cyrilzakka/clinical-trials huggingface dataset:
Lung Transplantation in Chronic HCV Infection With Post Transplant EPCLUSA Treatment

The purpose of this study is to evaluate whether treatment with Epclusa (sofosbuvir/velpatasvir) after lung transplantation in individuals with chronic hepatitis C infection is feasible, safe and effective at curing HCV.


Eligibility Criteria:
Inclusion Criteria:

* HCV RNA \>= 10\^3 IU/ml at screening
* Chronic HCV infection, defined as positive HCV antibody and/or HCV RNA more than 6 months prior to screening
* HCV Genotype 1, 2, 3, 4, 5 or 6
* Otherwise eligible for lung transplant at study site

Exclusion Criteria:

* Age \<18
* Treatment with any of the following agents:

  * Amiodarone. Subjects previously treated with amiodarone must have stopped the amiodarone at least 60 days prior to day 1 SOF/VEL
  * Carbamazepine, phenytoin, phenobarbital, oxcarbazepine
  * Rifabutin, rifampin or rifapentine
  * HIV regimens containing tenofovir or tipranavir/ritonavir
  * St John's wort
  * PPIs, including: Omeprazole, pantoprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole
  * Modafinil
* Have any serious or active medical or psychiatric illness which, in the opinion of the investigator, would interfere with subject treatment, assessment or compliance
* Hepatitis B surface antigen positive
* History of hepatic encephalopathy or variceal hemorrhage
* Abnormal hematological and biochemical parameters, including:

  * Hemoglobin \<8g/dL
  * Platelets \<= 50,000/mm\^3
  * ALT (alanine aminotransferase), AST (aspartase aminotransferase) or alkaline phosphatase \>=10 times ULN
  * Total bilirubin \>3mg/dL
  * Severe renal impairment, ie creatinine clearance (CrCl) \<30mL/min
* Pregnant women or women planning to become pregnant
* Women or are breastfeeding
* Active or recent history (\<=1 year) of drug or alcohol abuse
Combined Mode-Kinetic Chain Exercise With and Without Core Stability Exercises on Patients With Knee Osteoarthritis

The goal of this \[type of study: Randomized control trial\] is to \[ see the effects of Combined Mode Kinetic Chain Exercises along with or without core stability exercises on pain, range of motion and disability \] in \[ in patients with Knee Osteoarthritis\].The main question it aims to answer is:

Wether core stability exercises is effective if performed along with Combined chain kinetic exercises to improves the condition of Knee Osteoarthritis? Group A will receive Core Stability Exercises along with Combined Chain Kinetic Exercises and Group B will receive combined Chain Kinetic Exercises.

Knee joint Osteoarthritis is a prevalent and multifaceted condition, affecting a substantial portion of the general population (roughly 13% of women and 10% of men 60 years). Different techniques and treatment methods have been used to treat knee osteoarthritis. In this study, I will be identifying that core stability exercise if performed along with Combined chain kinetic exercise brings benefits to the patients of knee osteoarthritis. One of the techniques is Combined Chain Kinetic Exercise that i will be applying on both groups. The other one is the set of Core stability exercises.

The research involves two intervention groups (Group A and Group B) receiving specific treatments over 60 sessions within an twelve-week period. Group A incorporates the Combined Chain Kinetic Exercise,Core stability exercises, and transcutaneous electrical nerve stimulation (TENS) with a heating pad. Group B undergoes hot packs and TENS, followed by Combined Chain Kinetic Exercise, encompassing pain levels, range of motion (ROM), and Knee Injury and Osteoarthritis Outcome Score (KOOS) scores, will be evaluated using the Numeric Pain Rating Scale, Goniometer, and KOOS. Data analysis will employ SPSS version 26. Data will be collected at baseline, immediately post-intervention, and at follow-up intervals.

Eligibility Criteria:
Inclusion Criteria:

* Age 40 to 70 years with Knee Osteoarthritis

Exclusion Criteria:

* Participants suffering from any other condition of knee joint or if they are in active infection state
Efficacy and Safety of Insulin Detemir in Type 2 Diabetes Inadequately Controlled on OHA Therapy Alone

This trial is conducted in Japan. The aim of this trial is to investigate the efficacy of insulin detemir on blood glucose control in type 2 diabetes when added to current OHA treatment.


