cyrilzakka/clinical-trials huggingface dataset:
Impact of Oxygen Therapy on Fatigue in Patients With Hypermobile-type Ehlers-Danlos Syndrome

The hypothesis of the OXYSED study is that the delivery of 3 months of oxygen therapy via an oxygen concentrator would reduce fatigue, pain, headaches, kinesiophobia, drug intake, dyspnea, and improve walking performance, quality of sleep and quality of life of patients with Ehlers Danlos syndrome hypermobility type (EDS / HT).


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 18 years;
* Diagnosed with EDS/HT defined by the New York critieria;
* With intense fatigue defined by an FSS ≥ 4;
* Having given free and informed written consent;
* Speaking french language;
* Being affiliated with or benefiting from a social security scheme.

Exclusion Criteria:

* with progressive parenchymal pulmonary pathology (pulmonary fibrosis, post-smoking emphysema);
* having an ongoing pregnancy or breastfeeding;
* who have already received oxygen therapy for the EDS / HT indication in the last 6 months;
* having a pathology that causes fatigue, which is not compensated or treated; non-exhaustive list anemia, sleep apnea syndrome, psychiatric pathologies including severe depression, organ failure (cardiac, renal, respiratory, hepatic), endocrinopathies (hypo or hyperthyroidism, diabetes), nutritional deficiencies;
* Subject to a measure for the protection of justice.
Comparing of the Pharmacokinetic, Safety and Pharmacodynamic of QL1206 and Xgeva® in Healthy Adults

A randomized, double-blind and parallel group study to compare the pharmacokinetic, safety and pharmacodynamic of QL1206 and Xgeva® in healthy adults.

This is a phase I,single center, randomized, double-blind and parallel group clinical trial .

The primary objective is to assess the pharmacokinetic similarity of single and subcutaneous injections of QL1206 or Xgeva® in healthy volunteers.

The secondary objective are to assess the Clinical safety and immunogenicity similarity of single and subcutaneous injections of QL1206 or Xgeva® in healthy volunteers.

Meanwhile，observing the pharmacodynamic similarities of QL1206 or Xgeva® preliminarily.

Subjects would receive a single 120mg（1.7ml） of QL1206 or through subcutaneous injection.

Eligibility Criteria:
Inclusion Criteria:

* Sign the informed consent form and fully understand the test content, process and possible adverse reactions, and be able to complete the study according to the test plan requirements;
* Aged ≥18 years or ≤50 years, male or female (including the boundary value);
* Agree to take effective contraceptive measures throughout the study period (including not limited to: hormonal drugs of pregnancy, physical contraception, surgery, abstinence, etc., until at least 6 months after the last study is administered;
* Clinical laboratory examination, chest X-ray, abdominal B-ultrasound, electrocardiogram, physical examination, vital signs and various examinations are normal or abnormal without clinical significance.

Exclusion Criteria:

* Occurred or suffering from osteomyelitis or ONJ (mandibular necrosis) previously.
* Serum calcium levels are outside the normal range of the laboratory, or the subject uses calcium supplements in the screening period.
* The dental or jaw disease that is active, requiring oral surgery; or planned for invasive dental surgery during the study; or dental or oral surgery wounds have not healed;
* Subject has viral hepatitis (including hepatitis B and hepatitis C), AIDS antibodies, and Treponema pallidum antibodies;
Effectiveness of an Individualized Program of Muscular Strength and Endurance Program for Improving Germ Cell Cancer

Background: Patients with testicular germ cell cancer (GCC) have a high cure rate, however impaired muscle function and fatigue are the most common complications among patients with GCC undergoing treatment with chemotherapy. Although exercise is widely recommended, information about physiopathological effects of cancer therapy in skeletal muscle is very limited.

Methods/Design: The present study is a randomized controlled trial comparing an individualized program of muscular strength and endurance with aerobic training compared to a control group. All variables will be measured at the beginning and at the end of a 8-week intervention by the same evaluator, who will hide the disposition of participants to each group. Besides, it will be monitoring during de following 6 months (24 weeks) after training for all outcome variables.

Background: Patients with testicular germ cell cancer (GCC) have a high cure rate, however impaired muscle function and fatigue are the most common complications among patients with GCC undergoing treatment with chemotherapy. Although exercise is widely recommended, information about physiopathological effects of cancer therapy in skeletal muscle is very limited. Our aim is to evaluate the effects of an individualized exercise program with aerobic training in water running on cancer-related fatigue.

