cyrilzakka/clinical-trials huggingface dataset:
Genetic Study to Identify Gene Mutations in Participants Previously Enrolled in Clinical Trial NCI-99-C-0053 Who Have Von Hippel-Lindau Syndrome or Are at Risk for Von Hippel-Lindau Syndrome

RATIONALE: The identification of gene mutations in individuals who have or are at risk for von Hippel-Lindau syndrome may allow doctors to better determine the genetic processes involved in the development of cancer.

PURPOSE: This genetic study is finding gene mutations in participants with von Hippel-Lindau syndrome or who are at risk for developing von Hippel-Lindau syndrome.

OBJECTIVES:

* Obtain laboratory identification and confirmation of research results for gene mutations in participants previously enrolled in NCI-99-C-0053 who have von Hippel-Lindau (VHL) syndrome or who are at risk for VHL syndrome.
* Determine genotype status in these participants.

OUTLINE: Participants submit a blood or buccal sample for genetic mutation analysis. Participants may receive genetic counseling and/or the results of genetic testing, if desired.

PROJECTED ACCRUAL: A maximum of 260 participants will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Prior enrollment in the von Hippel-Lindau (VHL) Syndrome Epidemiology Study NCI-99-C-0053
* Meets 1 of the following criteria:

  * Diagnosis of VHL syndrome
  * At risk of VHL syndrome
  * Family member of patient with VHL syndrome
* VHL syndrome genotype is not known

PATIENT CHARACTERISTICS:

Age

* Adult

Performance status

* Not specified

Life expectancy

* Not specified

Hematopoietic

* Not specified

Hepatic

* Not specified

Renal

* Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* Not specified

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* Not specified
Safety and Efficacy of Autologous Transplantation of iPSC-RPE in the Treatment of Macular Degeneration

This project intends to perform autologous transplantation of induced pluripotent stem cell-derived retinal pigment epithelium (iPSC-RPE). The clinical-grade RPE will be transplanted into subretinal space to treat refractory age-related macular degeneration. The efficacy and safety of RPE transplants to treat macular degeneration will be monitored and analyzed with results from EDTRS, BCVA, OCT, ERG, microperimetry, and fluorescein angiography, before and after the treatment.

The investigators will generate iPSC lines from recruited participants and differentiate the iPSC into RPE. Autologous iPSC-derived RPE will be transplanted into participants eyes by subretinal injections. The safety and efficacy will be closely monitored and analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Aged 50-75 years;
* Clinical diagnosis is consistent with the definition of late dry AMD in the age-related eye disease study (AREDS), with one or more \>250 um geographic atrophy in the fovea;
* Clinical diagnosis is wet AMD, but no obvious efficacy after conventional treatment;
* The BCVA of the target eye will be 0.05 to 0.3;
* Voluntary as test subjects, informed consent, regular follow-up on time.

Exclusion Criteria:

* One-eyed subjects;
* Macular atrophy caused by other diseases in addition to AMD;
* Suffer from retinitis pigmentosa, choroidal retinitis, central serous choroiditis, diabetic retinopathy, or other retinal vascular and degenerative diseases besides AMD;
* Lens opacities (affecting the central vision), glaucoma, uveitis, retinal detachment, optic neuropathy, and other ocular histories;
* Other intraocular surgery histories besides cataract surgery;
* Combined with severe systemic diseases, such as heart failure, liver disease, renal insufficiency, cor pulmonale, COPD in the previous 12 months;
* Combined with severe infectious diseases, such as HIV, HBV, HCV, syphilis, tuberculosis, etc;
* Abnormal blood coagulation function or other laboratory tests;
* If female and of childbearing potential, pregnant, breastfeeding, or planning to become pregnant through the study;
* If male, refuse to use barrier and spermicide contraception during the study;
* Malignant tumor and history of malignancy;
* Any immune deficiency;
* Allergy to tacrolimus or other macrolides;
* Any immune deficiency;
* Use glucocorticoids, immunosuppressive drugs, or antipsychotic drugs in the previous 3 months;
* Use anticoagulant, or the platelet function is still not restored to normal after stopping antiplatelet drugs for 10 days;
* A history of addiction to alcoholism or prohibited drugs;
* Be participating in other intervention clinical trials or receiving other study medications;
* Poor compliance, difficulty to complete the study, or refusal to informed consent;
* Some other situations which might increase the risks of the subjects or interfere with clinical trials, such as mental disorders, cognitive dysfunction, etc.
Investigation on the Middle Size Molecule Elimination Characteristics of the FXCorDiax 100 in Relation to the FX 100 and the Polyflux 210 H Dialyser

