cyrilzakka/clinical-trials huggingface dataset:
Treadmill Training With Kinesiotaping Affects Balance and Gait in Chronic Stroke Patients

The goal of this clinical trial is to determine the effects of treadmill training with and without trunk kinesiotaping on balance and gait of chronic stroke patients. The main question it aims to answer is:- Does kinesiotaping have added benefit to improve gait and balance in chronic stroke patients?.

Researcher will compare the treadmill training group with the group receiving treadmill training with kinesiotaping to see if there is any difference in the outcomes.

Summary Stroke, one of the leading cause of death and disability worldwide, is defined as rapid deterioration of brain function due to disturbance in blood supply to the brain. According to the cause it is divided into two main types; ischemic stroke and hemorrhagic stroke. Stroke can lead to a number of physical impairments like muscle imbalance, impaired balance and postural control, poor voluntary control, body malalignment and disturbance of walking patterns etc. Ability to walk safely and participate in activities of daily living is the main goal of many individuals affected by stroke. Therefore, improving balance and gait is the primary focus of physical therapy interventions. Many therapeutic interventions such as , treadmill training, over ground gait training , Functional electrical stimulation, neurofacilitation approaches and strength training are used for improving balance and gait in patients affected by stroke, all of which have been proven to be beneficial. This study will be conducted to compare the effect of treadmill training with and without kinesiotaping on trunk muscles (rectus abdominis, erector spinae, external oblique and internal oblique) on gait and balance in chronic stroke patients.

Many studies have shown that trunk muscles have a very important role in balance and gait in patients with stroke and KT application may be an effective intervention for trunk function and postural control however, there is no evidence on whether providing support to the trunk with kinesiotaping during treadmill training will have any added benefit on balance and gait or not.

Eligibility Criteria:
Inclusion Criteria:

* both male and females
* Age 30-50 years.
* duration of onset of stroke \>6 months.

Exclusion Criteria:

* • patients with orthopedic diseases(such as contracture) in the trunk and both lower extremities

  * A history of other neurologic diseases or disorders (MS, Parkinsons).
  * History of fall in last 6 months.'
  * History of unstable CVS diseases
  * high skin sensitivity or skin diseases
  * lower extremity surgery or fracture, low back pain, or allergy to the KT.
First in Human Study of an Anti-IFN Gamma Monoclonal Antibody in Healthy Volunteers

The purpose of this study is to determine the safety, pharmacodynamic and pharmacokinetic profiles of a novel therapeutic drug when administered to healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* healthy adults between 18 and 50 years old
* non smokers
* able to adhere to study protocol requirements

Exclusion Criteria:

* any abnormal clinical safety laboratory parameters
Effect of Prebiotics on Function and Pain in Patients with Osteoarthritis and Obesity

The purpose of the present study is to determine if prebiotic supplementation can, through changes in the intestinal gut microbiota, lead to improvements in knee function and physical performance and reduce knee pain in adults with obesity and idiopathic metabolic knee osteoarthritis. We hypothesize that prebiotics will reduce systemic and local (knee joint) inflammation, thus improving knee function, lower pain medication use, and enhance performance of daily life activities.

Primary outcome:

1. To determine the change in knee joint function and physical performance in adults with obesity and knee osteoarthritis treated for 6 months with oligofructose-enriched inulin or placebo.

Secondary outcomes:

1. To determine the change in knee pain in adults with obesity and knee osteoarthritis treated for 6 months with oligofructose-enriched inulin or placebo.
2. To examine the change in body composition (fat mass and lean mass) in participants treated with oligofructose-enriched inulin or placebo.
3. To evaluate the change in quality of life in participants treated with oligofructose-enriched inulin or placebo.
4. To gain a mechanistic understanding of the influence of oligofructose-enriched inulin supplementation in metabolic OA through examination of gut microbiota composition and short-chain fatty acid concentrations.
5. To gain a mechanistic understanding of the influence of oligofructose-enriched inulin supplementation in metabolic OA through examination of serum inflammatory and metabolomics markers.

Eligibility Criteria:
Inclusion Criteria:

* Male and female adults aged 30-75 years of age.
* BMI greater than 30kg/m2.
* Diagnosis via x-ray of knee OA grade II and III (Kellgren and Lawrence).

