cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy Evaluation of BRL-101 in Subjects With Transfusion-Dependent β-Thalassemia

This is a non-randomized, open label, multi-site, single-dose, phase 1/2 study in subjects with Transfusion-Dependent β-Thalassemia (TDT). The study will evaluate the safety and efficacy of autologous CRISPR-Cas9 modified CD34+ human hematopoietic stem and progenitor cells (hHSPCs) (BRL-101)

This clinical trial is a multi-center, single-arm, single-dose, open-label study without dose escalation. The proposed dose is ≥ 3 × 106 CD34 + cells/kg administered as a single intravenous infusion. The primary objective of Phase 1 is to explore the safety of the study drug in different age groups. For subjects of each age group, myeloablative conditioning and dosing of the remaining subjects was initiated only after completion of dosing and safety observations and assessments in sentinel subjects. The Phase 2 primary objective was to determine the effectiveness of BRL-101 administered intravenously to patients with TDT.

Eligibility Criteria:
Key Inclusion Criteria:

* Fully understand and voluntarily sign informed consent. 3-35years old. At least one legal guardian and/or Subjects to sign informed consent.
* Clinically diagnosed as β-thalassemia major, phenotypes including β0β0, β+β+, β+β0, βEβ0 genotype.
* Subjects with no affection with HIV, TP, HBV, HCV, CMV and EBV.
* Subjects body condition eligible for autologous stem cell transplant.

Key Exclusion Criteria:

* Subjects acceptable for allogeneic hematopoietic stem cell transplantation and have an available fully matched related donor.
* Active bacterial, viral, or fungal infection.
* Treated with erythropoietin prior 3 months.
* Immediate family member with any known hematological tumor.
* Subjects with severe psychiatric disorders to be unable to cooperate.
* Prior hematopoietic stem cell transplant (HSCT).

Other protocol defined Inclusion/Exclusion criteria may apply.
Developing and Validating Digital Affective Patient Experience/Outcome Measure

The aim of the research project is to develop and validate a new digital measure of affective patient experience in maternal care. In this validating study extensive collection of affective ratings of 195 emotion words is collected. Pregnant women at different gestational stages are asked to provide affective ratings of 195 emotion words in relation to the dimensions: pleasure, arousal, dominance. Based on these ratings population averages and properties of emotion words will be calculated. The measure will be developed in respect to the analysis of affective rating and supplementing data.

As there is an increasing demand for and interest in measures that take patient's emotions into account, this research project aims to develop and validate a new digital measure of affective patient-reported experience/outcome in maternal care.

In this validating study extensive collection of affective ratings of 195 emotion words will be collected. Pregnant women (N=1000) at different gestational stages are asked to provide affective ratings of 195 emotion words in relation to the dimensions: pleasure, arousal, dominance. This is done by using a visual Likert scale (Self-Assessment Manikin). The pregnant women participating in the research are also asked to answer to various questionnaires to identify patterns of personality, behavior and the state of health and well-being. Based on the affective ratings population averages and properties of emotion words will be calculated. The measure will be developed in respect to the analysis of affective ratings and supplementing data.

The research provides insights on how affective ratings could be connected to clinical indicators and patient experience.

Eligibility Criteria:
Inclusion Criteria:

* ongoing pregnancy
* attending maternal care in the Hospital District of Helsinki and Uusimaa
* fluent in Finnish
* access to mobile communication device

Exclusion Criteria: none
50% Nitrous Oxide and 50% Oxygen (MEOPA) Conscious Sedation Versus Placebo in Fiberoptic Bronchoscopy

Fiberoptic bronchoscopy may generate pain, anxiety or cough and dyspnea. It may then induce discomfort and then run down its yield. Systematic local anaesthesia does not always suffice and FOB may be conducted under general anaesthesia. Premixed nitrous oxide and oxygen (MEOPA) could be efficient to avoid general anesthesia risks and to reduce organizational costs. Nitrous oxide induces anaelgesia and anxiolysis when administered in oxygen at a 50% concentration.

MEOPA is being delivered in France for every short painful medical in-patients procedure since 2001. At a concentration of 50% in oxygen, and delivered through a facial mask, it produces a conscious sedation useful during endoscopy. MEOPA safety is due to its short term effect, which ends 5 minutes after cessation of inhalation. It therefore allows ambulatory medicine.

