cyrilzakka/clinical-trials huggingface dataset:
Effects of Supplementary Oxygen on Dyspnoea and Exercise Tolerance in COPD Patients Given LTOT

The aim of the study is to evaluate effects of supplementary oxygen during exercise on dyspnoea and exercise tolerance in COPD-patients given long-time oxygen treatment


Eligibility Criteria:
Inclusion Criteria:

* COPD patients (male/female)given long-term oxygen treatment
* Able to perform two separate walking tests

Exclusion Criteria:

* Severe heart failure
Combined Treatment of Platelet-rich Plasma (PRP) and Low-intensity Extracorporeal Shockwave Therapy (Li-ESWT) on Erectile Dysfunction (ED)

The purpose of this clinical study is mainly to use platelet-rich plasma combined with low-intensity extracorporeal shockwave therapy to treat patients with erectile dysfunction and observe the improvement results.

According to statistics from the Taiwan Society of Andrology, 18 to 25 years old male population in Taiwan having erectile dysfunction (ED) trouble is as high as 5 to 10 percent. At the same time, statistics from the Taiwan Sexual Dysfunction Counseling Training Committee show that as many as 50 percent of men between 40 and 70 years old have erectile dysfunction. Erectile dysfunction is the most common sexual dysfunction in men and is believed to be related to nerve or blood vessel damage, and often significantly affects the patients' quality of life.

PRP is the abbreviation of "platelet-rich plasma". It can release growth factors and cytokines in the body to further promote tissue repair. The results of pre-clinical and clinical trials show that PRP can promote the repair of cavernous tissue, protect erection function of nerve, and stimulate the regeneration of nerve.

Low-intensity extracorporeal shockwave therapy (Li-ESWT) is a non-invasive treatment. Under this treatment, it will help body producing angiogenesis-related proteins, stimulating the formation of small blood vessels, generating new blood vessels at the site to be treated, and increasing the perfusion flow of local tissues. Li-ESWT has been clinically shown to have a significant effect on erectile dysfunction.

The purpose of this clinical study is mainly to use platelet-rich plasma combined with low-intensity extracorporeal shockwave therapy to treat patients with erectile dysfunction and observe the improvement results.

Eligibility Criteria:
Inclusion Criteria:

* Impotence for more than three months
* International index of erectile function, (IIEF) less than 21( including 21)
* Erectile hardness score, (EHS) less than 3( including 3)
* Age over 30 years old

Exclusion Criteria:

* Hypogonadism
* Bleeding tendency
* Could not cooperate with the treatment
* AIDS, syphilis and condyloma victim
* Received radical prostatectomy
* Prostate cancer or pelvis malignant tumor victim
* Gonad dysfunction
* Penis deformities
* Penile prosthesis implantation
* Psychiatric disease victim
* Neural disease ( multiple myeloma , brain atrophy, etc)
* Pacemaker implantation
* Not suitable join this trial judged by Investigator
* Alcohol or drug abuse
The Pharmacokinetic Study of Saquinavir New Tablet Formulation in HIV-infected Pregnant Women.

Pharmacokinetic study of Saquinavir and Ritonavir in HIV-infected pregnant women

It is generally accepted that HIV-infected pregnant women should receive treatment to prevent the transmission of HIV from mother-to-child.The (relative) contra-indications for the NNRTIs during pregnancy make a PI based regimen the most rational choice. Based on several experiences and investigations it is expected that saquinavir will play a role as a component of tripe drug regimens for HIV-infected pregnant women. Since the bid dose regimen of 1,000mg saquinavir and 100mg ritonavir is approved by the regulatory authorities and with the availability of a new 500mg tablet formulation of saquinavir,there is a need for a well-designed pharmacokinetic trial using the new 500mg saquinavir tablet formulation in the above mentioned dose.

