cyrilzakka/clinical-trials huggingface dataset:
A Study on the Management and Outcome of Patients With Systemic AL Amyloidosis in Europe

This is a retrospective, observational, multicenter study to collect Real-World Evidence (RWE) data on systemic AL-AMY patients in Europe. Data from paper/electronic medical records and/or electronic databases from key reference centers in Europe will be used. Data will either be entered by the site staff in the electronic Case Report Form (eCRF) or, where feasible, transferred directly, always in accordance to local regulations.

The lack of regulatory approved treatment options for AL amyloidosis (AL-AMY) justifies the need to understand the current treatment practice and outcomes of this disease. There is a need for objective Real-World Evidence (RWE) that reflects how treatments are initiated, combined and sequenced, and how their relative effectiveness and safety profiles emerge outside a clinical trial setting. Therefore, the aim is to generate RWE on systemic AL-AMY patients in Europe, including patient characteristics, resource use, treatments and associated patient outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Age\>18 years
* Confirmed diagnosis of AL-AMY and symptomatic organ involvement.
* Initiated first line treatment for AL-AMY in the period 2004-2018.
* Patients who have signed a participation agreement/ICF allowing data collection and source data verification in accordance with local requirements.

The inclusion of deceased subjects in the study is permitted under the condition that consent waiver has been granted by the Scientific Committee and/or Administrative Board of the participating sites and/or any applicable regulatory body, as per local regulations, to either implement a hospital informed consent form (ICF) already in place or provide written approval of this study-specific waiver. In the occasion that waiver of consent is not granted deceased subjects will not be enrolled in the study.

Exclusion Criteria:

* Patients under the age of 18 will not be considered eligible for this study
A Trial To Evaluate A Multivalent Pneumococcal Conjugate Vaccine In Healthy Adults 50-85 Years Of Age

This is a 2-stage, phase 1/2, randomized, active-controlled, observer-blinded study with a 2-arm parallel design in each stage.

In Stage 1 healthy adults 50 to 64 years of age with no history of pneumococcal vaccination will be randomized equally to receive either a single intramuscular dose of multivalent pneumococcal conjugate vaccine or a licensed tetanus, diphtheria, acellular pertussis combination vaccine (Tdap) (control group).

In Stage 2 healthy adults 65 to 85 years of age previously vaccinated with Prevnar 13 \>=2 months prior to investigational product administration will be randomized equally to receive either a single intramuscular dose of multivalent pneumococcal conjugate vaccine or the licensed 23-valent pneumococcal polysaccharide vaccine (control group).


Eligibility Criteria:
Inclusion Criteria:

* Stage 1: Healthy male or female adults 50 to 64 years of age with no history of pneumococcal vaccination
* Stage 2: Healthy male or female adults 65 to 85 years of age previously vaccinated with Prevnar 13 \>= 2 months prior to investigational product administration

Exclusion Criteria:

* Stage 1: Vaccination within 12 months before investigational product administration with diphtheria-, pertussis-, or tetanus-containing vaccine
* Stage 2: Previous vaccination with any pneumococcal vaccine other than a single prior dose of Prevnar 13
MATCH-UP: MAking Telehealth-Delivery of Cancer Care at Home Effective and Safe-Upscaled: A Pragmatic Cluster Randomized Trial

Many people with cancer spend a lot of time and money traveling to and from the doctor's office for cancer care. MSK's goal is to make getting cancer care easier by cutting down the need to make in-person visits to MSK. MSK is trying to do this through a new option called enhanced telehealth.


Eligibility Criteria:
Inclusion Criteria:

* Patients with breast or prostate cancer at Memorial Sloan Kettering Cancer Center who have had at least 3 prior medical oncology visits.

