cyrilzakka/clinical-trials huggingface dataset:
Long-Term Compassionate Use Study for Continued Administration of SCB01A-01

The primary objective is to characterize the safety profile of long-term exposure to SCB01A when administered to cancer subjects with advanced solid tumors. Furthermore, the efficacy profile will also be explored in this study.

This is a companion study to the protocol SCB01A-01 intended to provide long-term continued administration to subjects that completed Protocol SCB01A-01 on a compassionate basis. It is an open-label, single-arm study of SCB01A in subjects who have completed at least one cycles of treatment under the SCB01A-01 protocol.

Eligibility Criteria:
Inclusion Criteria:

Subjects who completed protocol SCB01A-01 and exhibited a favorable response or had no clinical evidence of disease progression (i.e. stable disease, partial response or complete response).

Exclusion Criteria:

Study participants meeting any of the following criteria will be excluded from enrollment:

1. Unwilling or unable to provide informed consent.
2. Unwilling or unable to comply with the requirements of the protocol.
3. Has unresolved toxicities from previous SCB01A-01 protocol.
Serratus Anterior Plane Block Versus Thoracic Paravertebral Block.

Compare between serratus anterior plane block and thoracic Paravertebral block in analgesia for patients with multiple rib fractures

The study will be conducted in a prospective randomised controlled. Patients will be allocated into three groups

Control group:

The patient will receive fentanyl patch 50 microgram

TPVB group:

The patient will receive thoracic vertebral plane lock 0.4ml/kg bupivacaine 0.1 25% will be administered. For continuous infusion catheter will be inserted . Then a rate of 7ml / hour to max 10 ml / hour of bupivacaine 0.0625%

SAPB group,:

Patient will receive serratus anterior plane block 0.4ml / kg bupivacaine 0.125% will be injected to open the space then a catheter will be advanced For continuous infusion of 0.0625 % bupivacaine at 7 ml / hour

Eligibility Criteria:
Inclusion Criteria:

* ASA 1_3 Age 18_60 Unilateral fracture ribs

Exclusion Criteria:

* Drug allergy Morbid obese Opioid dependence Patients refuse
Stretching Exercises on Hamstring Flexibility.

The hamstrings muscles are examples of muscle groups that have a tendency to shorten.

Limited flexibility has been shown to predispose a person to several musculoskeletal overuse injuries and significantly affect a person's function.

The objective of this study will be to compare the effect of three different methods of stretching techniques on the flexibility of hamstring muscle in subjects with short hamstring syndrome.

HYPOTHESES:

There will be no difference between sub-occipital muscle inhibition technique, neuro-dynamic slump stretch, or passive hamstring stretch on hamstring flexibility in subjects with short hamstring syndrome.

RESEARCH QUESTION:

Is there is any difference between suboccipital muscle inhibition technique, neurodynamic slump stretch, or passive hamstring stretch on hamstring flexibility in patients with short hamstring syndrome?

Eligibility Criteria:
Inclusion Criteria:

* undergraduate female students
* body mass index 18-25 kg/cm square.
* All subjects will be free from injury or disease expected to affect hamstring length or ability to perform the exercises.

Exclusion Criteria:

* Hamstring injury within the past year.
* Verbal report of performing regular lower extremity.
* Current Muscle stretching exercises.
* History of neck trauma (whiplash).
* History of recent fracture in any part of the body.
* History of neurological or orthopedic disorders
* Diagnosis of a herniated disk
* Low back pain in the last 6 months
Clearance of NRL972 in Patients With Cirrhosis and in Healthy Volunteers

A study in healthy volunteers and patients with liver cirrhosis to assess the effects of age, gender, and stable liver disease on the clearance of cholyl-lysyl-fluorescein (NRL972)


Eligibility Criteria:
Inclusion Criteria:

Subjects meeting the following conditions will be eligible for enrolment:

General - all subjects

1. Males or females (females of non-child-bearing potential or of child-bearing potential while taking medically appropriate contraception)
2. Caucasian
3. BMI: between 19 and 34 kg.m-2
4. BW: between 45 and 110 kg
5. willing and able to provide informed consent

   Healthy volunteers (group N)
6. Age: 18 - 40 years (inclusive) and \> 60 years
7. Assessed as healthy based on the pre-study examination