The purpose of the study is to compare clearance and removal rates of phosphate, ß2-microglobulin (ß2-m) and leptin and albumin loss with different dialyser membranes during post-dilution online hemodiafiltration.


Eligibility Criteria:
Inclusion Criteria:

* hemodialysis patients 18 years and older
* treated by post dilution on-line Hemodiafiltration (HDF) for at least one month
* who reached a dialysis dose (Kt/V) of at least 1.2 at each of the last two monthly checks
* who are on a stable anticoagulation and anemia management
* whose hemoglobin is between 10.5 and 13.0 g/dl
* who are clinically stable based on judgment of nephrologist
* who are on a regular thrice weekly HDF schedule, e.g. Monday-Wednesday-Friday or Tuesday-Thursday-Saturday,
* who have a good vascular access (fistula or graft) which enables easy insertion of the needles and suitable effective blood flow (\> 300 ml/min)
* who are able to understand the nature and requirements of the clinical investigation and who have given written informed consent

Exclusion Criteria: Patients

* with active Hepatitis B, Hepatitis C or HIV infection
* who are severely malnourished as judged by the principal investigator
* who are known or suspected to have allergy to the trial products or related products
* with a central venous catheter based vascular access
* who are abusing non-legal drugs or alcohol
* who have currently active malignant disease
* who are female of child-bearing age without effective measures of contraception, pregnant or breastfeeding
* who participate simultaneously in another clinical investigation
* who have participated in othe clinical investigations during the last month
* who are uncooperative
SNS for Treatment of PD Gait Disorder

Parkinson's disease (PD) is a progressive disease, characterized by dopaminergic neurons degeneration in the substantia nigra. Postural and gait disorders usually occur in advanced PD patients. However, existing drugs and deep brain stimulation (DBS) therapy are not effective enough for these axial symptoms or cannot maintain long-term efficacy, which seriously reduce patients' quality of life. Sacral nerve stimulation(SNS) is a treatment for urinary symptoms in PD. It has been reported that SNS can also improve PD gait disturbance, but the level of evidence currently is low. We assume that SNS may have a similar mechanism to spinal cord stimulation and may be an effective treatment for PD gait disorder. However, there are few studies on the mechanism of SNS treatment. Therefore, we will conduct a large sample, prospective case-control study to provide a higher level of clinical evidence for sacral nerve stimulation in the treatment of gait disturbance in PD. Our primary objective is to evaluate the efficacy of SNS for gait disorder in PD. PD patients who have received DBS surgery but still have severe gait problems will be included. This study will contribute to evaluate the efficacy of SNS for gait disorder in PD, provide level II evidence for expanding the indications of SNS, varicocelectomy., and improve patients' quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Idiopathic Parkinson's disease, Hoehn \& Yahr stage (medication off condition) at 2\~4;
* Gait and balance disorder, unstable posture, frequently falls (gaze and fall questionnaire (GFQ) score \> 32) and severe dysuria, extremely affects quality of life (overactive bladder score (OABSS) ≥12);
* SCS eligibility has been confirmed by neurologist and neurosurgeon;
* Patients willingly seek surgical treatment for PD gait disturbance；
* Ability to perform a gait/walking task (under close supervision);
* Informed consent and have good compliance.