Methods/Design: The present study is a randomized controlled trial comparing an individualized program of muscular strength and endurance with aerobic training compared to a control group. The investigators will conduct this trial in patients undergoing chemotherapy, recruited by the Departament of Oncology of Virgen de la Victoria Hospital (Málaga). Patients will be included and evaluated before the first cycle of chemotherapy and assigned experimental or control group randomly. All variables will be measured at the beginning and at the end of a 8-week intervention by the same evaluator, who will hide the disposition of participants to each group. Besides, it will be monitoring during de following 6 months (24 weeks) after training for all outcome variables.

Eligibility Criteria:
Inclusion Criteria:

* Patients programmed to chemotherapy

Exclusion Criteria:

-
The Impact of Preoperative FoodforCare at Home

Preoperative nutritional state is closely related to perioperative morbidity and complications. This study aims to determine the effect of a protein-rich meal service in the preoperative setting compared to usual care.

Each year, approximately 1.4 million patients in the Netherlands are operated. Adequate nutritional intake, mainly protein intake, before surgery is important to improve preoperative muscle strength and functional capacity. However, up to 40% of patients admitted to the hospital suffer from malnutrition and this further deepened during hospitalization, which is an independent risk factor for peri-operative morbidity and severe complications, ranging from increased muscle loss, to higher infection rates, delayed wound healing and subsequently a prolonged hospital stay. An adequate food service is one strategy to improve protein intake and thereby the nutritional status. Extension of the study period to the out-of-hospital setting is recommended to explore the effects of long-term exposure to this concept on nutritional, functional and clinical outcomes. Therefore, the investigators aim to evaluate whether home delivered protein-rich meals, as part of FoodforCare meal service, in the preoperative setting improves protein intake in patients undergoing surgery, compared to usual care. The second aim is to investigate the effects on functional and clinical outcomes.

Eligibility Criteria:
Inclusion criteria:

* 18 years or older
* surgical patients
* living within a 40 km radius around Nijmegen/Veghel
* inclusion at least 4 weeks before surgery
* surgery: Urology, Orthopedics, Gynaecology, General Surgery
* oral intake

Exclusion criteria:

* renal insufficiency (MDRD-GFR (glomerular filtration rate) \< 60ml/min and/or proteinuria)\*
* food allergy
* planned vacation during intervention period

  * proteinuria is defined in case of a protein creatinine ratio \> 0.5g/10mmol or an albuminuria \> 300mg/day.
Efficacy of Closed-loop Insulin Therapy in Prepubertal Child in Free-life

The study is a randomized trial preceded by a run-in period and followed by a non-randomized study extension. After 3 weeks of outpatient use of study pump (1 week) and study pump+CGM (2weeks) as run-in period, patient and parents will be admitted for 4-hour training to closed-loop (AP) mode. Following randomization (1:1), patient will be allocated to '24-hour' use of AP or 'dinner and overnight AP mode/day time pump and CGM use' for the next 18-week period. At 18-week visit, a study extension for a further 18-week period will be initiated. AP mode that will be prescribed to all patients will depend from an independent DSMB decision based upon study safety data collected after 6 and 12 weeks from the first 30 included patients. Visits will occur at week 27 (safety follow-up) and 36 (final visit).

The study is a randomized trial preceded by a run-in period and followed by a non-randomized study extension. After 3 weeks of outpatient use of study pump (1 week) and study pump+CGM (2weeks) as run-in period, patient and parents will be admitted for 4-hour training to closed-loop (AP) mode. Following randomization (1:1), patient will be allocated to '24-hour' use of AP or 'dinner and overnight AP mode/day time pump and CGM use' for the next 18-week period. A hotline phone number will be given to the patient and parents so that they can contact the study staff as needed. A logbook will be provided to collect details about hypoglycemic and hyperglycemic episodes, physical activity and noticeable events. Phone calls will be scheduled between investigator and patient+parents 48 hours, 1 week and 2 weeks after AP mode initiation. Potential misbehaviors will be corrected and all questions answered. If needed, AP parameters may be revised and reconfigured. Hospital visits will be scheduled 6, 12 and 18 weeks after AP mode initiation for the same purposes, plus HbA1c measurement at week 12 and 18. At 18-week visit, a study extension for a further 18-week period will be initiated. AP mode that will be prescribed to all patients will depend from an independent DSMB decision based upon study safety data collected after 6 and 12 weeks from the first 30 included patients. Visits will occur at week 27 (safety follow-up) and 36 (final visit).