Eligibility Criteria:
Inclusion Criteria:

* Duration of type 2 diabetes mellitus for at least one year
* Insulin naive patients
* OHA treatment for at least 12 weeks
* HbA1C between 7.5-10.0%
* Body Mass Index (BMI) below 30.0 kg/m2

Exclusion Criteria:

* Impaired renal function
* Impaired hepatic function
* Pregnant, breast-feeding (within a year after delivery), intention of becoming pregnant or not using adequate contraceptive methods
Reducing Rural Colon Cancer Disparities

The investigators will conduct pre-implementations assessments of primary care clinics within a rural health system to determine current practices and capacities regarding colorectal cancer (CRC) screening and follow-up, preferred evidence-based interventions (EBIs) to improve follow-up, and factors that could influence successful implementation and eventual impact of a multi-level intervention to increase timely and complete follow-up after positive fecal occult blood test (FOBT) in rural patients.


Eligibility Criteria:
Inclusion Criteria for Primary Care Provider/Staff Participants -Eligible providers and staff include physicians, nurse practitioners, nurses, case managers, medical assistants, administrative staff, or other employees of the clinic involved in the cancer screening and follow-up process.

Inclusion Criteria for Patient Participants (Interview)

-Positive FOBT or colonoscopy

Inclusion Criteria for Patient Participants (Survey)

* 50 years of age or older
* Had a colonoscopy at one of Southern Illinois Healthcare's facilities within the last 24 months

Inclusion Criteria for Colonoscopy Provider/Staff Participants -Provider and a staff or mid-level provider in each office (5 colonoscopy providers in the Southern Illinois Healthcare region)

Exclusion Criteria for Primary Care Provider/Staff Participants

-None

Exclusion Criteria for Patient Participants (Interview)

* Negative FOBT or colonoscopy
* Exclusion Criteria for Patient Participants (Survey)
* Younger than 50 years of age

Exclusion Criteria for Colonoscopy Provider/Staff Participants None
A Novel Multisensory-Rhythmic Intervention in Geriatric Rehabilitation

Human performance takes shape from the dynamic interaction between person, environment, and task. Goal-directed action is a complex task, which requires the elderly to adapt their motor response according to the environment constraints and task requirements to accomplish the task goal. Among age-related problems, motor control deficits are often the main problems which restricts the frail elderly from maintaining independence for activities of daily living. Therefore, to preserve the quality of life, motor function of the elderly must be taken into consideration, including early detection of motor control problems and development of appropriate intervention strategy for persons with either healthy or pathological brain aging. Rhythmic skill training which is a new mode of dual tasks using rhythmic cueing as an external agent for facilitating an automatized motor task. During training, rhythmic skill training can provide multi-component of sensory stimulation, strengthen motor planning and optimize motor execution, therefore, it will improve the motor performance for the elderly or patients with mild cognitive impairment. In addition, the neuroplastic changes related to sensory processing, selective attention, or working memory demands through music rhythm training can facilitate the cognitive function for the elderly which is a current trend of geriatric rehabilitation. Moreover, the advantage of virtual reality is that it provides important information related to knowledge of result, which can induce better motor and cognitive training effects. Therefore, this research project will focus on assessing and intervening motor adaptation of upper extremity for the healthy elderly and patients with mild cognitive impairment. The first purpose of the project will analyze the difference in efficiency of responsive and predictive grasping motor adaptation among the healthy young adults, healthy elderly and patients with mild cognitive impairment through a test of perturbation-based of pinch-holding-up-activity, and use artificial intelligence for more accurate classification for the grasp pattern of healthy young adults, elderly and patients with mild cognitive impairment. The second one is to verify the effects of virtual-reality based rhythmic skill training system on the motor adaptation capability of upper limb and cognition for the elderly and patients with mild cognitive impairment.


Eligibility Criteria:
Inclusion Criteria:

1. Montreal Cognitive Assessment (MoCA) score of 23 or higher,
2. Clinical Dementia Rating (CDR) of 0 (for normal subjects) or 1 (for mild cognitive impairment subjects),
3. Healthy young participants aged between 20-39 years, healthy older adults and mild cognitive impairment participants aged between 65-85 years,
4. No skeletal, muscular, or neurological problems in the upper limbs in the past year, and
5. Sufficient visual acuity to complete the tasks.

