cyrilzakka/clinical-trials huggingface dataset:
Combination Therapy of Betaseron-Prograf in Multiple Sclerosis

The purpose of the study is to evaluate the safety and tolerability of a combination of interferon beta 1-b (Betaseron®) and tacrolimus (Prograf®) in patients suffering from multiple sclerosis (MS) who have failed treatment with currently approved drugs for MS

Prograf is an immunosuppressant that weakens the immune reactions responsible to protect the organism against infections. It is currently available on the market for patients who have received an organ transplant, to prevent rejection. Because of its effect on the immune system, theoretically, Prograf should exert a significant effect in MS. It has been tried in a small number of MS patients at a lower dose than the one used in organ transplant, however the results of the study did not allow to draw definite conclusions on its safety and efficacy in MS.

Betaseron is approved in Canada for the reduction of the frequency of relapses in patients with relapsing-remitting MS and for the slowing of progression and reduction of the frequency of relapses in patients with secondary-progressive MS. The combination of Betaseron and Prograf may result in an additive effect or an increase in the actions of the drugs. However, the combination of the two drugs has never been studied.

The aim of this study is to see how well the combination of Betaseron and Prograf is tolerated by patients with MS. The side effects of the treatment, if any, will be followed. In addition, the efficacy of the combination will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* relapsing-remitting or secondary-progressive multiple sclerosis
* patients who have failed treatment with approved immunomodulator drugs (having experienced same or higher annual relapse rate or having experinced progression on the EDSS scale)
* Expanded Disability Status Scale (EDSS) score less than 7.0

Exclusion Criteria:

* any of the following conditions: diabetes mellitus, uncontrolled hypertension, active infection or viral diseases
An Investigational Study of Experimental Medication BMS-986278 Given With the Antibiotic Rifampin in Healthy Participants

The purpose of this study is to investigate the effects of experimental medication BMS-986278 given with the antibiotic Rifampin in healthy participants.


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Body mass index (BMI) of 18.0 to 30.0 kg/m2, inclusive, at screening

Exclusion Criteria:

* Women who are of childbearing potential or breastfeeding
* Any significant acute or chronic medical condition that presents a potential risk to the participant and/or that may compromise the objectives of the study, including active, or history of, liver disease, or intestinal disorder including irritable bowel syndrome
* History or presence of malignancy including hematological malignancies; participants with a history of basal cell or squamous cell carcinoma that has been treated with no evidence of recurrence within 5 years will be allowed for inclusion, as judged by the investigator
* History of significant cardiovascular disease
* Current or recent (within 3 months of study treatment administration) gastrointestinal disease that could impact upon the absorption of study treatment

Other protocol defined inclusion/exclusion criteria could apply
Study To Assess The Effect Of PF-04531083 On Heat Pain In Healthy Volunteers With Ultraviolet Light Sensitized Skin

PF-04531083 has been shown to reduce the amount of heat pain experienced by rats with skin that has been sensitized to heat by ultraviolet light. This study is designed to see if this is also true in man.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers.
* Body mass index between 17.5 - 30.5 kg/m2 and body weight greater than 50 kg.

Exclusion Criteria:

* Subjects that have any condition possibly affecting drug absorption (eg, gastrectomy).
* Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.
* Subjects with inadequate cardiac function (ECG demonstrating prolonged QTc interval at screening).
* Subjects with inadequate or excessive sensitivity to UVB light.
Assessment of Pattern of Abdominal Injury

This hospital-based cross-sectional study was done at SPHMMC and AaBET hospitals from January 2018 to December 2019.The study aimed to assess the pattern of abdominal injury at St Paul's Hospital Millennium Medical College (SPHMMC) and Addis Ababa Burn, Emergency and Trauma (AaBET) hospital, Addis Ababa Ethiopia.Data was collected from the trauma registry and patient files using a pretested structured questionnaire filled out by two trained data collectors.The collected data was entered and analyzed using statistical software SPSS version 25.0.

