cyrilzakka/clinical-trials huggingface dataset:
Blood Flow Restriction Therapy in Achilles Injury

Blood flow restriction (BFR) therapy is a brief and partial restriction of venous outflow of an extremity during low load resistance exercises. It is a safe and effective method of improving strength in healthy and active individuals, recovering from orthopedic pathologies and procedures. This prospective, randomized study will look at the implications this form of treatment has on the rehabilitation of Achilles injuries.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Achilles Injury
* Must be at least 18 years of age and younger than 65 years of age
* Intention to receive physical therapy as standard of care

Exclusion Criteria:

* Patients with intention to receive standard therapy and not the study therapy
* Patients with impaired circulation, peripheral vascular compromise, previous revascularization of the extremity, or severe hypertension
* Younger than 18 years of age or older than 65
* Legally incompetent or mentally impaired (e.g. minors, Alzheimer's subjects, dementia, etc.)
* Any patient considered a vulnerable subject
Stromal Lenticule Implantation for Management of Herpetic Stromal Keratitis

The aim of this study is the evaluation of corneal transparency and improvement of visual acuity in patients with herpetic stromal keratitis.

Stromal keratitis is an infectious ocular disease of either necrotizing or non-necrotizing form, due to an HSV infection, and characterized by corneal stromal necrosis, inflammation, ulceration and infiltration by leukocytes.

In our study these early findings suggest that the use of corneal stromal lenticules with stromal stem cells and live keratocytes could be a safe and efficient treatment for stromal scar after herpetic keratitis, and excluding the recurrence of the disease by removing the corneal scar after herpetic infection using Smile and implanting the lenticule equal to the volume of the removed scar tissue.

Stromal lenticule implantation is relatively simple, low-cost and offers advantages over corneal transplantation as a definitive procedure in the treatment of this disease.

Eligibility Criteria:
Inclusion Criteria:

* low transparenc of cornea
* low visual acuity
* recurrence of herpetic stromal keratitis

Exclusion Criteria:

* previous corneal or anterior segment surgery
* any infection
Cycling Dual-task in Parkinson's Disease

Taking into account the process of functional and cognitive evolution that patients with Parkinson's disease experience throughout the evolution of the pathology, the objective of this study is to evaluate the effect of a dual-task program combining cognitive tasks and forced cycling on the functional and cognitive capacity of these patients.


Eligibility Criteria:
Inclusion Criteria:

* Parkinson disease
* Hoehn and Yahr 1 and 2

Exclusion Criteria:

* Hoehn and Yahr \>2
Two-way Crossover Study in Healthy Male and Female Subjects to Evaluate the Bioequivalence of Jentadueto®.

The objective of the current study is to demonstrate bioequivalence of two 2.5 mg linagliptin/500 mg metformin fixed dose combination tablets compared to the free combination of the linagliptin 5 mg and metformin 1000 mg in healthy male and female volunteers.


Eligibility Criteria:
Inclusion criteria:

* Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation
* Healthy males and females according to the following criteria:

Based upon a complete medical history, including physical examination, vital signs (BP, PR), 12-lead ECG and clinical laboratory tests (haematology, clinical chemistry and urinalysis).

* Age 18 to 45 years (incl.)
* Body mass index by Quetelet between 18.50 to 24.99 kg/m2 (incl.)
* Female subjects of childbearing potential who agree on using double-barrier contraception during the study. If a female is postmenopausal (no menses for at least 2 years) or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) she will be exempt from the requirement. In case of using oral contraceptives, these should be withdrawn at least 2 months before the first drug dosing.
* Male subjects who agree on using effective contraception during the study (barrier contraceptive methods)

Exclusion criteria:

* Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
* Any laboratory value outside the reference range that is of clinical relevance
* Any evidence of a clinically relevant concomitant disease
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Positive results of blood tests for infections (HIV, syphilis, hepatitis B or C)
* A positive urine drug screening test at screening and on admission to the trial site in each treatment period.
* A positive alcohol breath test at screening and on admission to the trial site in each treatment period.
* Surgery of the gastrointestinal tract (except appendectomy)
Effect of Kinesio Tape in Muscle Fatigue Measured by Biering-Sorensen Test

Muscle fatigue affects adversely the athletes´ performance and it is therefore one of the most investigated topics currently. However we do not know accurately the mechanisms that produce it.

