cyrilzakka/clinical-trials huggingface dataset:
Telerehabilitation in Coronary Heart Disease

Cardiovascular diseases are the main cause of death worldwide. Aerobic fitness is related to long-term survival and a reduction in mortality and recurrent nonfatal myocardial infarction in subjects with cardiovascular disease. However, the majority of cardiac patients do not engage in enough physical activity to obtain benefits or in the long-term struggle to maintain a physically active lifestyle. There is a need for innovative rehabilitation methods aiming at increasing longer-term adherence and hence more sustained effects on health related physical fitness. One strategy might be the use of home-based training in combination of telemonitoring guidance. Therefore, the main objective of this randomized controlled clinical trial is to compare the longer-term (=1 year) effects of a 3-month supervised center-based rehabilitation program with a patient-tailored home-based cardiac rehabilitation program with telemonitoring guidance in CAD patients (phase III). The primary outcome measure is physical fitness. It is hypothesized that patients randomized to a home-based training program with telemonitoring guidance will demonstrate higher levels of physical activity at one year of follow-up, resulting in higher levels of physical fitness, compared to patients who have been enrolled to the supervised center-based cardiac rehabilitation program or control group. Ninety patients will be randomized to Home-based training, a center-based cardiac rehabilitation program or an advice only group (= control group). Assessment will be performed at baseline, immediately at completion of the intervention and at one-year of follow-up and will include measurements of exercise tolerance, cardiovascular risk factors, physical activity, muscle strength, endothelial function, health-related quality.


Eligibility Criteria:
Inclusion Criteria:

* Patients with CAD (post-PCI, post-MI, post-CABG)
* Patients on optimal medical treatment and stable with regard to symptoms and pharmacotherapy for at least 6 weeks
* Patients have successfully completed the 3 month ambulatory cardiac rehabilitation in hospital program
* 39 yrs \< age \< 76 years
* access to internet facilities or PC at home

Exclusion Criteria:

* Significant undercurrent illness last 6 weeks
* Known severe ventricular arrhythmia with functional or prognostic significance; significant myocardial ischemia, hemodynamic deterioration or exercise-induced arrhythmia at screening or heart disease that limits exercise
* Co-morbidity that may significantly influence one-year prognosis
* Functional of mental disability that may limit exercise
Increasing Availability and Acceptability of Circumcision in Zambia

This study proposes to balance supply and demand of male circumcision through a systematic scale-up of coordinated biomedical surgical and behavioral counseling services. The study will compare the combined biobehavioral sexual risk reduction intervention to the standard of care, which focuses exclusively on the provision of circumcision services alone, with the goal of optimizing both local and national HIV prevention efforts.


Eligibility Criteria:
Inclusion Criteria:

* HIV negative
* Uncircumcised male
* 18+ years of age
* Able to understand and sign informed consent in English, Bemba, or Nyanja
* Have not requested male circumcision services at the time of or following VCT
* Female partners of enrolled males are invited to participate

Exclusion Criteria:

* Men seeking circumcision services are not eligible for this study
* Men with genital abnormalities requiring MC, e.g. balanitis (inflammation of the preputial skin), posthitis (inflammation of the glans penis; common in patients with diabetes), phimosis (scarring of the distal margins of the foreskin) resulting from chronic balanitis, paraphimosis (the inability to pull the retracted foreskin back over the glans) or diseases of the foreskin, including localized carcinoma are not eligible for this study
* Men with congenital or acquired penile abnormalities that require the preputial skin for generative repair, such as hypospadias (urethra exits from underside of penis) are not eligible to participate
* Participants unable to provide informed consent will not be eligible.
Acute Effects of Motor Imagery and Physical Exercise on Tongue Strength and Pain Threshold in Healthy Adults

Motor imagery is the feeling and thinking that the movement is done by imagination without physically occurring. In addition to its use in various fields, its use in the field of physiotherapy is also increasing. Especially in situations where real movement is difficult or contraindicated, motor visualization is very advantageous when there is no physical contact.

Swallowing function is one of the vital functions that ensure human independence. Like many components in swallowing, tongue muscle is also important. It has been shown that the strength of the tongue decreases with age, disease or other reasons. In the development of the strength of the tongue, while physiological principles are taken as basis, a different procedure from normal procedures is performed. However, language is a part of the body where one can study on his own.

Such situations lead to research on whether language reinforcement can occur with motor imagery. Considering that in addition to long-term effects, acute effects may also affect the functions of individuals, the starting point of the study is formed. Studies have investigated the acute change in tongue strength and pain perception after motor imagery.

The primary aim of this study is compare the acute effects of different motor imagery methods and physical exercise on tongue strength and pain in heatlhy adults.