Exclusion Criteria:

* Knee OA resulting from a traumatic injury.
* Previous knee surgery.
* Concomitant use of any weight loss medication, previous bariatric or other intestinal surgery
* Presence of active infection, pregnancy or lactation.
* Regular use of a probiotic or prebiotic supplement within 3 months prior to enrollment.
* Antibiotic use within 3 months prior to enrollment
* Uncontrolled cardiovascular or respiratory disease, active malignancy, or chronic infections.
PURETHAL Grasses Rush Study

This study investigates the safety of two up-dosing regimen. The safety of PURETHAL Grasses will be evaluated in a rush regimen (maximum dose reached in 3 injections during 2 weeks) compared to the conventional regimen (maximum dose reached in 6 injections during 5 weeks).

The primary parameter will be the proportion of patients who experience systemic reactions \> grade I within 24 hours after injection or who need more than 2 additional injections during the up-dosing phase until the maintenance dose has been reached.

It is expected that up-dosing PURETHAL Grasses according to the rush regimen is as safe as using the conventional regimen.


Eligibility Criteria:
Inclusion Criteria

* Patients with rhinitis or rhinoconjunctivitis, with or without mild asthma (FEV1 \> 70%) for at least 2 years related to grass pollen, eligible for SCIT.
* Confirmation of IgE-mediated allergy by means of:

  * Positive SPT to grass pollen (mean wheal diameter ≥ 3 mm and negative control truly negative (no reaction), or
  * Specific serum IgE-test (ssIgE \>0.7 U/ml) for grass pollen, or
  * Positive provocation test for grass pollen.
* Age ≥ 18 years.
* Patients have given a written informed consent

Exclusion Criteria:

* Chronic asthma or emphysema, particularly with a FEV1 ≤ 70% of predicted value.
* Serious immuno-pathological diseases or malignancies (including auto-immune diseases, tuberculosis, HIV).
* Active inflammation/infection of the target organs (nose, eyes, lungs).
* Severe atopic dermatitis in need for systemic immunosuppressive medication.
* Symptomatic coronary heart diseases (e.g heart failure, recent myocardial infarction, unstable angina, serious arrhythmias) or severe (even under treatment) arterial hypertension.
* Severe kidney disease.
* Diseases with a contra-indication for the use of adrenaline.
* Treatment with systemic or local beta-blockers or immunosuppressive drugs.
* History of life threatening anaphylactic events, including anaphylactic food allergy, insect venom anaphylaxis, exercise or drug induced anaphylaxis.
* Any specific immunotherapy (including sublingual) during the study period or during the previous 3 years for a period longer than three months.
* Participation in a clinical study with a new investigational drug within the last three months.
* Pregnancy, lactation or inadequate contraceptive measures (adequate measures: oral contraceptives, IUD, condom use if used together with a spermicide and having no sexual relationship with a man).
* Alcohol or drug abuse.
* Lack of co-operation or severe psychological disorders.
* Completed or ongoing long-term treatment with tranquilizer or psycho active drugs.
* Low compliance or inability to understand instructions/study documents.
* Completed or ongoing treatment with anti-IgE-antibody.
* Patients being in relationship or dependence with the sponsor or investigator.
* Allergy to any of the excipients.
* Severe illness or any other condition, which makes the patient, in the opinion of the investigator, unsuitable for the study.
The Feasibility of Low Dose Chest CT for Virtual Bronchoscopy Navigation - Human Study.

Advances in medical imaging technology have made it possible to detect patients with small-sized lung lesions early. Generally, invasive methods such as PCNA were used to diagnose peripheral lung nodule. However, Radial probe endobronchial ultrasonography (RP-EBUS) is widely used in the histological diagnosis of peripheral lung nodule in recent years. In order to carry out RP-EBUS, it is necessary to know the path to the lesion to access it. Conventionally, the path to the peripheral lung nodule is identified by the drawing, but recently, the path is reviewed by the virtual bronchoscopy navigation (VBN) which is reconstructed 3-dimension image using the CT data. Currently, VBN is driven by using raw data acquired using standard thin sectioned chest CT protocol, but the problem is that additional doses of radiation are exposed to patients who have initially discovered lung lesions using low dose CT. Therefore, we conduct a randomized controlled trial to verify the suitability of VBN using the raw data acquired by low dose CT.