Exclusion Criteria:

* Lesion in spinal nerve or other surgical contraindications;
* Severe depression (Beck Depression Inventory scores \> 25) or dementia (Mini Mental State Examination \< 24);
* Medical history of stroke, amyotrophic lateral sclerosis or myasthenia gravis;
* Other neuropsychiatric disorders or relevant medical history;
* Taking prohibited medications (such as lithium, valproate, steroids, adrenergic agonists, etc.);
* Cardiac, renal or other important organs hypofunction or dysfunction, or unstable vital signs;
* Women reporting that they are pregnant;
* Any situation (medical, psychological, social, geographical, etc.) that may endanger patient's life or result in patients withdrawing from the study at present or in the future.
Computer-assisted Screening for Intimate Partner Violence in Family Practice

This study tested the effectiveness of computer-assisted screening for identifying patients at risk of intimate partner violence (IPV) in a Canadian family practice. It was hypothesized that the use of computer-assisted screening among female patients would lead to higher rates of IPV discussion-opportunity and IPV detection during medical consultations, compared to patients receiving standard medical care.


Eligibility Criteria:
Inclusion Criteria:

* woman
* at least 18 years of age
* visiting one of the participant physicians
* in a current or recent intimate relationship during the last 12 months
* having the ability to speak and read English and give consent

Exclusion Criteria:

* visiting a provider other than the regular family physician
* new patient
* previously approached for the study
* very sick
* had a dual appointment (herself and accompanied dependent)
Laser Therapy in Managing Vaginal Prolapse

Efficacy of laser therapy in postmenopausal women with symptomatic prolapse stage \>1. Assessment tools will include prolapse stage quantification system (POP-Q) and validated condition related questionnaires.

Postmenopausal women with symptomatic cystocele and/or rectocele stage 2 or 3 will be 1:1 randomly allocated to Er:YAG laser or watchful waiting group. Participants in the Er:YAG laser group will receive laser therapies at monthly intervals, while participants in the watchful waiting group will receive no treatment. All outcomes in both groups will be evaluated at baseline, 4-months and 6-months from baseline.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic prolapse stage \>1 (cystocele, vaginal vault prolapse, enterocele, rectocele) according to POP-Q System
* Negative Pap-smear

Exclusion Criteria:

* Asymptomatic prolapse
* prolapse stage \<=1
* prolapse of uterus
* presence of any type of genital infections (i.e herpes, vaginitis etc)
* vaginal bleeding
* underlying pathologies that could interfere in patients compliance (i.e psychiatric)
Environmental Pollutants and the Risk of Soft Tissue Sarcoma: A Pilot Study

The purpose of this study is to assess the feasibility of conducting a large hospital based case control study of the role of dioxins and dioxinlike polychlorinated dibenzofurans (PCDFs) and polychlorinated biphenyls (PCBs).


Eligibility Criteria:
Inclusion Criteria:

* Patients with Soft tissue sarcoma at MSKCC are eligible for this study if they meet the following criteria:
* Between 18 and 79 years of age
* were diagnosed within the previous 6 months with primary soft tissue sarcoma of one of the following histologic subtypes: liposarcoma, leiomyoscaroma, MFH, or synovial sarcoma
* are enrolled in protocol 02-060 ("Novel Biochemical and Molecularr Determinants for Soft Tissue Sarcoma"; PI, Dr. Samuel Singer)
* controls will be eligibile for this study if they meet the following criteria
* are b/w 18-79 years of age
* have no prior history of cancer (other than non melanoma skin cancer)

Exclusion Criteria:

* Individuals will be excluded if they
* are unable to sign informed consent for medical or other reasons
* do not speak english
The Effect of a Local Injection of a Platelet Concentrate on Infection and Healing of Surgical Wounds

The purpose of this project is to investigate whether a combination of a local injection of platelet rich plasma (PRP) combined with a daily supplement of vitamin C, zinc, L-arginine, as well as high protein diet (1.5 g of protein per kilo body weight per day) can promote tissue healing in patients undergoing open upper-abdominal surgery.

Primary endpoint is cases of wound infection and secondary endpoints are time of tissue regeneration (days), judged by traditional clinical observation and experimentally assessed by ultrasound.

The experiment is performed as a parallel two-armed, randomized, controlled trial.

A total of 40 subjects will be included in the trial i order to ensure the power of the study, despite a drop off of up to 25%.