Data was collected from the trauma registry and patient files using a pretested structured questionnaire filled out by two trained data collectors. The questionnaire was categorized into socio-demographics (age, sex, residency, and address), clinical profile (triage, v/s, type of injury, associated injury), management, and outcome (management, complication, disposition, and mortality). Completeness of data was checked by the principal investigator.

Eligibility Criteria:
Inclusion Criteria:

- All patients who are diagnosed clinically to have abdominal trauma

Exclusion Criteria:

* Patients who died before diagnosis
The Characteristics of Backscattering With Depth in the Progression of Keratoconus

To investigate the variation in backscattering with depth between forme fruste keratoconus (FFKC), keratoconus, and normal eyes; to determine the backscattering changes in the characteristics of keratoconus progression; and to explore the diagnostic value of backscattering in FFKC.

To investigate the variation in backscattering with depth between forme fruste keratoconus (FFKC), keratoconus, and normal eyes; to determine the backscattering changes in the characteristics of keratoconus progression; and to explore the diagnostic value of backscattering in FFKC. A Scheimpflug corneal tomography image and caliper tool were used to obtain backscatter at every 2% depth at the thinnest point of the cornea, with the measured values expressed in grayscale units (GSU).

Eligibility Criteria:
Inclusion Criteria:

1. BCVA \<20/20 and a history of myopia or astigmatism;
2. presence of any of the following positive signs on slit lamp examination: corneal stromal thinning, cone-shaped anterior protrusions, Fleischer's ring, Vogt's striae, epithelial or subepithelial scarring;
3. abnormal corneal topography (maximum keratometry (K) value of \>47.2 diopters (D), bow-tie pattern with skewed radial axes, or inferior-superior asymmetry(3-mm I-S keratometric difference \>1.4 D).

Exclusion Criteria:

1. Patients with severe corneal scarring that affected light scattering and density maps showing "black holes" 2.Participatients with other corneal diseases 3. Eyes that have undergone surgery or trauma 4. Eyes with corneal dystrophy

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Evaluating the Quality of Different Methods of Obtaining Informed Consent

This is a sub-study of a drug development study conducted by Pfizer, Inc. It will evaluate how well people who participate in research studies understand from the study consent form what the purpose of the study is, the risks and benefits of participating, the procedures they will undergo and their right to withdraw from the study before it ends. It will compare the understanding and satisfaction of those who are given a standard consent form with those who are given a simpler, concise consent form and examine how their understanding of the information is affected by the length, complexity, format, and reading level of the document.

People 18 years of age and older who are participating in a Pfizer drug development study and who are able to read and write English may be eligible for this sub-study.

Participants in Pfizer's drug development study who agree to participate in this sub-study are randomized to receive either the standard consent form or the concise consent form. The standard consent consists of a detailed, multiple page consent form. The concise form is simpler, written at a lower reading comprehension level. Both forms contain all of the required elements of informed consent according to federal regulations, and include information needed to make a decision about participating in the study. Each form also contains information regarding participation in this sub-study. The standard group signs the standard consent form; the concise group is given the standard consent after reviewing the concise form and is asked to review and sign it.

After reviewing the consent form for the main study, participants complete a 20-minute questionnaire that includes questions that measure understanding of study information such as its purpose, risks and benefits, compensation schemes, and other information. Additional questions ask about how the participants made the decision to enroll in the study.

...

This informed consent study is a sub-study of phase 1 drug development studies conducted by Pfizer International and is designed to evaluate research participant understanding and satisfaction after being randomized to receive written study information from either a standard consent form or a concise consent form.

Eligibility Criteria:
* INCLUSION CRITERIA:

All willing adults at least 18 years old who come to the Pfizer CRU to consider volunteering for a phase 1 study for which there is a consent sub-study and who are able to read and answer questions in English are eligible to participate in the sub-study. Only adults (over 18 years old) who can provide their own consent will be included. Because the consent forms for Pfizer studies are written in English, the sub-study will only include individuals who can read and answer questions in English.
Pharmacokinetic Study of LAF237 and Its Metabolites in Mild Renal Impaired Patients

This study will evaluate the pharmacokinetics of vildagliptin (LAF237) and its metabolites in patients with mild renal impairment compared to their sex, age and weigh based healthy volunteer counterparts.


