cyrilzakka/clinical-trials huggingface dataset:
CARDSUP - SWISS Circulatory Support Registry

The project's main goal is to collect baseline clinical and procedural data as well as to assess clinical outcomes for all patients undergoing ECMO or Impella implantation at all included sites. All patients undergoing ECMO and/or IMPELLA implantation will be prospectively registered. Device use is according to the decision of the treating physician and independent of this registry.

This prospective data collection is made up of an all-comers design, including all eligible consecutive patients receiving an Impella (2.5, 5, CP, or RP) or VA-ECMO device via femoral access who gave their consent (or, if not possible, their relative).

The project's main goal is to collect baseline clinical and procedural data as well as to assess clinical outcomes for all patients undergoing ECMO or Impella implantation at all included sites. All patients undergoing ECMO and/or IMPELLA implantation will be prospectively registered. Device use is according to the decision of the treating physician and independent of this registry.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Medical indication for implantation of a peripheral cannulated VA-ECMO or microaxial flow pump (IMPELLA) or newer LV / LA-Ascending Aorta devices.
* Signed informed consent by patient or relative or waived consent by EC

Exclusion Criteria:

* None
An Observational Study of Carbaglu® for the Treatment of MMA and PA in Adults and Pediatrics

To obtain short-term and long-term clinical safety information, in pediatric and adult patients with PA and MMA treated with Carbaglu®.

This study is being conducted to obtain short-term and long-term clinical safety information from adult and pediatric patients treated for hyperammonemia due to Methylmalonic Acidemia (MMA) and Propionic Acidemia (PA). This is an observational/non-interventional study. Patients will be treated per the prescribing information and routine medical practice.

Only available data will be collected as part of the study including developmental outcomes, details of treatment with Carbaglu® and other treatments for hyperammonemia including dietary and protein management, plasma ammonia levels, pregnancy and maternal complications, adverse effects on the developing fetus and neonate, adverse effects on the infant through first year of life.

Eligibility Criteria:
Inclusion Criteria:

1. Provision of signed and dated informed consent/assent form
2. Prescribed and treated with Carbaglu®
3. Have an established diagnosis of PA or MMA defined as follows:

   * Diagnosed with PA by semi quantitative urine organic acid analysis, defined as presence of elevated methylcitric acid and normal methylmalonic acid levels and no evidence of biotin related disorders in the organic acid analysis; OR
   * Diagnosed with MMA by semi quantitative urine organic acid analysis, defined as elevation of methylmalonic acid and no evidence of vitamin B12 dependent disorder on plasma amino acid analysis (vitamin B12 dependency is defined by documented vitamin B12 responsiveness).

AND/OR

* Confirmation by molecular genetic testing

Exclusion Criteria:

* None
Prospective Evaluation of the Diagnostic Efficacy of a EUS Guided FNB Needle (AQUIRE®)

The present study investigates the efficacy of a new Endoultrasound guided fine needle biopsy (EUS-FNB) device (AquireTM Boston Scientific= AQUIRE®) for obtaining histological tissue cylinders in the diagnosis of solid pancreatic tumors, submucosal tumors of the upper gastrointestinal tract (esophagus, stomach, duodenum) and lymph node disease..

The AquireTM FNB device uses a triple point tip that is designed to maximize tissue capture and minimize fragmentation.

The efficiency of the 22 Gauge needle is evaluated in a prospective single arm study. The material obtained will be collected for formalin fixation and analyzed by a pathologist blinded for the type of needle device.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Indication for EUS FNB with solid pancreatic tumors, submucosal tumors or lymph node disease of the upper gastrointestinal tract will be included

Exclusion Criteria:

* Cystic pancreatic tumors
* Contraindication for EUS FNB
* Lesion of interest cannot be reached endosonographically
Improving Primary Care After Stroke (IPCAS)

No formal primary care based model of care exists to support stroke survivors living in the community. A large variation in the range, quality and access to health services offered to stroke survivors between and within local clinical commissioning groups suggests that many of the stroke survivors' needs are not being met systematically. Therefore, to address the longer term needs we have developed a multi-factorial primary care model that seeks to enable greater engagement with stroke care and community services, to link effectively to specialist services, and to improve the lives of stroke survivors.