The aim of this study is to determine the influence of the Kinesio taping (KT) application in the paravertebral muscle fatigue in a sample of healthy young subjects.


Eligibility Criteria:
Inclusion Criteria:

* More than 18 years
* They were motivated to be included in the study

Exclusion Criteria:

* History of Low Back Pain (LBP) in the last 6 months that had lasted for at least 1 week and / or had required medical attention and / or had been off sick
* Back surgery
* Been diagnosed with cardiovascular disease or neurological or herniations, protrusions or severe scoliosis
* Had pain from a disease presenting infection, tumor or injury of an anatomical structure involved in the test
Submandibular Gland Stem Cell Transplantation

This study is a phase I safety and feasibility study to treat head and neck cancer patients with autologous salivary gland stem cell transplantation after postoperative (chemo)radiotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Squamous cell carcinoma (SCC) originating from the mucosa of the oral cavity;
* Primary resection of tumour including an electively or therapeutic ipsilateral neck dissection (at least levels Ib to III, including the submandibular gland).
* Postoperative radiotherapy or chemoradiation, including prophylactic or therapeutic irradiation of the contralateral side of the neck (where the remaining submandibular gland is), including at least levels Ib to IV), next to irradiation of the tumour bed and ipsilateral neck (current standard);
* Age ≥ 18 years;
* WHO performance 0-2;
* Written informed consent;

Exclusion Criteria:

* Primary (definitive) radiotherapy, with or without systemic treatment;
* Previous radiotherapy of the head and neck region (re-irradiation);
* Positive microbiological screening for Human Immunodeficiency Virus type 1 and 2, hepatitis B and C virus and Treponema pallidum.
* Presence of systemic disease known to affect salivary gland functioning (e.g., Sjögren's syndrome);
* Known allergy to mice and gentamicin
* History within the past five years of malignancies other than:

  * basal or squamous cell carcinoma of the skin
  * in situ carcinoma of the cervix;
* Females who are pregnant or lactating at entry.
A Study on a New Staining Method (C4d Staining) of Transplanted Kidney Biopsies

Patients who had received kidney transplantation may suffer from rejection. Recently, positive staining for C4d in kidney biopsies of malfunctioning transplant kidney is increasingly recognized as an important prognostic indicator of poorer long-term kidney outcome. Data is, however, lacking in Hong Kong.


Eligibility Criteria:
Inclusion Criteria:

* All renal allograft biopsies performed in Princess Margaret Hospital (PMH) during the period 1st April 2003 to 31st August 2005 for unexplained acute renal dysfunction (Creatinine rise from baseline by ≥ 20%) or delayed graft function in the immediate post-transplantation period were included in the study. Both cadaveric and living-donor transplant allografts were included.

Exclusion Criteria:

* patients who were \< 18 years' old at the time of renal biopsy or whose records were so incomplete that preclude meaningful analysis
Safety and Efficacy of Diverse Mesenchymal Stem Cells Transplantation for Liver Failure

HBV-related liver failure (HBV-LF), a dramatic clinical syndrome, is characterized with massive necrosis of liver cells. Liver transplantation might be the most effective therapy for HBV-LF. However, there are a lot of problems such as lack of donors, surgical complications, transplant rejection, and high cost, which could limit the application of liver transplantation. It is demonstrated that mesenchymal stem cells could directionally differentiate into hepatocytes and cholangiocytes in injured liver, as well as reduce inflammation of the liver by immune regulation. In this study, we assess the safety and efficacy of human bone marrow and umbilical cord mesenchymal stem cells transplantation for patients with HBV-LF.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18-65 years
* Liver failure
* Negative pregnancy test (female patients in fertile age)
* Written consent
* HBsAg positive
* TB≥171 μmol/L or ascend ≥17.1 μmol/L/per day,
* INR≥1.5 or 20%\<PTA≤40%
* 17≤MELD score≤30