Eligibility Criteria:
Inclusion Criteria:

* HIV infected woman
* 18 - 40 years of age
* able and willing to sign Informed Consent
* pregnant for a maximum of 31 weeks

Exclusion Criteria:

* history of sensitivity/idiosyncrasy to the drug
* relevant history of interference with drug metabolism
* inability to understand trial procedures
* abnormal specific serum levels
* use of specific concomitant medications
* active hepatobiliary or hepatic disease
* previous failure of saquinavir/ritonavir regimen
Rituximab and Dexamethasone in Treating Patients With Recurrent or Refractory Indolent Non-Hodgkin's Lymphoma

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining the monoclonal antibody rituximab with dexamethasone may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of rituximab and dexamethasone in treating patients with recurrent or refractory indolent non-Hodgkin's lymphoma.

OBJECTIVES: I. Determine the toxic effects of rituximab and dexamethasone in patients with recurrent or refractory indolent non-Hodgkin's lymphoma. II. Determine the objective tumor response rate and duration of response at 2 months after initiation of therapy, and the percentage of patients with progressive disease. III. Determine the maximum response, duration of response, and progression free interval for patients who have not progressed after 4 weeks of therapy. IV. Determine the failure-free and overall survival of these patients on this regimen. V. Compare the response rate and survival rates to results for similar patients (historical and concurrent) who have received 4 weeks of rituximab without dexamethasone, and patients who did not receive maintenance rituximab.

OUTLINE: Patients receive dexamethasone IV followed by rituximab IV on days 1, 8, 15, and 22 for one course. Two months after initiating treatment, patients are evaluated for disease progression. Patients with stable or responding disease may receive monthly dexamethasone and rituximab therapy for up to 10 additional months. Patients are followed every 3 months for 2 years, then every 6 months for years 3-4, and then yearly for up to 5 years.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven stage III or IV, recurrent or refractory, indolent B cell non-Hodgkin's lymphoma of the following types: Working Group Formulation A (small cell lymphocytic) Working Group Formulation B, C, and D (follicular) Must have relapsed after prior chemotherapy At least 1 lymph node or visceral lesion at least 2 cm in diameter

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Lymphocyte count less than 5,000/mm3 Hepatic: Not specified Renal: Not specified Other: Not pregnant or nursing Fertile patients must use effective contraception No active infection HIV negative No hepatitis B or C No concurrent life threatening condition

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior monoclonal antibody therapy for lymphoma (e.g., rituximab) Chemotherapy: See Disease Characteristics Endocrine therapy: No other concurrent corticosteroids and/or epinephrine (unless anaphylactic shock) Radiotherapy: Not specified Surgery: Not specified
13-valent Pneumococcal Conjugate Vaccine Study in Adults and Children in India

This study is to describe the safety and immunogenicity of 13vPnC in Indian adults 50 to 65 years of age and in Indian children 6 to 17 years of age.


Eligibility Criteria:
Inclusion Criteria:

Indian adults subjects between 50 and 65 years of age and indian children between 6 and 17years of age, determined by clinical judgment to be eligible for 13vPnC vaccination.

Exclusion Criteria:

Any contraindication to 13vPnC vaccination, vaccination with any pneumococcal vaccine within the last year
CE-IOUS Impact on Surgical Strategy of Liver Tumours and Liver Metastases

Contrast-enhanced intraoperative ultrasound (CE-IOUS) plays an increasingly important role in the surgical therapy planning of primary liver lesions as well as liver metastases.

The present study was designed to evaluate the significance of CE-IOUS by specificity and sensitivity and particularly the impact it exerts on the surgical strategy.

A secondary aim was assessing the outcome relevance of surgeries influenced by CE-IOUS.

CE-IOUS has been used during hepatobiliary surgery for almost 25 years. During this time, it has proven to be an excellent diagnostic tool for detecting and characterising previously unknown lesions.

It is still unclear to what extent the findings of this imaging modality impacts the strategy of such operations.

The currently planned study is intended to evaluate the impact of contrast-enhanced intraoperative ultrasound on the surgical procedure in hepatic surgery.

For this purpose, patient data of the time period between 2017 and 2019 was prospectively analysed.

Another aim of the study was to measure the outcome relevance of CE-IOUS. This assessment was carried out by comparing an intervention cohort with a control cohort. The control cohort consisted of patients that were operated due similar liver lesions as the intervention cohort however did not receive CE-IOUS during the operation. Aspects like the recurrence free time and overall survival rate of the two cohorts were compared together with the patients' characteristics of the groups themselves.