Eligibility Criteria:
Inclusion Criteria:

* Treatment of diabetes by insulin pump since \> 6 months
* HbA1c level \< 10%

Exclusion Criteria:

* Unwillingness of one parent or the legally responsible party to participate in insulin treatment
* Any associated chronic disease or therapy (except insulin) affecting glucose metabolism
Detection of Lipoarabinomannan in Urine Evaluation of the STANDARDTMF TBLAMFIA and Its Impact on the Initial TB Diagnosis

Evaluation of the performance of an in vitro test, the STANDARDTM F TB LAM Ag FIA (SD BIOSENSOR, INC.) for the early diagnosis of tuberculosis (TB) infection. This test is for in vitro professional diagnostic use and intended as an aid to early diagnosis of tuberculosis infection. The test will be used according to the instructions for use (IFU).

STANDARDTM F TB LAM Ag FIA is a fluorescent immunoassay which detects lipoarabinomannan in human urine sample. The test evaluated in this study may provide benefits for the development of non sputum-based, less invasive tuberculosis diagnostics that include easier to collect biological samples. The study can therefore be relevant for updating WHO guidelines for TB diagnosis. The results of the STANDARDTM F TB LAM Ag FIA will be interpreted according to the manufacturer´s instructions and will be compared to the results of the test performed to confirm the pulmonary TB, the extrapulmonary TB or the pulmonary NTM diagnosis (intention to treat assay). The test will be repeted at the end of the anti-TB therapy to evaluate if the test can be used as marker of treatment response. Healthy subjects without exposure or risk for TB factors will serve as a proxy for specificity; subjects with confirmed TB will serve as control group to estimate sensitivity.

Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria for PTB, PNTM and extraPTB:

* Adult subjects with documented active pulmonary TB, pulmonary NTM or extrapulmonary TB
* Subjects who have signed informed consent
* Aged ≥18 years

Inclusion criteria for HC:

* healthy donors who have signed informed consent
* aged ≥ 18 years
* no TB or NTM risk factors or exposure

Exclusion Criteria:

Exclusion criteria for PTB, PNTM and extraPTB:

* Do not have active pulmonary TB, NTM or extrapulmonary TB
* Do not sign the informed consent
* Are aged \< 18 years

Exclusion criteria for HC:

* Have active pulmonary TB or NTM
* Do not sign the informed consent
* Are aged \< 18 years
PRP in Intracytoplasmic Sperm Injection

Infertility is a major problem nowadays

ovarian and uterine factor of infertility are very hard to treat

Eligibility Criteria:
Inclusion Criteria:

* women with primary infertility

Exclusion Criteria:

* women with unexplained infertility
Platelet-rich Fibrin on Nerve Regeneration After Bilateral Sagittal Split Osteotomy

Patients who have mandibular deformity and will undergo bilateral sagittal split osteotomy will be included in the study.One side of the osteotomies randomly will be considered as study group and another side as a control group.In the study group , platelet rich fibrin will be placed after osteotomy and before rigid fixation.In the control group, fixation will be done without Platelet-rich Fibrin (PRF).Neurosensory disturbance will be evaluated 6 and 12 months after surgeries.

Patients who have mandibular deformity and will undergo bilateral sagittal split osteotomy will be included in the study.One side of the osteotomies randomly will be considered as study group and another side as a control group.In the study group , platelet rich fibrin will be placed after osteotomy and before rigid fixation.In the control group fixation will be done without Platelet-rich Fibrin. Before starting the surgical procedure, 20 mL of venous blood will take and placed in a centrifuge for 12 minutes with 28000rpm. After centrifugation, the cap will be removed from each tube and they will be placed into a sterile rack L-PRF™. Fibrin matrix will prepare. The L-PRF™ will be removed from the tube. Then, the clot right beneath the red blood cell clot will be placed on the surface tray and covered. Five minutes will be waited before removing and using the fibrin matrix.Neurosensory disturbance will be evaluated in 6 and 12 months after osteotomies by two-point discrimination (TPD) test and pin tactile discrimination(PTD) tests.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have class II or III deformity and will undergo bilateral sagittal split osteotomy

Exclusion Criteria:

* Patients who have bad split or obvious nerve injury during surgery will be removed from study inclusion
Princess® VOLUME Lidocaine for the Correction of Nasolabial Folds

In this study, eligible subjects with moderate to severe nasolabial folds will be treated with Princess® VOLUME Lidocaine and will return for follow-up assessments 2, 4, 24 and 36 weeks after the treatment. A Touch-up treatment may be done at Week 2, if deemed appropriate by the investigator.


