cyrilzakka/clinical-trials huggingface dataset:
Kerecis Real-World Fish Skin Graft Registry

Multi-center, observational (i.e., non-interventional), open-label, real-world Registry on the Use of Kerecis Devices

This observational (i.e., non-interventional), post-market, real-world, Registry was designed to collect, analyze, and identify relevant safety and performance outcomes for "all comers" using Kerecis devices in routine medical practice within a wide variety of United States (US) medical practice settings. These clinical data will be used at Kerecis for many purposes, which include, but are not limited to, device safety and performance evaluation as part of routine patient care and post-market clinical follow-up data commitments to regulatory authorities around the world.

Eligibility Criteria:
Inclusion Criteria:

* Provided informed consent
* Has at least one target wound treated with a Kerecis device according to physician medical judgement within one calendar month prior to the registry enrollment date

Exclusion Criteria:

* None
Bioequivalence Study of Rosuvastatin in Healthy Volunteers Under Fasting Condition

The present study is conducted to evaluate and compare the relative bioavailability for Rosuvastatin in two different products containing 10 mg film coated tablet after single oral administration.

A Randomized, Single-Dose, Two-Way Crossover, Open-Label, Bioequivalence Study of the two different products containing 10 mg film coated tablet after oral administration to 38 healthy adult volunteers under fasting conditions. Blood samples were collected at different time intervals and stored at -70⁰C freezer. Plasma concentrations of Rosuvastatin were analyzed and determined using a validated LC-MS-MS method then pharmacokinetics and statistical analysis were performed.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent is obtained for study.
* Age 18 - 55 years,
* Body mass index between 18.5 and 30 kg/m2
* Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on physical examination.
* Vital signs without significant deviations.
* All laboratory screening results are within the normal range or clinically non-significant

Exclusion Criteria:

* History or presence of any disorder or condition that would render the subject unsuitable for the study, place the subject at undue risk or interfere with the ability of the subject to complete the study in the opinion of the investigator.
* History of any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, allergic, dermatologic, hematologic, neurologic, or psychiatric disease, or cancer.
* Any confirmed significant allergic reactions against any drug, or multiple allergies.
* Clinically significant illness 28 days before study phase I.
* Alcohol or any solvent intake.
* Regular use of medication.
* Positive urine screening of drugs of abuse.
* Use of any systemic medications (prescription medications, OTC products, supplements, or herbal preparations) for 14 days prior to dosing and during the study.
* History or presence of significant smoking (more than one pack per day cigarettes) or refusal to abstain from smoking for 48 hours before dosing until checkout.
* Blood donation within the past 60 days.
* Participation in another bioequivalence study within 60 days prior to the start of phase I of the study.
CBT vs. ABM vs. for Social Anxiety

Adults with Social Anxiety Disorder will be pseudo randomly assigned to either an individual cognitive behavior therapy, attention bias modification treatment (allocation ratio - 1.5:1).

Outcome measures will be social anxiety symptoms and severity as measured by gold standard questionnaires as well as diagnosis of social anxiety disorder derived from structured clinical interviews based on Diagnostic and Statistical Manual (DSM) IV criteria.

The investigators expect to find significant reduction in social anxiety symptoms in all of the groups, with the cognitive behavior therapy group showing greater reduction in symptoms than the other groups. Mechanisms of change in all of the groups will be examined via measures of cognitive biases, affect, and other common and specific factors.

120 Adults with Social Anxiety Disorder will be pseudo randomly assigned to either an individual cognitive behavior therapy (CBT), attention bias modification treatment (ABM)).

Outcome measures will be social anxiety symptoms and severity as measured by gold standard questionnaires as well as diagnosis of social anxiety disorder derived from structured clinical interviews based on DSM-IV criteria.