Eligibility Criteria:
Inclusion Criteria:

* Participants age between 18-65
* Symmetrical chewing function, fluent mouth and tongue movements

Exclusion Criteria:

* Participants with systemic, cardiorespiratuar, central nerve system and romatologic diseases or musculoskeletal pain or craniocervical pathology
* A history of orofacial pain or temporomandibular diseases.
* Over-reacting for touching or tooth-pain
* Pregnancy or possibility of pregnancy
For Easy, Fast and Comfortable Colonoscopy, Which Position

Colonoscopy is one of the most common endoscopic procedures today. However, it sometimes can be a serious challenging situation both for the clinicians and patients. In this study, the investigators tried to determine which colonoscopic position allows easy, fast and comfortable way.

colonoscopy and colonoscopic screening are the most common routine studies to reduce the incidence of colorectal cancer.In this process, the most important problem for the endoscopist and the patient is pain, loop formation, (the reason why the device is not able to progress in the bowel) and in some patients it takes a long time due to these reasons and the risk of complication development.The subject of what should be the most ideal position in colonoscopy has previously been studied in some specific subgroups.There is not enough study on what should be the ideal position in colonoscopy. In this study, the investigators tried to determine which colonoscopic position allows easy, fast and comfortable way.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients aged for 18 to 80 years,
* colonoscopy indications (iron deficiency anemia ,Malignancy screening in patients over 50 years of age,secret blood positivity in stool, rectal bleeding,patients describing Hematoconia, chronic diarrhea, constıpatıon

Exclusion Criteria:

* patients with previous colon surgery
* serious comorbid disease (congestive heart failure ef\< %30 , advanced chronic obstructive pulmonary disease,terminal period cancer with a life expectancy of less than 5 years, those who have not had appropriate bowel cleaning,endoscopic treatment during colonoscopy or removal of diagnostic lesions,other sedatives for sedation other than midazolam
Vegetable Ivory Bone Material in Bone Healing Compared to Current Standard Methods of Bone Healing

The purpose of this research study is to evaluate whether a biobased natural vegetable ivory formulation can produce similar or better results compared to the current standard bone healing treatment.

The patient is identified and surgical site and sides reviewed. The patient is consented to have bilateral tooth extractions which are mirror images of each other either in the maxilla or mandible.

Local anesthesia is administered and attention directed to the bilateral identified teeth. Each tooth is luxated with a straight elevator and removed with a forcep with out bony removal. The sites are curetted as indicated, irrigated with normal saline irrigation , then the sterile bone graft material (allograft and vegetable ivory bone graft) are reconstituted with sterile normal saline and placed in the tooth sockets then sutures with a 3-0 gut suture. Once hemostasis is obtained and pot operative care instructions are given, the patient is monitored for 30 minutes following the procedure then discharged.

Eligibility Criteria:
Inclusion Criteria:

Have parallel sites from which teeth have been extracted

Exclusion Criteria:

They are not a candidate for bone grafting or a dental implant
Effects of Proteins Fraction Derived From Milk on Osteoporosis Prevention

Osteoporosis is defined as a systemic skeletal disease characterised by low bone mass and microarchitectural deterioration of bone tissue, with a consequent increase in bone fragility and susceptibility to fracture. Osteoporosis is a serious public health problem that is responsible for approximately 3 million women with osteoporosis in France, with approximately 150,000 cases per year occurring in vertebral fractures, of which only one third would be diagnosed and 50,000 hip fractures (causing death in 20% of cases). The frequency of the disease increases with age, particularly among women: 10% among women aged 60 years and 20% among women aged 65 and 40% among women aged 75. At menopause, oestrogen deficiency causes alterations of the immune system, decreased bone formation, microarchitectural deterioration and a decrease in bone mass. Various factors may contribute to this decrease in bone density such as diet, lifestyle, or the genetic background.

According to prospective studies, an overexpression of 135% of hip fractures is expected at European level in 50 years. Therefore, it is interesting to develop new prevention approaches aimed at maintaining the healthy aging population. Nutritional researches can consider setting up a real prevention.

Studies suggest that specific milk protein fraction contain factors able to promote bone formation, inhibit bone resorption in vitro. In animal model, they showed that the specific fraction prevents bone loss in aged ovariectomised rats by reducing bone resorption. Furthermore, in human volunteers, a supplementation with the specific milk protein fraction maintains balanced bone remodelling and increase bone mineral density. For example, in healthy postmenopausal women, it has been reported that a mean rate of gain of lumbar BMD in the MPF group (1.21%) was significantly higher than in placebo group (-0.66%; p\<0.05).

The objective of this study is to assess the efficacy of daily consumption of the milk proteins fraction on bone mineral density improvement in healthy postmenopausal women.


