cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Respiratory Parameters in Patients With Upper Limb Lymphedema

The aim of our study is to assess disease severity, respiratory muscle strength, respiratory functions, pectoralis minor muscle shortening, functionality, and quality of life (QoL) in patients with upper limb lymphedema (ULL), and to compare these findings with healthy controls.The disease severity was assessed using the Stillwell classification system; respiratory muscle strength was measured through maximum inspiratory and expiratory intraoral pressures (MIP, MEP, respectively); respiratory functions were evaluated with a spirometer; pectoralis minor muscle shortening was measured with a tape measure; functionality was assessed using the Disabilities of the Arm, Shoulder and Hand (DASH); and QoL was evaluated with the Lymphedema Quality of Life Questionnaire - Arm (LYMQOL-Arm).

The study had a cross-sectional observational study design. The participants were divided into two groups, patients with ULL in Group 1; the healthy individuals were included in Group 2. All assessments for both groups were performed by two different physiotherapists.

Eligibility Criteria:
Inclusion Criteria:

* aged 25-65 years with secondary, unilateral upper limb lymphedema in Phase 2 of the protection stage,
* wearing compression garments,
* who have not received manual lymph drainage (MLD) therapy in the last 3 months
* along with healthy controls of a similar age who volunteered to participate.

Exclusion Criteria:

* being in Phase 1 of lymphedema treatment (the edema-reducing phase),
* being classified as NYHA Class III and/or IV according to the New York Heart Association classification system,
* having a chronic respiratory disease,
* presence of active infection (such as lymphangitis or cellulitis), or undergoing radiotherapy/chemotherapy due to breast cancer.
Nutrition Effects on Fatigue During Tennis Playing

The main objective of this study is to investigate the effects of ingestion of different sports drinks (Nutrattente / Nutraperf / Nutrarecup) on fatigue induced by a tennis tournament simulation.


Eligibility Criteria:
Inclusion Criteria:

* About 18 to 35 years (inclusive) Subject has a stable weight for at least three months before the start of the study
* Subject able and willing to comply with the protocol and agreeing to give their consent in writing
* Subject affiliated with a social security scheme
* Subject willing to be included in the national register of volunteers who lend themselves to biomedical research
Spinal Balance With Wearables - Case-control

Observational case-control study to see if the Margin of Stability and Dynamic Postural Stability (measured using a motion capture gait laboratory and wearable device, respectively) are different in children with Adolescent Idiopathic Scoliosis and matched controls. Participants will walk across level ground and on a treadmill once for data collection and no follow-up is required.

The goal of this observational case-control study is to validate the Margin of Stability (MoS) and Dynamic Postural Stability (DPS) measures using a motion capture gait laboratory and wearable device in patients with Adolescent Idiopathic Scoliosis (AIS).

These measures will provide a consultant with objective data about a patient's movement and balance that the consultant and other healthcare professionals can use to infer about their spinal deformity progression or improvement. This research is an early step for working towards providing a distance medicine, non-invasive outcome measure that can be used alongside or in the absence of current clinical measures and radiography. Use of this data could reduce the frequency with which radiographs are required and so reduce the impact of radiation exposure. This wearable device could complement and improve upon existing outcome measures in the treatment of spinal deformity, reduce the need for radiographs and ameliorate the need for distance patient monitoring methods. A motion capture gait laboratory will be used as the gold-standard comparison.

A pilot study has been carried out on healthy participants with a simulated spinal deformity in a kinematic gait laboratory and using the wearable device, which showed altered balance in the simulated scoliosis group compared to controls.

The aim of this project is to:

1. To see if there's a difference in MoS and DPS between children with AIS and controls,
2. To see if a difference can be detected using motion capture gait analysis and a wearable device,
3. To see how similar results from the wearable device are to the motion capture gait laboratory,
4. To test the ability of the wearable device to measure a scalable difference between radiographic curve magnitude in patients with AIS.

Participants will attend one data collection appointment where they will walk across level ground and on a treadmill. No follow-up is required.