The investigators expect to find significant reduction in social anxiety symptoms in all of the groups, with the cognitive behavior therapy group showing greater reduction in symptoms than the other groups. Mechanisms of change in all of the groups will be examined via measures of cognitive biases, affect, and other common and specific factors.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Generalized Social Anxiety Disorder, LSAS\>50
* If on medication, patients must be on a stable dose
* Hebrew language fluency

Exclusion Criteria:

* Primary Axis I or Axis II disorder other than SAD
* suicidal ideation
* Substance dependence within the past three months or current substance abuse
* Mental retardation or another pervasive developmental disability
* Current or past schizophrenia or psychosis, current bipolar disorder, or organic brain syndrome
Effectiveness of ESWT and PNF in Scleroderma With Calcinosis

Investigation of the effects of ESWT and PNF exercises added to ESWT on calcinosis in Ssc patients. Calcinosis cutis is a common, difficult-to-treat manifestation of systemic sclerosis associated with high morbidity. The aim of this study is to investigate the efficacy of ESWT therapy for calcinosis cutis in Ssc patients. The effects on grip strength, sleep, function and quality of life will be investigated.

In Ssc patients, ESWT and PNF exercises that they take to ESWT should not be taken on calcinosis. Calcinosis cutis is a common, difficult-to-treat manifestation of disseminated systemic sclerosis with high morbidity. The effects on machine power, sleep, function and quality of life will be investigated. Evaluation Methods - Treatment ROM (with goniometer), second force (dynamometer), ultrasound (evaluation of calcinosis size), DASH (evaluation of ability to maintain upper extremity activities) , HAMIS (hand function test patient-specific functions assessment), Pitsburgh Sleep Quality Index (PUKI) - (Sleep assessment assessment), Pain assessment (with VAS), Health assessment questionnaire (SHAQ) (health status assessment) will be evaluated. As a result of the evaluation, two groups will be separated and one group will be ESWT, one group will be applied PNF stretching in addition to EWST. Treatment PNf Tension : 10 sec against max resistance. The time will be done with isometric contraction. 5 sec. It will wait for active circuit. 8-10 will be repeated. 10 seconds between applications. listening range will be left. PNF will be applied 3 times a week, once a week. ESWT: ESWT will be applied 3 times in total, 20 minutes once a week. 2000 impulses will be applied on calcinosis. The Patients will do the taught PNF exercises once a day as a home program. H1: PNF stretching exercises go on calcinosis when Ssc patients go to ESWT and ESWT. H2: ESWT and decreased to ESWT in Ssc patients PNF stretching exercises were not effective on calcinosis.

Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with SSc according to ACR/EULAR 2013 criteria
* Being diagnosed with Calcinosis by a physician
* Have the ability to adapt to exercises
* Stability of medical treatments

Exclusion Criteria:

* Being diagnosed with a known additional rheumatological or chronic disease
* Having a deformity that prevents doing the exercises
* Cognitive impairment
* Being pregnant
Clinical Effect and Safety of Tamsulosin 0.4mg in Patients With LUTS/BPH Refractory to Tamsulosin 0.2mg

The purpose of this study is to explore the efficacy and safety of tamsulosin 0.4mg (Harnal® D. 0.2mg, 2T) in patients with LUTS/BPH refractory to tamsulosin 0.2mg (Harnal® D 0.2mg, 1T).

Alpha-adrenoreceptor antagonists have become the primary medical treatment for lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH). The next treatment method is trans-urethral resection of prostate (TURP). TURP is the most efficient BPH treatment for relieving symptoms and improving uroflow, but it is also the invasive and morbid.

Tamsulosin has higher selectivity for the pharmacological a1-adrenoceptor subtype and the cloned a1a subtype than for the a1b subtype. Tamsulosin 0.4 mg improved Qmax to a slightly greater extent than alfuzosin 10 mg.(26% and 16% versus baseline, respectively)(http://www. fda.gov/cder/approval/ index.htm;accessed October 27, 2003.) and Tamsulosin 0.4 mg o.d. has been reported to be well tolerated irrespective of age and/or cardiovascular comorbidity/co-medication (Michel et al 1998) and no interaction with several antihypertensive agents has been reported. (Lowe et al. 1997) Our study is to explore the efficacy and safety of tamsulosin 0.4mg (Harnal® D. 0.2mg, 2T) in patients with LUTS/BPH refractory to tamsulosin 0.2mg (Harnal® D 0.2mg, 1T).