Exclusion Criteria:

* Hepatocellular carcinoma or other malignancies
* Severe problems in other vital organs(e.g.the heart,renal or lungs)
* Pregnant or lactating women
* Severe bacteria infection
* Anticipated with difficulty of follow-up observation
* Liver failure caused by other reasons, such as autoimmune diseases, alcohol, drug and so on
* Other candidates who are judged to be not applicable to this study by doctors
Improving Sleep in Gynecologic Cancer Survivors

This purpose of this study is to learn about how to provide treatment to gynecologic cancer survivors who have difficulty sleeping.

This study has two parts.

In Part 1, 15 gynecologic cancer survivors will receive three candidate intervention components known to reduce sleep disturbance (i.e., sleep restriction, stimulus control, systematic light exposure) simultaneously for six weeks. Participants will then complete semi-structured individual interviews to provide feedback about barriers to and facilitators of intervention adherence. Results of Part 1 will inform the design and delivery of the candidate components in Part 2.

In Part 2, a 2\^3 full factorial design will be followed to randomize 80 gynecologic cancer survivors to one of eight six-week intervention conditions reflecting all possible combinations of the three candidate intervention components.

Eligibility Criteria:
Inclusion Criteria:

* History of Stage I, II, or III gynecologic cancer
* Age 18+ years
* English language proficiency
* Current sleep disturbance demonstrated by a Pittsburgh Sleep Quality Index (PSQI) score \> 5
* Usual sleep onset time between 9:00PM and 3:00AM
* Reliable telephone and Internet access

Exclusion Criteria:

* Stage IV disease
* Diagnosed or suspected psychiatric or medical condition that may interfere with participation (e.g., psychosis, dementia, bipolar disorder, abuse of alcohol or illicit substances within the past 6 months, narrow angle glaucoma, retinal disorders, epilepsy or a similar condition)
* Diagnosed sleep apnea, narcolepsy, periodic limb movement disorder, or restless legs syndrome unless well controlled
* Use of medications that may be contraindications for study procedures due to safety concerns or due to potential impact on intervention efficacy or assessment validity (e.g., sedatives/hypnotics), to be identified on a case-by-case basis
* Shift worker
* Severe physical or cognitive impairment (≥ 2 errors on a brief six-item version of the Mini Mental State Exam \[MMSE\] or Patient Reported Functional Status \[PRFS\] score \> 2, which is based on the Eastern Cooperative Oncology Group \[ECOG\]but has been modified to be in lay language)
* Plans to travel across 3 or more meridians/time zones during the 6 intervention weeks or plans to cross any meridians/time zones during the 2 weeks leading up to wearing an actiwatch.
* History of a primary diagnosis of a distinct non-gynecologic or non-skin cancer other than a non-melanoma skin cancer within the 5 years prior to enrollment
* For participants with Stage III ovarian cancer: less than 2 years post-completion of primary gynecologic cancer treatment and/or less than 60 days post-surgery. For patients with any other gynecologic cancer/stage: less than 30 days post-completion of primary gynecologic cancer treatment and/or less than 60 days post-surgical intervention (e.g., hysterectomy)
* Male
* Have received CBT-I or systematic bright light therapy within the past 6 months
Changes Following Inpatient Child-oriented Family Treatment

Children receiving IFT (intensive family therapy) were assessed for symptom profile and global functioning before admission, 3 months after discharge and 1 year after discharge. Children were assessed by parents, children, their teachers and themselves. Parents were assessed by themselves at the same points in time through psychological self-report questionnaires.

The study is intended to explore covariates to change in children as well as in parents during (pre-treatment) the treatment and follow-up periods.