This will be a two-arm cluster randomised controlled trial. Participating general practices will be randomised to deliver either the new model of stroke care or current usual care. The aim of this trial will be to assess the clinical and long-term cost effectiveness of the new model of primary care for stroke survivors living in the community. The primary outcome for the trial will be measured using two sub-scales (emotion and handicap) of the Stroke Impact Scale questionnaire at 12 months.

The IPCAS trial is a two-arm cluster randomised controlled trial with general practices as the unit of randomisation. The aim of this trial is to evaluate the clinical and long-term cost effectiveness of a novel model of primary care for stroke survivors living in the community.

People with a history of stroke on the registers of GP practices in the East of England and the East Midlands will be invited to take part. We will aim to recruit approximately 920 people registered with 46 general practices. We will target Practices with a stroke register comprising a minimum of 100 patients, to ensure that we reach our cluster target of 16 - 24 participants.

Potentially eligible participants will be sent an invitation to take part in the study by their GP surgery. Once all invitation letters and reminders have been sent out to patients in a practice, the GP practice will be randomised. GP practices will be randomised in a ratio of 1:1 to intervention or control. Intervention practices will deliver the new model of primary care. The control arm will consist of current usual care.

Data collection will occur at baseline and at 6 and 12 months. This will comprise a combination of postal and telephone administered questionnaires and a review of general practice notes. The primary endpoint for the trial will be two sub-scales (emotion and handicap) of the Stroke Impact Scale (SIS v3.0) as co-primary outcomes at 12 months (adjusted for baseline). Economic evaluation as well as quantitative and qualitative assessments of intervention fidelity will also be performed.

Eligibility Criteria:
Inclusion Criteria:

* On practice register with a history of stroke.
* Able to provide written informed consent (with or without the help of a carer).
* Age 18 years or older.

Exclusion Criteria:

* Patients on the palliative care register.
* Patients living in a nursing home.
The Effectiveness and Safety of Niacinamide 4% and Virgin Coconut Oil 30% for Secondary Prevention of Occupational Hand Dermatitis

Occupational hand dermatitis (OHD) often occurs in intensive care unit (ICU) nurses, especially in individuals who are vulnerable due to irritant exposure e.g. hand rub alcohol and repeated hand washing activities. The use of moisturizer is one of the recommendations for skin care in OHD. Niacinamide which has anti-inflammatory effects and can improve the skin barrier function. Virgin coconut oil (VCO) is rich in lipids and lauric acid, and has an occlusive effect. Until now there are no guidelines and reference types of moisturizers for secondary prevention in DTAK.

The aim of this study is identify the effectiveness and safety between moisturizing cream containing niacinamide 4% and VCO 30% for secondary prevention of occupational hand dermatitis in ICU nurses This study also measured HECSI , TEWL, and SCap before and after treatment

Eligibility Criteria:
Inclusion Criteria:

ICU nurses who:

* Sign the informed consent of the study after receiving explanation before all activity related with this study begin.
* Has Occupation Hand Dermatitis that fulfill the Mathias criteria with dermatitis severity mild to moderate which the score is 1, 2 or 3 corresponding with Investigator Global Assesment (IGA)
* Agree to follow the study protocol

Exclusion Criteria:

* History of allergic or irritate by Niacinamide or VCO or other component in moisturizer
* Receiving medium to high potency of topical Corticosteroid or systemic immunosupresant therapy or history of oral corticosteroid therapy in the last 1 month
Efficacy of a Scarf to Facilitate Mother-newborn Contact Designed to Facilitate Skin-to-skin Contact

The skin-to-skin contact maneuver (kangaroo) has shown benefits in newborn babies. This is two-arm randomized open clinical trial to evaluate whether the use of a scarf specifically designed to facilitate the skin-to-skin method is effective in terms of increasing the skin-to-skin mother-neonate time, compared to traditional clinical practice. Mothers of full-term babies with expected delivery in the study centers will be included. Those mothers with a language barrier that prevents collaboration in the study procedures, cognitive impairment or morbid obesity will be excluded. The primary endpoint is the average daily skin-to-skin time during hospital admission days. A superiority analysis will be made in terms of the skin-to-skin time of the intervention arm, compared to the control arm.