Exclusion Criteria:

* Any subjects with significant mental illness, central nervous system disorders, or medical history
Randomized Clinical Trial, Conventional Treatment-controlled, Studying the Efficacy of Plasma Rich in Growth Factor (PRGF®) in Alveolar Ridge Preservation After Simple Exodontia in the Anterior Region of Maxilla.

This RCT aims to study the efficacy and safety of PRGF-Endoret in alveolar ridge preservation in the aesthetic zone. The control group is the spontaneous healing occuring after the suturing of the alveolus. The primary endpoint is the bone regeneration measured in biopsies obtained from the regenerated alveolar bone.


Eligibility Criteria:
Inclusion Criteria:

* - Subjects of both sexes with an age greater than or equal to 18 years.
* Clinical indication for a simple exodontia in the aesthetic zone (from left 2nd premolar to the right 2nd premolar in the maxilla).
* Need of a dental implant placement in the extraction site.
* Availability to follow-up during the treatment period
* Subjects with non-active periodontal disease.
* Buccal dehiscence \< than 25% in the vestibular table

Exclusion Criteria:

* - Presence of an active infection
* Loss of any plate of the socket
* Severe inflammation in the area of the exodontia previous to the intervention
* Have previous diagnosis of a coagulopathy.
* Have previous diagnosis of any autoinmune disease.
* Have received radiotherapy, chemotherapy or immunosuppressive treatments, systemic corticosteroids and/or anticoagulants the 30 days prior to inclusion
* Regular treatment with AINES or other antiinflammatory drugs
* Previous history of chronic hepatitis or heatic cirrhosis
* Positive markers for VHC, AgHBs, VIH I/II or Treponema pallidum
* Uncontrolled diabetes mellitus (Glycosylated hemoglobin higher than 9%)
* Subjects submitted to hemodyalisis
* Presence of malignant tumour, haemangiomas or angioma in the exodontia region.
* Previous history of ischemic cardiopathy in the last year.
* Pregnancy or womens in childbearing age who do not take contraception measures.
* Nursing womens
* Metabolic bone disease
* Ongoing treatment with biphosphonates both through oral or intravenous administration
* Smoking habits (\> 10 cigarrettes/day)
* In general, any disability to participate in the study
rTMS and Conventional Physical Therapy After Stroke

Given previous evidence that non invasive brain stimulation enhances the effects of conventional therapies, this randomized sham-controlled trial with 4-weeks follow-up aimed to determine if the repetitive transcranial magnetic stimulation (rTMS)combined with conventional physical therapy (VRT) would be superior to physical therapy in improving upper limb function and quality of life with chronic stroke individuals.


Eligibility Criteria:
Inclusion Criteria:

* stroke onset ≥ 6 months;
* muscle tone at the wrist with a modified Ashworth scale (MAS) score between 1+ and 3;
* minimum age of 30 years old and maximum age of 75 years;
* absence of cognitive impairment, as determined by the cut-off scores on the Mini-mental state exam

Exclusion Criteria:

* history of seizure or cerebral aneurism;
* antispasticity drugs within 6 months before enrollment;
* previous surgery involving metallic implants;
* unstable vital signs;
* other neurological diseases
* aphasia
Safety And Efficacy Study Of Ziprasidone In Pediatric Psychotic Illness

The purpose of this research is to determine if Ziprasidone is safe and effective for use in children and adolescents with a psychotic illness, and to determine of Ziprasidone treatment leads to weight changes in children.

Ziprasidone is a recently FDA approved antipsychotic, and it holds promise in the treatment of pediatric psychosis due to its low liability for weight gain and other side effects. This is important because early intervention in persons with a psychotic illness is important for their long-term treatment and outcome. Unfortunately, pediatric samples are often more sensitive to the side effects of psychotropic medications. Because psychotropic medications are often used by clinicians long before they are studied in pediatric populations, it is important to further study these agents.