IFT is an intensive combinatory family treatment which is child-oriented, and traditionally used in an inpatient family treatment unit in child and adolescent psychiatry.

Measures include ones on bonding (PBI), personality traits (NEO-PI), anxiety and depressive symptoms (HADS), attributional tendencies (PAT) and social desirable responding (BIDR). A subgroup was also assessed before a waiting period (pre-treatment).

Eligibility Criteria:
Inclusion Criteria:

* Family offered inpatient family treatment in child and adolescent psychiatry.

Exclusion criteria

* inpatient treatment terminated prematurely
Circulating Biomarkers Repository in Adults Diagnosed With Primary and Metastatic Brain Tumors

The purpose of this protocol is to create a repository of blood samples from patients diagnosed with primary and metastatic brain tumors who are being seen in the Department of Radiation Oncology at Duke Cancer Center.

Repository blood samples will be used to study the association of circulating biomarkers with radiation therapy outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Have a confirmed diagnosis of primary or metastatic brain tumor (histology or imaging as appropriate)

Exclusion Criteria:

* None
Prospective Assessment of Meos Telemedicine E-portal on Ambulatory Care of Type 1 Diabetic Patients

Primary objective of TELEDIAB-3 study is to demonstrate that the use of Meos Telemedicine ePortal for sharing information between diabetologist and type 1 diabetic patient is not inferior to a conventional care regarding metabolic results at 12 months.

Meos is the name of the website (Telemedicine ePortal) tested in this trial ; it is used to share informations between diabetologist and type 1 diabetic patients.

Eligibility Criteria:
Inclusion Criteria:

* Patient with type 1 diabetes mellitus for ≥ 12 months or more
* Age \> 18 years old
* Patient who is followed since 6 month into investigator hospital
* Patient with available internet access at least once a week, and ability to understand MEOS website navigation
* Patient using a compatible glucose meter (One touch ultra, Optium xceed, or BG star)

Exclusion Criteria:

* Patient with no easy and regular access to the Internet;
* Patient found to be unfit for use of the telematic tools or e-mail tools
* Patient with toxicomania, alcoholism or psychological troubles
* Type 2 diabetic patients
* Patient who does not need strict metabolic objectives
* Pregnant or parturient women
* Person with no freedom (prisoner)
Qingdao: Insulin Pump Follow-Up Program

The purpose of the study is to observe/ collect clinical data, subject users' feedback, and device data to better understand the real-life usage and acceptance of the 722 Pump in type 1 diabetes subjects,\<18 years of age, and the role of insulin pump therapy in Qingdao,China.

This is a prospective, multi-center, non-randomized and noninterventional post-market release study. Subjects will participate in 2 phases with each phase requiring the subject to use the continuous subcutaneous insulin infusion (CSII) pump over the course of the study. During the study, subjects and parent or legal guardian will be trained to wear the glucose sensor in the abdominal area for 3 days to transmit real-time (RT) data to the pump. The duration of each study phase is approximately 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Subject is age \< 18 years at time of screening
* Subject has a clinical diagnosis of type 1 diabetes
* Subject is willing to perform required sensor calibrations
* Subject is willing to wear the Medtronic MiniMed Paradigm® REAL Time System continuously throughout the study
* Subject is a participant in the Qingdao project.

Exclusion Criteria:

* Subject is actively participating in an investigational study (drug or device) wherein he/she has received diabetes treatment from an investigational study drug or investigational study devices in the last 2 weeks
* Subject has known hypersensitivity to insulin or insulin infusion set(including tape)
* Subject has used the insulin pump and/or real time CGM/sensor within 90 days before the screening visit for more than 10 days in the outpatient setting:

  * For example, subjects who have used insulin pump and/or real time CGM/sensor in the inpatient setting will still be eligible for enrollment.
  * For example, subjects who have used insulin pump and/or real time CGM/sensor for 8 days in the outpatient setting within 90 days before screening visit will still be eligible for enrollment.
  * For example, subjects who have worn the insulin pump and/or real time CGM/sensor for 3 months in the outpatient setting a year before the screening visit will still be eligible for enrollment
* Subject has been treated with drugs with a known effect on BG within 8 weeks before enrollment other than diabetes medications such as insulin or oral anti-diabetic agents.
* Subject has any systemic disease or medical condition found on screening that may interfere with the safety of the patient and efficacy of the study treatment, in the opinion of the Investigator, may preclude him/her from participating in the study.
* Subject is being treated for hyperthyroidism at time of screening
* Subject has taken any oral, injectable, or IV steroids within 8 weeks from time of screening visit, or plans to take any oral, injectable, or IV steroids during the course of the study
* Subject is currently abusing alcohol9. Any condition that either the Investigator believes would interfere with study participation or evaluation of results.
Effect of Patient Priorities Care Implementation in Older Veterans With Multiple Chronic Conditions

The investigators will conduct a randomized control trial enrolling 366 older Veterans with multiple chronic conditions receiving primary care at the Michael E. DeBakey VA Medical Center and VA Connecticut Medical Center to determine if Patient Priorities Care reduces treatment burden, increases priorities-aligned home and community services, and sets shared health outcome goals compared with usual care. The investigators will randomize at the patient level rather than clinic or clinician level to evaluate the effect of identifying patient priorities on clinician decision making and alignment of care with identified priorities.


Eligibility Criteria:
Inclusion Criteria:

* 2 encounters in prior 18 months
* 3 active health problems on active problem list or prescribed 10 medications

Exclusion Criteria:

* nursing home resident
* end stage renal disease on dialysis
* active serious mental illness (psychosis, schizophrenia, etc)
* active substance use disorder
* complete hearing loss
* dementia
* Non-English speaker (translator required)
* 4 or more no-show appointments in the last 6 months
* the investigators will present a list of eligible patients to PCPs prior to chart review to identify patients who the PCP:

  * a) believes cannot participate independently or provide informed consent due to cognitive impairment
  * b) "would not be surprised if the patient passed away within the next 12 months?"
Creating an Artificial Night on Physiological Changes in Preterm Infants

Effects of creating an artificial night on physiological changes, weight and feeding tolerance in preterm infants.

Introduction:Nowdays,with medical advances in intensive care increased chance of survival in premature infants.One of the major concerns exposure to high light levels in neonate \& subsequent it is increase in metabolism rate.So,this study was conducted to determine the effect of creating an artificial night on physiological changes, weight and feeding tolerance in preterm infants.

Methods: This is a randomized clinical trial dual group study, 38 preterm infants (gestational age of 30-34weeks)due to prematurity hospitalized at Ghaem NICU,were evaluated within 10 days. Infants were divided into two groups of 1200-1700 and 1701-2200g based on the weight and the weight of each group were randomized into artificial night(dark period was from 19 to 7 during incubator was covered with linen cloth \& light period was from 7 to 19 removed the cover) and control groups(continuous lighting). Mothers \& infants through questionnaires,interviews,observation \& document completion, changes in physiologic \& weight befor entering the study \& then physiologic changes twice a day,weight \& feeding tolerance were collected daily.Data were analyzed using spss v.16 software.


Eligibility Criteria:
Inclusion Criteria:

Premature newborn infants with gestational age of 30-34 weeks Birth weight of 1200-2200g Taking care and supervision in the incubator to measure weight and grow up Keeping the axillary temperature in the range of 36-37° C Keeping the heart rate in the range of 100 to 160 beats per minute Breast feeding through a nasogastric tube or gastric orally Healthy infants without congenital anomalies No history of taking specific drugs or alcohol by mother during the pregnancy. Mother's lack of addiction

Exclusion Criteria:

Illness of the infant (affecting with secondary sepsis, seizures; increased or decreased blood pressure, successive apnea, feeding intolerance or feeding stoppage) Starting phototherapy Discharge of the infant earlier than 10 days Parents' lack of consent with the study