cyrilzakka/clinical-trials huggingface dataset:
Exercise and Two Different Kinesiotape Applications in Patients With Sacroiliac Joint Dysfunction

This study is a randomized controlled study. 99 patients between the ages of 18-65 who were diagnosed with sacroiliac joint dysfunction will be included in the study.

33 patients will be given a home exercise program that strengthens the waist and hip girdle (to be shown once in the hospital by a physiotherapist and the form of the exercises will be given), 33 patients will be given kinesiotaping (KT) with ligament correction technique with the exercise program, and 33 patients will be given kinesiotaping with lymphatic correction technique with the exercise program. Patients will do the exercises once a day for 1 month. KT will be repeated once a week for 3 weeks. When taping is performed, it will be kept for 5 days.The patients' pain at rest and during movement will be measured using the Visuel Analog Scale (VAS). Patient Global Assessment and Oswestry Disability Index (ODI) will be questioned. Evaluations will be performed before, 4th week and 1 month after treatment (8th week).

Eligibility Criteria:
Inclusion Criteria:

* Patients with sacroiliac joint dysfunction between the ages of 18-65

Exclusion Criteria:

* Patients with rheumatological inflammatory disease
* Inflamatory sacroiliitis
* Patients with polyarthrosis, herniated disc, severe symptomatic disc degeneration, spinal stenosis and spondyloarthrosis.
* Patients with a history of pelvic trauma
* Patients with metabolic bone disease, infection, malignancy, pregnancy
* Patients with open wounds in the lumbar and sacral area
The Preventive Role of Fractionated Laser Resurfacing Against Actinic Neoplasia in an At-Risk Geriatric Population

The purpose of this study is to determine if the Fractionated Laser Resurfacing (FLR) procedure can protect one forearm/wrist from precancerous actinic keratosis (AKs) as well as prevent skin cancer in older subjects with active AKs. This study builds on a similar study ongoing at the Dayton Veterans Administration dermatology clinic. This study is also testing if a photograph of the skin can be used to predict where the AKs and an skin cancers will form.


Eligibility Criteria:
Inclusion Criteria:

* Adult Males and Females aged 60 and older
* Have at least 5 AKs on each forearm/wrist, but no more than 10 to allow for easy monitoring
* Skin type fair (Fitzpatrick I-II)
* Females must be post-menopausal and not be on systemic hormone replacement therapy
* Able to comprehend procedures and risks

Exclusion Criteria:

* More than 10 AKs on an extremity
* AKs that are large (2-3+, hyperkeratotic grade 3 lesions)
* AKs that are very thick (\>3 mm)
* Medical history of diabetes
* History of poor wound healing or scarring
* Large tattoos that can interfere with study
* Other serious health issues and other skin diseases that could interfere with the study
* Recent (within 1 year) field therapies such as efudex cream or PDT to forearms/wrists.
* Planning to leave region in next 5 years
* Subjects with allergies to xylocaine will be excluded if they need this topical anesthetic.
Impact of the COVID-19 Epidemic on Glycemic Balance and the Level of Stress in Diabetic Patients

Prospective, non-interventional, multicentric study

The rapid spread of the COVID-19 pandemic and the isolation at home implemented in France, creates unprecedented challenges for diabetic patients.

Patients with diabetes have been considered to be at higher risk of infection by the virus, with a greater risk of mortality; this has been a great source of anxiety for them.

It is well known that stress has an impact on plasma glucose levels. The French situation where a general confinement has been decreed over the whole territory (which is not the case for all countries) and for a period of two months, makes it possible to study the impact of this unique situation on stress, sedentary lifestyle, changes in diet and decrease in physical activity. There are no similar experiences described in the literature.

The investigators hypothesize there will be an increase of HbA1c in the coming months.

The main objective is to assess changes in glycemic control in diabetic patients after the confinement period.

The secondary objectives are to:

* Evaluate the prevalence of a state of psychological distress (which could be described as post-traumatic) following this epidemic situation in a population of patients with diabetes and to determine the main characteristics of patients with such a state of psychological distress.
* Study the evolution of the psychological state at a distance from confinement (6 months later) with the same questionnaire.
* Analyze characteristics of lifestyle during confinement: food (snacking), frequency of leaving home, sleep disorders and assess a possible association with variations in HbA1c.