The standard thin sectioned protocol CT consists of scout, enhanced and non-enhanced image. Therefore, in this study, non-enhanced protocol CT was taken with low dose protocols with three different radiation doses to acquire raw data and drive VBN, and compared with the VBN result driven with raw data obtained with standard protocol. The primary endpoint of this study is to verify the consistency and accuracy of the VBN results driven by the raw data obtained with the low dose protocol CT.

Eligibility Criteria:
1. Inclusion Criteria:

   1. Patients older than 18 years
   2. Competent to give informed consent
   3. Patients requiring a pathological diagnosis of pulmonary nodules using RP-EBUS.
   4. Patients who need chest CT before RP-EBUS.
2. Exclusion Criteria:

   1. Pregnancy
   2. Patients who could not receive chest CT
   3. Inability to obtain informed consent
   4. Patients unable to perform RP-EBUS
Evaluation of the Functionality of an Extract Rich in Phytosterols and Phytostanols on Parameters Related to the Lipid Profile of Individuals With Hypercholesterolemia, Mainly in the Levels of Total Cholesterol, LDL Cholesterol and Oxidized LDL

The aim of this clinical trial is to evaluate the functionality of an extract rich in phytosterols and phytostanols on parameters related to the lipid profile of individuals with hypercholesterolemia, mainly on total cholesterol and LDL cholesterol levels

A total of 45 participants with hypercholesterolemia (total cholesterol\>200 mg/dL) will be recruited. Participants must not be taking any medication or nutritional supplement aimed at lowering cholesterol levels. Social networks and advertisements at the Universidad Católica San Antonio de Murcia (UCAM) and the Centro de Edafología y Biología Aplicada del Segura (CEBAS) will be used to recruit the individuals.

First, participants will attend to an informative session to learn in more detail about the objectives of the study and the procedures to be followed. In this session participants will sign the informed consent.

They will be divided into two groups:

* One group (n=23) that will take an extract rich in phytosterols and phytostanols (mainly β-sitosterol, β-sitostanol, campesterol and stigmasterol), resveratrol and hydroxytyrosol. The extract will be taken in capsule format.
* A control group (n=22) that will take a placebo supplement.

At the beginning of the study, anthropometric measurements of the participants will be taken. The participants' blood pressure will also be measured. An interview-questionnaire will be conducted to learn about and evaluate participants´s diet, physical activity and sleep quality. A blood sample will also be taken from the participants for biochemical analysis (total cholesterol, HDL, LDL, oxidized LDL, triglycerides and transaminases). From this day on, all participants will take two capsules daily of the phytosterol-rich extract or the placebo capsule, as appropriate, for 56 days. Capsules will be taken at night after dinner. Sampling and biochemical analysis will be repeated on days 28 and 56.

Eligibility Criteria:
Inclusion Criteria: total cholesterol\>=200 mg/dl -

Exclusion Criteria: total cholesterol\<200 mg/dl

-
A Study to Evaluate the Safety of D-TRANS Fentanyl With Naltrexone in Adult Patients With Chronic Pain and Who Are Opioid Tolerant

The primary objective was to evaluate the safety of D-TRANS fentanyl with naltrexone HCl system compared to the Duragesic (fentanyl transdermal system) in opioid tolerant patients.

This was a multicenter, randomized, double-blind, double-dummy safety study in adult patients who required continuous opioid treatment for chronic pain. Patients had to be on a stable dose of duragesic for 21 days prior to the start of the study treatment period and have completed a screening period of at least 14 days to enter this study. Eligible patients were randomized (2:1) to receive the equivalent strength of D-TRANS fentanyl with naltrexone HCl (and placebo Duragesic) or the same dose of Duragesic (and placebo D-TRANS fentanyl with naltrexone HCl \[D-TRANS fentanyl with naltrexone\]) for a 15-day treatment period. If necessary, patients could be titrated to higher or lower doses during the 15-day treatment period. Each system was worn for 72 hours then replaced by a new system until the end of the 15-day treatment period. Patients were telephoned 3 times a day during the first 3 days of the study and then once daily for the remainder of the study to determine if there were any signs of opiate overdose or withdrawal. The patient was to be followed as medically indicated based on the responses to the questions. Safety assessments included summarizing the incidences of adverse events (including topical adverse events), vital signs measurements, and clinical laboratory evaluations. Blood samples were also collected for analysis of naltrexone and fentanyl concentrations at scheduled times during the study. Efficacy assessments included patient global assessments, investigator global assessments, pain intensity, and brief pain inventory. Blood samples were also to be collected for analysis of naltrexone and fentanyl prior to any dose change and if a patient experienced a serious adverse event possibly or probably related to study drug. Duragesic delivering fentanyl doses of 25 mcg/h, 50 mcg/h, 75 mcg/h, or 100 mcg/h, and a D-TRANS placebo on Days 1, 4, 7, 10, and 13 or D-TRANS fentanyl with naltrexone delivering fentanyl doses of 25 mcg/h, 50 mcg/h, 75 mcg/h, or 100 mcg/h, and a placebo.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of chronic pain who require continuous opioid analgesia
* Must enter the study on a stable dose of Duragesic for at least 21 days and consent to use a medically acceptable method of contraception throughout the entire study, and for females 1 week after the study is completed and for males 3 months after the study is completed.