Eligibility Criteria:
Inclusion Criteria:

* Operations during study period from 01/2017 until 12/2019
* Elective liver surgery in the department of surgery at the University Hospital Regensburg
* Liver resections due to primary hepatic tumours (benign, malignant) or hepatic metastases
* Liver surgery with intraoperative use of CE-IOUS

Exclusion Criteria:

* Intraoperative use of CE-IOUS outside the department of surgery
* Liver transplantations
* Use of CE-IOUS only for exclusion of hepatic metastasis
Total Parenteral Nutrition Associated Cholestasis (TPNAC) and Plasma Amino Acid Levels in Neonates

The purpose of this study is to analyze if the infants who received Primene solution, have lower serum levels of methionine and cysteine and higher serum levels of taurine, we also analyze if the infants who received Primene solution develop TPN-associated cholestasis in a smaller proportion than those who received Trophamine solution.

Total parenteral nutrition is an essential component of the care of premature and ill infants. Prolonged parenteral nutrition is associated with complications affecting the hepatobiliary system, such as cholelithiasis, cholestasis, and steatosis. The most common of these is total parenteral nutrition-associated cholestasis (TPNAC), that occurs because of reduced bile flow from the liver into the duodenum. Cholestasis causes liver damage and in some cases, death. Infant and neonate are at particular risk for this complication. The incidence of TPNAC ranges from 7.4 to 84%.

Animal studies have implicated amino acids in the production of cholestasis; whereas studies in human neonates suggest a direct effect of amino acid infusions on the hepatocyte canalicular membrane. An appropriate amino acid solution might compensate for the metabolic immaturity of infants and perhaps reduce total parenteral nutrition associated complications such as cholestasis. Therefore, is important to compare the frequency of cholestasis and blood amino acid concentration during Primene and Trophamine use.

Eligibility Criteria:
Inclusion Criteria:

* Newborns greater than 1500 g who enter the Intensive Care Unit and their pathology requiring total parenteral nutritional support (necrotizing enterocolitis, intestinal atresia, short bowel syndrome).
* Gestational age greater than 30 weeks
* Patients with normal liver function tests for their age, prior to the initiation of total parenteral nutrition.
* Authorization from both parents or legal guardian for recruiting of the child into the study with consent signed form after the purpose and procedures have been explained

Exclusion Criteria:

* Patients with acute renal failure
* Congenital liver disease, end-stage liver disease
* Patients with liver damage secondary to viral or bacterial infection
* Patients with liver damage secondary to drugs
Prostate Cancer Screening in Men With Germline BRCA2 Mutations

The purpose of this study is to determine the incidence of prostate cancer in men with the BRCa2 gene mutation as an independent indicator for prostate cancer screening.

This is a cohort screening study to prospectively identify the incidence of prostate cancer in a population of BRCA2 carriers. All men identified to have a BRCA2 mutation as part of the Yale Cancer Genetic Counseling Program will be approached and offered participation in the study via our program newsletter, BRCA listserv, Facebook page and a targeted mailing.

Standard of care screening at the Yale Cancer Center for men with a normal prostate cancer risk consists of a PSA test and prostate physical examination beginning at age 50 years and if either is abnormal an MRI of the prostate followed by Fusion-targeted biopsy of the prostate is performed.

Eligibility Criteria:
Inclusion Criteria:

* All men ≥30 years of age with at least a ten-year life expectancy
* A known BRCA2 mutation
* Ability to have an MRI
* Able to give informed consent will be approached to participate in the study

Exclusion Criteria:

* If a man has received or is currently receiving treatment for prostate cancer
The Fall Monty Activity Programme Feasibility Study

Between 45-73% of people who have had a stroke fall over in the months and years following their stroke. Falls not only lead to injuries such as broken hips, but they may also lead to fear of falling. As a consequence people can get fearful to walk, keep up their household tasks and their social activities such as visiting friends and family.