Twenty subjects with the diagnosis of a psychotic disorder, according to DSM-IV criteria, will be recruited for the study. If subjects have completed baseline evaluations, labs, EKG, and rating scales and are still eligible to participate, subjects will start on 20mg of Ziprasidone at night. The second week this will increase to 20 mg twice a day. At visits that occur at 2,4,6,and 8 weeks, the subject's dose of medication can be increased in 20mg per day increments. This allows for a maximum possible dose of 100mg. Dosage may be decreased at any time secondary to side effects.

The potential benefits are that new information will be added to the field of pediatric psychiatry and the possibility that the medication may result in improved symptoms of psychosis. The potential benefits of this study outweigh the possible risks.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Schizophrenia, Schizophreniform DO, Schizoaffective DO or Psychotic Disorder NOS
* Male/female, ages 7.0-17 years old
* Normal intelligence, ability to provide assent and consent
* Not currently receiving adequate treatment

Exclusion Criteria:

* Known hypersensitivity to ziprasidone (past failed trial)
* History of QTc prolongation
* Recent myocardial infarction
* Uncompensated heart failure
* Currently treated with other QTc prolonging medications
* Unstable medical illness
* If on diuretics, monitor regularly for hypokalemia
Docetaxel and Irinotecan in Treating Patients With Advanced Solid Tumors

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase I/II trial to study the effectiveness of docetaxel and irinotecan in treating patients who have advanced solid tumors.

OBJECTIVES: I. Determine the maximum tolerated dose of irinotecan when combined with docetaxel in patients with advanced solid malignancies. II. Determine the dose limiting toxicity of this regimen in these patients. III. Assess any antitumor activity of this regimen in these patients.

OUTLINE: This is a dose escalation, multicenter study of irinotecan. Patients receive docetaxel IV over 1 hour followed immediately by irinotecan IV over 30 minutes on days 1, 8, 15, and 22. Treatment continues every 6 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of irinotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity. Patients are followed every 3 months for 1 year, then every 6 months thereafter.

PROJECTED ACCRUAL: Approximately 15-25 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven solid malignancy for which no effective therapy is currently available CNS metastases allowed if CNS disease is stable for at least 4 weeks following completion of surgery and/or radiotherapy

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: At least 3 months Life expectancy: ECOG 0-2 Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 1.2 mg/dL SGOT and/or SGPT no greater than 1.5 times upper limit of normal (ULN) (no greater than 2.5 times ULN allowed if alkaline phosphatase no greater than ULN) Alkaline phosphatase no greater than 2.5 times ULN (no greater than 4 times ULN allowed if SGOT and/or SGPT no greater than ULN) Renal: Creatinine clearance at least 55 mL/min Other: HIV negative No active infection Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No concurrent medical condition that would preclude compliance with study

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy regimens containing topotecan, irinotecan, or docetaxel At least 4 weeks since other prior chemotherapy (6 weeks since prior nitrosoureas, melphalan, or mitomycin) Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 4 weeks since prior wide field radiotherapy No prior radiotherapy to greater than 20% of bone marrow Surgery: See Disease Characteristics Recovered from any prior surgery Other: No other concurrent investigational agents
Effectiveness Accompaniment Perioperative Patients With Psychiatric Illness on the Lives Perioperative

The experimental strategy is to develop a specific device about the anesthetic and surgical acts for a subject with a documented psychiatric condition and to benefit from surgery. This device is based on 3 stages: pre-operative phase, Phase perioperative and postoperative phase. A nurse anesthetist will come into contact with the subject the day before surgery. This contact will be concomitant with the pre-anesthesia visit. She explained about the general organization of the arrival in the operating room. The interview will be a minimum of 15 minutes and beyond if necessary. This will be accompanying this the next day in the operating room in order to optimize its hospitality and installing the block, guide the subject through all the steps before falling asleep. Finally, even accompanying will be present upon awakening the subject in the recovery room.