Two randomized double blind controlled studies were driven in fiberoptic bronchoscopy (Fauroux 2004, Atassi 2005) and showed its efficacy on pain control and sedation.

We will perform our Study to estimate MEOPA efficacy in term of pain control (Visual Analogic Scale (VAS)), anxiety control (COVI Scale), cough and number of general anaesthesias, comparing FOB under MEOPA and Oxygen (double blind, randomized, placebo-controlled study.


Eligibility Criteria:
Inclusion Criteria:

* Man or woman over 18 who should undergo a fiberoptic bronchoscopy (inpatient and outpatient)

Exclusion Criteria:

* Child under 18
* Pneumothorax
* ocular surgery in the previous 3 months,
* intracranial overpressure
* lucidity impairment
* emphysema bullae
* face trauma
* angina pectoris
* hemodynamic instability
* acute respiratory distress
* hypercapnia \> 45 mm Hg
* pregnancy
* lidocaine allergia
* lack of approuval from the patient to perform the study will of the patient to undergo FOB with premixed nitrous oxide-oxygen
A Study to Determine the Safety and Efficacy of Albiglutide in Patients With Type 2 Diabetes

A study to determine the safety and efficacy of albiglutide in subjects with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes
* BMI 20-45kg/m2 inclusive

Exclusion Criteria:

* females who are pregnant, lactating or within \<6 weeks post-partum
* current symptomatic heart failure (NYHA Class III-IV)
A Real-world Study of the Efficacy and Safety of ICIs as First-line Therapy for Advanced Malignancies

In this study, we collected the data of immunohistochemistry, gene detection, image, OS, PFS, Orr, and so on. Secondly, the database of immunotherapy for malignant tumor was established, and the predictive model was constructed to verify and establish the rationality and validity of the biomarkers and predictive system of immunotherapy


Eligibility Criteria:
Inclusion Criteria:

1. Informed consent has been signed and, in the judgment of the investigator, the patient is able to comply with the study protocol and sign a written informed consent.
2. the advanced malignant tumors (solid tumors of the non-small-cell lung carcinoma, stomach, breast, urinary system, etc.) were diagnosed by histopathology.
3. the stage IV according to the eighth edition of IASLC.
4. PS 0-2, the expected survival \> 3 months.
5. the age of 18-75 years.
6. no contraindication to treatment with immune checkpoint inhibitors.

Exclusion Criteria:

1. the patients' compliance was poor, which violated the rules of the trial;
2. the patients with severe dysfunction of vital organs (heart, liver and kidney) ;
3. the patients with other malignant tumors;
4. the researchers considered that the patients should not participate in other conditions of the trial.
Calorie-restricted, Ketogenic Diet and Transient Fasting During Reirradiation for Patients With Recurrent Glioblastoma

Increased glucose metabolism is characteristic for solid tumors. Thereby, glucose is important for the generation of ATP, supply of anabolic substrates and defense against reactive oxygen species in tumor cells. In preclinical models, restricting glucose availability using a ketogenic diet, calorie-restriction or transient fasting inhibits tumor growth.

Therefore, the purpose of the study is to evaluate whether a calorie-restricted, ketogenic diet and transient fasting can enhance the efficacy of reirradiation in patients with recurrent glioblastoma.


Eligibility Criteria:
Inclusion Criteria:

* age \>= 18 years
* recurrence of a histologically confirmed glioblastoma or gliosarcoma
* at least 6 months after first surgery
* at least 6 months after first radiotherapy
* interdisciplinary recommendation for reirradiation
* karnofsky performance status \>= 60, ECOG \<= 2
* creatinine \<= 2,0 mg/dl, urea \<= 100 mg/dl
* ALAT, ASAT \<= 7x upper normal limit

Exclusion Criteria:

* bowel obstruction, subileus
* insulin-dependent diabetes
* decompensated heart failure (NYHA \> 2)
* myocardial infarction within the last 6 months, symptomatic atrial fibrillation
* severe acute infection
* malnutrition, cachexia
* other medical conditions that might increase the risk of the dietary intervention
* pregnancy
* uncontrolled thyroid function
* pancreatic insufficiency
* dementia or other clinically relevant alterations of the mental status which could impair the ability of the patient to apply to the diet or understand the informed consent of the study
The Changes of Coping With Stressful Events Among Adolescents Under the COVID-19 Pandemic.

