cyrilzakka/clinical-trials huggingface dataset:
Long-Term Nutritional Support in Patients With the Acquired Immunodeficiency Syndrome: Comparison of Liposyn III 2 Percent With Liposyn II 20 Percent

To compare two lipid emulsions in the long-term parenteral alimentation of patients with AIDS in relation to: Clinical effectiveness. Effect on immunologic function. Effect on HIV load as measured by p24 antigen levels. Effect on relative HIV infectivity.


Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Zidovudine (AZT).
* All drugs used for the standard treatment of opportunistic infections.
* Other drugs used for the treatment of other AIDS conditions if they have been started more than 3 months prior to study entry.

Patients must have:

* Diagnosis of AIDS.
* Weight loss of \> 10 percent premorbid body weight.
* Presenting diagnosis of either opportunistic infection or Kaposi's sarcoma.
* Require home total parenteral nutrition (TPN) for a period of approximately 3 months.
* Life expectancy = or \> 90 days.

Prior Medication:

Allowed:

* Zidovudine (AZT).

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

* Life expectancy \< 90 days.
* Biliary stasis.
* History of drug abuse.

Patients with the following are excluded:

* Life expectancy \< 90 days.
* Biliary stasis.
* History of drug abuse.

Prior Medication:

Excluded within 3 months of study entry:

* Immunomodulators.
* Experimental antiviral DT. History of drug abuse.
Lentivirus Transduced Acute Myeloid Leukaemia Blasts Expressing B7.1 (CD80) and IL-2

The purpose of this study is to assess the safety and tolerability of an 'AML Cell Vaccine' in patients with poor prognosis acute myeloid leukaemia (AML).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of AML defined according to the WHO classification
* Age ≥ 18 years
* New presentation or relapsed AML
* Patients must be able to give written informed consent
* Failure to enter complete morphological remission (\>5% bone marrow AML cells) or persistence of cytogenetic abnormality following intensive combination chemotherapy At day+100 post-transplant
* HIV negative
* No GvHD
* No continuing use of immunosuppressive drugs
* Absence of active systemic fungal or viral infection including HTLV-1, hepatitis B or C.
* Adequate renal and liver function confirmed by: creatinine clearance \>30mls/min; bilirubin \<3.0 x upper limit of normal; AST \<3.0 x upper limit of normal; prothrombin time \<2.0 x upper limit of normal.

Performance status of 1 or less by ECOG criteria or \>80% by the Karnovsky score

* Patient must provide written informed consent and be willing to comply for the duration of the study.
* Life expectancy \>36 weeks
* Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test within 10 - 14 days and again within 24 hours of starting the study. In addition, sexually active WCBP must agree continued abstinence from heterosexual intercourse or to use adequate contraceptive methods starting 4 weeks prior to the initiation of therapy (see appendix G for pregnancy testing and birth control guidelines while on study). WCBP must agree to have pregnancy tests every 3 weeks while on study drug (every 14 days for women with irregular cycles) and 4 weeks after the last dose of study drug. Men must also agree to use a condom if their partner is of child bearing potential, even if they have had a successful vasectomy.

Exclusion Criteria:

* Age \< 18 years
* Patients not fit for intensive chemotherapy
* Complete morphological and cytogenetic remission following intensive combination chemotherapy
* Absence of HLA compatible donor
* HIV positive
* Evidence of graft versus host disease at day+100 post transplant
* Evidence of relapse of leukaemia (≥5% bone marrow blasts)
* Concurrent use of other forms of anti-leukaemic therapy
* Other malignancy with the exception of carcinoma in situ.
* Significant history of heart disease (unstable angina, myocardial within the past six months, congestive cardiac failure requiring daily treatment)
* Evidence of active lung disease determined by chest x-ray and absence of chronic lung disease (FEV1\<60% predicted, Vital capacity \<60%, Tlco\<50%)
Comparison of a Powered Bone Marrow Biopsy Device With a Manual System

Bone marrow biopsy quality as quantified by biopsy cylinder length and diagnostic usefulness is improved with a powered bone marrow biopsy device in comparison with a manual device.


