cyrilzakka/clinical-trials huggingface dataset:
Combination of Bevacizumab and Allogeneic NK Immunotherapy for Metastatic Solid Tumors

The aim of this study is the safety and efficacy of Bevacizumab plus allogeneic natural killer (NK) immunotherapy to many kinds of recurrent solid tumors.

By enrolling patients with recurrent solid tumors adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of the combined therapy using Bevacizumab and NK cells.

The safety will be evaluated by statistics of adverse reactions. The efficacy will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).

Eligibility Criteria:
Inclusion Criteria:

* All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies after cancer recurrence
* Body tumor 1-6, the maximum tumor length \< 5 cm
* KPS ≥ 70, lifespan \> 6 months
* Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/L, hemoglobin ≥ 80 g/L

Exclusion Criteria:

* Patients with cardiac pacemaker
* Patients with brain metastasis
* Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction
Natural Gels for Treatment of Plaque Psoriasis

The aim of the study is to evaluate the safety and the therapeutic activity of the combination of Natural Gel combination and hair mask of plant origin in patients with mild to moderate plaque psoriasis.

This is a random, double blind placebo -vehicle- controlled study. Patients recruiting and inclusion into the study is well defined. Expert on site monitoring will assure execution of all assignments as detailed in the protocol (screening, consent form, double-blind group assignment) .

Statistical analysis:

* It is calculated that 52 patients will be needed for this study.
* Type I error probability associated with this test is 0.05 .
* Uncorrected chi square will be used to assess changes in the measured variables.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects with stable (for at least 6 months), mild to moderate (less than 10% of the skin surface area) plaque psoriasis.
2. Male and female ≥ 18 years old.
3. Subject is capable of giving a written informed consent.

Exclusion Criteria:

1. Subjects treated by topical or photo or systemic anti psoriatic therapy during 4 weeks prior to the study.
2. Subjects treated with Biological products for psoriasis for the last 3 months prior to starting the present study.
3. Subjects with any other type of psoriasis but vulgaris (plaque ).
4. Use of investigational agents \< 30 days prior to the study.
5. Low compliance.
6. Subjects who are mentally or physically unable to comply with all aspects of the study.
7. Pregnant women.
8. Known allergic reaction to fragrance or any ingredient of the test products.
9. Other inflammatory skin disease in the treatment area that may confound the evaluation of the psoriasis.
10. A medical condition that may put the patient at a general risk and therefore would prevent participation in the clinical trial.
Abdominal Wall Repair With Strattice in Germany: a Cohort Study

Incisional hernia is the most frequently seen long term complication in surgery causing much morbidity and even mortality in patients. Despite studies on the optimal closing technique for laparotomies, the risk for incisional hernia after midline incision remains about 5-20%. It has been established that implementing a mesh reduces recurrence of the incisional hernia but still the results of repair are often disappointing. Incisional hernias can become increasingly complex due to complicated abdominal wall defects caused by a disturbed anatomy, fistulas, burst abdomen, wound and mesh infections. In these cases it is not save to repair the incisional hernia by means of a synthetic mesh and other augmentation tools need to be implemented.

In the recent years the use of biological meshes has been gaining popularity. Recent reports of the use of collagen-based prosthesis have suggested that they support new vessel growth, do not excite a significant foreign body reaction, form fewer adhesions, are well incorporated into host tissues with minimal wound contraction, and can be used in grossly contaminated wounds with fewer infective complications. Biologic meshes are harvested from a source tissue and processed for medical use but they vary widely in their processing methods. They include tissues of human or animal origins, both chemically cross-linked and non cross-linked processes, and submucosal, pericardial, or dermal tissue sources. Current studies investigating the effectiveness of these meshes are small and have short periods of follow-up. These shortcomings can be explained to high cost of the meshes and unclear indication when to use a biological mesh.

The aim of this study is to investigate the short and long term effects of the Strattice biological mesh. The investigators will also inquire why a biologic mesh was used and what the direct and indirect costs were.