Eligibility Criteria:
Inclusion Criteria:

* Age from 18 to 75 years of age (inclusive).
* Male, non-fertile female or female of childbearing potential using a medically approved birth control method.
* Body mass index (BMI) ≤42 kg/m2 (inclusive) at Screening.
* Able to provide written informed consent prior to study participation.
* Able to communicate well with the investigator and comply with the requirements of the study.

For renal insufficient patients only

* Patients must have stable renal disease without evidence of renal progressive disease
* If patient is diabetic, must be treated with standard anti-diabetic therapy andmust agree to continue their anti-diabetic therapy throughout the duration of the study.
* If patient is diabetic, must be on a stable dose of standard anti-diabetic therapy or diet and exercise regimen over the past 4 weeks prior to Screening.

For healthy subjects only

* No current significant medical conditions as determined by history and physical.
* A serum creatinine with a calculated CrCl of \>80 ml/min.
* Matched to renal impaired patients (Group A) undergoing study by age (±5 years), sex and weight (±10% BMI).

Exclusion Criteria:

Subjects meeting any of the following criteria during screening or baseline evaluations will be excluded from entry into or continuation in the study:

* Pregnant or lactating female.
* A history of certain disorders as specified in the protocol.
* Subjects that have been enrolled in a LAF237 (vildagliptin) study or other DPP-4 inhibitor studies six months prior to Baseline.
* History of renal transplant at any time in the past and on immunosuppressant therapy.
* Acute infections which may affect blood glucose control within 4 weeks prior to Screening and other concurrent medical condition that may interfere with the interpretation of efficacy and safety data during the study.
* Certain electrocardiogram (ECG) abnormalities:
* Malignancy including leukemia and lymphoma (not including basal cell skin cancer) within the last 5 years.
* Liver disease such as cirrhosis or positive hepatitis B and C.
* Any alcohol related hepatic disease.
* Patients undergoing any method of dialysis (hemodialysis or peritoneal dialysis)
* Concurrent medical condition that may interfere with the interpretation of safety and tolerability data during the study.
* Use of certain medications as specified in the protocol.
* Laboratory abnormalities as defined by the protocol
* History of active substance abuse (including alcohol) within the past 2 years.
* Smokers defined as any subject who reports heavy cigarette use (i.e., 10 or more cigarettes per day). Urine cotinine will also be measured and recorded at Screening and Baseline.

Other protocol-defined inclusion/exclusion criteria may apply.
Improved Bowel Cleansing Method for Colonoscopy Based on High Risk Population of Bowel Preparation

The purpose of this study is to observe the difference in bowel preparation quality between compound sodium picosulfate#CSP combined with lactulose and polyethylene glycol electrolyte#PEG combined with lactulose in high-risk population.

The quality of bowel preparation is crucial for colonoscopy. Some high-risk factors for inadequate bowel preparation have been identified , including age \>70, previous colon surgery, constipation, diabetes, Parkinson's disease, history of stroke or spinal cord injury, prior history of inadequate bowel preparation, body mass index (BMI) \>25, use of tricyclic antidepressant or narcotics. Patients were considered as high risk if they have any of the above factors.This is a single-center ,endoscopist-blinded study to compare the efficacy of CSP combined with lactulose and PEG combined with lactulose in bowel preparation. In colonoscopy procedures, endoscopists who were blinded to the intervention evaluated the overall quality of colonoscopy cleaning according to the Boston Bowel Preparation Scale. Patients' tolerance, defecation, adverse events and adenoma detection rate (ADR) were also evaluated.

Eligibility Criteria:
Inclusion Criteria:Adults undergoing colonoscopy who have at least one risk factor: age\>70, previous colon surgery, constipation, diabetes, Parkinson's disease, history of stroke or spinal cord injury, prior history of inadequate bowel preparation, body mass index (BMI) \>25, use of tricyclic antidepressant or narcotics.