   Hepatic cirrhosis
8. Age: 18 - 75 years
9. stable compensated liver cirrhosis (cryptogenic, posthepatic, alcoholic) with histo-logical or macroscopic (e.g. laparascopy, biopsy, ultrasound sonography or other adequate imaging techniques) confirmation

Exclusion Criteria:

Subjects of any of the following categories will be excluded from enrolment:

General - all subjects

1. Previous participation in the trial
2. Participant in any other trial during the last 90 days
3. Donation of blood during the last 60 days or a history of blood loss exceeding 300 mL within the last 3 months
4. History of any clinically relevant allergy
5. Presence of acute or chronic infection
6. Uncontrolled diabetes mellitus
7. Resting systolic blood pressure \> 160 or \< 90 mmHg, diastolic blood pressure \> 95 or \< 50 mmHg
8. Clinically relevant ECG-abnormalities, prolonged QTc with \> 450 msec in males and \> 460 msec in females in particular
9. Positive HIV test
10. Positive alcohol or urine drug test on recruitment
11. Daily use of \> 30 gr alcohol
12. Smoking more than 15 cigarettes/day or equivalent of other tobacco products
13. Use of prohibited medication
14. Suspicion or evidence that the subject is not trustworthy and reliable
15. Suspicion or evidence that the subject is not able to make a free consent or to under-stand the information in this regard

    General - all females
16. Positive pregnancy test
17. Lactating
18. Not using appropriate contraception in premenopausal women

    All healthy subjects
19. Presence or history of any relevant comorbidity
20. Presence of any relevant abnormality in the laboratory safety tests, especially low Hemoglobin, increased liver enzymes, reduced serum creatinine
21. Positive serology for HBsAg, anti HBc and anti HCV
22. History of alcohol and/or drug abuse

    Patients with hepatic disease
23. Biliary liver cirrhosis
24. Liver impairment due to space-occupying processes (e.g. carcinoma)
25. State after liver transplantation or patient scheduled for liver transplantation
Non-gene Edited Anti-CD7 CAR T Cells for Relapsed/Refractory T Cell Malignances

This is a phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of non-gene edited anti-CD7 CAR (also called anti-CD7 CAR) T cells in patients with relapsed and/or refractory T cell lymphoma or leukemia

Anti-CD7 CAR is a chimeric antigen receptor immunotherapy treatment designed to treat leukemia/lymphoma expressing CD7 antigen. T-cell acute lymphoblastic leukemia, T-acute lymphoblastic lymphoma and T-cell non-Hodgkin lymphoma are a subset of leukemias and lymphomas that are positive for the surface protein CD7. The purpose of this study is to evaluate the efficacy and safety of anti-CD7 CAR T cells.

Eligibility Criteria:
Inclusion Criteria:

1. Signed written informed consent; Patients volunteer to participate in the research
2. Diagnosis is mainly based on the World Health Organization (WHO) 2008
3. Patients have exhausted standard therapeutic options
4. Systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 1 weeks
5. Female must be not pregnant during the study

Exclusion Criteria:

1. Patients declining to consent for treatment
2. Prior solid organ transplantation
3. Potentially curative therapy including chemotherapy or hematopoietic cell transplant
4. Any drug used for GVHD must be stopped \>1 week
A Efficacy and Safety Trial of Controlled Release (CR) Morphine in Cancer Patients

The purpose of the study is to determine the effect of Egalet® Morphine once daily compared to MST Continus twice daily on pain intensity and use of rescue medication for break through pain after 2 weeks of treatment in patients with pain due to cancer.


Eligibility Criteria:
Inclusion Criteria:

* The patient has stable strong opioid use equipotent to 30-240 mg oral morphine sulphate daily for a minimum of 2 weeks prior to entering the run-in phase.
* The patient has opioid-sensitive pain caused by active cancer.
* The patient is aged minimum 18 years.