Eligibility Criteria:
Inclusion Criteria:

* adult subject;
* Subject with chronic mental illness defined by ICD-10 classification \[ICD-10, 1992\], corresponding to psychoses say no emotional or affective psychoses say;
* Subject to which mental pathology is evolving for more than 6 months;
* Topic targeted for elective surgery;
* Topic judged capable of performing a self-administered questionnaire;

Exclusion Criteria:

* minor, pregnant or nursing women, about not being affiliated to the social security scheme, subject under guardianship;
* Subject with a mental illness do not belong to sections of ICD-10 contained in "inclusion criteria";
* Subject to benefit from surgery as part of the emergency;
Comparison of Weight Loss Programs for Individuals With Severe Obesity

The purpose of this study is to evaluate the effectiveness of a technology-based system (the Body Media FIT system) for enhancing weight loss in severely obese individuals (BMI: ≥ 40 kg/m2). The investigators will compare two 6-month interventions: 1) a standard behavioral weight loss program (SBT) and 2) a standard behavioral weight loss program plus the use of the Body Media FIT system (SBT+FIT). The Body Media® FIT system is a novel weight loss tool consisting of an armband that measures energy expenditure, a digital display watch that provides "real time" physical activity and energy expenditure feedback, and access to a system website which allows individuals to track their food intake and set exercise and dietary goals. We will examine differences in physical activity, weight loss, and program adherence between groups.


Eligibility Criteria:
Inclusion Criteria:

* Age 21-55
* Body mass index (BMI) ≥40kg/m2 (or no more than 440 lbs)

Exclusion Criteria:

* Recent weight loss (≥ 10 pounds within the past 6 months)
* Currently pregnant, pregnant within the last 6 months, or planning on becoming pregnant in the next 6 months.
* Presence of any condition that would limit exercise participation (assessed by the Physical Activity Readiness Questionnaire (PAR-Q)).
* A history of myocardial infarction or other heart-related surgeries.
* Currently enrolled in a commercial weight loss program.
* A recent (\< 1 year) diagnosis or hospitalization for a psychological condition or history of psychosis (e.g. - Schizophrenia, Bipolar, Eating Disorder)
* Diagnosed with cancer within the past year or currently undergoing cancer treatment.
* Currently taking weight loss medications.
* Currently do not have daily access to a computer or Internet.
* Individuals with diabetes
World Health Organization (WHO) , COVID19 Case Series of Post Covid 19 Rhino Orbito Cerebral Mucormycosis in Egypt

Objectives: identify and recognize clinical Characteristics, Pathophysiology, and management of a group of patients with rhino Rhino-Orbito-Cerebral Mucormycosis infection associated with Covid 19 viral infection


Eligibility Criteria:
Inclusion Criteria:

* all patients with mucormycosis post covid 19

Exclusion Criteria:

* The patient not suffered from covid 19
Pemetrexed and Gemcitabine for Treatment Resistant Patients With Metastatic Colorectal Cancer and KRAS Mutations

This study aims to investigate the efficacy and safety of the combination of pemetrexed and gemcitabine in heavily pre-treated, chemotherapy resistant colorectal cancer patients with KRAS mutations.


Eligibility Criteria:
Inclusion Criteria:

* Histologically verified adenocarcinoma in colon or rectum
* Age \>18
* Metastatic colorectal cancer progressed after chemotherapy regimens containing fluoropyrimidines, oxaliplatin and irinotecan.
* KRAS mutation in primary tumour or metastasis.
* Measurable disease according to RECIST
* ECOG performance status 0, 1 or 2
* Adequate function of liver, kidneys and bone marrow measured by biochemistry (max. 2 weeks before enrolment)
* EDTA clearance: Uncorrected GFR \> 45 ml/min.
* Neutrophilocytes ≥1.5 x 10\^9/l, leukocytes ≥3.0 x 10\^9/l, thrombocytes ≥100x10\^9/l
* ALAT ≤ 3 x upper normal value (ULN), bilirubin ≤ 3 x upper normal value, Aptt and INR normal (or 2-3 at AC treatment). (ALAT and basic phosphatase ≤ 5 x upper normal value in case of liver metastases).
* Blood samples and paraffin embedded tissue from primary tumour and/or metastases for translational research.
* Fertile men and women (women \<2 year after last menstruation) must use efficient birth control.
* Signed informed consent.

Exclusion Criteria:

* Clinically significant other concurrent disease making the patient unfit for participation in the study according to the investigator.
* Other malignant disease within 5 years prior to study enrolment, except from planocellular and basal cell carcinomas in the skin or carcinoma-in-situ cervix.
* Other experimental treatment within 30 days prior to treatment start.
* Pregnant or breastfeeding women.
* Clinical or radiological signs of CNS metastases.
* Planned radiation of target lesions.
* Concurrent vaccination against yellow fever.