This study aims to describe the changes in coping strategies used by adolescents for stressful life events under the background of epidemic normalization; and explore the causes of coping strategy changes of stressful life events under the background of normalization of the epidemic situation among adolescents.

Under the special background of normalization of the epidemic situation, this paper describes and discusses the subjective feelings, changes in coping strategies, and causes of adolescent stressful life events, and puts forward a coping mechanism model of stressful adolescent events, which reflects the psychological changes of adolescent groups in the era of the epidemic situation and provides the basis for subsequent intervention measures.

Eligibility Criteria:
Inclusion Criteria:

* Aged 14-25
* Chinese nationality, who has lived in China since the outbreak of the COVID-19 epidemic, and has experienced or is experiencing the epidemic and its normalization.
* Have the normal cognitive ability, expression ability, and social participation ability.

Exclusion Criteria:

* Be diagnosed with psychological or mental illness.
* Incapacitated or unable to provide informed consent.
* Patients with severe diseases.
Effect of Immersive Virtual Reality Exergames in Patients With Parkinson's Disease

The study aimed to investigate the effect of applying cognitively challenging exergames using fully immersive virtual reality in patients with Parkinson's disease.

It has been reported that dual-task training involving both cognitive and physical functions helps improve walking speed during dual-task performance without increasing the fall risk in patients with Parkinson's disease (PD). Compared with conventional physical therapy, there are studies that dual-task training significantly improved walking speed and stride in PD patients. In addition, a systematic review study has been reported that it helps to improve balance and cognitive function when dual-task training is performed for patients with neurological diseases including Parkinson's disease.

Virtual reality is expected to promote functional recovery in patients with neurological disorders in terms of providing an enriched environment, goal-directed tasks and repetition, and inducing interest and motivation. Therefore, the study aimed to investigate the effect of applying cognitively challenging exergames using fully immersive virtual reality in patients with PD.

Eligibility Criteria:
Inclusion Criteria:

* Clinically diagnosed as idiopathic Parkinson's disease
* Modified Hoehn \& Yahr stage 2, 2.5, or 3

Exclusion Criteria:

* Moderate to severe cognitive dysfunction with Mini-mental State Examination score \< 19
* Severe dyskinesia or severe on-off phenomenon
* Plan to adjust medication at the time of screening
* Other brain diseases such as stroke, brain tumor, etc
* History of seizure
* Vestibular disease or paroxysmal vertigo
* Other comorbidities that make it difficult to participate in this study
The Effects of Dietary Salt on Post-exercise Hypotension

The new American Heart Association (AHA) blood pressure guidelines are expected to raise the prevalence of high blood pressure to \~46% in the United States. One recommendation for lowering blood pressure is aerobic exercise, which produces a period of lowered blood pressure (post-exercise hypotension; PEH) that lasts up to 24 hours. It is believed that PEH may be responsible for the observations of lowered blood pressure following initiation of exercise. However, most Americans eat too much salt, which expands plasma volume and may prevent PEH, rending aerobic exercise ineffective in improving blood pressure status.

Recently released blood pressure guidelines from the American Heart Association and American College of Cardiology are expected to raise the prevalence of hypertension in America from \~33% to \~46%. A single bout of aerobic exercise produces a prolonged period (up to 24 hours) of lowered blood pressure (post-exercise hypotension; PEH). Repeated bouts of aerobic exercise results in maintenance of lowered blood pressure, leading to recommendations of aerobic exercise for improvement of blood pressure status. However, more than 90% of Americans consume more sodium in their diets than is recommended. This is alarming, as excess dietary sodium intake expands plasma fluid volume, which may in turn attenuate the reduction in BP following exercise. Therefore, the objective of this project is to determine the effects of high dietary sodium intake on PEH. The investigators hypothesize that, compared to a recommended sodium diet, a high salt diet will attenuate post-exercise hypotension.