Exclusion Criteria:

* Patient is enrolled on a therapeutic clinical trial.
* Patients whose primary language is not currently supported by Epic.
Control of Pain From Braces With Patient Advice Sheets

To compare the analgesic property of acupressure with NSAIDs (Ibuprofen) in controlling pain following orthodontic treatment. This will be achieved by assessing the effectiveness of acupressure in controlling pain and discomfort by measuring the degree of pain relief after bonding of brackets to teeth and placement of initial archwire.

Single centred randomised controlled trial with subjects recruited from a hospital orthodontic outpatient department in Dundee Dental Hospital.

If informed consent is obtained, then the subject details will be delivered to the trial coordinator for randomisation to one of the groups, NSAIDs or acupressure group.

All subjects who are eligible for inclusion will be advised of the nature and purpose of the trial. The total number of subjects recruited will be approximately 36 with the acupressure and NSAID group containing approximately 18 subjects each.

All subjects who meet the inclusion criteria will be informed of the study and written consent sought for their participation. Subjects will be recruited from the new patient clinics and routine treatment waiting list. .

The subjects will be asked to measure the level and duration of pain and discomfort using a pain diary to record their experiences using visual analogue scales (VAS). The pain diary will be completed from 4 hours to 7 days after treatment after the insertion of the first orthodontic aligning archwire.

Intervention Groups In the acupressure group the subjects will be given an advice sheet and advised to use a definitive acupressure point on the back of the hand region to control orthodontic pain.

In the NSAID group the subjects will be given an advice sheet and advised to take Ibuprofen for the orthodontic pain

Pain scores via VAS will be analysed at 4hours, 24 hours, and 7 days after the orthodontic treatment. The VAS consists of a horizontal line, 100 mm in length with descriptive words at each end of the line which act as anchors e.g. no pain, great pain. The patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks

Eligibility Criteria:
Inclusion Criteria:

* aged 12-25
* malocclusion requiring treatment
* scheduled to begin orthodontic treatment
* requires fixed orthodontic braces on upper and lower teeth.

Exclusion Criteria:

* previous orthodontic treatment
* current use of analgesics
* contraindications to the use of NSAIDs
* previous acupressure experience
* pregnant
Ultrasound-guided Transmuscular Quadratus Lumborum Block for Percutaneous Nephrolithotomy

Patients undergoing percutaneous nephrolithotomy (PNL) suffer from acute postoperative pain, despite a multimodal analgesic regime.

We hypothesize that active (ropivacaine) transmuscular quadratus lumborum (TQL) block will significantly reduce postoperative opioid consumption and pain following PNL operation compared with placebo (saline) TQL block.

The aim of this study is to investigate the effect of ultrasound-guided (USG) TQL block concurrent with a multimodal analgesic regime compared to the multimodal analgesic regime alone (and placebo TQL block) in a randomized and placebo controlled design.

Patients undergoing percutaneous nephrolithotomy (PNL) suffer from acute postoperative pain, despite a multimodal analgesic regime, and the patients receive considerable amounts of long lasting opioids. For the patients this greatly increase the risk of experiencing the adverse effects of opioids.

The ultrasound-guided (USG) transmuscular quadratus lumborum (TQL) block is a single dosage of local anesthetic (LA) delivered in the plane between the psoas major muscle and the quadratus lumborum muscle. LA spreads cephalad into the thoracic paravertebral space to reach the somatic ventral rami (intercostal nerves) and the thoracic sympathetic trunk. The TQL block can reduce visceral pain and pain originating from the abdominal wall and has an expected duration of analgesic efficacy of 24 hours.

The aim of this study is to investigate the efficacy of the active USG TQL block together with the multimodal analgesic regime to reduce postoperative opioid consumption and pain compared to placebo USG TQL block and the multimodal analgesic regime in a randomized and placebo controlled design.

Eligibility Criteria:
Inclusion Criteria:

Scheduled for elective PNL operation in general anaesthesia with propofol and remifentanil.