Exclusion Criteria:

* The patient has a life expectancy less than 2 months.
* The patient has received chemotherapy or radiation therapy less than 4 weeks prior to entering run-in phase
* Patients with medical conditions contraindicating morphine treatment
* The patient has hepatic disease or impaired kidney function
* The patient is taking monoamine oxidase inhibitors (MAOIs) or has taken a MAOI within two weeks prior to entering baseline.
* The patient is taking other opioid agonists or antagonists, zidovudine or cimetidine.
Effects of Flourish HEC and BioGenesis to Improve Conception

This study intends to address whether improving the vaginal microbiome can help couples increase chances of conceiving.

Disrupted vaginal microbiomes are associated with a number of poor reproductive outcomes, including infertility, miscarriage, premature rupture of membranes, preterm labor and delivery, delivery of a low birthweight baby, and maternal infections (chorioamnionitis, endometritis). A healthy vaginal microbiome is typically thought to be one that is dominated by one of several Lactobacillus species, such as L. crispatus, L. gasseri, or L. jensenii. Several studies have shown that non-lactobacilli-dominant biomes are associated with poor in vitro fertilization or intrauterine insemination outcomes. Fewer studies have examined fertility in the home setting, and none to date has asked whether improving the vaginal microbiome (VMB) could increase fertility. This study addresses both. By assessing the VMB before and after using a vaginal care system which supports a healthy VMB, we will be able to examine whether there are associations between VMB composition and infertility, and whether shifting the VMB toward a lactobacillus-dominant state is able to improve chances of conception.

In this study, women will either follow routine care (control) or routine care plus the vaginal care system and fertility lubricant (intervention) for 3 months or until becoming pregnant, whichever comes first. In addition to tracking conception rates during those 3 months, we will follow women for an additional year following completion of the 3-month timeframe. If any woman is pregnant at the one-year mark, her pregnancy will be followed until delivery (or early termination) to track delivery outcomes and adverse events.

Eligibility Criteria:
Inclusion Criteria:

Women part of a cisgender couple aged 18 to 40 who are attempting to become pregnant and are attending a fertility clinic.

Exclusion Criteria:

1. Pregnant
2. Lactating
3. Severe male factor, hormonal imbalance (oligoovulatory/anovulatory cycles, cycles longer than 35 days), genetic abnormalities (chromosomal abnormality, common genetic mutation between partners), or severe uterine or tubal factor
4. Any diagnosis that would require the participant to undergo in vitro fertilization to become pregnant
5. Known allergies to any component of BioNourish®, Balance, BiopHresh®, or BioGenesis™
6. Known active vaginal infection at enrollment
Intracardiac CD133+ Cells in Patients With No-option Resistant Angina

The purpose of the study is to evaluate the efficacy of therapy with autological CD133+ cells in patients with angina resistant to pharmacological treatment and without the possibility of effective revascularization. Cells will be isolated from patients bone marrow and administered directly into the muscle of left ventricle. The main objective is to assess the treatments' influence on improvement of myocardial perfusion and function, and on decrease of occurrence of symptomatic angina.

Patients with a Stable angina pectoris (CCS II-IV) can potentially benefit from treatment with autological CD133+ cell populations, which include cells with a higher expression of cardiac and endothelial differentiation markers.

REGENT VSEL Trial will include Patients with Angina resistant to pharmacological treatment and without the possibility of effective revascularization.

The main objective of the study is to assess the treatments influence on:

* improvement of myocardial perfusion
* global and segmental contractility (LVEF)
* occurrence of symptomatic angina
* quality of life

Regent Vsel is a prospective, randomized, double blind, placebo-controlled study with a planned number of 60 Patients.

Randomization will be carried out according to a 1:1 mode. Every Patient will undergo a bone marrow aspiration. CD133+ cells will be isolated from bone marrow aspirates. Patients randomized to experimental group will receive isolated cells (direct left ventricular muscle administration). Patients enrolled to control group will get only a placebo solution injected into the muscle.