Eligibility Criteria:
Inclusion Criteria:

- Moders attending the first hospital visit with the midwife, with delivery planned in either of the two study hospitals

Exclusion Criteria:

* Language barrier that prevents collaboration in the study procedures
* Cognitive impairment preventing collaboration in the study procedures
* Morbid obesity
PI3Kδ Inhibitor Parsaclisib Combined with Chidamide for the Treatment of Relapsed/Refractory Peripheral T-cell Lymphoma

This is a prospective single-arm, multicenter, phase Ib/II clinical trial of PI3Kδ inhibitor Parsaclisib combined with chidamide for the treatment of relapsed/refractory peripheral T-cell lymphoma.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 to 75 years old (including 18 and 75)
2. Agreeing to sign the written informed consents
3. Diagnosed as peripheral T-cell lymphoma, including peripheral T-cell lymphoma, unspecified type, anaplastic large cell lymphoma (ALK negative or positive), angioimmunoblastic T-cell lymphoma, enteropathy Related T-cell lymphoma, hepatosplenic T-cell lymphoma, γ/δ T-cell lymphoma, NK/T-cell lymphoma, and other subtypes of PTCL that the investigator judges to be suitable for participating in this study
4. Received at least first-line anti-tumor therapy in the past, whether or not Chidamide has been used
5. Having at least one measurable lesions
6. World health organization-Eastern Cooperative Oncology Group Performance Status (ECOG) 0-2
7. Life expectancy no less than 3 months
8. enough main organ function
9. Pregnancy test within 7 days must be negative for women of childbearing period, and appropriate measures should be taken for contraception for women in childbearing period during the study and six months after this study
10. Agreeing to follow the trail protocol requirements

Exclusion Criteria:

1. Types other than peripheral T-cell lymphoma listed in the enrollment criteria
2. Diagnosed as central nervous system lymphoma
3. Received palliative treatment for other malignant tumors in the past 2 years
4. Uncontrolled active infection
5. Congestive heart failure, uncontrolled coronary heart disease, arrhythmia and heart infarction less than 6 months
6. The non-hematological toxicity caused by the previous anti-tumor treatment has not recovered to ≤1 grade, and the hematological toxicity has not recovered to ≤2 grade
7. Patients with a history of mental illness
8. Those who are known to be allergic to the active ingredients or excipients of the drug parsaclisib and chidamide
9. Received PI3Kδ inhibitor treatment in the past
10. Received autologous hematopoietic or allogeneic hematopoietic stem cell transplantation within 3 months
11. World health organization-Eastern Cooperative Oncology Group Performance Status (ECOG) \>2
12. There are factors that affect the absorption of oral drugs
13. Pregnant or lactating women
14. Researchers determine unsuited to participate in this trial
IVF Outcome Following Progestogen Ovarian Stimulation

The new strategy is by using the progestogen to block the luteinizing hormone(LH) surge either endogenous during luteal phase stimulation, or exogenous in the follicular phase i.e progestin primed ovarian stimulation (PPOS). The goal of PPOS is to develop a single dominant follicle. Various types of oral Progestin had been studied before including Medroxyprogesterone Acetate (MPA) and Utrogestan with different dosage. A different study by Wang et al conducted by using MPA to patients with PCOS. The use of MPA is contraindicated in human pregnancy whereas Dydrogesterone had been extensively used worldwide for the treatment of threatened miscarriage as well as luteal support in infertility setting. Previous protocol on PPOS showed inconclusive results. Therefore in this study, Dydrogesterone was used as the Progestin Primed Ovarian hyperstimulation to explore its effect on PCOS women IVF outcome.

This is a prospective controlled cohort study conducted at the Department of Medical Assisted Conception (MAC) unit of the University Kebangsaan Malaysia Medical Centre (UKMMC). From May 2018 through May 2019, women with Polycystic Ovarian Syndrome (PCOS) undergoing IVF/intracytoplasmic sperm insemination(ICSI) regimens for the treatment of infertility were recruited.

Patients recruited will then be randomized accordingly using the randomizer software. Group A will be the interventional group and group B will be the control group.

Oocyte retrieval will be performed 34-36 hours following the human chorionic gonadotrophin (hCG) trigger. Sperm was obtained on the same day. Mature oocytes will be fertilized with sperm via IVF or ICSI. Fertilized embryos were observed via time laps method and the progress and cleavage were monitored before planning for embryo transfer. Embryo transfer will be performed on day 3 or day 5 after oocyte retrieval.