Eligibility Criteria:
Inclusion Criteria:

* Age of 18 years or older
* Signed informed consent
* Abdominal wall repair
* Strattice mesh implantation prior to inclusion in BASE cohort

Exclusion Criteria:

* Age under 18 years
* No signed informed consent
* Other operation than abdominal wall repair
* Other mesh than Strattice mesh
Response to Albuterol Delivered Through an Anti-static Valved Holding Chamber During Nocturnal Bronchospasm

Delivery of HFA albuterol through an antistatic valved holding chamber (VHC) will improve bronchodilator response during nocturnal bronchospasm.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years.
* Physician diagnosis of asthma.
* FEV1 60-80% predicted during the day.
* FEV1 increases ≥ 12 % and to ≥ 80% predicted after 2- 4 puffs of albuterol HFA MDI delivered by antistatic VHC.
* No smoking in the previous year and \< 10-pack year history.
* No history of severe asthma attacks requiring ER visit or hospitalization in the previous three months.

Exclusion Criteria:

* Patient required a short course of oral steroid in the past 30 days.
* Any disease that is inadequately controlled or any medication that would worsen asthma or interact with asthma medications.
* History of viral respiratory tract infection in the 3 weeks prior to the screening visit.
* Positive pregnancy test.
Ambulance Crews' Experiences of Using a Mechanical Chest Compression Device.

Should a person have a cardiac arrest (where their heart stops beating) they require treatment of cardiopulmonary resuscitation (CPR). This includes providing chest compressions. Traditionally these compressions are provided by hand but mechanical chest compression devices (MCCD) have been investigated for use in out of hospital resuscitation attempts.

Research trials recruiting human participants have concluded recently. They all found no difference in survival outcomes when MCCD and manual compressions were compared.

Despite this, the latest expert review on MCCD suggests that MCCD can be a reasonable alternative to high quality manual compressions when these cannot be provided. MCCD continue to be used by Specialists in the local ambulance service and historically by those recruiting patients to a national multi centre trial of MCCD. There is another, as yet under-investigated element, and that is of ambulance crews' experiences of using such devices. Therefore it is a reasonable topic to investigate.

This study will invite local United Kingdom (UK) National Health Service (NHS) operational ambulance crews to participate in a 1-2 hour online focus group discussion (a collective group discussion) about their experiences of using MCCD. The participants will be any operational ambulance crew member, employed by the local ambulance Trust and who had experience of using any type of MCCD. The focus groups will be audio recorded; participants will be aware of this when they choose to participate.

The aim of this research is to collect and report ambulance crews' experiences of using mechanical chest compression devices for out of hospital resuscitation attempts.

Ultimately there may of course be benefits for patients by exploring whether MCCD play a part in out of hospital resuscitations. Funding has been offered by a manufacturer one of the types of MCCD; they have had no involvement in the design or analysis of the study.

Once transcribed, the data will be analysed manually. The content of each focus group will be coded and then each participants' individual responses will be coded, first using open coding, then focused coding to identify emergent themes, before concluding with the categories that have been identified. The constant comparison method of data analysis will be used.

Eligibility Criteria:
Inclusion Criteria:

* aged 18 or over
* an employee of the local ambulance service
* employed as an operational ambulance crew member, irrespective of title
* to have experienced an out of hospital resuscitation where MCCD was used, irrespective of the type of device or their level of involvement.

Exclusion Criteria:

* not an employee of the local ambulance service
* have no experience of using a mechanical chest compression device at an out of hospital resuscitation
* the participant is unwilling to provide consent to participate
* the participant is unwilling to provide consent to be audio recorded.
Thoracolumbar Brace for Individuals With Parkinson's Disease

This pilot study looked to see if a new brace would change the way people with Parkinson's Disease positioned their bodies. It also gathered information on the experience of wearing the brace.


