeding woman or woman of childbearing potential, unwilling to utilize adequate contraception or not to become pregnant during the entire study;
* Fever (\>38°C), or chronic, persistent, or recurring infection(s);
* History of demyelinating disease;
* Current underlying hepatobiliary disease.

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Validation of the Small Intestine Microbiome Aspiration (SIMBA) Capsule

Prospective, open label trial to establish the ability of the SIMBA Capsule to accurately obtain a sample from the small bowel of participants with IBS (10 constipation-predominant (IBS-C) and 10 diarrhea-predominant (IBS-D)) and healthy participants (n=10). The accuracy of targeting the small bowel will be established by visual confirmation via X-ray. The clinical utility of the collected sample will be evaluated by analysis with samples obtained by the current gold standard (duodenal aspirate), as well as stool analysis and LBT.


Eligibility Criteria:
Inclusion Criteria

1. Aged between 18 and 70 years.
2. Diagnosis of IBS by Rome 4 criteria (IBS groups) or no previous diagnosis of IBS or suspected IBS (Control group).
3. Ability to understand and provide informed consent.
4. Ability and willingness to meet the required schedule and study interventions.
5. No planned change in diet or medical interventions during the study duration.
6. Adequate mobility to transfer repeatedly between X-ray (standing or lying), and waiting (sitting).
7. Willing and able to undergo a sedated esophagogastroduodenoscopy (EGD) with aspirate and brushing.

Exclusion Criteria

1. Prior gastrointestinal disease, surgery, or radiation treatment which, in the investigator's opinion, would lead to intestinal structuring or obstruction with a risk of capsule non-excretion (particular diseases which would be assessed on a case-by-case basis would include, achalasia, eosinophilic esophagitis, Crohn's disease, cancer diagnosis or treatment within the past year, or previous esophageal, gastric, small intestinal, or colonic surgery. Appendectomy or cholecystectomy more than 3 months prior to enrollment are acceptable).
2. Use of any medications in the previous week that could substantially alter gastrointestinal motor function (e.g., opioids, prokinetics, anticholinergics, laxatives), or acidity (PPI, H2RA).
3. History of oropharyngeal dysphagia or other swallowing disorder with a risk of aspiration of the capsule.
4. Females of childbearing age who are not practicing birth control and/or are pregnant or lactating.
5. No antibiotics, or colon cleanses/bowel prep for 2 weeks.
6. \< 2 bowel movements per week (Control Group).
A Study of Venetoclax and AMG 176 in Patients With Relapsed/Refractory Hematologic Malignancies

This dose-escalation study evaluating the safety, pharmacokinetics and preliminary efficacy of venetoclax in combination with AMG 176 in participants with relapsed or refractory acute myeloid leukemia (AML) and participants with Non-Hodgkin's lymphoma (NHL)/diffuse large B-cell lymphoma (DLBCL).

This study will include a dose escalation phase to identify the maximum tolerated dose/recommended phase 2 dose (MTD/RPTD) of venetoclax plus AMG 176 as well as a dose expansion phase to confirm safety, explore efficacy, and confirm the suitability of the preliminary RPTD.


Eligibility Criteria:
Inclusion Criteria:

* Adequate kidney, liver and hematology values as described in the protocol.
* Diagnosis of relapsed or refractory (R/R) acute myeloid leukemia (AML) or R/R Non-Hodgkin's lymphoma (NHL)/diffuse large B-cell lymphoma (DLBCL) confirmed by the World Health Organization (WHO) criteria, as appropriate.
* Meets the following disease activity criteria:
* AML: must have received at least 1 prior therapy for AML and be ineligible for cytotoxic therapy and allogeneic stem cell transplant.
* NHL/DLBCL: measurable disease with a bidimensional lesion measuring at least 1.5 cm; received at least 1 prior therapy for NHL with no curative treatment option as determined by the investigator and be ineligible for a stem cell transplant.

Exclusion Criteria:

* History of clinically significant medical condition that, in the opinion of the investigator, would adversely affect participation in this study.
* History of of any malignancy within the last 6 months except for those specified in this protocol and low-grade malignancies not requiring active treatment such as non-melanoma skin cancer, cervical intraepithelial neoplasia, or prostate cancer in situ.
* Prior allogeneic stem cell transplant or autologous stem cell transplant within 100 days of study drug administration and no signs or symptoms of acute or chronic graft-versus-host disease.
* Previous enrollment in a randomized trial including either venetoclax or AMG 176.
* Known active or chronic pancreatitis; severe chronic obstructive pulmonary disease with hypoxemia; central nervous system manifestations of malignancy.
* Active, uncontrolled infection.
Imiquimod 5% Cream in the Treatment of External Genital or Perianal Warts in HIV+ Patients

Imiquimod 5% cream in the treatment of external genital or perianal warts in HIV+ patients

To evaluate the percentage of HIV+ subjects successfully treated with HAART, with total clearance (100%) of baseline external genital or perianal warts within 16 weeks of treatment with imiquimod 5% cream.