Eligibility Criteria:
Case Inclusion Criteria:

* Diagnosed with Adolescent Idiopathic Scoliosis
* Single, right-sided thoracic, left-sided thoraco-lumbar or left-sided lumbar curve
* \<= 1cm leg length discrepancy
* Diagnostic radiographs of curvature within 3 months
* Ability to walk without assistance
* Willing and able to comply with clinical study visit requirements

Control Inclusion Criteria:

* Ability to walk without assistance
* Willing and able to comply with clinical study visit requirements

Case \& Control Exclusion Criteria:

* Previous spinal surgery or joint replacement
* Syndromic, neuromuscular or pathologic condition
* Neurological, vestibular, somatosensory or orthopaedic comorbidities
* Pregnancy
* Poor understanding of written and/or spoken English
A Study Investigating Ways to Make Local Anaesthetic Hand Surgery Less Painful - Reducing Tourniquet Associated Pain

Hand surgery requires a reduced blood flow to the hand during the operation, which is achieved using a tourniquet (tightly inflated circumferential cuff) around the upper arm. However this tourniquet is painful. This study investigates whether breathing oxygen can reduce the pain associated with the tourniquet to both improve patient experience and potentially to allow longer operations to be completed under a local anaesthetic (rather than a general anaesthetic, where the patient is put to sleep, which is more costly, time consuming and risky for the patient).

* This study is a randomised controlled trial of healthy volunteers (for example medical students, nurses and doctors).
* Each volunteer is randomised to receive either oxygen or normal air through a mask whilst wearing an inflated upper arm tourniquet and rating their pain on a scale. The equipment set-up is identical for each volunteer, with the tourniquet inflated to a pressure of 250mmHg in every person.
* Within each arm of the study, volunteers are again randomised to wear the tourniquet on either their dominant or non-dominant arm.
* The study is double-blind (the volunteer and the investigator running the test are unaware of whether oxygen or air is being received) to avoid bias.
* The volunteer can ask for the tourniquet to be removed at any time and will wear the tourniquet for a maximum of 30 minutes.
* The pain ratings and also heart rate and blood pressure are then analysed to identify whether the volunteers receiving oxygen experienced less pain or were able to tolerate the tourniquet for longer than those receiving air.

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* More than 18 years of age

Exclusion Criteria:

* Diabetes
* Vascular disease
* Previous operations to arms
* Raynaud's disease
* Analgesia taken in last 24 hours
* Chronic pain
* Hypertension
* Allergy to any substance used in the study
* Unable to give valid consent to participate
* Obesity
Work Productivity and Social Activities In Patients With Ankylosing Spondylitis

The aim of this study is to evaluate the relationship between decrease in work productivity and social activities in patients with Ankylosing Spondylitis (AS) with disease activity, depression and quality of life together with demographic data.

For this study, which is planned as a cross-sectional clinical study, 100 patients who were diagnosed with AS between the ages of 18-65 and who applied to the Istanbul Physical Therapy Rehabilitation SUAM Physical Medicine and Rehabilitation Outpatient Clinic between April 15, 2019, and April 15, 2020, and 100 healthy volunteers compatible with age. was included. Demographic data of the participants were recorded. Work productivity and activity reduction questionnaire: general health (WPAI: GH), social role participation questionnaire short form (SRPQ), short form-36 (SF-36), hospital anxiety, and depression scale (HADS), will be evaluated. Besides, if the patient group exists, laboratory results (CRP, erythrocyte sedimentation rate, HLA-B27), and bath ankylosing spondylitis functional index (BASFI), bath ankylosing spondylitis disease activity index (BASDAI), Bath ankylosing spondylitis metrology index (BASMI), visual analog scale (VAS) resting, night and activity values were recorded.

Eligibility Criteria:
Inclusion Criteria:

* Patients with AS diagnosis between the ages of 18-65
* Healthy volunteer individuals between the ages of 18-65 without known musculoskeletal disease

Exclusion Criteria:

* Those with serious systemic diseases that may interfere with working (respiratory system, cardiovascular system, renal and metabolic diseases)
* Those with orthopedic and psychiatric diseases
* Those with inflammatory diseases other than known AS
* Pregnant
* People with disability due to the history of trauma
* Those with injury after the operation
* Those with diseases that cause neurological sequelae
A Prospective, Randomized TrialComparing Oral N-Acetylcysteine and Intravenous Sodium Bicarbonate

The purpose of this study is to compare the efficacy of oral N-acetylcysteine and intravenous sodium bicarbonate for the prevention of Contrast-Induced Nephropathy (CIN) after cardiac catheterization.