All results will be analyzed using Statistical Package for the Social Sciences(SPSS) version 21 software. Descriptive analysis will be done for demographic data and presented in mean ± Standard deviation (SD). Demographic characteristic between the two groups will be compared with the use of the Mann-Whitney U test. The categorical data was analysed by using Chi-square test for the association of variables. A p-value of 0.05 or less was considered to be significant.

Eligibility Criteria:
Inclusion Criteria:

* · Aged 20 - 40 years old

  * Basal serum follicular stimulating hormone(FSH) level of no more than 10 IU/L
  * Diagnosis of PCOS met using Rotterdam criteria.

Exclusion Criteria:

* low AMH level (AMH less than 3 ng/ml).

  * Contraindicated to ovarian stimulation treatment eg: history of severe ovarian hyper stimulation syndrome(OHSS)
  * Presence of uterine pathology eg: adenomyosis, large uterine fibroid.
  * Patients who has had poor ovarian stimulation of twice or more.
Multidetector CT Left Appendage Atrial Thrombosis Exclusion in Patients With Atrial Fibrillation

The aim of the LATE (multidetector CT Lefi Appendage atrial Thrombosis Exclusion in patients with atrial fibrillation) study is to evaluate the diagnostic accuracy of cardiac Computed Tomography (TC) with 64 detectors and double acquisition phase in candidate patients ablation of atrial fibrillation (AF) with the Navx (or Carto) technique, using trans-esophageal ultrasound (TEE) as the standard reference.

This study is based on the use of an experimental protocol in cardiac TC which involves, in addition to the acquisition of an early arterial phase (standard protocol routinely performed in all patients), the execution of a possible late phase at a very low dose of radiation (experimental protocol) aimed at increasing the accuracy of the method in the diagnosis in patients with AF. The LATE study aims to demonstrate the high diagnostic accuracy of dual acquisition phase cardiac TC in the diagnosis of intraauricular thrombosis by comparing it with reference standard; in light of this result, cardiac TC could constitute a single non-invasive diagnostic tool in the future for the global evaluation of both atrial anatomy and endoawicular thrombosis with a clear improvement in patient management both in clinical and economic terms.


Eligibility Criteria:
Inclusion Criteria:

* patients candidates for cardiac TC and transesophageal ultrasound examination for the evaluation of cardiac anatomy and for the exclusion of intra-auricular thrombosis.

Exclusion Criteria:

* \< 18 years patients
: Protescal: Prevention of Hypertrophic Scar and Keloid Formation Post Caesarean Section

This study aimed to evaluate the effectiveness of Protescal in preventing post caesarean section hypertrophic scar and keloid formation.

A randomized controlled trial was conducted for six months involving 90 women who underwent caesarean section without any history of previous abdominal surgery and who were planning for further pregnancy. They were randomized into two groups. The Protescal group was given Protescal gel which was applied over the uterine incision site and subcutaneous tissue layer prior to skin closure (n = 45), whereas in the control group, no Protescal gel was applied (n = 45). The primary outcome was to assess the healing of the external scar.

Eligibility Criteria:
Inclusion Criteria:

* All women undergoing elective caesarean section, without any history of previous abdominal surgery ; who planned for further pregnancy and consented to participate in this study.

Exclusion Criteria:

* Patient that allergic to protescal
* Patient with previous abdominal surgery
* Patient refusal or patients who are not able to give consent
TevaGastrim for Stem Cell Mobilization Sibling Donors

The aim of this study is to evaluate the efficacy of TevaGastrim which is a biosimilar version of Filgrastim recombinant human G-CSF (G-CSF) in mobilizing sufficient number of stem cells from normal sibling donors for allogeneic stem cell transplantation.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 and 70 years.
2. Normal sibling donor that is HLA matched to a patient with AML or MDS that needs and is eligible for allogeneic stem cell transplantation
3. Written informed consent.

Exclusion Criteria:

1. Inability to tolerate PBPC harvest.
2. Peripheral venous access not possible.
3. Positive pregnancy test for female donors.
4. Positive serology for hepatitis C and/or HBSAg, unless negative for antigen PCR.
5. Psychiatric, addictive, or any disorder which compromises ability to give truly informed consent for participation in this study.
6. Treatment with other investigational drugs.
7. Known sensitivity to CHO derived products.
8. HIV positive.
9. History of malignant disease or current malignancy.
Safety and Efficacy of OsmoPrep® Tablets Versus HalfLytely® and Bisacodyl Tablet Bowel Prep Kit for Colon Cleansing

The purpose of this study is to compare the safety and efficacy of OsmoPrep tablets versus HalfLytely and Bisacodyl Tablet Bowel Prep Kit in subjects who are undergoing colonoscopy.


