cyrilzakka/clinical-trials huggingface dataset:
Adrenoleukodystrophy National Registry Study

The aim of this registry to understand the natural history and disease progression in ALD and potentially develop bio-markers using the biospecimens collected using this registry.

This is a prospective, non-therapeutic protocol designed to create and maintain a registry of participants with Adrenoleukodystrophy (ALD) and known/presumed mutation for ALD. This study also involves maintaining a prospective biorepository to collect and store buccal swab, blood, stool and urine samples as well. In this protocol, pediatric (including infants), adolescents and adult patients with confirmed or presumed ALD (based on positive VLCFA testing and/or confirmed mutation) will be offered potential study participation. Additionally, presumed mutation for ALD (based on pedigree or confirmed mutation) will be offered potential study participation. After appropriate consent (online or in-person), subjects will be requested to provide a medical history (with authorization of release of medical records), longitudinal biospecimens, and permission to perform laboratory analyses on these samples. The overall goal is to understand the natural disease course in affected and unaffected patients (identified patients and relatives with a diagnosis of ALD), as well as women with ALD to assemble a resource of clinical, medical, and biological data from the participants. This study also aims to understand the outcomes of this disease, as well as possibly develop biomarkers to identify prognostic markers for disease progression, which may help develop effective interventions. The biospecimen bank and registry will provide access to samples and data for the ongoing studies as well as will provide an important resource for the future research.

Eligibility Criteria:
Inclusion Criteria

* Age 0 - 100
* ALD patients or family member meeting any of the following criteria:

  * Any patient diagnosed with ALD (confirmed by positive VLCFA testing and/or genetic mutation).
  * Known or presumed mutation with ALD based on pedigree or confirmed mutation in ABCD1 gene
* Participants living in the United States and territories

Exclusion Criteria

* Patients diagnosed with ALD who lack the capacity to consent/assent AND do not have a designated legally authorized representative or guardian.
* Patients who have undergone BMT or other cellular therapy .
* Patients not fluent in English who are unable to consent in-person at the BMT Journey Clinic.
* Patients who are illiterate
* Patient determined by the PI or designee to be unlikely to complete required study components (due to language barriers, compliance issues, etc.)
Circulation Improving Resuscitation Care (CIRC)

During resuscitation of out of hospital cardiac arrest patients the use of a mechanical chest compression device Autopulse will improve survival compared to manual compressions.

Sudden out-of-hospital cardiac arrest (OOH-CA) remains a significant cause of death, in spite of recent declines in overall mortality from cardiovascular disease. Several studies document sub optimal quality of manual chest compressions and this may influence outcome. However, studies comparing manual and mechanical chest compressions have resulted in conflicted results. The investigators think this may be based on methodology and design issues of the trials as much as not focusing on training and experience in operating a mechanical device clinically. Therefore the investigators will focus on these issues and implement three phases in the study (In field training, Run In phase, and Study phase). The investigators will also focus on early use of mechanical CPR after arrival at patient side and randomization at arrival. In order to achieve this the investigators will follow the Norwegian CPR Guidelines with 3 min CPR before defibrillation and the 3 min algorithm. Quality of CPR will be monitored.

Eligibility Criteria:
Inclusion Criteria:

* Patents aged 18 years (or local age of consent) or more who suffer non-traumatic arrest of presumed cardiac etiology in an out-of-hospital setting and who do not meet any of the exclusion criteria below.

Exclusion Criteria:

* Traumatic arrest (blunt, penetrating, burns)
* Arrest due to exsanguinations, strangulation, smoke inhalation, drug overdose, electrocution, hanging, drowning.
* Known or clinically apparent pregnancy
* Do Not Attempt to Resuscitate (DNAR) orders
* Apparent patient weight more than 225 kg (500 lbs)
* Wards of the state
* Prisoner
* CPR device other than AutoPulse
* Patients who are reached after 16 minutes after the time of emergency call (911). This exclusion is determined at the time of CRF abstraction, not during treatment of the patient.