Exclusion Criteria:

* Skin disease that precluded the use of a transdermal system
* Clinically significant laboratory abnormalities
* Significant mental status changes that result in disorientation, memory impairment, or inability to report accurately
* Illicit drug, prescription drug, or alcohol abuse
* Cardiopulmonary disease
* Pregnant or breastfeeding.
Randomized Trial of Accelerated Partial Breast Irradiation

This study is to compare radiation toxicity of accelerated partial breast irradiation (ABPI) with whole breast irradiation (WBI) in low-risk breast cancer.

This study is a single-center phase II randomized clinical trial to enroll low-risk breast cancer treat with breast-conserving surgery. All eligible patients are randomized to receive either ABPI (40Gy/10fx/2wks) or WBI(43.5Gy/15fx/3wks). Intensity modulated radiation therapy (IMRT) technique is used. Grade 2 or more acute and late toxicities are prospectively evaluated and compared.

Eligibility Criteria:
Inclusion Criteria:

* Life Expectation: \> 5 years
* Enrollment date no more than 12 weeks after breast-conserving surgery or no more than 8 weeks after adjuvant chemotherapy
* Histologically confirmed diagnosis of invasive ductal carcinoma (grade 1-2), or mucinous carcinoma, or papillary carcinoma, or tubular carcinoma, or medullary carcinoma: primary tumor ≤ 3.0cm in maximum diameter and pN0; or histologically confirmed DCIS: primary tumor ≤ 2.5cm in maximum diameter, low-medium grade
* Unifocal tumour (confirmed by diagnostic MRI)
* No lymphovascular invasion
* ER positive (defined as medium-strongly nuclear staining in \>1% of the cancer cells)
* Negative radial resection margins of \>= 2 mm
* Surgical clips placed in the tumor bed
* Written informed consent.

Exclusion Criteria:

* Stage Ⅱ-Ⅲ
* Multifocal tumors
* Histologically confirmed diagnosis of invasive ductal carcinoma (grade 3), - - - invasive micropapillary carcinoma, carcinoma of lobular in situ, invasive - - - lobular carcinoma
* Paget's disease of the nipple
* Underwent oncoplastic surgery of ipsilateral breast
* Underwent neoadjuvant chemotherapy or hormonal therapy
* Previous or simultaneous contralateral breast cancer
* Undergone ipsilateral chest wall radiotherapy
* Active collagen vascular disease.
Post-Market Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (CF-EAS-AC) for the Treatment of Symptomatic Atrial Fibrillation

The purpose of this study is to confirm the safety and effectiveness of the CardioFocus Endoscopic Ablation System with Adaptive Contact in the treatment of atrial fibrillation.


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic, Paroxysmal Atrial Fibrillation (AF)
* 18 to 70 Years of age
* Others

Exclusion Criteria:

* Generally good overall health as determined by multiple criteria
* Willing to participate in a study
* Others
Vitamin D and Endometrial Receptivity in Infertile Women

This is a prospective study comparing vaginal and endometrial biomarkers and the trophoblast spheroid attachment rate in women with fertility problems before and after taking Vitamin D for 8 weeks.

The aim of this study is to assess the effect of vitamin D supplementation on vaginal / endometrial biomarkers and endometrial receptivity in women with fertility problems.