Exclusion Criteria:

1. presence of any contraindications for colonoscopy (gastrointestinal obstruction or perforation,severe acute inflammatory bowel disease,toxic megacolon,severe heart failure,unable to swallow,severe heart failure,etc);
2. Patients with galactosemia;
3. hypersensitivity to any of the ingredients;
4. Pregnancy or lactation;
5. Use of lactulose,prokinetic agents or purgatives within 7 days;
6. Unwilling to sign informed consent.
Effects of Procyanidine on Semen Parameters and DNA Fragmentation Index During Cryopreservation of Abnormal Human Semen Samples

Cryopreservation is the storage of biological material at subzero temperatures at which biochemical processes of cell metabolism and the biochemical reactions that lead to cell death are slowed, interrupted or stopped.Many investigators have focused on the use of antioxidants in the freezing media to reduce the negative effects of reactive oxygen species(ROS) on spermatozoa and in this context addition of vitamin E to cryoprotective medium enhanced the post-thaw sperm motility and preserved sperm DNA integrity , superoxide dismutase (SOD) and catalase (CAT) were added to boar spermatozoa freezing media and they not only increased sperm motility and viability but also decreased post-thaw ROS generation which led to improvement in results of in vitro fertilizing with thawed spermatozoa.However, the impact of in vitro addition of proanthocyanidins to human semen before cryopreservation on post-thawing semen parameters, DFI has not been studied yet. The research question evaluated in the current study was whether semen samples of infertile men supplemented or not with procyanidine before cryopreservation, differ in post-thawing semen parameters and sperm DNA fragmentation index (DFI).


Eligibility Criteria:
Inclusion Criteria:

Infertility defined as:

* At least twelve (12) months of non-achieving pregnancy despite unprotected sexual intercourse or six (6) months, if the female is \> 35 years of age AND
* At least two (2) semen analyses with at least one abnormal parameter (sperm concentration, motility and morphology), according to WHO 2010 criteria.
* Not on any type of infertility treatment for the last three (3) months
* Sperm concentration \> 8 x 106/ml and semen volume at least 2.5 ml for technical reasons.
* Normal hormonal profile (TSH, FSH, LH, total testosterone, prolactin)
* Seminal white blood cells \< 1 x 106/ml
* No abnormalities in scrotal ultrasound.

Exclusion Criteria:

* Underlying genetic cause of infertility
* History of undescended testis (cryptorchidism)
* History of orchidectomy
* History of testicular cancer
* History of severe cardiac, hepatic or renal disease.
* History of endocrine disease (primary or secondary hypogonadism, hyperprolactinemia, thyroid disease, pituitary or adrenal disease)
* History of epididymo-orchitis, prostatitis, genital trauma, testicular torsion, inguinal or genital surgery
* History of systemic disease or treatment during the last three (3) months
* Positive sperm culture for Chlamydia or Ureaplasma urealyticum
* Female infertility factors
* Body mass index (BMI) \> 30 kg/m2
* Participation in another interventional study and a likelihood of being unavailable for follow-up.
Managing Chronic Kidney Disease in Eastern North Carolina

The purpose of this program is to educate primary care physicians in four underserved clinics in eastern North Carolina about chronic kidney disease.

The Division of Nephrology within the Brody School of Medicine recently form a center to focus attention on the needs of patients with kidney disease in eastern North Carolina. It is estimated that more than 40 million Americans have or at risk for CKD. The estimate for CKD in eastern North Carolina is exacerbated by poor access to health care. The mission of the East Carolina University Center for the Study and Treatment of Kidney Disease (ECCKD) is to increase education and awareness, improve treatment and outcomes through research, and better serve patients with CKD in eastern North Carolina.

Eligibility Criteria:
Inclusion Criteria:

* Primary care clinics in eastern North Carolina with a high penetration of chronic kidney disease, risk factors for chronic kidney disease and poverty.
Developing a Exercise Program for Patients Undergoing Hematopoietic Stem Cell Transplantation

Background: Hematopoietic stem cell transplantation (HSCT) is a highly aggressive treatment, which is associated with numerous treatment-related side effects, such as fatigue and decreased functional activity. While recent studies have shown that physical exercise for patients undergoing HSCT is safe and feasible, and has a positive effect on the quality of life, fatigue, and lower limb muscle strength. However, there is no consensus regarding the intensity, type and frequency of exercise program, and few studies mention the patients' experience of exercise barriers and facilitators during HSCT. Therefore, the clinical implementation of exercise program is quite difficult.