  * If patient is unaccompanied, or accompanied by a person or persons unfamiliar with their his-tory, determination of these exclusion criteria will, perforce, be left to the best estimation of the rescue personnel. At no time, should an attempt to determine these criteria be allowed to delay the administration of life-saving treatment.

    * These criteria will be determined in the best estimation of the rescue personnel, or if the AutoPulse signals that the patient is outside the parameters for AutoPulse deployment.
A Randomized Phase III Trial of Hyperthermic Isolated Limb Perfusion With Melphalan, Tumor Necrosis Factor, and Interferon-Gamma in Patients With Locally Advanced Extremity Melanoma

Randomized study. Initially, 3 patients will be entered on Arm I as a pilot feasibility study and to standardize the technical aspects of the study. Subsequently, all patients are randomized to Arms I and II.

Arm I: Regional Hyperthermia plus Regional Single-Agent Chemotherapy. Hyperthermic intravenous limb perfusion, HILP; plus Melphalan, L-PAM, NSC-8806.

Arm II: Regional Hyperthermia plus Regional Single-Agent Chemotherapy and Biological Response Modifier Therapy. HILP as in Arm I; plus L-PAM; and Tumor Necrosis Factor (Knoll), TNF, NSC-635257; Interferon gamma (Genentech), IFN-G, NSC-600662.

Patients with locally advanced melanoma confined to an extremity (Stage IIIA or Stage IIIAB) will be treated in a randomized Phase III study with hyperthermic isolated limb perfusion. One arm of the study will be a standard 60 minute perfusion with melphalan as a single agent. The second arm of the study will combine melphalan, tumor necrosis factor, and interferon-gamma in the isolated limb perfusion reproducing a regimen shown to have 100% response rates in a Phase II European trial. Patients will be followed for local response rates, duration of response, treatment toxicity, and disease-free survival.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

Biopsy-proven Stage IIIA or IIIAB melanoma (M.D. Anderson staging system) of an extremity, as follows:

Advanced local disease indicated by 2 or more satellite or in-transit metastases.

Lower limb regional metastases must be distal to the apex of the femoral triangle except inguinal lymph node metastases.

Upper limb regional metastases must be distal to the deltoid insertion except axillary lymph node metastases.

No evidence of systemic disease outside the involved extremity.

Recurrent disease subsequent to prior successful limb perfusion allowed.

Bidimensional directly measurable dermal or subcutaneous lesion required.

PRIOR/CONCURRENT THERAPY:

No prior isolated limb perfusion.

Biologic Therapy: At least 1 month since Biologic Therapy.

At least 3 months since regional therapy of the extremity.

Chemotherapy: At least 1 month since chemotherap.y

At least 3 months since regional therapy of the extremity.

Endocrine Therapy: Not specified.

Radiotherapy: At least 1 month since radiotherapy.

Surgery: Not specified.

PATIENT CHARACTERISTICS:

Age: 18 and over.

Performance status: ECOG 0 or 1.

Hematopoietic: Platelets greater than 150,000.

Hepatic: Bilirubin less than 1.5 mg/dl; Coagulation profile normal.

Renal: Creatinine less than 2.0 mg/dl.

Cardiovascular: No evidence of peripheral vascular disease, e.g.:

No history of claudication.

OTHER:

HIV negative.

No pregnant or nursing women.
PKUDOS: Phenylketonuria (PKU) Demographic, Outcomes, and Safety Registry

The objective of this study is to evaluate the safety of long-term treatment with Kuvan.

The PKUDOS program is a voluntary, multicenter, strictly observational program for patients with PKU who have either received Kuvan therapy, or currently receive Kuvan, or intend to begin receiving Kuvan therapy within 90 days of entering the registry.