Eligibility Criteria:
Inclusion Criteria:

* age \> 18
* \>= one previous bone marrow procedure
* INR \> 1.4
* tThrombocyte count \> 10 x109/l
* informed consent signed

Exclusion Criteria:

* cognitive impairment
* excessive tissue at anatomical landmarks
* BMI \> 35 kg/m2
* allergy to premedication
* unable to lay flat in prone position
Avatrombopag for Platelet Recovery Post-UCBT in Patients With Bone Marrow Failure Disease

To evaluate the efficacy and safety of Avatrombopag for platelet recovery after unrelated cord blood transplantation (UCBT) in patients with bone marrow failure disease

Persistent thrombocytopenia is a common complication after umbilical cord blood transplantation (UCBT), which necessitates platelet transfusion and leads to increased transplant-related mortality. This is a single-center, single-arm, phase II clinical trial aimed at evaluating the efficacy and safety of Avatrombopag for platelet recovery after UCBT in patients with bone marrow failure disease (BMFD). The study was conducted in patients diagnosed with BFMD and receiving UCBT. After the subjects signed and informed and qualified, they received Avatrombopag treatment from the first day to the 28th day after transplantation. In this study, the cumulative of platelet implantation rate at 28 days after transplantation was used as the main therapeutic index, and 40 patients were planned to be enrolled.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥12 years old, male or female;
* Patients diagnosed with bone marrow failure disease including aplastic anemia (AA), Fanconi anemia (FA), paroxysmal nocturnal hemoglobinuria (PNH) and undergoing UCBT;
* ECOG score ≤2;
* Voluntary participation in this clinical trial, patients fully understand the trial content and sign the informed consent；

Exclusion Criteria:

* Pregnant or lactating women；
* Known allergy to Avatrombopag;
* A history of severe thrombotic events or known risk factors for thrombosis or active thromboembolism requiring anticoagulation;
* A history of platelet dysfunction or bleeding prone disease or severe bleeding (requiring more than 2 units of red blood cell infusion or a hematocrit drop of ≥10%) within 7 days prior to screening;
* Chronic active hepatitis B and C;
* Repeat or multiple transplantation or multiple organ transplantation;
* HIV positive, EBV-DNA positive, CMV-DNA positive;
* Have severe infection or complicated with serious heart, liver, lung, kidney, neurological or metabolic diseases;
* A serious adverse event (Level 4 or 5) as defined by the Standard General Terminology for Adverse Events Version 4.0 occurred during the pre-treatment period;
* Participants participate in another clinical study with any exploratory drug or device within 30 days prior to baseline visit; Observational studies are allowed;
* Subjects with cognitive impairment or uncontrolled mental illness;
* Subjects and/or authorized family members to refuse treatment with Avatrombopag;
* Those who are judged by the researchers as not suitable for inclusion (such as accompanying medical history, which may affect the safety of the subjects or it is estimated that the treatment cannot be adhered to due to financial problems).
Longitudinal Evaluation of the Impact of Parenteral Nutrition

Patients with type 3 intestinal failure are completely reliant on artificial feeding and often manage this at home; home parenteral nutrition (HPN). HPN therapy is life saving for these patients.

The Parenteral Nutrition Impact Questionnaire (PNIQ) is a proven tool for measuring quality of life when receiving HPN.

This study will recruit HPN patients across the United Kingdom (UK) and ask them to complete the PNIQ survey at several different time points. This will assess the impact of HPN over time. Family members involved in the participants HPN care will also be asked to complete a carer burden survey (at one time point) to assess the impact of HPN on carers.

Providing a person with food through a vein is known as parenteral nutrition (PN) or artificial tube feeding. This process is used when nutrients from food can't be taken in by the intestine (intestinal failure). Patients with type 3 intestinal failure are completely reliant on artificial feeding and often manage this at home; home parenteral nutrition (HPN). HPN therapy is life saving for these patients.

It is important to assess patients quality of life and their own reported effects of the HPN. The Parenteral Nutrition Impact Questionnaire (PNIQ) is a proven tool for measuring quality of life when receiving HPN.

A recent study involving the use of the PNIQ in multiple hospitals in the UK, showed that those on fewer nights of HPN had better quality of life than those on more nights of HPN. Whilst this was useful for looking at quality of life at one time point, it is now important to assess change in quality life over time and any impact on family members quality of life.

This study will recruit HPN patients across the UK and ask them to complete the PNIQ survey at several different time points. This will assess the impact of HPN over time. Family members involved in the participants HPN care will also be asked to complete a carer burden survey (at one time point) to assess the impact of HPN on carers.

The study is being funded by Shire Pharmaceuticals Ltd.

Eligibility Criteria:
Inclusion Criteria:

Patients:

* All people in receipt of HPN including new patients
* Those 18 years and over.

Carers:

* A family member or person involved in the healthcare of the participating patient. (We will ask patients to nominate their closest family member who in their opinion is potentially most effected by the parenteral feeding.)
* Those 18 years and over.

Exclusion Criteria:

Patients:

* Cannot give informed consent
* Cannot read or write in English.

Carers:

• Family members not directly involved with caring for participants
Voices Of Individuals: Challenges and Experiences Of bvFTD

The VOICE Of bvFTD study is a telephone interview research study about life with or at risk for behavioral variant frontotemporal dementia (bvFTD). The study aims to understand how bvFTD impacts individuals' day to day lives, how people think about themselves, and what challenges they face.