Research has shown that exercises for strength and balance can help both older people and patients after stroke to get fitter and healthier and help to prevent them from having a fall. People also have less falls if they have learned about falls facts and home safety precautions. Research has further suggested that people have less fear of falling and less injuries from a fall if they have learned how to fall ('safe landing' strategies). Based on these research findings the researchers have developed a new falls prevention programme called the Fall Monty Activity Programme (FallMAP). This programme aims to aid in functional recovery and reduce falls by combining a mix of activities such as falls education, strength and balance exercises, and activities that teach people how to get up from the floor and how to fall safely.

Especially because people with residual impairments following a stroke have an increased risk of a fall, the feasibility of this programme will be tested in a small group of people after stroke first. This study is a first step in establishing whether the different components of the FallMAP are acceptable and practical for both patients after stroke and staff who deliver the program. In particular, it is important to evaluate if it is feasible to provide the seven combined components as one comprehensive programme. Secondly, the question whether participating in the programme can positively influence the participants' fear of falling, quality of life, leg strength, balance and mobility will be explored. If this feasibility study suggests the programme can work in the clinical setting, then a definitive randomised controlled trial will be proposed in order to look at whether the full programme is effective at reducing falls in patients after stroke.


Eligibility Criteria:
Inclusion Criteria:

* Aged over 50 and more than 6 months post-stroke.
* Living in the community.
* Having a good cognition (≥ 25 points on the Short Mini-Mental State Examination).
* Able to walk at least three times weekly outside the home without hands-on supervision (with or without the use of a walking aid).

Exclusion Criteria:

* The presence of medical issues preventing someone from participating in moderate to vigorous strength and balance exercises.
* A receptive aphasia impacting on ability to follow instructions.
* The inability to provide informed consent.
A Cohort Study of the Intestinal Microbiota of Premature Infants

Premature infants are at risk for a variety of diseases, the investigators would like to learn more about why some premature babies are at higher risk and some are protected from these diseases.

Scientists at UC Davis and other universities have developed new ways to measure the bacteria and a large number of small molecules in specimens of infant blood, urine, stomach fluid and poop and in mother's milk. These discoveries allow us to consider questions that were impossible to answer before these new techniques were developed. One such question is whether the bacteria in the poop of a premature baby can help us predict the baby's risk for developing infection or a common and serious disease of premature infants called necrotizing enterocolitis. A second question is whether the DNA of a premature baby (obtained from saliva with a q-tip) can predict higher risk for diseases of premature babies.

Samples from eligible infants will be collected and stored for future comparisons. These samples include stool specimens from a messy diaper twice weekly, urine samples from cotton balls in the diaper once weekly, a small sample of stomach fluid once a week just prior to a feeding obtained through the feeding tube, a sample of mom's milk once a week, left-over blood from lab draws, and a sample of saliva on one occasion.

The analysis of key specimens from this cohort will allow us to study the impact of the bacteria in the intestines on outcomes like growth and common diseases of premature infants.

Eligibility Criteria:
Inclusion Criteria:

* gestational age \< 33 weeks at birth

Exclusion Criteria:

* none
NPWT vs Primary Closure in SSI Prevention for Emergency Laparotomies for Peritonitis

The study aims to evaluate the efficacy of negative pressure wound therapy (NPWT) compared with primary closure (PC) in surgical site infection (SSI) prevention for laparotomy for peritonitis.

Surgical site infection is a particularly common morbidity in contaminated surgeries leading to prolonged length of hospital stay, healing time, and a significant financial burden on healthcare systems.

Hence, the objective of PRISTINE trial is to compare the effectiveness of subcutaneous NPWT with PC for SSI prevention in patients who, due to wound contamination, are prone to infection. Moreover, with a further cost analysis, the investigators aim to evaluate the rationale for the implementation of routine preventive NPWT for laparotomy for diffuse peritonitis.

Patients qualified for an emergency laparotomy for peritonitis in University Clinical Centre (UCC) Division of Oncological, Endocrine and General Surgery will be identified. Prior to laparotomy, participants will be randomized in 1:1 ratio to subcutaneous NPWT or PC. The assigned intervention will be performed intraoperatively, after fascia closure.

All participants will receive an empirical antibiotic therapy regimen consisting of tazobactam/piperacillin or ciprofloxacin+ metronidazole. Participants will be followed-up postoperatively for one year.