It is thought that N-acetylcysteine may reduce the ability of generated oxygen free radicals to damage cells by scavenging them. N-acetylcysteine may also increase the biologic effects of nitric oxide by combining with nitric oxide to form S-nitrosothiol, a more stable form and potent vasodilator. It also increases the expression of nitric oxide synthesis and may improve blood flow. Oxidants activate a signal-transduction cascade and molecular response that may initiate the cell-death pathway. These pathways seem to be sensitive to the redox state of the cell and are inhibited by N-acetylcysteine, which promotes pathways that lead to repair and survival whenever cells are under oxidant stress.

Eligibility Criteria:
Inclusion Criteria: 19 years of age

* Baseline serum creatinine or
* Calculated creatinine
* Stable Renal Function
* Left Ventricular ejection fraction
* Non-pregnant, non-lactating females (all women of childbearing potential must have a negative serum pregnancy test. No contraception will be required
* Able to sign informed consent

Exclusion Criteria:

* Acute renal failure
* History of Kidney transplant
* Currently receiving N-acetylcysteine

  _ Contraindication of hypersensitivity to N-acetylcysteine or sodium bicarbonate
* Left ventricular ejection fraction
* Pregnant, lactating females
* Allergy to contrast dye
Effect of Floorball on Healthy Subjects

To investigate the effect of floorball on health and performance in healthy subjects over 65 years.


Eligibility Criteria:
Inclusion Criteria:

* Healthy
* age 65-85
* physical activity \<2 hours pr. week.

Exclusion Criteria:

* age \<18 years
* Injuries that prevent the subject from playing floorball
* Alcohol \>14 units pr. week.
* Pregnancy
* Other serious conditions
Clinical Study to Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 720 Injected for Jawline Contouring

A Multicenter, Evaluator-Blinded, No-Treatment Control Design Clinical Study to Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 720 Injected for Jawline Contouring

This is a Multicenter, Randomized, Evaluator-Blinded, No-Treatment Control Design Clinical Study to Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 720 Injected for Jawline Contouring.

Eligibility Criteria:
Inclusion Criteria:

* Male or female adults 18 - 75 years of age (inclusive)
* 2 (moderate) or 3 (severe) on Jawline Contour Rating Scale (JCRS)
* want a filler injection procedure for the replacement of volume loss in the jawlines

Exclusion Criteria:

* have an active or infective skin disease
* have lower-face volume deficit due to congenital defect, trauma, abnormalities in adipose tissue related to immune-mediated diseases
* have a tattoo or excessive facial hair in the evaluation area
* have received permanent facial implants
* have undergone semi-permanent filler within 24 months
* have undergone temporary dermal filler treatment in the lower face (below the orbital rim) within 12 months
* have streptococcal disease
* have a medical history of hypertrophic cicatrix, hyperpigmentation or keloid
* have a history of anaphylaxis, multiple severe allergies, or allergy to lidocaine (or any amide-based anesthetic), or hyaluronic acid products
* have history of bleeding disorder
* have severe cardiovascular, hepatic or renal diseases considered as per Investigator's discretion
* have known malignant tumors or cancerous or precancerous lesion
* positive pregnancy test indicating pregnancy
* active COVID-19 infection and suspected COVID-19 infection within the past 14 days
A Phase II Trial on Treatment of Steroid-refractory Bronchiolitis Obliterans With Interferon Gamma 1b After Allogeneic SCT

Improvement of quality of life in patients with BO and establishment of a new third line therapy

Primary Objectives:

Objective improvement of lung function, i.e.:

* Improvement of SO2, pO2 or pCO2 in oxygen dependent or improvement of FiO2 in respiration dependent patients ≥ 20 % or
* Reduction of oxygen need in oxygen dependent patients ≥ 1L O2/min with constant parameters at blood gas analysis (BGA) or
* Improvement of obstructive parameters ≥ 20 % or
* Improvement of lung function score (LFS) at least about one grade Improvement of lung function should be detectable at least by two consecutive examinations of lung function or BGA within at least four weeks.