Eligibility Criteria:
Inclusion Criteria:

1. Stable angina CCS II-IV despite maximum pharmacotherapy for at least 2 weeks since last medications change
2. Presence of ≥ 1 myocardial segment with ischemia features in Tc-99m SPECT
3. Patients disqualified from revascularization procedures by Heart Team
4. Patient age \> 18 and \< 75 year old
5. Patient must provide written informed consent for participation in study

Exclusion Criteria:

1. Acute coronary syndrome in less than 6 months prior to enrollment
2. Heart failure NYHA III-IV
3. LVEF \<35%
4. Presence of intracardiac thrombus (echocardiography confirmed), massive calcification of the aortic valve and left ventricular aneurysm
5. Previous cardioverter-defibrillator or cardiac stimulator implantation
6. Allergy to contrast agents
7. History of malignancy
8. HIV, HBV, HCV infection
9. Life expectancy less than 6 months
10. Bleeding diathesis
11. Renal insufficiency (GFR \< 30 mL/min/1.73m2)
12. Pregnancy, lactation, or ineffective contraception in women of childbearing potential
Effects of Exercise Training in Chronic Obstructive Pulmonary Disease Versus Alpha-1-Antitrypsin-deficiency-patients

Chronic Obstructive Pulmonary Disease (COPD)-patients (caused by smoking-level) and Alpha-1-Antitrypsin-deficiency patients showed different developments during rehabilitation in regard to improvement of 6-minute-walking distance. The aim of this study is to investigate differences between training adaptations in COPD-patients and Alpha-1-deficiency patients. Both groups take part in a standardized multimodal 3-week-rehabilitation with strength and endurance training. In addition to conventional diagnostic procedures, muscle biopsies from the M. vastus lateralis will be conducted before and after rehabilitation program followed by biochemical, histochemical and immunohistochemical analysis of the probes.


Eligibility Criteria:
Inclusion Criteria:

* COPD
* Alpha-1-Antitrypsine-deficiency, phenotype: ZZ
* FEV1%pred. \<50

Exclusion Criteria:

* acute exacerbation
* exacerbation in the last 4 weeks
A Study to Assess the Bioavailability and Effect of Food of BMS-986419 Immediate-release Tablet Formulation in Healthy Adult Participants

The purpose of this study is to assess the impact of the BMS-986419 new immediate release (IR) tablet formulation compared to the current enteric (DR) capsule formulation, and to assess the effect of food on the drug levels of the IR tablet formulation in healthy adult participants.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female participants without clinically significant deviation from normal, as determined by the investigator, in medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory evaluations.
* Body mass index (BMI) of 18.0 to 32.0 kilograms per meter squared (kg/m\^2), inclusive, and body weight ≥ 50 kg.
* A female participant is eligible to participate if she is a woman not of childbearing potential (WNOCBP)

Exclusion Criteria:

* Any significant acute or chronic medical illness (eg, history of intracranial or intraspinal hemorrhage, CNS lesions, recent bacterial or fungal meningitis, etcetera) as determined by the investigator.
* Current or recent (within 3 months of study intervention administration) gastrointestinal disease that could affect the absorption, distribution, metabolism, and excretion of study intervention (for example, bariatric procedure).
* History of Gilbert's syndrome.
* Women who are of childbearing potential and women who are breastfeeding.
A Comparison Study Of Two Different Techniques For Identifying The Epidural Space In Parturients In Labour

The purpose of this study is to determine whether the use of the Epidrum device to identify the epidural space in labouring parturients reduces morbidity, when compared to standard loss of resistance techniques.


Eligibility Criteria:
Inclusion Criteria:

* Parturients receiving epidural analgesia for labour

Exclusion Criteria:

* parturients that withold consent
* parturients less than 18 years old
TONEFITreha: Proof of Concept and Usability Study.

The importance of physical activity and exercise-based interventions in neuro-orthopaedic rehabilitation is undisputed. Yet, patients and clinicians do not implement minimally required doses of physical activity in standard rehabilitation programs. This is partly due to intrinsic factors such as motivation, or due to physical condition that prevent any kind of exercise. In most cases, however, it is owed to limited time spent with therapists who would be able to supervise and apply the required doses to induce any potential exercise effects. Methods to semi-autonomously exercise with high motivation and continuous feedback would complement existing therapies and allow adherence to minimal dose recommendations.

For this study, a prototype of a new portable training solution for intensive walking exercise with built-in sensor-technology and a smartphone interface will be tested regarding its usability and its efficiency in a clinical setting.


Eligibility Criteria:
Inclusion Criteria:

* In-patients with non-specified pathological background
* At trial centre for at least 2 weeks
* If less than 4 weeks, willingness to visit clinic for the remaining exercise sessions.
* Must be able to walk independently (no or minimal gait impairment)
* Deemed fit for walking group exercise and other exercise (medical expert opinion).
* Cleared for low-intensity endurance exercise by treating physicians and therapists (medical expert opinion).
* Informed Consent as documented by signature (Appendix Informed Consent Form).