In case of an SSI all participants, regardless of their initial allocation, will be treated according to the standard of care with prolonged NPWT and targeted antibiotic therapy.

Eligibility Criteria:
Inclusion Criteria:

* qualified for an emergency laparotomy for peritonitis
* gave written informed consent

Exclusion Criteria:

* qualified for open abdomen treatment
Radiation Therapy and Combination Chemotherapy for Medulloblastoma

This phase II trial is studying giving radiation therapy together with combination chemotherapy after surgery to see how well it works in treating children with newly diagnosed medulloblastoma.

OUTLINE:

Adjuvant induction chemoradiotherapy: Beginning within 28 days after prior resection, patients undergo radiotherapy to the craniospinal axis 5 days a week for 4 weeks and then conformal radiotherapy to the tumor bed 5 days a week for 2 weeks. Beginning 1 week after the initiation of radiotherapy, Temozolomide is applied to these patients as a chemotherapy drug with a dosage of 75mg/m2, daily. The chemotherapy and radiation are combined as temozolomide is taken 1 hour prior to every fraction of radiotherapy.

Maintenance chemotherapy: Beginning 4 weeks after the completion of induction chemoradiotherapy, patients receive eight 4-week cycles of temozolomide (dosage: the 1st cycle, 150mg/m2, daily × 5 days, 4 weeks a cycle; the 2-8th cycle, 200mg/m2, daily × 5 days, 4 weeks a cycle and repeated again).

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed posterior fossa medulloblastoma
2. No residual tumor greater than 1.5 cm\^2 after resection by postoperative MRI No tumor in the spinal or cerebral subarachnoid space by MRI No tumor in the subarachnoid space by Cerebrospinal fluid (CSF) No failure to perform staging studies (spine MRI and CSF cytology) preoperatively or postoperatively
3. Must begin radiotherapy on study within 28 days after surgery

Exclusion Criteria:

1. Prior radiotherapy and anti-tumor chemotherapy other than corticosteroids are not allowed.
2. Patients must begin radiotherapy on protocol within 28 days of completion of surgery. Exceptions need to be approved by the Principal Investigator.
3. Patients with the following will not be eligible:

\> 1.5cm3 residual tumor following resection as indicated by post-operative MRI. tumor in spinal or cerebral subarachnoid space either by MRI of brain and spine tumor in subarachnoid space by CSF cytology failure to perform staging studies (spine MRI, CSF cytology) either pre- or post- operatively
Effect of Ozurdex® 0.7 mg on Improvement of Efficacy of Bevacizumab for Central Retinal Vein Occlusion

This is a study designed to determine if the addition of Ozurdex® to bevacizumab (Avastin®) eye injections reduces the need for repeat bevacizumab eye injections in patients with nonischemic central retina vein occlusion.

This is a multicenter clinical study designed to determine if the addition of Ozurdex® injection to bevacizumab (Avastin®) eye injections reduces the need for repeat bevacizumab eye injections in patients with nonischemic central retina vein occlusion.

Eligibility Criteria:
Inclusion Criteria:

1. male or female subjects (aged 18 or older);
2. provide written informed consent and sign/date a health information release;
3. women of childbearing potential must be willing to practice effective contraception for the duration of the study.

Exclusion Criteria:

1. any systemic disease or clinical evidence of any condition which would make the subject, in the opinion of the investigator, unsuitable for the study or could potentially confound the study results;
2. use of systemic steroids within 1 month prior to Baseline Visit (Visit 1) or anticipated use at any time during the study (inhaled and intranasal steroids are allowed);
3. sitting systolic blood pressure equal to or greater than 160 mmHg or diastolic blood pressure equal to or greater than 100 mmHg at the Baseline Visit (Visit 1);
4. use of warfarin, heparin, enoxaparin or similar anticoagulants within 2 weeks prior to Baseline Visit (Visit 1) or anticipated use at any time during the study;
5. known allergy or hypersensitivity to the study medications or their components;
6. previous enrollment in an Ozurdex® clinical trial or previous use of an Ozurdex® implant.