This is an observational, prospective, multicenter study. Participation in the study will be offered to all consecutive patients seen in Diabetes consultations, who meet the selection criteria.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient (≥ 18 years old)
* Diabetic patient (type 1 or type 2) regardless of their diabetes treatment who experienced complete confinement in their own home, in France.
* Patients who had a measured HbA1 or an estimated HbA1c with a glucose sensor Freestyle libre with a known result, between November 1, 2019 and February 29, 2020.
* Patients agreeing to have their HbA1c measured between May 15 and July 31, 2020.
* Having been informed of the study and not objecting to participating in it

Exclusion Criteria:

- Adults over the age of legal protection (safeguard of justice, curatorship, guardianship), persons deprived of their liberty.
ClosureFAST - Radiofrequency Great Saphenous Vein Treatment

The purpose of this study is to confirm that the ClosureFAST system can be used as an alternative to the current ClosurePlus catheter for treating the GSV and to accumulate pivotal data for optimization of the operating parameters.

The purpose of this study is to confirm that the ClosureFAST system can be used as an alternative to the current ClosurePlus catheter for treating the GSV and to accumulate pivotal data for optimization of the operating parameters. The results from this study will be used to further evaluate the risks and benefits of the ClosureFAST device and to obtain clinical evidence that the treatment provides effective and durable clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 80 years of age at the time of enrollment
* Symptomatic lower limb venous disease involving the GSV

Exclusion Criteria:

* Thrombosis in the vein segment to be treated
* Known or suspected pregnancy or actively breast feeding at time of treatment
Activity of Mefloquine Against Urinary Schistosomiasis

Urinary schistosomiasis is a debilitating disease in Central Africa and pregnant women are frequently suffering from this condition. Mefloquine is currently investigated as preventive treatment against malaria in pregnancy and mefloquine is also known to exert activity against schistosomiasis. The investigators want to test the hypothesis whether mefloquine may active against urinary schistosomiasis when used as preventive treatment against malaria in pregnancy.

Objectives

The principal aim of this clinical trial is to evaluate whether mefloquine - when given as intermittent preventive treatment against malaria in pregnancy - shows in vivo activity against concomitant Schistosoma haematobium infection. This study is therefore a "proof of principle" study and is not intended to establish a clinically satisfying cure rate or to formally compare the efficacy of mefloquine with the standard therapy.

Hypothesis

Two underlying hypotheses have been formulated for this proof of principle study.

Primary hypothesis: Mefloquine reduces egg excretion of Schistosoma haematobium by 50% compared to sulfadoxine/pyrimethamine (S/P) treatment when given as IPTp Secondary hypothesis: Mefloquine may lead to an adequate cure rates of Schistosoma haematobium infections compared to S/P (\>80%)

Trial Design

The evaluation of mefloquine activity against S. haematobium will be evaluated in the course of an open label multicenter randomized controlled trial assessing the efficacy, tolerability, and safety of mefloquine IPTp against malaria. This study is therefore a nested randomized controlled trial taking advantage of the randomization and treatment allocation procedures of the IPTp trial and assessing the additional efficacy outcome of reduction of S. haematobium egg excretion.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women after first trimester and before 28th week of pregnancy
* HIV negative
* Egg excretion of Schistosoma haematobium (mean \>10 eggs per mL urine)
* Asymptomatic (no signs of complicated Schistosomiasis, no severe anemia)
* Ability to comply with study protocol

Exclusion Criteria:

* Intake of anthelminthic or antimalarial drug within 2 months prior to inclusion
* Allergy to study drugs
Evaluation of the Omnipod DASH in Children and Adolescents With Type 1 Diabetes Mellitus

In this study the usability of the Omnipod DASH insulin administration system is evaluated prospectively by two questionnaires. The effect on the metabolic control is evaluated retrospectively by analysis of data from the medical records of the patients.