Received oral and written information about the trial Signed the informed consent American Society of Anesthesiologists (ASA) classification 1-3

Exclusion Criteria:

Cannot cooperate Does not speak or understand Danish Allergy towards drugs used in the trial Large daily consumption of opioids Known alcohol or drug abuse Difficulty or inability to visualize the relevant muscular or fascial structures necessary to perform the USG-TQL block Pregnancy

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NC Xperience PMCF Study( rEPIC04B)

Multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study to confirm and support the clinical safety and performance of NC Xperience to meet EU Medical Device regulation (MDR) requirements in all the CONSECUTIVE patients treated with NC Xperience .

The objective of this multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study is to confirm and support the clinical safety and performance of the NC Xperience in a NON-SELECTED, Real World population under daily clinical practice when used as intended by the manufacturer to meet EU Medical Device regulation requirements for post-market clinical follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Patient treated with NC Xperience according to routine hospital practice and following instructions for use
* Informed consent signed

Exclusion Criteria:

* Not meet inclusion criteria
Influence of Changes in Food Group Variety on Food Cravings, Energy Intake, and Weight Loss After Bariatric Surgery

The purpose of this study is to find out if there is any change in diet on food cravings and weight loss in the 12 months following bariatric surgery.

Research suggests that satiation processes in obese patients may be impaired, possibly resulting in excessive energy intake and poorer weight loss outcomes. One factor that may contribute to disruption of satiation processes and related overconsumption is dietary variety. Additionally, food cravings for restricted foods are believed to contribute to poor compliance to diets, and in controlled feeding studies, food cravings are the most frequently provided reason for poor dietary adherence. Interestingly, several investigations have found that cravings decrease when individuals follow a very-low-calorie or monotonous diet (9-11). Thus, reductions in the variety of the diet may also reduce food cravings, and assist in dietary adherence. It is also possible that the type of surgical procedure performed may influence changes in dietary variety, and consequently food cravings. To date, few studies have analyzed bariatric surgery patients' selection of foods within specific food groups and no study has examined the variety of foods consumed within food groups. Changes in food group variety which facilitate improvements in regulation of energy intake and body weight among obese individuals after behavioral weight loss may have a similar impact in patients who undergo bariatric surgery. Additionally, no studies have examined the relationship between changes in dietary variety and food cravings, and how these factors may be related to weight loss outcomes in any population.

Primary Objectives:

To examine by surgery type(Roux-En-Y gastric bypass \[RYGB\], laparoscopic adjustable gastric banding \[LAGB\], vertical sleeve gastrectomy \[VSG\])

1. changes in dietary variety from pre- to post-bariatric surgery at 3, 6, and 12-months
2. changes in variety of high-energy-dense foods and changes in cravings of high-energy-dense foods at 3, 6, and 12 months and
3. changes in variety of high-energy-dense and low-energy-dense foods and changes in energy intake and weight loss at 3, 6, and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 65 years
* Bariatric surgery occurring within 3-6 months

Exclusion Criteria:

* Intend to move outside of the metropolitan area within the time frame of the investigation.
* Are pregnant, lactating, less than 6 months post-partum, or plan to become pregnant during the time frame of the investigation.
A Dose-escalation Study of Ombrabulin in Combination With Paclitaxel and Carboplatin in Patients With Advanced Solid Tumors

The primary objective of the study is to determine the maximum tolerated dose (MTD) based on the incidence of dose limiting toxicity (DLT) and the maximum administered dose (MAD) of ombrabulin combined with paclitaxel and carboplatin administered every 3 weeks in patients with advanced solid tumors.

Secondary Objectives:

* To assess the overall safety profiles of the combination therapy
* To characterize the pharmacokinetic profile of ombrabulin, its active metabolite RPR 258063, paclitaxel, and carboplatin when used in combination
* To document the objective tumor response

The duration of the study for each patient will include an up to 4-week screening phase, 21-day study treatment cycles, an end of treatment visit and a follow-up period.