Women will have vaginal swab and endometrial biopsy twice. The first endometrial biopsy is performed using a Pipelle sampler 7 days after luteinizing hormone surge (LH+7) at baseline and the attachment rate of the trophoblast spheroid onto the isolated endometrial epithelial cells will be assessed to assess endometrial receptivity at baseline. Implantation biomarkers will be checked.

They will take Vitamin D 50,000 IU once per week for 4 weeks, followed by 50,000 IU once every 2 weeks for 4 weeks. After 8 weeks of Vitamin D, a second vaginal swab and endometrial biopsy using a Pipelle sampler by standard technique will be collected from the patients 7 days after luteinizing hormone surge (LH+7) and the endometrial receptivity will be compared.

The laboratory staff will not know whether the patient is taking any vitamin D when performing the trophoblast spheroid attachment assay/ biomarkers.

Eligibility Criteria:
Inclusion Criteria:

* Age of women \< 40years old
* Normal uterine cavity as demonstrated by pelvic scanning with or without saline infusion sonogram or hysteroscopy
* Regular ovulatory cycles

They will be divided into three groups:

* RIF patients (n=35)- those who have failed to get pregnant after replacing four or more cleavage stage embryos or two or more blastocysts in two consecutive transfers.
* RPL patients (n=35)- those who have failed in three pregnancies before 24 weeks of gestation and includes embryonic and fetal losses.
* 'Infertile group'(n=35)- infertility except RIF and RPL, e.g. those seeking for preimplantation genetic testing, male factor infertility, unexplained infertility.

Exclusion Criteria:

* History of any medical condition or medications that may predispose to vitamin D sensitivity, altered vitamin D metabolism and/ or hypercalcemia, including active tuberculosis or current therapy for tuberculosis, sarcoidosis, history of renal/ ureteral stones, parathyroid disease, renal or liver failure or current use of anti-convulsants
* Taking vitamin D supplement
* Endometrial polyp or fibroid distorting the uterine cavity
* Presence of hydrosalpinx not corrected surgically
* Refusal to join the study

  • Discontinuation criteria-
* If the woman becomes pregnant during the study
* Pelvic inflammatory disease/ uterine perforation after endometrial biopsy
* Vitamin D toxicity (hypercalcemia)
* Withdrawal by patient
Ambulatory Continuous Peripheral Nerve Blocks for Treatment of Post-Amputation Phantom Limb and Stump Pain

Research study to determine if putting local anesthetic-or numbing medication-through one or two tiny tube(s) placed next to the nerves that go to an amputated limb will decrease phantom limb and/or stump pain.

Specific Aim 1: To determine if, compared with current standard-of-care treatment, the addition of an ambulatory continuous peripheral nerve block decreases post-amputation phantom limb and stump pain.

Hypothesis 1: Following upper or lower extremity amputation, phantom limb and/or stump pain will be significantly decreased four weeks following a multiple-day ambulatory continuous peripheral nerve block as compared with patients receiving standard-of-care treatment (as measured on the 11-point numeric rating scale).

Specific Aim 2: To investigate the possible relationship between the addition of a multiple-day ambulatory continuous peripheral nerve block to standard-of-care treatment of post-amputation phantom limb and/or stump pain and cortical reorganization.

Hypothesis 2: Following upper or lower extremity amputation with subsequent phantom limb pain/sensation and/or stump pain, the addition of a multiple-day ambulatory continuous peripheral nerve block to standard-of-care treatment will result in cortical reorganization during and four-weeks following the perineural infusion (as measured by MRI).

Eligibility Criteria:
Inclusion Criteria:

* previous upper or lower limb amputation including at least one metacarpal or metatarsal bone, respectively
* age 18 years or older
* phantom limb and/or stump pain described as at least a 2 on the NRS for the previous week \[and pain occurring on a weekly basis over the previous month\]
* willing to have an ambulatory perineural infusion for 6 days
* willing to avoid additional "new" analgesic interventions from 4 weeks prior to at least 4 weeks following catheter placement, and preferably to 6 months following catheter placement
* the availability of a "caretaker" who will transport the subject home following the procedure and remain with the subject for the first night of the infusion

Exclusion Criteria:

* known hepatic or renal insufficiency
* allergy to the study medications
* possessing a contraindication to perineural catheter placement or perineural local anesthetic infusion