In the study the usability of the Omnipod DASH (= insulin patch pump) is evaluated prospectively by two questionnaires. The first questionnaire concerns practical items on the application of the pump (e.g. Is it easy to fill to pod?), the wearing of the pump (e.g. Is it comfortable to wear the pump?) and the comparison with insulin administration with insulin pens or other insulin pumps (e.g. is it less painful to administrate insulin by the Omnipod DASH pump). The second questionnaire asks for possible problems that the patients experienced during the wearing of the pump (e.g. did you experience an allergic skin reaction). The questions are formulated to be answered by a 5-point likert scale.

The metabolic control is studied retrospectively from data extracted from the medical records, i.e. the results of the determination of HbA1c and the results from continuous glucose monitoring (CGM) at the start, and after 2, 4 and 6 months of the wearing of the Omnipod DASH insulin pump.

Eligibility Criteria:
Inclusion Criteria:

* Children and adolescents with type 1 diabetes mellitus
* Patients who started in 2021 with the Omnipod DASH insulin administration system in the Jessa Hospital

Exclusion Criteria:

* Children and adolescents without type 1 diabetes mellitus
* Children and adolescents with type 1 diabetes treated with insulin pens or other insulin pumps
Prospective Clinical Analysis of Ultrasound-guided Biceps Corticosteroid Injections

Using randomization, prospectively determine superiority of either ultrasound-guided or landmark-guided biceps corticosteroid injections with regard to various clinical variables.

Patients are diagnosed with biceps tendinitis in the outpatient clinic. After diagnosis, all the patients that meet inclusion/exclusion criteria will be offered to enroll in the study. Study will be described to the patient with regard to protocol and consent. All questions regarding the study will be answered, and it will be explicitly described that the study involvement will not change clinical care. It will be explained that investigators expect a follow up appointment at minimum at three weeks and three months. There may be further follow up requested up to 1 year from enrollment.

After collection of informed consent, the patient will be randomized to either ultrasound-guided or landmark-guided injection. The patient will complete clinical scores at the initial visit prior to the injection. After injection, the patient will have follow up scheduled for three weeks and three months. To ensure patient blinding, an ultrasound will be placed on the patient for both groups, but only active imaging with be performed for the ultrasound-guided patient group. For clinician blinding, a different clinician than the injecting clinician will perform the follow up examinations. The patient is instructed to not seek additional injections or physical therapy during the study.

Eligibility Criteria:
Inclusion Criteria:

* Pain at intertubercular groove
* Anterior humeral pain
* Positive Speed's Test
* Bicep's tendinitis is primary diagnosis for patient
* Patient agrees to follow up and consent

Exclusion Criteria:

* Prior biceps surgery or injections
* Prior SLAP or labral repair
* Concomitant shoulder arthroplasty
MCID in 30 STS Test After PR in COPD Patients

The sit-to-stand test (STST) is a feasible alternative for measuring peripheral muscle strength of the lower limbs.

Our aim was to evaluate, in Chronic Obstructive Pulmonary Disease (COPD) patients, the minimal clinically important difference (MCID) of 30-second STST (30-STST) after pulmonary rehabilitation (PR).

Stable COPD inpatients undergoing 30-STST and 6-minute walk test (6MWT) before and after PR were included. Responsiveness to PR was determined by pre-to-post PR (Δ) evaluation of 30-STST. The MCID was evaluated using an anchor-based method.

The sit-to-stand test (STST) is a feasible alternative for measuring peripheral muscle strength of the lower limbs used as standard test at the beginning and at the end of pulmonary rehabilitation programme.

Our aim was to retrospectively evaluate, in Chronic Obstructive Pulmonary Disease (COPD) patients, the minimal clinically important difference (MCID) of 30-second STST (30-STST) after pulmonary rehabilitation (PR).