Secondary Objectives

* Morphological improvement of BO/BOOP at CT scan
* Reduction of steroids about at least 20 %

Eligibility Criteria:
Inclusion Criteria

* Allogeneic SCT
* Age ≥ 18 years
* BO, firmed by 2 out of 3 examinations:

  * Lung function/ BGA
  * CT scan in in- and expiration or
  * Histological diagnosis
* Therapy refractory BO, i.e. no improvement during at least three therapies, among:

  * Azithromycin + inhaled steroids/ bronchodilators
  * Systemic steroids 1 mg/kg BW
  * One of the following therapies: MMF, mTOR inhibitors or ECP
* Effective contraception (before, during and for 8 weeks after the treatment)
* Blood count: no severe neutropenia, defined as ANC \> 1000/ml, platelets \> 50/nl and haemoglobin \> 8 g/dl
* Liver parameters (bilirubin, gammaGT, AP, ASAT, ALAT) lower than 3 x paramount normal range
* Kreatinin lower than 3 x paramount normal range
* Informed consent

Exclusion Criteria:

* Age \< 18 years
* Pregnant or nursing woman
* No appropriate contraception
* Participation in any other study within 4 weeks before or during the study
* Active acute GvHD of other organs than the lung \> grade II or severe active chronic GvHD
* No appropriate antibiotic/ antimycotic therapy in documented infection
* Severe bone marrow suppression (ANC \< 1000/ml) or graft failure
* Liver parameters (bilirubin, gammaGT, AP, ASAT and ALAT) higher than 3 x paramount normal range
* Kreatinin higher than 3 x paramount normal range
* Participation in another study within 4 weeks before or during the study
Phase I Study to Assess Safety and Pharmacokinetics of GMI-1271 in Healthy Adult Subjects

In this study, the investigators will evaluate the safety, pharmacokinetics and effect on target biomarkers of coagulation, cell adhesion, and leukocyte and platelet activation of GMI-1271, an E-selectin antagonist, in healthy volunteers.

Investigators will evaluate in a single ascending dose (SAD) and multiple ascending dose (MAD) fashion, the safety, pharmacokinetics and effect on target biomarkers of coagulation, cell adhesion, and leukocyte and platelet activation of GMI-1271, an E-selectin antagonist, in healthy volunteers.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-75 years
* Male or female
* Medically healthy, as defined by the absence of clinically significant screening results (e.g. laboratory profile, medical history, electrocardiogram (ECG), physical examination)
* BMI 18-35 kg/m2
* Voluntary consent to participate in the study
* No evidence of Lower Extremity Deep Vein Thrombosis (LE DVT) at baseline by ultrasound

Exclusion Criteria:

* Use of any prescription, investigational, herbal, supplemental, or over the counter medications including aspirin within 14 days (for the SAD phase) and 7 days (for the MAD phase) prior to day 1 or unwilling/unable to refrain from the use of these medications on days 1-8 for the SAD phase and days 1-12 of the MAD phase of the study
* Previous administration of GMI-1271
* Positive drug testing at screening and baseline or positive alcohol testing at baseline or unwilling/unable to refrain from the use of drugs or alcohol on days 1-8 for the SAD phase and days 1-12 for the MAD phase of the study
* Pregnant or breastfeeding
* Unwilling or unable to use contraception during the time of participation in the trial and 14 days afterwards (sexual abstinence is permissible)
* Positive HIV, Hepatitis B surface antigen or Hepatitis C antibody at screening
* Hypersensitivity or allergic reaction to compounds related to GMI-1271
* Use of moderate caffeine (≥ 300 mg/day) within 48 hours prior to dosing (day 1)
* History of bleeding disorder
* Any liver function test \> 1.5 times upper limit of normal or renal insufficiency with creatinine clearance \< 30 ml/min.
A Study of the Effects of Canagliflozin on Plasma Volume in Patients With Type 2 Diabetes Mellitus

The purpose of the study is to evaluate the effects of canagliflozin on plasma volume and renal parameters in patients with Type 2 Diabetes Mellitus who are currently taking metformin and being treated for high blood pressure.