Purpose: The purpose of this study is to develop a feasible exercise program for hospitalized patients undergoing hematopoietic stem cell transplantation.

Methods: Action Research is used to collect quantitative and qualitative data. Through the rolling revision of the exercise program during HSCT, finally develop a feasible exercise program.

Expected results: Developing a feasible exercise program for hospitalized patients undergoing hematopoietic stem cell transplantation.


Eligibility Criteria:
Inclusion Criteria:

1. First-time hematopoietic stem cell transplantation (HSCT) patients who are ambulatory, their primary caregivers, and physical therapists and nurses participating in the exercise intervention;
2. Age 20 years or older;
3. Capable of understanding and complying with the study objectives;
4. No psychiatric disorders or cognitive impairments.

Exclusion Criteria:

1. HSCT patients deemed unsuitable for exercise participation based on the attending physician's assessment;
2. HSCT patients at risk of fractures or confined to bed rest due to musculoskeletal conditions.
Expanded Access Program Using IMM-101 for Patients With Advanced Pancreatic Cancer

An Expanded Access Program for IMM-101 for patients with advanced pancreatic cancer.

IMM-101 is a suspension of heat-killed whole cell Mycobacterium obuense. Since it is a heat-killed preparation, treatment is not associated with the potential side-effects of delivering live or attenuated organisms.

Five studies with IMM-101 have been completed including a 110-patient randomised Phase II study in pancreatic cancer and exploratory studies in other solid tumours (melanoma, colorectal cancer and advanced melanoma).

Eligibility Criteria:
Inclusion Criteria:

This Expanded Access Program is available for patients of 18 years or older with advanced pancreatic cancer for whom, in the opinion of their treating physician, other treatment options or clinical trials in this indication are unsuitable.

Exclusion Criteria:

Female patient of child-bearing potential who is not, in the opinion of the physician, using an approved method of birth control (e.g., physical barrier \[patient and partner\], contraceptive pill or patch, spermicide and barrier, or intrauterine device \[IUD\]).
Predicting the Conversion From Mild Cognitive Impairment to Dementia

Mild cognitive impairment (MCI) is believed to be the early stage of dementia. The investigators assume that some psychological and imaging risks may predict the conversion. In the current longitudinal study, psychological and imaging data of people with MCI will be obtained at baseline, and will be followed at 26 weeks and 52 weeks. The predictors will be found in comparison with controls.

MCI increases the risk of later developing dementia. About 10-15% of the amnestic form of mild cognitive impairment will progress to Alzheimer's disease in one year. But some people with MCI never get worse. Others with MCI later have test results that return to normal for their age and education.

To develop a new drug for the prevention of dementia(dementia due to Alzheimer's disease or vascular dementia), investigators need a sensitive and specific tool for recognizing patients who will converse to dementia. The investigators want to establish an operational diagnostic criteria instead of a descriptive criteria for mild cognitive impairment.

Eligibility Criteria:
Inclusion Criteria:

* complaint about cognitive decline compared to previous performance
* objective cognitive impairment in one or more cognitive domains for age
* preservation of independence in functional abilities
* Mini-Mental State Examination(MMSE) scores between 24 and 30
* a Clinical Dementia Rating(CDR) score of 0.5

Exclusion Criteria:

* dementia
* patient with any following disease: Parkinson's disease, multiple system atrophy, normal pressure hydrocephalus, progressive supranuclear palsy, subarachnoid hemorrhage, brain neoplasms, Huntington disease, epilepsy
* depression(HAMD \>7) or psychosis
* uncontrolled severe medical conditions(i.e., acute heart failure, renal insufficiency)
* current treatment with benzodiazepines, antidepressants, antipsychotics, or other medications with significant psychotropic or central cholinergic effects
* abnormal thyroid, low vitamin B12 level or low folic acid level
* patient with visual and auditory disorders can't cooperate with neuropsychological assessment
* patient can't cooperate with following up
* informed consent is not obtained