Stable COPD inpatients undergoing 30-STST and 6-minute walk test (6MWT) before and after PR were included. Responsiveness to PR was determined by pre-to-post PR (Δ) evaluation of 30-STST. The MCID was evaluated using an anchor-based method.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis for COPD according to the GOLD criteria.
* no exacerbations over the previous four weeks

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* completing PR program
* smoking history ≥10 pack years
* regular treatment with inhaled bronchodilators and inhaled steroids

Exclusion Criteria:

* any unstable medical condition
* Contraindications for participation in the PR program included musculoskeletal disorders, malignant diseases, unstable cardiac condition, and lack of adherence to the program -
Desvenlafaxine for Treatment of Hot Flashes in Women With Breast Cancer Taking Tamoxifen

This study is a randomized, placebo-controlled study of desvenlafaxine versus placebo. The purpose of this study is to determine if desvenlafaxine was effective in decreasing the frequency and severity of hot flashes in breast cancer patients taking tamoxifen.


Eligibility Criteria:
Inclusion Criteria:

i. Women age 18 years and older with localized breast cancer. Histologic documentation of atypical ductal hyperplasia, ductal carcinoma in situ (DCIS), lobular carcinoma in situ (LCIS), or invasive adenocarcinoma of the breast stages I-III A.

ii. Current daily tamoxifen use (≥ 6 days/week). Any planned surgery, adjuvant chemotherapy or radiation must have been completed.

iii. History of bothersome hot flushes: ≥ 14 hot flushes/week (average ≥ 2 hot flushes/day), sufficiently severe that intervention is desired. Participants must have had bothersome hot flushes for at least one month prior to enrollment.

Exclusion Criteria:

i. Women who is pregnant or breast feeding, or who has a history of seizure disorder or hepatic or renal insufficiency ii. Concurrent systemic hormone replacement therapy (estrogen, progestational agents, androgens) or use of corticosteroids iii. Concurrent use of other antidepressants, anxiolytics and antipsychotics, gabapentin, pregabalin and clonidine for treatment of hot flushes or depression.

iv. Presense or past history of severe psychiatric symptoms such as hallucinations and delusions, manic episodes, or high suicide risk.
Intensity Training and Cardiovascular Health in Colombian Adults

Several studies have shown relationship between exercise intensity and improvement cardiometabolic health. It has been suggested that high intensity interval training and also moderate training generate positive effects on metabolic risk factors. For these reasons, it is necessary to clarify which type of training, is more effective to improve cardiometabolic health in latinamerican population.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent.
* Interested in improving health and fitness.

Exclusion Criteria:

* Systemic infections.
* Weight loss or gain of \>10% of body weight in the past 6 months for any reason.
* Currently taking medication that suppresses or stimulates appetite.
* Uncontrolled hypertension: systolic blood pressure 160 mm Hg or diastolic blood pressure 95 mm Hg on treatment.
* Gastrointestinal disease, including self-reported chronic hepatitis or cirrhosis, any episode of alcoholic hepatitis or alcoholic pancreatitis within past year inflammatory bowel disease requiring treatment in the past year, recent or significant abdominal surgery (e.g., gastrectomy).
* Asthma.
* Diagnosed diabetes (type 1 or 2), fasting impaired glucose tolerance (blood glucose 118 mg/dL), or use of any anti-diabetic medications.
* Currently taking antidepressant, steroid, or thyroid medication, unless dosage is stable (no change for 6 months).
* Any active use of illegal or illicit drugs.
* Current exerciser (\>30 min organized exercise per week).
* Indication of unsuitability of current health for exercise protocol (PARQ).
* Any other conditions which, in opinion of the investigators, would adversely affect the conduct of the trial.
Effectiveness of the Geriatric Activation Program Pellenberg (GAPP) on the Geriatric Rehabilitation Ward

The aim of this study is to investigate the effectiveness of our developed week-treatment program GAPP, on strength, balance, speed, functionality and cognition, with the main goal to achieve a better independence for activities of daily living (ADL).

Each day of the week an exercise program of 45 minutes is given assigned to a specific aspect of the rehabilitation; strength, balance, speed, functional training and one day is for testing or group therapy.

Participants will be followed for four weeks, with testing on day one, after two weeks and at the last day of the four-week program.

The aim of this study is to investigate the effectiveness of our developed week-treatment program GAPP (Geriatric Activation Program Pellenberg), on strength, balance, speed, functionality and cognition, with the main goal to achieve a better independence for ADL.