Eligibility Criteria:
Inclusion Criteria:

* 50-80 years of age
* Diagnosed with Parkinson's Disease
* Participant self-reports mild difficulty with posture
* Independent in ambulation without an assistive device (i.e., no walker or cane)
* Able to give consent determined via telephone screen assessment or at minimum can follow simple directions
* Able to tolerate 5 minutes of standing or walking at a time per self-report

Exclusion Criteria:

* Rigid or fixed spine, as determined by self-report and use of thoracolumbar flexibility screen
* Symptoms present before the age of 50
* Other neurologic diagnosis, as determined by self-report
* Spinal surgery
* Lives in a nursing home or skilled facility
* Uncorrected vision loss
* Skin that is sensitive to tape or extremely fragile
* Recent surgery (within the last 3 months) that affects mobility, as determined by self-report
* Chest pain at rest or with activity per self report
* Shortness of breath with daily activity per self report
* Severe orthostatic hypotension assessed during in-person screen with sitting and standing blood pressure, evidenced by a 20-point drop in systolic blood pressure or 10-point drop in diastolic blood pressure and symptoms (e.g., dizziness) that don't resolve in 5 minutes.
* High blood pressure 180/110 resting or systolic blood pressure \<90 mmHG
* Resting heart rate \> 100 bpm or \<50 bpm
* Waist circumference \< 31" or \> 51" that would prevent proper fitting of CALIBRACE.
An Efficacy and Safety Study of Oral Azacitidine (CC-486) as Maintenance Therapy in Chinese Participants With Acute Myeloid Leukemia in Complete Remission

The purpose of this study is to evaluate the efficacy and safety of Oral Azacitidine (CC-486) in Chinese participants with acute myeloid leukemia in complete remission.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed, histologically confirmed de novo acute myeloid leukemia (AML) or AML secondary to prior myelodysplastic disease or chronic myelomonocytic leukemia (CMML)
* Eastern cooperative oncology group performance status of 0, 1, or 2
* Has undergone induction therapy with intensive chemotherapy with or without consolidation therapy
* Must have achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) status within 6 months (+/- 7 days) prior to starting study therapy

Exclusion Criteria:

* Suspected or proven acute promyelocytic leukemia or acute myeloid leukemia with previous hematologic disorder such as chronic myeloid leukemia or myeloproliferative neoplasms, excluding myelodysplastic syndromes and chronic myelomonocytic leukemia
* Candidate for allogeneic bone marrow or stem cell transplant at screening
* Have achieved CR/CRi following therapy with hypomethylating agents
* AML associated with inv(16), t(8;21), t(16;16), t(15;17), or t(9;22) karyotypes or molecular evidence of such translocations
* Proven central nervous system leukemia
* Prior bone marrow or stem cell transplantation

Other protocol-defined inclusion/exclusion criteria apply
Independent Use of Brain Measurement-Based Rehabilitation System by Stroke Survivors

The Axem Home study is a randomized open label trial analyzing the safety and feasibility of coupling the Axem Home prototype device with exercise to improve motor recovery following a stroke.

The Axem Home study is a randomized, open label, phase I clinical trial evaluating the safety and feasibility of coupling feedback to participants on their levels of sensorimotor brain activity (via the Axem Home prototype device) with exercise rehabilitation. 15 participants will be enrolled in each arm of the study. Both groups will participate in an exercise program, but only one group (the intervention group) will receive the Axem Home prototype device.

Study participants will be evaluated at baseline, after 3 weeks, and after 6 weeks (upon the completion of their time in the Early Supported Discharge program). Evaluators will be blinded as to which group participants are in. The study is constructed with randomization to remove selection and allocation biases.

Eligibility Criteria:
Inclusion Criteria:

* Accepted into the Calgary Stroke Program's Early Supported Discharge program for stroke survivors
* Aged 18 or older
* Visual acuity better than 20/50 in both eyes
* Able to give consent
* Clinician reported upper-extremity movement deficit

Exclusion Criteria:

* Score ≥15 on the PHQ-9
* Score \<10 on the MoCA or \<20 on the CASP
* Inclusion in another interventional trial
* Have open wounds on their scalp
A Novel Approach for Reducing Hyperoxaluria and Kidney Stone Risk.

This pilot study is proposing a novel approach to directly target intestinal oxalate absorption with the drug Tenapanor, which was recently FDA-approved for treating hyperphosphatemia in patients with chronic kidney disease. Tenapanor works by blocking paracellular phosphate absorption by the intestine, but the underlying mechanisms have not been clearly defined. Since phosphate and oxalate ions are absorbed through the same paracellular pathway, and are of similar size and charge, Tenapanor is hypothesized to also reduce dietary oxalate absorption and consequently lower urinary oxalate excretion.