Eligibility Criteria:
PKUDOS Registry

Inclusion Criteria:

* Patient has confirmed diagnosis of PKU with hyperphenylalaninemia documented by a Phenylalanine level of greater than or equal to 360 umol/L (6 mg/dL)
* Patient has previously received Kuvan
* Patient is currently receiving Kuvan
* Patient intends to receive Kuvan therapy within 90 days of enrollment into the registry
* The Patient is being followed at a PKUDOS participating center
* Willing and able to provide written authorization or, if under the age of 18 years, provide written assent (if required) and written patient authorization by a parent or legal guardian
* Willing to provide personal health information

Exclusion Criteria:

* Patients are not eligible to participate in PKUDOS if they are participating in a BioMarin-sponsored clinical study of Kuvan
* Patients not previously treated with Kuvan and patients that are unwilling to begin Kuvan therapy within 90 days of entry into the registry

PKU MOMS Subregistry

Inclusion Criteria:

* Willing to enroll in (or are already enrolled in) PKUDOS
* Agree to follow the standard of care for pregnant women with PKU in the United States (NIH, 200, NIH Consensus Statement)
* Agree to be followed by a hospital or PKU clinic offering the standard of care for maternal PKU
* Are within 10 weeks of their last menstrual period

Exclusion Criteria:

* Patients who have not adhered to the standard of care for pregnant women with PKU in the United States are not eligible to participate in PKU MOMS
Phase II Study of Azacitidine and Sargramostim as Maintenance Treatment for Poor-Risk AML or MDS

To determine the impact of maintenance therapy in patients with MDS/AML in remission.

We propose a phase II study to determine the impact of maintenance therapy with 5-azacytidine and GM-CSF in patients with poor-risk AML or MDS, who are in remission after definitive treatment with either stem cell transplant or cytarabine-based consolidation chemotherapy.

In order to precede relapse and to avoid lead time bias, treatment would need to commence within 185 days of definitive therapy. Furthermore, approximately 50% of relapses occur within the first year and up to 80% within two years after SCT, therefore we would limit the duration of maintenance therapy to one year, followed by two years of follow-up.

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 6 months
2. Initial diagnosis of poor -risk AML or MDS (defined in section 3.2), treated with either stem cell transplant or cytarabine-based consolidation chemotherapy, within the past 60-185 days
3. ECOG performance status 0-2
4. No morphologic evidence of leukemia or active MDS as determined by JHH Hematopathologist independent review of a bone marrow aspirate and biopsy done following the completion of therapy and within 14 days prior to enrollment
5. Peripheral blood count recovery: Neutrophil count ≥ 1000 /µL, platelet count ≥ 50x 109 /µL without platelet transfusions, and adequate hematocrit independent of red cell transfusions .
6. No evidence of extramedullary leukemia, such as CNS or soft tissue involvement
7. Adequate end organ function as measured by the following: AST and ALT \< 4 x normal, total serum bilirubin \< 2 x upper limit normal (unless due to hemolysis, Gilbert's syndrome, or ineffective erythropoiesis), creatinine \< 2 x upper limit of normal
8. Ability to give informed consent
9. In agreement to use an effective barrier method of birth control to avoid pregnancy during the study and for a minimum of 30 days after study treatment, for all male and female patients who are fertile

Exclusion Criteria:

1. Patients with untreated or uncontrolled infections
2. Patients with untreated or uncontrolled grade 3 or 4 GVHD
3. Pregnancy and lactation
4. Concurrent use of any other investigational agents.
5. Known HIV-positive patients.
6. Known hypersensitivity to 5AC or GM-CSF
The Clinical Study of SHR-7631 for Injection in Patients With Advanced Solid Tumors

This study is an open-label, phase I clinical trial of SHR-7631 in patients with advanced solid tumors. The whole study is divided into three stages: dose escalation, dose expansion and efficacy expansion.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors which is relapsed or refractory to standard treatment, or lack of standard treatment, or standard treatment is not applicable currently;
2. Have at least one measurable tumor lesion per RECIST v1.1 (subject with only non-target tumor lesion will be permitted if he/she is planned to participant in dose escalation stage or with mCRPC);
3. ECOG performance status of 0-1;
4. Life expectancy ≥ 12 weeks;
5. Adequate bone marrow and organ function
6. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form.
7. Age 18 to 75 years old (including both ends), gender is not limited;

Exclusion Criteria:

1. Patients with active central nervous system metastases or meningeal metastases;
2. Ongoing or previous anti-tumor therapies within 4 weeks prior to the first dose of study drug;
3. Prior treatment with antibody-drug conjugate (ADC) consisting of topoisomerase I inhibitors;
4. History of serious cardiovascular and cerebrovascular diseases;
5. Severe infection within 4 weeks prior to the first dose;
6. Adverse reactions of previous anti-tumor treatment have not recovered to Grade ≤ 1 per NCI-CTCAE v5.0.
Intrathecal Morphine for Robotic-assisted Laparoscopic Hysterectomy.