Eligibility Criteria:
Inclusion Criteria:

* Male ≥ 45years
* (LUTS/BPH patients refractory to tamsulosin 0.2mg during 4 weeks)

  \*All of the following:
* Moderate to severe LUTS : IPSS ≥ 13
* An enlarged prostate (≥ 20mL, or moderately enlarged)
* Decreased peak flow rate : Qmax ≥4ml/s, ≤15mL/s volume voided ≥ 125 mL)

Exclusion Criteria:

* Post voided residual urine ≥ 200mL
* Patients performing catheterization
* Urinary tract infection patients
* Patients taking 5 alpha reductase inhibitor
* Known hypersensitivity to tamsulosin
* History of postural hypotension or syncope
* Hypertension patients treated with other alpha1-blockers
* Patients newly taking anticholinergic medication within 1 month
* Hepatic insufficiency (AST/ALT ≥ 2 times of normal range)
* Renal insufficiency (s-Cr ≥ 2mg/dL)
Effect of N_Acetylcysteine on Liver Functions in Donors in Living Liver Transplantation

our practice for the past 10 years we have noticed a transitional impairment of liver function (elevated liver enzymes, total and direct bilirubin, and elevated serum lactate levels) following donors' liver resection. Several drugs have been investigation on liver regeneration , proven benefit of N-Acetylcysteine (NAC) on rats with steatohpatitis


Eligibility Criteria:
Inclusion Criteria:

* ASA I or II donors
* healthy adult

Exclusion Criteria:

* kidney, liver disease
* any contraindications for organ donation
Evaluation of Left Ventricular Autothreshold, Phase Two

This study will collect data, from an implanted Cardiac Resynchronization Therapy-Defibrillator (CRT-D) device, to further evaluate a new feature for future heart failure devices.

ELEVATE 2.0 is an acute, prospective, multi-center, feasibility study randomized within patient test sequence and pulse width, designed to characterize the performance of the Left Ventricular Auto Threshold (LVAT) feature.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have a COGNIS CRT-D device implanted for at least 24 hours, with or without a right atrial lead
* Patients who have an active LV bipolar lead
* Patients who have an active right ventricular (RV) defibrillation lead
* Patients who are willing and capable of participating in all testing associated with this Clinical Investigation
* Patients who are age 18 or above, or of legal age to give informed consent specific to state and national law

Exclusion Criteria:

* Patients who have a COGNIS CRT-D that has less than or equal to one year of battery life remaining
* Patients who are pacemaker-dependent
* Patients who will not tolerate a pacing pause of up to 6 seconds
* Patients who have a unipolar LV pace/sense lead, unless the patient has any commercially available epicardial leads with at least two electrodes (from one or more leads)
* Patients with pre-existing leads other than those specified in this investigational plan
* Patients with a pre-existing unipolar pacemaker
* Patients who are unable or unwilling to maintain a supine or sitting position for 40-50 minutes
* Patients enrolled in any concurrent study, without Boston Scientific written approval
* Women who are pregnant
BioFreedom Ultra Registry

Over the past three decades, coronary stent struts have been made progressively thinner. Thin strut drug-eluting stents (DES) performed better than their thicker counterparts in a recent study. Thinner struts discourage abnormal coronary flow after implantation and associated with greater flexibility, deliverability and better clinical outcomes. Lower strut thickness may be particularly advantageous in small target vessels because thicker struts and smaller minimum in-stent lumen diameter are independent predictors of in-stent restenosis.