Each day of the week an exercise program of 45 minutes is given assigned to a specific aspect of the rehabilitation.

Monday: speed and coordination, including as many repetitions as possible in one minute for: quick arm movements in standing, quick trunk movements in sitting, quick weight transfers in standing, stepping.

Tuesday: functional training, including walking stairs, transfers, sitting to lying and reverse, moving objects in the room, functional fit-o-meter.

Wednesday: balance, including maximum weight transfers in all directions, exercises with reduced base of support, reaching.

Thursday: strength, including sit to stand with a weight belt, lifting a weight bimanual of the table, walking with ankle weights, arm extension with therapy bands.

Friday: testing or group activity. One week the following test will be taken: Berg Balance Scale, 10m walking test, Digit Symbol Substitution Test, knee extension and elbow extension strength with the microfet2, Basic-ADL and Geriatric Depression Scale.

The other week there will be a group session, this could be in sitting (like moving on music) or standing (like petanque).

Walking will be practiced every day of the week and individual needs (like specific hand rehabilitation or pain problems) will be addressed besides the program when needed.

Eligibility Criteria:
Inclusion Criteria:

* admitted to the geriatric rehabilitation ward of UZ Leuven, campus Pellenberg
* the ability to walk 10m with help of a person or walking aid
* an expected stay of at least four weeks
* a signed informed consent

Exclusion Criteria:

* medically instable
* not able to understand the questions and tasks of the program or testing
Sitagliptin for the Treatment of Type 2 Diabetes

Patients newly diagnosed with T2D will be recruited and will receive sitagliptin treatment for 3 months. The gut microbiome of the participants before and after the treatment and the effectiveness of sitagliptin treatment on type 2 diabetes will be evaluated.

The dipeptidyl peptidase-4 inhibitor sitagliptin is a classic anti-diabetic drug(1) and is widely applied to both scientific research and clinical trial(2-6). This clinical trial aims to study the effectiveness of sitagliptin treatment in T2D patients and related change of gut microbiome. 50 Patients newly diagnosed with T2D will be recruited. With patient's informed consent, patient-related vital signs (such as age, height, weight, body mass index), laboratory indicators (including glycated hemoglobin, glycated albumin, low-density lipoprotein, total cholesterol, triglycerides), fasting blood glucose, insulin levels and Insulin resistance index (HOMA-IR)(7) will be recorded and analyzed. The feces of the patients will be collected to analyze the gut microbiome. All of the patients will receive the sitagliptin treatment for 3 months. The gut microbiome of the patients and the effectiveness of sitagliptin treatment on diabetes will be evaluated at indicated times during follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18-65 years old newly diagnosed with type 2 diabetes
* HbA1c ≥ 7%

Exclusion Criteria:

* The positive of diabetes antibodies
* Anti-diabetic drugs therapy before participation
* Pancreatitis
* Coronary artery disease
* Liver function impairment
* Renal function impairment
* History of intestinal surgery
* Chronic hypoxic diseases (emphysema and cor pulmonale)
* Infectious disease
* Hematological disease
* Systemic inflammatory disease
* Cancer
* Pregnant
* Ingesting agents known to influence glucose or lipid metabolism;
* Any antibiotics or probiotics in the past three months prior to the study.
Transcranial Doppler and Quantitative Pupillometry as Neurological Prognostic Factors in Brain Damaged Patients Admitted to Intensive Care Unit

Transcranial Doppler is performed daily in Intensive Care Unit in brain damaged patients. For a few years now, the measurement of the photomotor reflex by quantitative Pupillometry has been routinely performed in Intensive Care Units. The objective of this work is to see if Transcranial Doppler recorded parameters and Pupillary parameters are correlated to the neurological prognosis evaluated at 9 months by the Modified Rankin Score (mRS) and the Glasgow Outcome Scale Extended (GOS-E).


Eligibility Criteria:
Inclusion Criteria:

* All brain damaged patients (stroke or head trauma)
* Admitted to Intensive Care Unit since December 1, 2020

Exclusion Criteria:

* Refusal by the patient or his/her legal representative.
* Benefiting from legal protection