The VOICE Of bvFTD study is a study being conducted at the University of Pennsylvania. The study was developed and initiated in collaboration with the Johns Hopkins Bloomberg School of Public Health and the National Human Genome Research Institute. The goal of this study is to learn more about what it is like to live with or at high risk of developing behavioral variant frontotemporal dementia (bvFTD). The study will involve telephone interviews to help learn as much as possible about living with bvFTD. The hope is that this will guide future research, resource development, and clinical practice.

Participants will have at least two phone calls from the study team. During the initial phone call, which will take about 15 to 20 minutes, the participant will be asked some basic questions about demographics and the study details will be reviewed as part of the consent process. During another call the participant will be asked some questions to assess his or her thinking, and will complete the interview which will last about 30 to 60 minutes. There are no physical or medical procedures included in this study. The consent process, screening, interview scheduling, and the interview itself will take place over two or three phone calls, which may occur over several weeks.

A person may be able to take part in this study if they are a person with bvFTD, or if they have been found to have a genetic change that causes bvFTD.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Speak fluent English
* People with bvFTD must have been diagnosed with behavioral variant frontotemporal degeneration (bvFTD)
* People with a known genetic risk factor for bvFTD must have an identified disease-causing change in a gene that is known to cause bvFTD, such as in C9ORF72, MAPT, GRN, VCP, TARDBP, CHMP2B, or another gene that has been identified as causing FTD in the family
* The diagnosis or genetic testing results must have been disclosed to the participant at least two months prior to study enrollment

Exclusion Criteria:

* Inability to complete the informed consent comprehension process
* Under 18 years of age
* Does not speak English
* Received diagnosis or testing result less than two months prior to study enrollment
to Assess the Safety of Ga68-Dolacga Injection in Healthy Volunteers

This is a phase 1 study to evaluate the safety of Ga68-Dolacga Injection in healthy volunteers and to assess the normal reference range and inter-individual variability of the Ga68-Dolacga Injection in estimating liver reserve in healthy volunteers.

Ga-68 is a positron-emitting radionuclide with short half-life of 68 minutes. Dolacga is a non-radiolabeled formulated drug product and will be reconstituted to become the finished radiopharmaceutical product Ga68-Dolacga Injection, a PET tracer specifically targeting to surface receptors of hepatocytes. The study aims to evaluate the safety of Ga68-Dolacga Injection in healthy volunteers and to assess the normal reference range and inter-individual variability of the Ga68-Dolacga Injection in estimating liver reserve in healthy volunteers.

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent must be obtained before any assessment is performed.
2. Male or female subjects aged 20 or above, inclusive, at date of consent.
3. Body mass index (BMI) between 18.5 and 23.0, inclusive, (BMI will be calculated as weight in kilogram \[kg\]/height in meters2 \[m2\])
4. Female subjects must be documented by medical records or physician's note to be either surgically sterile (by means of hysterectomy, bilateral oophorectomy, or tubal ligation) or post-menopausal for at least 1 year or, if they are of child-bearing potential, must commit to use a barrier contraception method for the duration of the study.
5. Male subjects and their partners of childbearing potential must commit to the use of two methods of contraception, one of which is a barrier method for male subjects for the study duration.
6. Male subjects must not donate sperm for the study duration.
7. Willing and able to cooperate with study procedures
8. Physically and mentally healthy subjects as confirmed by an interview, medical history, clinical examination, and ECG
9. Laboratory values within reference range, unless values are deemed by the Principal Investigator as "Not Clinically Significant"
10. Negative result for hepatitis B and C antigen test

Exclusion Criteria:

1. Known or suspected allergy, hypersensitivity, or intolerance to any ingredients of study product as stated in this protocol
2. Implantation of metal devices including cardiac pacemaker, intravascular metal devices
3. Current or prior history of major psychiatric disorders, epilepsy and major depression
4. History of positive test for human immunodeficiency virus (HIV)
5. History of chronic alcohol or drug abuse within the last 6 months
6. Pregnant women, lactating or breast-feeding women
7. Clinically significant abnormal laboratory values and/or clinically significant or unstable medical illness
8. General PET exclusion criteria
9. Prior participation in nuclear medicine treatments or computer tomography examinations in the last year
10. Subject has received an investigational drug or device within 30 days of screening.
11. Subjects having high risks for the study according to the PI discretion
12. Subjects who can't be followed up for any reason
Sensory Reeducation in Peripheral Nerve Injuries of Hand

Objectives: To develop a protocol for early treatment using sensory reeducation through the mirror after surgical reconstruction of the median nerve and / or ulnar hand, and its comparison with the evolution of the return of skin sensitivity after a not early rehabilitation which will be conducted by physiotherapists, with blinding of the evaluators.