BioFreedom Ultra is a thin strut (84μm), cobalt-chromium, carrier-free drug-coated stent with Biolimus A9 drug. The BioFreedom Ultra stent is intended for percutaneous coronary intervention (PCI) for high-bleeding-risk (HBR) patients treated with 1-month dual antiplatelet therapy. BioFreedom Ultra received CE mark in October 2020 supported by the LEADERS FREE III trial which enrolled 400 HBR patients using the same inclusion criteria as the LEADERS FREE randomized trial. LEADERS FREE III is a single-arm trial, with all patients treated using the BioFreedom Ultra stent. The data was compared to the BioFreedom stainless steel drug-coated stent (DCS-StS) and bare-metal stent (BMS) groups from LEADERS FREE. The primary safety endpoint of the trial was a composite of cardiac death, myocardial infarction, or definite/probable stent thrombosis. The primary efficacy endpoint was clinically driven target lesion revascularization. The study found that the BioFreedom Ultra was non-inferior to the DCS-StS for safety and superior to the BMS for efficacy. Definite or probable stent thrombosis at 1 year in this HBR population was only 1%. Recently, the Biofreedom QCA randomized trial compared the Biofreedom Ultra with the stainless steel version (DCS-StS) in an all-comer population. In this prospective, single-blind non-inferiority randomized (1:1) trial, BioFreedom Ultra was non-inferiority for late lumen loss at 9 months in comparison with DCS-StS.


Eligibility Criteria:
Inclusion Criteria:

This is an "all comers" registry and patient who will be enrolled have to meet following criteria:

* Patient must be at least 18 years of age
* Patient must have indication to percutaneous coronary intervention including:

  * Stable angina or evidence of myocardial ischemia with stress echocardiography/ myocardial SPECT/exercise test, or
  * Unstable angina / non ST-elevation myocardial infarction, OR
  * ST-elevation myocardial infarction with de novo culprit lesion.
* Presence of one or more coronary artery stenosis \>50% with reference diameter 2.0-6.0mm which can be covered by one or multiple stents

Exclusion Criteria:

* Known intolerance to any of the device components
* Inability to provide written informed consent
* Participating in other trial before reaching primary endpoint
* Planned surgery within 1 month of PCI unless dual antiplatelet therapy is maintained throughout the peri-surgical period.
A Perioperative Sintilimab and Chemotherapy in Esophageal Squamous Cell Carcinoma

This study is aimed to evaluate the efficacy and safety of sintilimab combined with chemotherapy versus chemotherapy in perioperative treatment of locally advanced esophageal squamous cell carcinoma.

This study was designed as an open-label, randomized controlled, phase II trial. Subjects will be systematically randomized at a ratio of 1:1 and will be assigned to either the experimental group (sintilimab combined with chemotherapy group) or the control group (chemotherapy alone group). They will receive 2-3 cycles of neoadjuvant therapy followed by radical esophagectomy and lymph node dissection and adjuvant therapy determined by investigators. The primary endpoint is 1-year Event-free survival (EFS) rate.

Eligibility Criteria:
Inclusion Criteria:

* Esophageal squamous cell carcinoma suggested by gastroscopic histopathology.
* The primary tumor is located in the middle and lower of the esophagus.
* cT2-4aN0～3M0 or cT1N+M0 diagnosed by enhanced CT/MRI scan.
* Tumor was evaluated as resectable by surgeon before neoadjuvant therapy.
* Eastern cooperative oncology group (ECOG) performance status of 0 to 1.
* Can eat semi-liquid food.
* Less than 20% body weight loss within 6 months prior to enrollment.
* Sign the consent form before treatment and be able to comply with the relevant procedures such as treatment and visits stipulated in the protocol.
* With adequate organs function 1 week before enrollment and tolerable to chemotherapy and surgery.
* Female subjects of childbearing age or male subjects whose sexual partners are females of childbearing age should take effective contraceptive measures throughout the treatment period and 180 days after the last dose of the test drug.
* Agree and be able to provide archived or fresh pathological tissue and whole blood, urine and fecal samples for biomarker testing.

Exclusion Criteria:

* With metastases or unresectable primary lesion suggested by imaging before treatment.
* History of previous subtotal gastrectomy.
* Patients with active malignancy within 2 years other than the tumor studied in this study or a localized tumor that has been cured such as resected basal or squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, or breast cancer.
* Received any anti-tumor therapy for the research disease in the past, including radiotherapy, chemotherapy, immunotherapy (including but not limited to interleukin, interferon, thymus hormone) and traditional Chinese medicine therapy.
* With signs of pre-esophageal perforation. With any active autoimmune disease or has a history of autoimmune disease.
Safety and Efficacy of Intravenous OAV101 (AVXS-101) in Pediatric Patients With Spinal Muscular Atrophy (SMA)

To evaluate the safety, tolerability and efficacy of intravenous administration of OAV101 (AVXS-101) in patients with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene weighing ≥ 8.5 kg and ≤ 21 kg, over a 12 month period.