The proposed proof-of-concept studies will determine whether Tenapanor reduces urine oxalate in normal human subjects receiving a high-oxalate diet in a crossover placebo-controlled short-term metabolic study.

Study Design Screening - One 24-hour urine for analysis of stone-risk profile, one blood sample for comprehensive metabolic panel and cystatin C, one stool sample for fecal calprotectin, physical exam, social and medical history, vital signs, demographic information, personal information.This is a two-phase study, each phase is 5 days in duration.

Phase 1: The subjects will consume a pre-prepared oxalate-rich metabolic diet for 5 days while taking 30 mg Tenapanor or Placebo twice a day just prior to the morning and evening meals. On days 4 and 5 they will collect two 24-hour urines for measurement of urine oxalate and stone-risk profile.

Washout: The subjects will undergo a 9-day washout period. Phase 2: The subjects will consume a pre-prepared oxalate-rich metabolic diet for 5 days while taking 30 mg Tenapanor or Placebo twice a day just prior to the morning and evening meals. On days 4 and 5 they will collect two 24-hour urines for measurement of urine oxalate and stone-risk profile.

Eligibility Criteria:
Inclusion Criteria:

* Normal, healthy adult volunteers

Exclusion Criteria:

* Personal history of kidney stones
* Pregnant or nursing
* Recurrent urinary tract infections
* Lithogenic urine chemistry at baseline (oxalate \> 45 mg/24 h, urine calcium \> 300 mg/24 h)
* Chronic kidney disease (eGFR \< 90 mL/min/1.73m2)
* Personal history of GI disease, GI obstruction, or GI surgery
* Chronic diarrhea
* Intestinal inflammation (Fecal calprotectin \> 120 mcg/g)
* Drugs which are substrates of OATP2B1 (e.g. enalapril)
* Chronic use of sodium polystyrene sulfonate, angiotensin-converting enzyme inhibitors, diuretics, antacids, alkali treatment, or carbonic anhydrase inhibitors.
Telemonitoring in Patients With Heart Failure

The purpose of this study is to investigate if telemonitoring results in a decrease in hospital admissions, with equal quality of care defined as mortality, quality of life and unplanned visits with caregivers. Telemonitoring is expected to be more cost-effective than usual care in patients with heart failure.


Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18 years
* Patients with heart failure NYHA classification II-III-IV
* Patient experienced a period of fluid retention
* Patient is treated by a cardiologist
* Patient is followed-up by a heart failure nurse
* Adequate knowledge of the Dutch language
* Patient has an active telephone connection, preferably analogue
* Patient is mental competent
* Patient has the disposal of a balance

Exclusion Criteria:

* Patients suffering from COPD, Gold classification 3 or 4
* Patient is a dialysis patient
* Patient has a visual restriction to read the dialogues on the Health Buddy
* Patient is hard of hearing or deaf
* Patient suffers from a lethal sickness with a prognosis \< 1 year
* Patient participates in another trial
* Patient needs a hospital admission on short time, i.e., \< 3 months
* Patient used the Health Buddy in an earlier stage
* Patient is an illiterate person.
Effects of BFR Interventions in Healthy Individuals and Individuals With COPD

The purpose of the study is to investigate the effect of different blood flow restriction (BFR) interventions on muscle function and adaptations both in healthy well-trained individuals and individuals diagnosed with COPD.


Eligibility Criteria:
Inclusion criteria for participants with COPD group are:

* Diagnosis with COPD

Exclusion criteria participants in the COPD group are

* Having experienced an acute exacerbation of COPD within the last 6 weeks (Study A)
* Taking part in pulmonary rehabilitation within the last 3 months (Study A)
* Presenting with a history of thromboembolic event in the lower limbs.

Inclusion criteria for healthy participants are:

* Age between 18 and 40 years.
* Maximal oxygen uptake (VO2max) of \>55 ml O2/kg/min for men and \>50 ml O2/kg/min for women
* BMI of \<26 and normal ECG and blood pressure.

Exclusion criteria for healthy participants are:

* Smoking
* chronic disease,
* Use of prescription medication
* Pain due to current or previous musculoskeletal injury
* Resistance training more than once per week in the 12 months leading up to the intervention.
The Hypotension Prediction Index in Free Flap Transplant in Head and Neck Surgery.