This is a double-blind (neither the patient or study staff will know the identity of the treatment assigned) in patients with Type 2 Diabetes Mellitus (T2DM) who have inadequate glycemic (blood sugar) control on metformin monotherapy (metformin taken alone for control of T2DM) and who are currently being treated for hypertension (high blood pressure) with agents called angiotensin converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs). In the study, patients will be randomized (assigned by chance) to receive treatment with canagliflozin or a placebo (a treatment identical in appearance to canagliflozin but does not contain active drug) for 12 weeks. During the 12-week treatment period, patients will also take metformin at a dose of at least 1500 mg/day in addition to their prescribed ACEI or ARB for hypertension. Patients will participate in the study for up to approximately 22 weeks.

Eligibility Criteria:
Inclusion Criteria:

* All patients must have a diagnosis of T2DM with inadequate glycemic control (ie, HbA1c of \>=7.0% and \<=9.0% at Screening) on metformin monotherapy and be receiving therapy with an antihypertensive agent (an ACEI or ARB) for at least 4 weeks prior to Screening

Exclusion Criteria:

-History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy; or a severe hypoglycemic episode within 6 months before screening
Open and Endovascular Surgical Treatment for Artery Injuries

Traumatic injuries of peripheral arteries are often associated with multiple injuries, massive hemorrhage, state of shock, and loss of blood supply, as well as with high mortality. Traditionally, an open surgical approach is suggested for the management of artery injury. With the advancement of endovascular techniques, the traditional open vascular exposure and vessel repair are no longer the only option available. The purpose of this study is to compare the effectiveness, long-term safety and explore the safety and efficacy factors between open and endovascular surgical techniques.


Eligibility Criteria:
Inclusion Criteria:

Injuries in the peripheral arteries; Loss of blood supply to the remote area; High-risk emergency artery reconstruction; Participate in the study voluntarily, accept follow up study. -

Exclusion Criteria:

Bleeding can be easily control; There is contraindications for surgical operation. -
Liposomal Vincristine Plus Dexamethasone in Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia

The purpose of this study is to find the highest safe dose and to assess the anti-tumor effect of liposomal vincristine with dexamethasone in patients with relapsed or refractory acute lymphoblastic leukemia (ALL).

OBJECTIVES:

* Determine the maximum tolerated dose (MTD) of liposomal vincristine given with dexamethasone in patients with relapsed or refractory acute lymphoblastic leukemia (ALL).
* Determine the efficacy of liposomal vincristine given with dexamethasone in these patients.

Eligibility Criteria:
Inclusion Criteria:

* Previously treated, relapsed or refractory ALL (including lymphoblastic lymphoma and Burkitt's subtypes) with measurable disease.
* Performance status ≤3 (ECOG).
* All ages are eligible. Those aged 12 years or older may be counted towards the MTD in the Phase I portion of the trial. Pediatric patients are eligible, but must be treated at a dose level previously tested in an adult (one full course).
* Adequate liver function (bilirubin ≤2 x upper limit normal), and renal function (creatinine ≤2 x upper limit normal).
* Negative pregnancy test in females of childbearing potential.
* Patients with prior history of stem cell transplant are eligible if they meet all other eligibility requirements.

Exclusion Criteria:

* Active serious infection not controlled by oral or intravenous antibiotics.
* Treatment with any investigational agents or chemotherapy agents in the last 21 days before study entry, unless full recovery from side effects has occurred or the patient has rapidly progressive disease judged to be life threatening by the Investigator.
* Concurrent treatment with other anti-cancer agents other than dexamethasone.
* Known CNS leukemia or lymphoma requiring intrathecal or craniospinal radiation therapy or with CNS neuropathy limiting evaluation of study drug. Patients with controlled CNS disease (no progression signs or symptoms at the time of study entry) may be eligible after approval by the Principal Investigator. Lumbar puncture not required in asymptomatic patients.
* Prior history of Grade 3 or 4 sensory or motor neuropathy related to chemotherapeutic treatment, or persistent Grade 2 or greater active neuropathy.
* History of active neurologic disorders unrelated to chemotherapy (including familial neurologic diseases and acquired demyelinating disorders).
* Prior history of hypersensitivity reactions to vincristine or any of the other components of VSLI.
* Pregnant and/or lactating women; or fertile men or women not willing to use contraception.