This was an open-label, single arm, multi-center study designed to evaluate the safety, tolerability and efficacy of OAV101 in participants with SMA who weigh ≥ 8.5 kg and ≤ 21 kg. The study aimed to enroll approximately 24 to 30 participants, with approximately 6 to 10 participants across each of 3 weight brackets (8.5 to 13 kg, \>13 to 17 kg, \>17 to 21 kg).

Eligible participants received a single administration of OAV101 at the approved dose of 1.1e14 vg/kg on Day 1 (Treatment period), and were followed for a period of 12 months.

Participants were admitted to the hospital on Day -1 for pre-treatment baseline procedures. After receiving OAV101 on Day 1, participants underwent in-patient safety monitoring over the next 48 hours, after which the participant could be discharged, based on Investigator judgment.

After study completion, eligible participants could enroll into a Long Term follow-up study to collect additional safety and efficacy data. (COAV101A12308 (NCT05335876) https://classic.clinicaltrials.gov/ct2/show/NCT05335876?term=COAV101A12308\&draw=2\&rank=1))

Eligibility Criteria:
Inclusion

* Symptomatic SMA diagnosis based on gene mutation analysis with bi-allelic survival motor neuron 1 (SMN1) mutations (deletion or point mutations) and any copy of the survival motor neuron 2 (SMN2) gene.
* Weight ≥ 8.5 kg and ≤ 21 kg at the time of Screening Visit 2
* Naive to treatment or have discontinued an approved drug/therapy

Exclusion:

* Previous OAV101 use or previous use of any adeno-associated virus serotype 9 (AAV9) gene therapy
* BMI \< 3rd percentile
* Participant with history of aspiration pneumonia or signs of aspiration
* Elevated anti-AAV9 antibody
* History of gene therapy, hematopoietic transplantation, or solid organ transplantation
* Inability to take corticosteroids
* Concomitant use of immunosuppressive therapy
* Requiring invasive ventilation, tracheostomy or awake non-invasive ventilation 9. Administration of vaccines 2 weeks prior to infusion of OAV101
* Awake hypoxemia or awake oxygen saturation level decrease
* Hepatic dysfunction
* Presence of a confirmed or suspected infection
* If previously treated with disease modifying therapy, specified washout times apply
* Documented any parental consanguinity.
Familien-SCOUT: Comprehensive Support for Families With a Parent Suffering From Cancer

When a parent with minor children falls ill with cancer, it is extremely stressful for all of the family members, including the partner and children. Familiar everyday routines are often disrupted even at an early stage, and for a prolonged period. Financial difficulties, the threat represented by the uncertain course of the disease, and worries about the children's future have a cumulative effect. The affected families are thereby pushed to their limits organizationally and emotionally. The burden involved tends to be underestimated, and secondary psychological conditions often develop among all the family members. They often do not have adequate access to support.

The aim of this project is to establish a care management system that provides support for families with underage children in which one parent is seriously ill. In order to reduce the burden on families, "family SCOUTS" are to be used who can provide advice and information at an early stage. They are intended to encourage families to discuss things openly, and they should also facilitate access to all the support services available.

The project will evaluate whether the use of family SCOUTS reduces the burden on the family in comparison with families who do not have a family SCOUT. For this purpose, investigations will be carried out before and after the family SCOUTS are deployed. Standardized questionnaires, interviews, and routine data from the participating health-insurance companies will provide the basic data.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed ICD diagnosis of cancer in one parent
* Custody of at least one underage child
* Adequate knowledge of German
* Availability of informed consent to participate in the study from the patient and/or healthy parent and linkage to questionnaire data and routine data

Exclusion Criteria:

* Withdrawal of consent by the ill or healthy parent
* Relevant cognitive limitation, advanced dementia
* Individuals who are in relationships of dependence or employment to the project managers or their representatives