Eligibility Criteria:
Inclusion Criteria:

* Male or female 18 years of age or older
* Presence of two fully visible, approximately symmetrical nasolabial folds, with each of the folds, scored 2-3 according to the 5-grade Nasolabial Folds Severity Rating Scale
* Healthy skin in the facial area and free of diseases that could interfere in cutaneous aging evaluation
* Willingness to abstain from any aesthetic or surgical procedures in the treatment area for the duration of the clinical investigation
* Written signed and dated informed consent

Exclusion Criteria:

* Pregnancy, lactation, planned pregnancy or unwillingness to use contraception at any time during the study (for women of child-bearing potential only)
* History of allergic reaction or hypersensitivity to hyaluronic acid, lidocaine, or any amide-based anesthetic
* Presence of silicone implant or another non-absorbable substance (permanent fillers) in the nasolabial region
* Presence of infectious, inflammatory, or proliferative lesions in the nasolabial region
* Cutaneous lesions in the treatment area
* History or presence of any autoimmune or connective tissue disease, or current treatment with immune therapy
* Use of anticoagulant, antiplatelet or thrombolytic medication
* Any medical condition which, in the investigator's opinion, prohibits the inclusion in the study
Evaluation of a Primary Care Based Heart Failure Management Program

Evaluation of a primary care based (family physicians) HF management strategy in patients with heart failure in the community

Cluster randomized clinical trial (family physician is cluster) evaluating a primary care based heart failure management strategy

Eligibility Criteria:
Inclusion Criteria:

1. Men and women, age more or equal to 65 years AND
2. Diagnosis of HF confirmed with the following criteria:

   1. Previous hospital admission for HF OR
   2. Definite HF confirmed with the Boston HF criteria OR
   3. Possible HF confirmed with the Boston HF criteria AND evidence of left ventricular systolic dysfunction (left ventricular ejection function \<40%) on echocardiography, radionuclide angiography, or left ventricular angiogram documented in the patient's family physicians clinic chart.

Exclusion Criteria:

1. Patients with terminal illness (e.g. cancer) with a life expectancy of less than one year.
2. Patients in a long-term-care facility with nursing care.
3. Patients awaiting cardiac surgery for correctable causes of HF (e.g., severe valvular disease or extensive ischemia) during the study period.
4. Patients expected to be away from the country during the intervention period for a duration of \>3 months.
5. Patients unable or refusing to sign consent.
6. Patients currently followed in the Hamilton Health Sciences HF clinic. These patients are excluded as they are currently enrolled in a HF disease management strategy.
7. Patients currently enrolled in another clinical trial.
A Study to Compare Oral Absorption of YM060 Between Orally-disintegrating Tablet and Conventional Tablet Under With Water Intake

A study to compare time-course changes of plasma concentration of YM060 orally-disintegrating tablet with those of conventional tablet. Tablets will be administered with water.


Eligibility Criteria:
Inclusion Criteria:

* healthy assessed by the principal investigator or sub-investigators
* non-smoking or stop smoking at least 90 days before the study
* body weight: over 50.0kg and less than 80.0kg
* body mass index (BMI): over 17.6 and less than 26.4

Exclusion Criteria:

* participated in another clinical trial (including a post-marketing clinical study) within 120 days before the study
* donated 400mL of whole blood within 90 days, 200mL of whole blood within 30 days or blood components within 14 days before the study
* received any drugs within 7 days before the study or going to receive any drugs
* deviance from normal range in vital signs (blood pressure, pulse rate, and body temperature) or 12-lead ECG
* deviance from normal range in lab-tests
* history of drug allergy
* history or current diagnosis of stomach, small intestine or large intestine diseases
* history or current diagnosis of inflammatory bowel disease (Crohn's disease or colitis ulcerative)
* history or current diagnosis of colitis ischemic
* history or current diagnosis of hepatic diseases
* history or current diagnosis of cardiovascular diseases
* history or current diagnosis of respiratory diseases
* history or current diagnosis of malignant tumor
* received ramosetron tablet
Clinical Trial Comparing Epidurals and Local Anaesthetic Wound Catheters in Patients Having Bowel Surgery

The purpose of this study is to find out whether the use of Painbuster® (a local anaesthetic wound catheter) can be used instead of epidurals for patients having bowel surgery in an enhanced recovery programme. The investigators want to find out whether or not using this device means people need to stay in hospital for less time after surgery.