Eligibility Criteria:
Inclusion Criteria:

* Caucasian Female
* Natural or surgical menopause between 1 and 5 years
* Aged between 50 to 65 years
* BMI between 19 and 30 kg/m²

Exclusion Criteria:

* Medications: oral steroidal anti-inflammatory, anti-osteoporotic treatment, hormone replacement therapy
* Low bone mineral density (T-score\<-3
* Diseases affecting bone metabolism(Paget's disease, Cushing's disease, thyroid disease...)
* Intolerance or allergy to milk proteins and allergy to soy or soy lecithin
* Heavy smoking
* Excessive alcohol drinking
* Intensive sports practice according to the investigator
Early Ultrasound Screening of Heterotopic Ossification After Severe Neurological Trauma

Prospective, bi-centric diagnostic, performance study on a new diagnostic procedure with ultrasounds against a reference diagnostic procedure.

The primary objective is to study the performance of ultrasound coupled with clinical examination at 1 week of admission for early screening of heterotopic ossification (HO) in patients admitted to a post intensive care rehabilitation unit (PICRU) after a severe neurologic trauma.

The CT scan at 5 weeks of admission is considered as the gold standard. CT scan reader will be blinded to clinical data.

Heterotopic ossification still pose the problem of diagnosis and clinical management that is too late and invasive when complications arise. The challenge would be to identify patients at earlier stage of HO development in order to start an early treatment. This study will focus on the performance of ultrasound in the early screening of HO for patients admitted to a post intensive care rehabilitation unit after severe neurological trauma, this population being at high risk of HO.

Patient enrollment will be performed only at the PICRU of the Raymond Poincaré Hospital (AP-HP). Another center (the imaging department of the same hospital) will participate in this research for ultrasounds and CT scans, but will not perform any recruitment.

Eligibility Criteria:
Inclusion Criteria:

* Patients ⩾ 18 years;
* Admitted to a neurological post intensive care rehabilitation unit for the first time;
* Hospitalized in ICU before being admitted to PICRU for a for traumatic brain injury (initial Glasgow coma scale \< 14 and brain radiological abnormalities at the time of admission to ICU and / or a traumatic spinal cord injury (para- or tetraplegia with at least half of key muscles of the 2019 ISNCSCI classification with a strength of less than 3 below the neurological level of the injury at the time of admission to PICRU);
* Patient's written consent obtained (or from an authorized relative);
* Affiliation to a social security scheme.

Exclusion Criteria:

* History of moderate or severe traumatic brain injury;
* History of spinal cord injury (para- or tetraplegia);
* History of stroke or disabling neurological disease;
* History of hospitalization in neurological or neurosurgical or traumatological ICU for another reason;
* Breast-feeding or pregnancy;
* Under court protection.
Cisplatin and Gemcitabine in Treating Patients With Refractory or Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer

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 trial to study the effectiveness of cisplatin plus gemcitabine in treating patients with refractory or recurrent ovarian epithelial, fallopian tube, or primary peritoneal cancer.

OBJECTIVES: I. Determine the maximum tolerated dose of intraperitoneal (IP) gemcitabine given in combination with IP cisplatin in patients with refractory or recurrent ovarian epithelial, fallopian tube, or primary peritoneal cancer. II. Determine the safety of this regimen in this patient population. III. Determine the pharmacokinetics of IP gemcitabine administered with IP cisplatin.

OUTLINE: This is a dose escalation study of gemcitabine. Patients receive intraperitoneal cisplatin on day 1 plus intraperitoneal gemcitabine on days 1, 8, and 15. No treatment will be given on day 22. Courses are repeated every 4 weeks. Patients receive up to 4 courses of therapy. Dose escalation of gemcitabine continues in cohorts of 3 patients until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 2 of 6 patients experience dose limiting toxicity (DLT). Patients are followed every 3 months for 2 years, then every 6 months thereafter.

PROJECTED ACCRUAL: Approximately 3-24 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically documented epithelial ovarian carcinoma or fallopian tube cancer or primary peritoneal cancer following initial cytoreductive surgery and chemotherapy with at least one cisplatin based chemotherapy regimen Must have undergone a second assessment procedure (laparoscopy or laparotomy) within 8 weeks of protocol entry, and have confirmation of residual disease no greater than 1.0 cm at the end of the procedure

PATIENT CHARACTERISTICS: Age: Not specified Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 3 times upper limit of normal (ULN) SGOT less than 3 times ULN Alkaline phosphatase less than 3 times ULN Renal: Creatinine less than 1.6 mg/dL Creatinine clearance at least 50 mL/min Other: Must have a functioning implanted subcutaneous intraperitoneal catheter No neuropathy of grade III or greater from prior chemotherapy No contraindication to intraperitoneal therapy e.g., intraabdominal infection or widespread adhesions

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See Disease Characteristics
Needs Assessment Evaluating Quality of Life Issues for Gastroparesis Patients and Caregivers

The project will involve conducting a Needs Assessment for Gastroparesis patients and their caregivers with the goal of identifying quality of life issues associated with this disease. Identifying these issues will ameliorate management and support systems for gastroparesis currently existent in the community and, hopefully, provide information for the establishment of more resources to assist the patients and their families.