Changes in the cerebral cortex begins soon after peripheral nerve injury resulting in overlapping cortical areas on adjacent as a result of the absence of stimuli in the area of cortical representation of the injured nerve. Sensibility reeducation is a process of reprogramming the brain through a progressive learning proposing feed the somatosensory cortex with alternative stimulus to preserve the cortical map of the hand and facilitate the sensory recovery. This study is based on the hypothesis that sensory reeducation starting in the first days after surgery by training with the mirror promotes greater preservation of the cortical map of the original hand, with better functional results. We also believe that sensory reeducation performed early with the mirror will enhance the return of sensibility, emphasizing functional reorganization with less alteration of the cortical map of the hand. Metodology: Will be included patients over 18 with injury of the median and/or ulnar nerve at the first week after surgery. Patients will be randomized into an early group with the use of mirror and a classic group of sensory reeducation. In evaluating the Rosen score will be used with motor, sensory and pain/discomfort components. The assessment instruments used were: Semmes Weinstein monofilaments, Jamar® and Pinch Gauge® dynamometer, goniometry, shape and texture identification (STI), Sollerman test, Disabilities of the arm, shoulder and hand questionnaire (DASH), two points discriminator and numeric pain scale.

Eligibility Criteria:
Inclusion Criteria:

* patients over 18 years
* male or female
* reconstruction of peripheral nerve or ulnar median
* primary or secondary graft through the Hospital of the Medical School of Ribeirão Preto, University São Paulo
* possible associated tendon and skin lesions
* flexor zones I, II, III, IV or V.

Exclusion Criteria:

* nerve damage that may associated with multiple complex lesions, bone or joint injuries
* presence of central nervous system injury
* chronic diseases metabolic and degenerative rheumatic diseases, leprosy and diseases affecting the peripheral nervous system.
The Relationship Between Postoperative Changes of Oral and Intestinal Flora and Prognosis

Specific oral microbiome has been found to contribute to the development of colorectal cancer. We speculate that specific oral microbiota related to colorectal cancer relapse after curative treatment. This study aim to discover if any difference of oral microbiota exist in patients who suffer from cancer relapse compared with patients who do not. Finally develop patient-centred programmes of surveillance protocols base on microbiota analysis.

Colorectal cancer is a major cause of cancerrelated deaths and the third most commonly diagnosed cancer worldwide.Current estimates indicate that 20-30% of those who undergo treatment will experience recurrence and 35% of all patients will die within 5 years.

The human colon plays host to a diverse and metabolically complex community of microorganisms. While the specific oral microbiome has been found to contribute to the development of colorectal cancer. Investigators speculate that specific oral microbiota related to colorectal cancer relapse after curative treatment.

Patients are routinely offered surveillance in order to detect disease recurrence at an early, asymptomatic stage, with the intention of improving survival. Nevertheless, controversy continues to surround the optimal surveillance protocols. Investigators aim to discover if any difference of oral microbiota is exist in patients who suffer from relapse compared with patients who do not.

Future surveillance after colorectal cancer treatment should focus on risk-stratification. Finally investigators will develop patient-centred programmes of surveillance protocols base on microbiota analysis.

Eligibility Criteria:
Inclusion Criteria:

* Requirements of informed consent and assent of participant, parent or legal guardian as applicable
* Patients who underwent exhaustive colorectal cancer surgical resection and accept colonoscopy
* Patients between the age of 35 and 75 years old without considering sex
* Patients with BMI= 18.5-23.9
* Participants can follow the visit plan

Exclusion Criteria:

* Patients with colorectal cancer with distant metastasis
* Chronic renal diseases and hepatic cirrhosis
* Chronic ischemic heart disease with unstable angina, chronic heart failure at class III or IV and acute myocardial infarction in the last 6 months
* Individuals with a history of Chronic diarrhea
* Individuals with a history of Diabetes mellitus
* Individuals with a history of Hypertension
* Individuals with a history of autoimmune diseases
* Use of antibiotics and probiotics 3 mouth before samples collection
* Individuals with a history of abdominal operation due to any reason
* Individuals with any history of cancer other than colorectal cancer
* Individuals with Inflammatory bowel disease
Named Patient Program for Mitomycin for Pyelocalyceal Solution

This program provides controlled, pre-approval access to JELMYTO in response to unsolicited requests by physicians, hospitals, pharmacies, distributors, ministries of health or other parties on behalf of specific, or named patients, in select countries where JELMYTO has not yet received a marketing authorization and in situations when patients have exhausted all available treatment options.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are suitable to receive JELMYTO and for whom there is reasonable expectation that JELMYTO may provide clinical benefit based on the medical judgment of their prescribing physician.