Eligibility Criteria:
Inclusion criteria:

* Patients with advanced solid tumor for which the combination paclitaxel and carboplatin is potentially effective such as lung cancer, epithelial ovarian cancer.
* Patients who have signed and dated an Institutional Review Board (IRB)-approved patient informed consent form prior to study enrollment or performance of any study-specific procedures.

Exclusion criteria:

* Less than 20 or above 75 years of age ECOG performance status ≥2.
* Patients with more than 1 line of previous chemotherapy for advanced or metastatic disease (adjuvant/neoadjuvant and targeted agents \[eg gefitinib\] excluded)
* Concurrent treatment with any other anticancer therapy (except palliative radiotherapy),
* Women of childbearing potential who does not agree with contraception.
* Washout period of less than 28 days from prior anticancer therapies
* Symptomatic brain metastases and carcinomatous leptomeningitis.
* Other serious illness or medical conditions
* Current peripheral neuropathy ≥grade 2 and ototoxicity,
* Absolute neutrophils counts\<1.5 x 10E9/L. - Platelets count\<100 x 10E9/L. - hemoglobin \<9.0 g/dL (without red blood cell transfusion within 28 days before the test). - Creatinine Clearance\<55 mL/min. - Total bilirubin \>upper normal limits of the institutional norms. - ALT/AST \>1.5 times the upper normal limits of the institutional norms. - AP\>2.5 times the upper normal limits of the institutional norms.
* Medical history of myocardial infarction, angina pectoris, congestive heart failure, coronary artery bypass graft , arrhythmia , stroke or history of arterial or venous thrombo-embolism within the past 180 days requiring anticoagulants.
* Patient with a LVEF \<50% by echocardiography.
* Patient with uncontrolled hypertension and patient with organ damage related to hypertension such as left ventricular hypertrophy or grade 2 ocular fundoscopic changes or kidney impairment.
* Hypertension defined as systolic BP \>140 mmHg or diastolic BP \>90 mmHg on two repeated measurements at 30 minutes interval.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Hematoma Block as an Adjunct to Procedural Sedation for Forearm Fracture Reduction

The purpose of our study is to determine if the use of a hematoma block together with intravenous sedation and analgesia is an effective means of managing forearm fractures in the Emergency Department. To determine this, we have designed a randomized, double-blind, placebo controlled trial of hematoma block versus saline for the manipulation of forearm fractures under conscious sedation with ketamine and midazolam. Our hypotheses are two-fold: First, the use of a hematoma block together with conscious sedation will allow for improved pain control. Second, the use of a hematoma block together with conscious sedation will allow us to use less sedation, therefore promoting faster recovery from sedation and more efficient patient turnover in the Emergency Department.


Eligibility Criteria:
Inclusion Criteria:

* English or Spanish speaking
* Ages 3-17
* Closed distal forearm fracture requiring reduction under sedation in the Emergency Department
* Fracture involves the distal third of the forearm

Exclusion Criteria:

* Multiple trauma victims
* Associated nerve or vascular damage
* Associated elbow or humerus injury
* Sensitivity or allergy to lidocaine
* Contraindications to procedural sedation
* Previous attempts at reduction for the same injury
Center M: Digital Health Innovation Pilot

Center M is a digital health solution to Perinatal Depression (PD) which provides an alternative to Mindfulness Based Cognitive Therapy - Perinatal Depression (MBCT-PD). Center M shifts treatment to a telehealth model, reduces the number of sessions, and transitions home practice materials to a digital format. This study will include a clinical trial in which participants will be randomized to the Center M treatment with smartphone app delivery of homework compared to treatment as usual (TAU).