The aim of the current study is to evaluate the effects of the Hypotension Prediction Index (HPI) on the degree of intraoperative hypotension in patients undergoing free flap surgery. The hypothesis is that implementation of the HPI algorithm will reduce the time-weighted average (TWA) intraoperative hypotension below a threshold of 65 mmHg (16), and to reveal the relationship between the episodes of hypotension and free flap viability and function.


Eligibility Criteria:
Inclusion Criteria:

* Patients qualified to head and neck free flap surgery
* Written informed consent

Exclusion Criteria:

* Patients under 18 years
* Lack of health insurance
* Pregnancy
* Known history of congenital heart disease, severe aortic and/or mitral stenosis, heart failure and ejection fraction \< 35 %
* Persistent atrial fibrillation and other arrhythmias impairing arterial pressure-based cardiac output (APCO) monitoring
Evaluate Bacteriophage as a Useful Immunogen in Patients With Primary Immune Deficiency Diseases (PIDD)

This protocol is designed to ascertain whether the bacteriophage 0X174 neoantigen is safe and effective as an antigen used in the evaluation of primary and secondary immune responses. Bacteriophage 0X174 is given intravenously 2 billion PFU/Kg of body weight; small blood specimens of 3-5 ml (about 1 teaspoon) are collected after 15 minutes, 7 days, 14 days, and 28 days. Blood is collected at intervals following the administration of the bacteriophage and the number of phage/ml is determined by the agar overlay method using suspension of E. coli C and serially diluted patient's serum. Phage-specific IgG and IgM are measured by neutralization assay. Capacity of switch from IgM to IgG is determined.


Eligibility Criteria:
Inclusion Criteria:

1. subject/parent or guardian willing to sign consent and adhere to study schedule
2. known or suspected primary immune deficiency

Exclusion Criteria:

1. pregnancy
2. breastfeeding
3. unwilling to sign consent or adhere to study schedule
4. \< 2 yrs of age or \> 85 yrs of age
5. previous reaction to vaccine
Study on the Effect of Exercise Intervention Combined With Physical Therapy on Chronic Ankle Instability Symptoms

Purpose; Through experimental observation of exercise intervention (blood flow restriction training combined with low load ankle muscle strength training and balance training) combined with instrument tool therapy (Instrument Soft Tissue Release Technique, IASTM), the intervention effect on ankle function, strength, and joint range of motion of sports dance athletes with ankle instability was observed.

Method; 45 subjects with unstable, restricted or uncomfortable ankle joints were selected as observation subjects and randomly divided into ankle blood flow restriction training combined with IASTM group (n=15), ankle blood flow restriction training alone (n=15), and traditional ankle strength training (n=15). The intervention lasted for 6 weeks, once a week. Cumberland ankle instability assessment, FAAM ankle function assessment score, and ankle range of motion measurement were performed at three time points before intervention, after the first intervention, and after 6 weeks of intervention for three groups. The ankle strength test was only compared and analyzed at two time points before and after intervention.


Eligibility Criteria:
Inclusion Criteria:

* Age: 18-35 years old
* Course of illness: Suffering from chronic ankle instability symptoms that last for at least 3 months
* Symptoms: Ankle instability, frequent ankle sprains, discomfort during walking or exercise
* Functional screening: Two or more tests tested positive for ankle joint function screening before the experiment
* Structural examination: No joint structural lesions or congenital ankle deformities,
* Medical history: Have not undergone ankle surgery or have external injuries
* Health status: No serious heart, lung, nervous system or other systemic diseases
* Exercise level: Able to complete the exercise intervention and evaluation tasks specified in the experiment
* Agree to participate in the study: Has limited exercise ability and is unable to complete the research task

Exclusion Criteria:

* Under 18 years old or over 35 years old
* Acute ankle injury or no joint injury
* No ankle instability or unwillingness to cooperate with research requirements
* Failed ankle function screening
* Structural lesions or congenital ankle deformities present in the ankle joint
* Have undergone ankle surgery or have obvious injuries or wounds
* Serious heart, lung, nervous system or other systemic diseases
* Due to limited athletic ability, unable to complete research tasks
* Disagree to participate in the study, or inability to understand and comply with the research protocol