Is there any difference in the intensity of postoperative pain, nausea, urinary retention and legth of hospital stay in patients undergoing robotic assisted laparoscopic surgery if they receive intrathecal morphine or peroral and intravenous opiates during the surgery and is there a significant difference in the need of opiates after the surgery.


Eligibility Criteria:
Inclusion Criteria:

\* Patients accepted for robotic-assisted laparoscopic surgery

Exclusion Criteria:

* Coagulopathy,
* Prior spine surgery,
* Chronic pain problems,
* Drug abuse,
* Pregnancy
* \< 18 years
Utility of Ultrasonography During Internal Jugular Vein Catheterisation in Pediatric Patients

Central venous access may be essential in pediatric patients for fluid and a blood product administration, medication, parenteral nutrition, renal replacement therapy and hemodynamic monitoring. Obtaining central venous access in pediatric patients can be challenging, failure rates in pediatric patients range from 5% to 19% with reported complication rates from 2,5% to 22% The landmark technique has been standard approach for many years. In comparison with landmark method in pediatric patients the use of ultrasound is associated with an increased success rate decreased operative time, reduced number of cannulation attempts , and a decreased number of carotid artery punctures. We wanted to evaluate our success rate using ultrasound as a guidance during central vein insertion.


Eligibility Criteria:
Inclusion Criteria:

* pediatric patients required internal jugular vein catheter

Exclusion Criteria:

* aged smaller than 1 month
To Compare Efficacy and Safety of CT-P39 and EU-approved Xolair in Patients With Chronic Spontaneous Urticaria

A Double-blind, Randomized, Active-controlled, Parallel Group, Phase 3 Study to Compare Efficacy and Safety of CT-P39 and Xolair in Patients with Chronic Spontaneous Urticaria Who Remain Symptomatic despite H1 antihistamine Treatment

CT-P39, containing the active ingredient omalizumab, is a recombinant humanized monoclonal antibody that is being developed and manufactured as a proposed biosimilar to Xolair (omalizumab) by the Sponsor. CT-P39 is identical to Xolair with respect to concentration and presentation. The 150 mg of drug product (CT-P39) will have the same pharmaceutical form and strength as 150 mg Xolair (in a prefilled syringe \[PFS\] for subcutaneous injection) and is intended to have a similar quality profile compared with Xolair.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with CSU
* Diagnosed as CSU refractory to H1-antihistamine

Exclusion Criteria:

* Chronic urticaria with clearly defined underlying etiology
* Clinically significant allergic reaction and/or hypersensitivity to any component of omalizumab
* History of anaphylactic shock
* History of and/or concomitant immune complex disease (including Type III hypersensitivity)
* Parasitic diseases or colonization on stool evaluation for ova and parasites
* Unable to receive background therapy with protocol-defined antihistamines or contraindicated to epinephrine
A 12 Week Study to Evaluate the Efficacy of an Eye Cream

This single center, open-label clinical study was conducted to assess the efficacy and tolerance of a topical eye cream when used over the course of 12 weeks by healthy women with moderate to severe under-eye dark circles, moderate under eye puffiness, and mild fine lines and wrinkles. A total of 37 subjects were enrolled into the study.