Eligibility Criteria:
Inclusion Criteria:

1. Subject able to understand and willing to give written informed consent.
2. Subject ≥ 18 and \< 70 years of age.
3. Male or female with an HIV infection documented by serology (enzyme linked immunoabsorbent assay (ELISA)), Western Blot assay, or HIV viral load.
4. Treated with HAART for at least six months and compliant with the treatment.
5. Evidence of efficacy of HAART: total CD4+ lymphocyte counts of ≥ 200 cells/mm3 AND plasma HIV RNA level \< 104 RNA copies/mL within four weeks prior to the Treatment Initiation Visit.
6. Presence of at least one visible genital or perianal wart as determined by clinical diagnosis.
7. Total wart area \> 10 mm2 and ≤ 4000 mm2 (diameter \> 0.4 cm and ≤ 7.1 cm)
8. Karnofsky Performance Status ≥ 70 %.
9. Accepting to abstain from sexual intercourse when study drug is on the skin.
10. In case of a coexisting AIDS-defining illness, both this illness and any treatment being received for it must have been stable for the four weeks preceding enrolment in the trial.
11. If female and of childbearing potential, have negative urine pregnancy tests, and willing to use a medically acceptable method of contraception during the 16-week treatment period. Subjects were considered to be of childbearing potential unless the uterus or both ovaries had been removed or they were two or more years postmenopausal. For this study, the following were considered to be acceptable methods of contraception:

    * Surgical sterilization, defined as tubal ligation of the subject or a vasectomy of the subject's partner if that subject is in a monogamous heterosexual relationship (at the Investigator's discretion)
    * Oral, injectable, or implantable contraceptives
    * Condoms (with spermicide)
    * Diaphragm/cervical cap (with spermicide)
    * Intrauterine devices (IUDs)
    * Complete abstinence (at the Investigator's discretion)

Exclusion Criteria:

1. Women pregnant or lactating;
2. Treatment within four weeks prior to the Treatment Initiation Visit and throughout the entire study with:

   * Any genital wart therapy, or Immunomodulators
   * Systemic antiviral drugs other than acyclovir, valacyclovir, or famcyclovir and other than HAART
Metabolite Levels in Ovarian Cancer Patients Receiving Maintenance PARP Inhibitors

This study evaluates blood samples and compares levels of metabolites (levels of vitamins, carbohydrates, proteins, etc., that are in the blood), before and after the plasma exchange in patients scheduled to receive immunotherapy for their ovarian cancer. The information gained from this study may help researchers better understand the side effects from each treatment and possibly lessen those side effects for future treatments.

PRIMARY OBJECTIVE:

I. To determine the extent to which PARP inhibitor (PARPi) treatment reduces systemic levels of mesenchymal stem cell (MSC)-derived cancer support factors in patients with cancer.

OUTLINE:

Patients undergo collection of blood samples prior to drug initiation, weekly thereafter for the first month of therapy, monthly for the first month, and at disease progression or after cessation of treatment to monitor for toxicity. Blood samples are analyzed. Patients' medical charts are also reviewed to determine outcomes after PARP inhibition.

Eligibility Criteria:
Inclusion Criteria:

* Adults
* Patients with ovarian cancer starting PARP inhibitor treatment

Exclusion Criteria:

* Patients unwilling to return for blood draws, patients unwilling to continue PARP inhibitor treatment for at least one month
Acupuncture in the Treatment of Depression

The current large randomized placebo-controlled trial is testing the ability of acupuncture to treat major depression. The study is unique in that treatment effects will be from the perspective of both Western psychiatry and Chinese medicine.

Depression is an unfortunately common condition for which people often seek alternative (non-Western) treatments, perhaps because conventional treatments do not consistently provide lasting relief. A pilot study (Allen, Schnyer and Hitt, 1998) suggests that acupuncture, a popular but under-researched alternative treatment derived from Chinese medicine, holds sufficient promise as a treatment for depression to warrant a larger-scale clinical trial. The investigators propose to conduct a larger-scale test of the efficacy of acupuncture in this trial. Because relapse and recurrence of Major Depression are quite common, the investigators also will assess the clinical status of participants for 18 months after treatment concludes. In the first phase of this double-blind randomized clinical trial, 150 men and women meeting criteria for Major Depression will be randomly assigned to a treatment approach or to a waitlist control. All participants will ultimately receive acupuncture designed to address their own particular constellation of depressive symptoms. At the end of this first phase, blind assessments will be used to compare treatment effects from the perspectives of both Western psychiatry and Chinese medicine. After this treatment phase, participants will be assessed several times over the next 18 months. The study is designed to evaluate the efficacy and clinical significance of acupuncture as a treatment for Major Depression, and to examine the convergence of Western-based and Chinese-medicine-based outcome measures. Finally, the study will determine whether changes in energetic pattern mediate changes in Western defined depression severity, and explore whether patient and history variables predict responses to acupuncture treatments.

Eligibility Criteria:
Inclusion Criteria:

* Must meet criteria for Major Depression.
* Must be free of other mental or physical disorders that could cause depression, and also free from conditions that would typically exclude participants from trials involving pharmacologic antidepressants.
* Cannot be receiving other treatments or require immediate clinical attention.