Exclusion Criteria:

* Health condition does not allow free movements of body segments (e.g. un-consolidated upper limb fracture)
* Contraindications to low-intensity endurance training (e.g. congestive heart failure, unstable angina, peripheral arterial occlusive disease).
* Fresh wounds around waist and trunk.
* Orthopaedic condition that limits walking ability (e.g. newly operated total hip replacement).
* Women who are pregnant or breast feeding,
* Intention to become pregnant during the course of the study
* Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable double-barrier method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, combined with mechanical barriers (e.g. condoms or diaphragms) or who are not using any other method considered sufficiently reliable by the investigator in individual cases. Female participants who are surgically sterilised / hysterectomised or post-menopausal for longer than 2 years are not considered as being of child bearing potential.
* Known or suspected non-compliance, drug or alcohol abuse,
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant (derived from medical history),
* Previous enrolment into the current study,
* Enrolment of the investigator, his/her family members, employees and other dependent persons.
Novel Biomarkers Related Xuebijing Injection Improves Sepsis

Sepsis is a life-threatening clinical syndrome of organ dysfunction caused by dysregulation of the body's response to infection, and is a common cause of ICU admission for critically ill patients, posing a serious threat to human health. The study demonstrated that hemopexin injection significantly reduced the 28-day all-cause mortality rate of sepsis patients, and this study clarified the specific target and molecular mechanism of hemopexin injection in the treatment of sepsis, which may be of great scientific significance and clinical value for the precise treatment of sepsis and the research and development of new drugs.


Eligibility Criteria:
Inclusion Criteria:

1. Meeting the Sepsis 3.0 diagnostic criteria;
2. SOFA score ≥ 2 and \< 13;
3. Signed informed consent.

Exclusion Criteria:

1. Age \<18 years or \>75 years;
2. Pregnant or lactating women;
3. Presence of severe primary diseases including malignant tumors severe hematologic disorders and HIV infection;
4. Current use of immunosuppressants or history of organ transplantation within the past 6 months;
5. Comorbidities that significantly affect vascular endothelial structure and function such as acute myocardial infarction.
Coughing in Infratentorial Brain Lesion Patients

To record diaphragm excursion in infratentorial brain lesions patients with dysphagia during coughing and compare them to those with supratentorial brain lesion patients with dysphasia and those with no dysphagia at a university affiliated rehabilitation department.

Our previous work has shown that stroke patients with dysphagia have impaired diaphragm excursion in comparison to those with no dysphagia. It has been postulated that respiratory and cough function are primarily controlled by respiratory and swallowing centers located in the brainstem.We postulated that those with infratentorial brain lesions would have more impaired cough and respiratory function than those with non-brainstem lesions and supratentorial brain lesions.

However there has been no studies whether those with infratentorial brain lesions have more impaired cough function and decreased diaphragm excursion than those with supratentorial brain lesions.

Eligibility Criteria:
Inclusion Criteria:

Group 1- Brainstem lesion subjects with dysphagia that would require insertion of a nasogastric tube Group 2- Non-brainstem lesion subjects with dysphagia that would require insertion of a nasogastric tube Group 3- Stroke patients with no evidence of dysphagia

Exclusion Criteria:

* Episode of acute pneumonia or pulmonary embolism at time of enrollment
* Previous history of chronic respiratory disorders or other systemic disorders that may affect respiratory function ( ex, rheumatoid arthritis, chronic renal disease, spinal cord injury)
* Stroke patients with multiple brain lesions
* Episode of Diaphragm weakness due to peripheral polyneuropathy or unilateral phrenic nerve palsy
* Previous episode of abdominal or thoracic surgery within one year of enrollment
* Concomitant diagnosis of myopathy, muscular dystrophy or other disorders that may affect respiratory muscles.
* Episode of rib fracture within one year of enrollment
* Chronic alcoholism
* Patient with previous diagnosis of dementia or with impaired cognitive function that may limit full participation at the evaluation
* Patient with tracheostomy state