This project will involve: a) distributing questionnaires to up to 200 participants (100 patients and 100 caregivers) at the Shands Gastrointestinal clinic and b) focus groups including patients, medical provider, and the clinic case manager. The questionnaires will provide information on the relative effect of gastroparesis on the quality of life of the patients and their caregivers. Assessment of this needs assessment will then help identify areas of potential resource improvement and mobilization to provide support for the patients and their family members.

Eligibility Criteria:
Inclusion Criteria:

* Gastroparesis patients at the GI clinic of Shands Hospital at the University of Florida
* Caregivers to Gastroparesis patients at the GI clinic of Shands Hospital at the University of Florida

Exclusion Criteria:

* Inability to fill out the questionnaires by any cause
A Efficacy and Tolerability Study of TEGAFOX Sequential S-1 in the Treatment of Adjuvant Chemotherapy for Gastric Cancer

This study is designed to compare the three chemotherapy regimens(TEGAFOX Sequential S-1 or SOX Sequential S-1 or SOX non-Sequential S-1) for postoperative patients with gastric cancer, observe and record the efficacy and tolerance,to evaluate which regimen is better.


Eligibility Criteria:
Inclusion Criteria:

* 75≧Age≧18
* Histologically or cytologically confirmed gastrointestinal cancer
* Stage Ⅱ or Ⅲ or Ⅳ
* ECOG ≦2
* Accept the gastric cancer radical resection
* Life expectancy of at least three months
* Written informed consent to participate in the trial

Exclusion Criteria:

* History of severe hypersensitivity reactions to the ingredients of S-1\\TF\\5-FU/calcium folinate or oxaliplatin
* Inadequate hematopoietic function which is defined as below:

  * white blood cell (WBC) less than 5x10\^9/L
  * absolute neutrophil count (ANC) less than 2x10\^9/L
  * platelets less than 100\*10\^9/L
* Inadequate hepatic or renal function which is defined as below:

  * serum bilirubin greater than 2 times the upper limit of normal range
  * alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2.5 times the ULN if no demonstrable liver metastases or greater than 5 times the ULN in the presence of liver metastases
  * blood creatinine level greater than 2 times ULN
* Presence of peripheral neuropathy
* Receiving a concomitant treatment with other fluoropyrimidine drug or flucytosine drug
* Women who is pregnant or lactating or fertile women of child-bearing potential unless using a reliable and appropriate contraceptive method throughout the treatment period (Including male)
* Psychiatric disorder or symptom that makes participation of the patient difficult;
* Concomitant illness that might be aggregated by active, non-controlled disease such as congestive heart failure, ischemic heart disease, uncontrolled hypertension or arrhythmia with in six months
* Severe complication(s), e.g., paresis of intestines, ileus, radiographically confirmed interstitial pneumonitis or pulmonary fibrosis, glomerulonephritis ,renal failure, poorly-controlled diabetes
Cytokine Profile of Conjunctivitis, Performed Through Tears Analysis Among Patients Treated With Dupilumab

This study aims to assess the cytokine profile of tears in patients suffering from conjunctivitis versus patients without ocular involvement, when treated with Dupilumab


Eligibility Criteria:
Inclusion Criteria:

* patients with severe atopic dermatitis resistant to main immunosuppressive drugs
* treated with Dupilumab
* with or without conjunctivitis
* postmenopausal women (since minimum 24 months), surgically sterilized women or women on contraception

Exclusion Criteria:

- pregnant or breastfeeding women
Colorectal Cancer Screening Using Stool DNA-based SDC2 Methylation Test

A study of colorectal cancer screening using stool DNA-based SDC2 methylation test


Eligibility Criteria:
Inclusion Criteria:

* Patient who agreed the clinical trial and signed informed consent
* High risk patient for colorectal cancer (family history of colorectal cancer, history of adenomatous polyp excision, inflammatory bowel disease \> 15 years, or history of hereditary colorectal cancer)
* Patient who scheduled to receive colonoscopy
* Stool \> 20g before bowel preparation for colonoscopy

Exclusion Criteria:

* No high risk patient under 60 years
* History of colorectal cancer
* Stool \< 20g or sample after bowel preparation
* Diarrhea or liquid stool which cannot be evaluated
* Patient who is judged as not suitable for clinical trial including a psychiatric disorder by a physician