Eligibility Criteria:
Inclusion Criteria:

* Patient at Rigshospitalets Surgical gastroenterology clinic
* Planned to have a Pancreaticoduodenectomy preformed
* Being able to understand Danish, the trial and what it means to be enrolled in the trial
* Capable of signing a written consent
* Living i the Regional Capital (excl. Bornholm) or the Regional of Sjælland (north of Næstved)

Exclusion Criteria:

* Dysregulated diabetes mellitus type I or II
* Alcohol consumption above 14 or 7 x 12 g alcohol per week (men vs women)
* Participating in another clinical trial
Effects of Tea Catechin Consumption on the Prophylaxis of Influenza Infection

The Purpose of this study is to evaluate the effects of 5 months catechin consumption on the prevention of influenza infection.

Catechins are the major components of tea flavonoids and are reported to possess physiological activities such as antiviral effects. Recent experimental studies have revealed that tea catechin extracts prevent influenza infection, but few studies have been conducted on the clinical effects of tea catechin consumption on the prophylaxis of influenza infection. Based on these backgrounds, we designed a prospective randomized controlled study to evaluate the effects of 5 months tea catechin consumption on the prophylaxis of influenza infection.

Eligibility Criteria:
Inclusion Criteria:

* aged over 20 years
* possible to maintain without drinking tea more than 250 ml per day during the study
* possible to maintain without taking supplements or herbal products including catechin extracts during the study
* possible to fill out a questionnaire personally
* Obtained written informed consent before participation

Exclusion Criteria:

* Possessing some chronic infectious diseases in need of therapy
* Possessing tea or catechin allergy
* Possessing a history of influenza infection before six months prior to the study
* diagnosed as inadequate for other reasons to participate the study by principal investigator
The Effect of the DryMouth Shield on Snoring

To measure the effect of the DryMouth Shield on snoring.

The primary outcome of this study is to aid in the final design of the DryMouth Shield and to assess the effect of the DryMouth Shield on snoring frequency. To accomplish this we will compare the frequency of snores during 1) overnight polysomnography without using the DryMouth Shield and 2) overnight polysomnography using the DryMouth Shield. Secondary outcomes of the study will include: 1) compare the difference in the volume of snores without and with the use of the DryMouth Shield; 2) estimate the changes in apnea hypopnea index without and with the use of the DryMouth Shield; 3) describe symptoms of dry mouth without and with the use of the DryMouth Shield 4) describe symptoms of bruxism without and with the use of the dry mouth shield and 5) gather patient feedback about the user experience with the dry mouth shield.

Eligibility Criteria:
Inclusion Criteria:

1. reports of snoring that disturbed a bed partner or housemate and
2. an objective measure of snoring such as a previous home sleep study, lab based polysomnography, or smart phone application with a snoring index of at least 20%

Exclusion Criteria:

1. Patient's with a body mass index of greater than 35 kilogram/meter squared.
2. A history of chronic lung disease with permanently impaired lung function testing.
3. A history of cardiovascular disease including but not limited to coronary artery disease or cerebrovascular disease.
4. Current smokers.
5. Patient's with a comorbid sleep disorder including but not limited to severe sleep apnea with an apnea hypopnea index of 30 events per hour, nocturnal hypoxia necessitating oxygen, current positive airway pressure use or restless legs syndrome
6. Poor nasal patency in the judgment of the investigator
7. Use of narcotics, benzodiazepines or other respiratory suppressing medication
8. Females who are pregnant.
Effect Of Itraconazole On The Pharmacokinetics Of Palbociclib

This study is designed to evaluate the potential effect of itraconazole on the pharmacokinetics of palbociclib.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive.
* Body mass index of 17.5 to 30.5 kg/m2, and a total body weight \>50 kg (110 lbs).
* Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
* Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic diseases.
* Any condition possibly affecting drug absorption.
* A positive urine drug screen or alcohol breath test.
* Pregnant female subjects; breast feeding female subjects, female subjects of childbearing potential, male subjects with partners currently pregnant, male subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for 90 days after the last dose of investigational product.
Effect of Probiotics Containing Yogurts on the Composition of Biofilms in Patients Under Orthodontic Treatment