Eligibility Criteria:
Inclusion Criteria:

* All patients who are undergoing either laparoscopic or open colorectal resection will be considered eligible for the study.

Exclusion Criteria:

* Patients under 18 years of age
* Pregnant females
* Patients undergoing an abdominoperineal resection
* Patients unable to understand English
Treatment of Mild to Moderate Joint Pain in Patients With Chronic Plaque Psoriasis Receiving Efalizumab

The purpose of this study is to evaluate tolerability and effectiveness of conventional treatment for mild to moderate arthritic or arthralgic symptoms while subjects are being treated with efalizumab for psoriasis.

The study objective is to demonstrate that mild to moderate arthritis or arthralgia may be controlled using conventional therapy while being treated with efalizumab, without loss of efficacy.

Eligibility Criteria:
Inclusion Criteria:

* Females cannot become pregnant while participating in study.
* Have a history of plaque psoriasis for at least 6 months.
* Receiving or about to receive efalizumab for the treatment of chronic plaque psoriasis.
* Have mild to moderate arthritis or arthralgia occurring while on treatment with efalizumab or untreated mild to moderate arthritis or arthralgia present at the time of initiating treatment with efalizumab.

Exclusion Criteria:

* Previous systemic treatment with biologics other than efalizumab, within 3 months.
* Treatment with any systemic corticosteroids or intra-articular corticosteroid injection, cyclosporine or methotrexate within 28 days.
* Any previous treatment with chlorambucil or cyclophosphamide.
* Have active tuberculosis or are currently receiving treatment or prophylactic therapy for tuberculosis.
* Have other serious disorders; such as, congestive heart failure, prior or current history of blood dyscrasia, or central nervous system demyelinating disorders.
* Has a sensitivity, intolerance, or history of gastrointestinal bleeding associated with diclofenac, indomethacin, and/or ibuprofen.
Effect of Addition of Dronedarone to Standard Rate Control Therapy on Ventricular Rate During Persistent Atrial Fibrillation (AFRODITE)

The primary objective of this study is to:

Assess whether the addition of dronedarone to existing conventional rate control therapy leads to a reduced ventricular rate after 1 week in patients with a high Heart Rate (HR) at rest during Atrial Fibrillation (AF) in comparison to an increase of conventional therapy.

The secondary objectives of this study are to compare both study arms with regard to:

* Ventricular rate after 3 months
* Number of registered AF episodes
* Number of symptomatic AF episodes
* Severity of AF and AF-like symptoms
* Rate of premature study discontinuation
* Number of symptomatic episodes of bradycardia
* Incidence of low heart rate (\<60 bpm)


Eligibility Criteria:
Inclusion Criteria:

* Persistent AF with HR \>80 bpm at rest despite treatment with ≤ 2 rate control agents (i.e. beta blocker and/or calcium antagonist - Patients using digoxin are eligible)
* Documented AF in the past 24 hours
* Treated with the following rate control medication:
* beta blocker or
* calcium antagonist or
* beta blocker plus calcium antagonist or
* beta blocker plus digoxin or
* calcium antagonist plus digoxin
* Anticoagulant treatment in line with local guidelines

Exclusion Criteria:

* Incapacitated patients
* Paroxysmal or permanent AF
* Use of class I or III anti-arrhythmic drugs in the past 12 weeks
* Scheduled cardioversion or pulmonary vein ablation
* Unstable New York Heart Association (NYHA) class III and all class IV Heart Failure
* AV block grade 2 or 3
* Known severe renal impairment (serum creatinine \> 180 μmol/l)
* Known severe hepatic impairment (AST, ALT \> 3 x Upper Limit of Normal (ULN))
* Contra-indication for dronedarone
* Participation in a clinical drug study in the 3 months prior to inclusion
* Women of childbearing potential, who do not use adequate contraception
* Lactating women

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.