Eligibility Criteria:
Inclusion Criteria:

* Between 18 and 70 years of age, inclusive
* Scheduled for colonoscopy within 21 days of the screening visit
* Able to swallow tablets the size of a multivitamin without difficulty

Exclusion Criteria:

* History of biopsy-proven acute phosphate nephropathy
* Known allergy or hypersensitivity to treatment arms
* History of gastric stapling or bypass procedure or history of gastric retention
* History of any other sodium phosphate preparation within 6 months prior to colonoscopy
McGRATH MAC Video Laryngoscope

This study was designed to determine the first attempt success rate of tracheal intubation with the McGRATH™ MAC laryngoscope using direct visualization in patients with known difficult airways, as well as exploring the possibility of identifying a particular direct Cormack-Lehane (C-L) grade view where indirect (video) visualization can be most beneficial during laryngoscopy and intubation.


Eligibility Criteria:
Inclusion Criteria:

* BMI \< 50 kg/m2
* Two or more of the following inclusion criteria: Mallampati class: III-IV; Reduced mouth opening \< 4 cm; Neck circumference \> 40 cm for females and \> 43 cm for males; Thyromental distance \< 6 cm; Ratio of the patient's height to thyromental distance ≥ 23.5; Sternomental distance \< 12 cm

Exclusion Criteria:

* BMI ≥ 50 kg/m2
* emergency status
* cervical injury or pathology
* neck irradiation
* known difficult airway
* risk of gastric aspiration
* hemodynamic instability
* requiring rapid sequence intubation
Study in Patients With Untreated Multiple Myeloma and Renal Insufficiency

The study will evaluate the effects of BHQ880 in patients with previously untreated multiple myeloma and renal insufficiency who are not considered candidates for bisphosphonate therapy. The primary objective of the study will be to evaluate the effect of BHQ880 in combination with bortezomib and dexamethasone, compared to placebo administered with the combination on the time to first Skeletal Related Event (SRE) on study.


Eligibility Criteria:
Inclusion Criteria:

1. Confirmed diagnosis of multiple myeloma
2. Life expectancy of more than 6 months in the absence of intervention
3. Must not have received previous or be receiving current antimyeloma therapies
4. Renal insufficiency
5. Recovered from the effects of any prior surgery or radiotherapy

Exclusion Criteria:

1. Prior IV bisphosphonate therapy at any time or oral bisphosphonate therapy within 4 months of study entry
2. Paget's disease of bone or uncorrected hyperparathyroidism
3. Impaired cardiac function
4. Known HIV, known active hepatitis B, or known or suspected hepatitis C infection
5. Pregnant or nursing (lactating) women,
6. Women of child-bearing potential, UNLESS agreeable to using 2 birth control methods

Other protocol-defined inclusion/exclusion criteria may apply
Kentucky Access to Recovery Evaluation

Evaluate the long-term effectiveness of implementing vouchers as a linkage strategy in a population requiring recovery support services (RSS) when no other funding sources are available. A within-subjects study design will be used to test the effectiveness of the Kentucky Access to Recovery (KATR) last resort voucher linkage approach to reduce the risk of nonfatal and fatal overdoses by (a) increasing an individual's recovery capital; (b) reducing resumption of illicit substance use; and (c) promoting relinking to RSSs if illicit substance use is resumed.


Eligibility Criteria:
Inclusion Criteria:

* be in SUD treatment or have completed within the past year SUD treatment for opioid use disorder or stimulant use disorder or have a history of overdose from opioid use
* be a first-time participant in KATR
* be in early stages of recovery (less than one year in recovery)
* be a resident of a KATR service county
* be at or below the 200% federal poverty level
* not have financial resources available through other funding mechanisms for RSSs
* be 18 years of age and older
* be in need of recovery supports that will enhance their likelihood of staying in recovery

Exclusion Criteria:

* Under 18
* Participated in KATR previously