Eligibility Criteria:
Inclusion Criteria:

* Recreationally active

Exclusion Criteria:

* high blood pressure (\>140/90 mmHg)
* history of cardiovascular disease
* history of cancer
* history of diabetes
* history of kidney disease
* obesity (BMI \> 30 kg/m2)
* smoking or tobacco use
* current pregnancy
* nursing mothers
* communication barriers
Simulation-assisted Teaching in Learning Gastroscopy

This project is a single-blinded randomized controlled trial investigating the effect of simulation-based teaching in learning gastroscopy for medical doctors.


Eligibility Criteria:
Inclusion Criteria:

* Medical doctors in medical gastroenterology or surgery

Exclusion Criteria:

* prior experience with gastroscopy
Peripheral Facilitated Antegrade Steering Technique in Chronic Total Occlusions

Study of the BridgePoint Medical System in the crossing of chronic total occlusions of the lower extremities.


Eligibility Criteria:
Inclusion Criteria:

* suitable candidate for non-emergent, peripheral angioplasty
* documented de-novo or restenotic peripheral CTO lesion with TIMI 0 flow for at least 90 days and satisfactory distal vessel visualization (collateral supply)
* limb ischemia or claudication, Rutherford class I-III (grade 1-5) caused by the occluded artery

Exclusion Criteria:

* intolerance to aspirin or a neutropenic response to Ticlopidine or Clopidogrel
* appearance of thrombus or intraluminal filling defects
* peripheral intervention in the target limb within two weeks of the procedure
* renal insufficiency (serum creatinine of \> 2.3 mg/dl)
* contraindication to a peripheral artery intervention
* participation in another investigational protocol
Multi-center Assessment of Grafts in Coronaries: Long-term Evaluation of the C-Port Device

The Study plan is a post-market prospective, multi-center, open-label registry. The vein graft failure rates for the currently commercialized C-Port devices will be compared to an a priori rate taken from the peer-reviewed literature.

To satisfy the requirements set forth in post-market surveillance orders issued by the US FDA to Cardica, Inc., the following outcomes will be evaluated:

1. Acute, midterm, and one-year graft failure rates for coronary revascularization using the C-Port® xA™ Distal Anastomosis System, C-Port® FlexA™ Distal Anastomosis System, and C-Port® XCHANGE™ Distal Anastomosis System when in general use in the United States compared to hand-sewn anastomoses.
2. Technical failure rates when attempting to complete an anastomosis using the C-Port xA, FlexA, and XCHANGE Distal Anastomosis Systems.
3. The technical success rate of hand-sewn anastomoses following technical failures of the C-Port devices and the hand-sewn graft patency rates and clinical sequelae at one year.

Eligibility Criteria:
Inclusion Criteria:

* Able to give informed consent.
* Willing and able to have follow-up visits and examinations.
* Less than 80 years old.
* Have an ejection fraction of \>30 %.
* Have a life expectancy of \>1 year.

Pre-Operative Exclusion Criteria:

* Currently participating in other clinical trials that would conflict with this protocol.
* Unable to meet study requirements.
* Currently pregnant.
* Require preoperative use of an intraaortic balloon pump.
* Have a history of a bleeding disorder or history of a thromboembolic disease requiring anticoagulation therapy.
* Have congestive heart failure or been classified as NYHA Class IV.
* Have an aspirin allergy or other contraindications to aspirin use.
* Previous coronary artery bypass surgery.
* Vasculitis or other nonatherosclerotic cause for coronary artery disease.

Intra-Operative Exclusion Criteria:

* At least one target vessel site where the C-Port anastomosis will be placed that is free from severe calcification or severe atheromas
* Target vessel wall properties where the C-Port anastomosis will be placed are suitable for hand-sewn anastomosis
* Target vessel diameter is ≥ 1.3 mm
* Target vessel has a single wall thickness ≤ 0.75mm
* Hemodynamically stable
FOLFIRINOX in Patients With Inoperable Pancreatic Cancer