Aim: To assess in vivo if the intake of yogurt containing Bifidobacterium animalis ssp. lactis DN- 1173010 probiotic for a period of 2 weeks affects the salivary levels or biofilms of mutans streptococci and the lactobacilli of patients undergoing orthodontic treatment. Methods: A crossover, double-blind, randomized and placebo controlled clinical trial will be performed with 26 volunteers during 4 periods. During periods 2 and 4 (2 weeks each) the volunteers will have a daily ingestion of yogurt containing probiotic or of control yogurt which did not contain probiotic. Periods 1 and 3 were run-in and wash-out periods of 1 and 4 weeks, respectively. Experimental samples of saliva and biofilm will be collected from each participant at the end of each phase. Mutans streptococci, lactobacilli, total aciduric microorganisms, Candida spp. and total cultivable microorganisms will be counted. The values before and after the treatment will be compared with Wilcoxon's test (p\<0.05).


Eligibility Criteria:
Inclusion Criteria:

* excellent oral health
* patients under bimaxillary orthodontic treatment

Exclusion Criteria:

* any chronic disease
* antibiotics and/or antimicrobial use in the previous 3 weeks
* topic fluoride or chlorhexidine use in the previous 3 weeks
* presence of cavitated or active carious lesions
* patients with intolerance to lactose.
Evaluation of the Activity of a Pharmacological "Anticellulitis" Product vs. a Reference Product on the Market

Aim of this study was to evaluate by clinical, morphometric and non invasive instrumental evaluations the activity of an "anticellulitis" cosmetic product vs a reference product of the market (comparison within subjects), applied once a day, for an uninterrupted period of 4 weeks, on 22 female healthy volunteers with low/moderate oedematous - fibrosclerotic lipodystrophy on the thighs.

It was also aim of the study to evaluate cosmetic acceptability by the volunteers and products efficacy and tolerance both by investigator and volunteers.


Eligibility Criteria:
Inclusion Criteria:

* female volunteers
* volunteers aged more than 18 years old
* volunteers with low/moderate oedematous - fibrosclerotic lipodystrophy on the thighs
* volunteers with no weight variation (± 1.5 kg) during the last month preceding the study inclusion
* volunteers with regular menstrual cycle (28-32 days) or in menopause from at least 2 years
* volunteers who are giving a written informed consent.

Exclusion Criteria:

* pregnancy
* lactation
* smoke (admitted 10 cigarettes/day)
* assumption of alcoholic drinks/wine/beer (admitted up to 125 ml for meal)
* oral contraceptive/replacement therapy started less than 1 year ago
* alimentary diet
* change in the normal habits in the last month (unusual physical activity)
* use of any product or weight-loss treatment (manual or instrumental massage) on skin test areas during the last month
* use of any drug able to cause a weight body variation
* presence of clinically important vascular disorders
* insufficient adhesion to the study protocol and to the treatment
* participation in a similar study during the previous month
* dermatological disease
* clinical and significant skin condition on the test area (e.g. lesions, scars, malformations)
* suspect thyroid disfunction
* thyroid disorders/diseases
* other endocrine diseases as diabetes, metabolic disorders etc.
* hepatic, renal or cardiac disorder
* cancer
* topical drugs or surgical procedure on the test areas during the previous 3 months
* systemic corticosteroids
* aspirin or non-steroid anti-inflammatory drugs (FANS)
* diuretic drugs
Evaluation Of CanADVICE+®M-Health System To Support Breast Cancer Patients Receiving Capecitabine

This feasibility study will be conducted in order to provide proof of concept for the CanADVICE+® system comprising a smart phone app and a healthcare organization server side application based on Web 2 technologies. The main objective of this project is to optimise pharmaceutical counselling services by providing drug related information, in a digital format, to patients with metastatic breast cancer receiving Capecitabine.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with metastatic breast cancer
* Commencing first cycle of Capecitabine
* Familiar with and own an android smartphone
* Willing to participate

Exclusion Criteria:

* Patients \<18 years
* Patients taking part in any other trial containing Capecitabine
* Chemotherapy-naïve patients