Eligibility Criteria:
Inclusion Criteria:

* Currently pregnant
* Age 18-50 years
* Fluent in English
* Available and able to attend online group scheduled meetings

Exclusion Criteria:

* Current or past enrollment in a mindfulness-based intervention group
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for IPF

This trial will study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of Idiopathic pulmonary fibrosis

Studies have shown that stem cell treatment is safe for Idiopathic pulmonary fibrosis (IPF) and can improve the prognosis of afflicted patients. Patients with IPF will receive a single intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells. The total dose will be 100 million cells. Patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.

For patients with more severe disease requiring chemotherapeutic drugs such as methotrexate, an autologous T Cell vaccine will be utilized created from the patient's own T cells obtained by apheresis

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Idiopathic Pulmonary Fibrosis
* Understanding and willingness to sign a written informed consent document

Exclusion Criteria:

* Active infection
* Active cancer
* Chronic multisystem organ failure
* Pregnancy
* Clinically significant Abnormalities on pre-treatment laboratory evaluation
* Medical condition that would (based on the opinion of the investigator) compromise patient's safety.
* Continued drug abuse
* Pre-menopausal women not using contraception
* Previous organ transplant
* Hypersensitivity to sulfur
Safety, Tolerability, and Activity Study of ISIS SOD1Rx to Treat Familial Amyotrophic Lateral Sclerosis (ALS) Caused by SOD1 Gene Mutations

This study will test the safety, tolerability and pharmacokinetics of single doses of ISIS 333611 administered into the spinal canal as 12 hour infusions.

This study will test the safety, tolerability, and pharmacokinetics of single doses of ISIS 333611 administered as 12-hour intrathecal infusions. Four dose levels (0.15, 0.5, 1.5 and 3 mg) will be evaluated sequentially. The volume of the infusion is 0.25 mL/12 hours. Each dose level will be studied in a cohort of 8 patients where 6 are randomized to active treatment with ISIS 333611 and 2 are randomized to placebo.

Eligibility Criteria:
Inclusion Criteria:

* Clinical signs of weakness attributed to ALS.
* Familial ALS with a documented SOD1 gene mutation.
* Age 18 years or older.
* Capable of providing informed consent and willing to comply with trial procedures and time commitments.
* Vital capacity (VC) at least 50% predicted value for gender, height and age at screening and not using invasive respiratory support.
* If taking riluzole, patients must be on stable dosage for at least 30 days prior to starting the study and expect to remain at that dosage until the end of the study.
* Medically able to undergo temporary insertion of intrathecal catheter.
* Normal test results for coagulation parameters.

Exclusion Criteria:

* Treatment with another investigational drug for ALS (e.g. pyrimethamine, ceftriaxone, lithium, tamoxifen, arimoclomol, high dose creatine, biological agent, or device within 1-month of Screening or 5 half-lives of study agent, whichever is longer. No prior treatment with siRNA, cell transplant, or gene therapy is allowed.
* Dosing in ISIS 333611-CS1 in a previous dose cohort within 60 days of screening.
* Presence of any of the following clinical conditions:

  1. Drug abuse or alcoholism within one year of the Screening visit.
  2. Unstable cardiac, pulmonary, renal, hepatic, endocrine, hematologic function, or active infectious disease.
  3. Documented history of HIV infection.
  4. Unstable psychiatric illness defined as psychosis or untreated major depression within 90 days of the Screening Visit.
* Any condition that may impact intrathecal infusion including:

  1. History of structural spinal disease including tumors and hyperplasia.
  2. Presence of an implanted shunt for the drainage of CSF or an implanted CNS catheter.
  3. Clinically significant abnormalities in hematology or clinical chemistry parameters as assessed by the Site Investigator during the Screening visit.
  4. Ongoing medical condition that according to the Site Investigator would interfere with the conduct and assessments of the study. Examples are medical disability (e.g., severe degenerative arthritis, compromised nutritional state, peripheral neuropathy) that would interfere with the assessment of safety and efficacy of study material or device performance, or would compromise the ability of the patient to undergo study procedures.
  5. ALT or AST \>/= 3 x ULN, unless discussed with and approved by the Medical Monitor.