The prognosis of patients with locally advanced unresectable pancreatic cancer is poor, and the median survival is less than 1 year. FOLFIRINOX therapy, which induces tumor downstaging sufficient to allow surgical resection, could improve the overall survival of patients with locally advanced pancreatic cancer. Based on the FOLFIRINOX regimen for advanced pancreatic cancer, a phase II study of this regimen in patients with locally advanced unresectable and borderline pancreatic cancer is planned to determine the rate of conversion to operability.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed locally advanced unresectable or borderline resectable adenocarcinoma of pancreas
* Patients must have measurable disease as defined by RECIST 1.1 RECIST evaluations must have occurred within 4 weeks prior to study entry
* No evidence of hepatic or pulmonary metastatic disease by CT or CT/PET scans
* Male or non-pregnant and non-lactating female age \> or equal to 18 years and \< or equal to 70 years of age
* Patient must have received no prior therapy for the treatment of locally advanced unresectable or borderline resectable pancreatic cancer
* Patients must have adequate blood counts at baseline and blood chemistry levels
* Patient has ECOG Performance Status 0 to 1

Exclusion Criteria:

* Patients with islet cell neoplasms excluded
* Patients with known brain metastases
* Therapeutic Coumadin for a history of pulmonary emboli or deep vein thrombosis (DVT)
* Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
* Known infection with HIV, hepatitis B or hepatitis C
* Major surgery or vascular device placement within 4 weeks prior to Day 1 of treatment in study
* Prior chemotherapy or radiation for pancreatic cancer
* History of allergy or hypersensitivity to the study drugs
* Patient is enrolled in any other clinical protocol or investigational trial
* Metastatic disease on radiological staging
* Prior malignancy within last 3 years
* Significant cardiac disease
* Any prior gastrointestinal (GI) disease or history of prior pelvic or abdominal radiation in which in opinion of the investigator may place the patient at increased risk
* peripheral sensory neuropathy \> or equal to grade 2 at baseline
Effects of Expectations on Hypoalgesia Produced by Mental Practice

The main objective of this research work is to evaluate and quantify the hypoalgesia generated by motor imagery influenced by the presence of expectations.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 60
* Healthy and with no pain subjects

Exclusion Criteria:

* Any cognitive impairment that hindered viewing of audiovisual material.
* Difficulty understanding or communicating.
* Presence of systemic pathology, Central Nervous System or rheumatic disease.
* Inadequate understanding of the Spanish language to follow instructions for measuring and treatment.
* Collaboration of pregnant women.
* Underage subjects
* Subjects with pain at the time of the study.
Safety And Feasibility of Early DischargE - a Prospective And Randomized Trial of Low-risk Primary Percutaneous Coronary Intervention (PCI) Patients

The purpose of this study is to determine if early hospital discharge (at 48-72 hours), is feasible, safe, cost-effective, and/or improves compliance with medications, positive lifestyle changes and quality-of-life, in low-risk patients with ST-elevation myocardial infarction treated with primary percutaneous coronary intervention (primary PCI).

Patients with acute ST-segment elevation myocardial infarction (STEMI) have traditionally been hospitalized for at least 5-7 days to monitor for serious complications, including heart failure, arrhythmias, re-infarction and death. With the advent of primary percutaneous coronary intervention (PCI) as the treatment of choice for STEMI, fewer patients are completing their infarcts and the incidence of complications is decreasing. The Zwolle Primary PCI Index is one of several externally validated risk scores that can be used to identify low-risk primary PCI patients who can safely be discharged at 48-72 hours. Recent reviews have found that a majority of primary PCI patients with risk scores that deem them "low-risk" are kept in hospital longer than predicted by these scores.

SAFE-DEPART is a trial where low-risk primary and rescue PCI patients will be randomized either to an intervention arm (early hospital discharge, early outpatient follow-up with a nurse practitioner) or to standard of care (no recommended discharge date, no outpatient follow-up with a nurse practitioner). At 6 weeks time, a blinded research assistant will contact patients and collect data on feasibility, safety, quality-of-life, and cost-effectiveness outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Patient with ST-elevation myocardial infarction (STEMI)
* Treatment with either primary or rescue PCI
* Zwolle risk score \<= 3

Exclusion Criteria:

* Developed MI while in hospital for another reason
* Time from angioplasty to enrollment \> 24 hours