This single center, open-label clinical study was conducted to evaluate the efficacy and tolerability of an eye cream on healthy female subjects between 35 to 60 years of age with Fitzpatrick Skin Type I - VI, and moderate to severe dark circles and under-eye puffiness. This study aims to evaluate the following objectives:

1. To evaluate the eye cream impact on undereye dark circles, undereye puffiness, fine lines and wrinkles periorbital eye area, and overall appearance periorbital eye area, as evaluated by investigator clinical grading, chromameter, VISIA clinical photography, and subjective questionnaire performed at baseline, week 4, week 8, and week 12.
2. To evaluate the eye cream impact on under eye blood flow, as evaluated by laser doppler performed at baseline, week 8, and week 12.
3. To assess objective and subjective tolerability of Dryness, Erythema, and Edema, and Burning, Stinging, Peeling, and Itching evaluated by investigator and subjective grading at baseline, week 4, week 8, and week 12.

A total of 37 subjects completed the study.

Eligibility Criteria:
Inclusion Criteria:

* Females in good general health
* With Fitzpatrick Skin Type I - VI
* Moderate to severe under eye dark circles
* Moderate undereye puffiness
* Mild to moderate fine lines and wrinkles

Exclusion Criteria:

* Subjects who have used retinol or eye cream / serum 7 days prior to study commencement
* Nursing, pregnant, or planning a pregnancy during this study
* Having a health condition and / or pre-existing or dormant dermatologic disease on the face
The Effect of Statin Treatment on Trained Innate Immunity

The innate immune system plays a pivotal role in the development and progression of atherosclerosis. Recently, it was reported that monocytes can develop a long-lasting immunological memory after stimulation with various microorganisms, which has been termed 'trained innate immunity'. This memory is induced by epigenetic reprogramming, in particular trimethylation of lysine 4 at histone 3 (H3K4me3).

In this study, the investigators aim to investigate the immunophenotype of circulating monocytes in patients with elevated LDL cholesterol levels and the effect of statins on this phenotype.

The innate immune system plays a pivotal role in the development and progression of atherosclerosis. Recently, it was reported that monocytes can develop a long-lasting immunological memory after stimulation with various microorganisms, which has been termed 'trained innate immunity'. This memory is induced by epigenetic reprogramming, in particular trimethylation of lysine 4 at histone 3 (H3K4me3).

The main objective is to study whether circulating monocytes of patients with elevated levels of LDL have a phenotype of trained innate immunity compared to control patients. Subsequently the investigators will study the effect of treatment with statins on the increased inflammatory response and epigenetic changes of the innate immune system.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older
* Elevated LDL levels (\>4.9 mmol/l)
* Decision made by treating physician to initiate statin treatment

Exclusion Criteria:

* previous cardiovascular events.
ATAC - Endometrial Sub-Protocol

To compare the difference between the ARIMIDEX group and the tamoxifen group in the incidence of abnormal endometrial histological findings arising after treatment has commenced.


Eligibility Criteria:
Inclusion Criteria:

* Patients eligible for entry into the main ATAC trial (1033IL/0029)
* Not received any previous tamoxifen, for whatever reason
* Not undergone a hysterectomy and do not have a hysterectomy planned within the next 6 years
* No previous endometrial ablation

Exclusion Criteria:

* Excluded from entry into the main ATAC trial (1033IL/0029). As detailed in Section 4.4 of the main ATAC trial (1033IL/0029)
Mindfulness Based Stress Reduction in Multiple Sclerosis (MS)

This study focuses on stress, cognition, mood and fatigue and its effect on medication compliance. Medication compliance is measured by the weight of discarded needles. The investigators will be administering neuropsychological testing at baseline and the final visit. The subjects will complete self-report assessments during their 8 weeks in the study.

Group A will have additional weekly phone support for meditation, while Group B will have meditation training only.


Eligibility Criteria:
Inclusion Criteria:

* Patients with either definite MS according to the revised McDonald criteria (Polman 2005) or patients with CIS (defined as an initial MS relapse with objective documentation and 2 or more lesions within the CNS of which at least one must involve the brain)
* Patients on GA therapy for at least 6 months
* Age 18 - 70

Exclusion Criteria:

* Unwilling to comply with study procedures
* Use of other DMT in conjunction with GA
* Unable to provide informed consent.
* Current (past 30 days) substance abuse
* Newly initiated (past 30 days) psychiatry treatment
* Enrolled in another program of meditation in the past six months.