cyrilzakka/clinical-trials huggingface dataset:
Foot Positions Affect Basketball Players With Flatfoot

This study investigated the effect of various initial foot positions on knee and ankle proprioception, balance, dynamic balance, vertical jump, and electromyographical muscle activity in basketball players with FF.

Objective: To investigate the effect of various initial foot positions on knee and ankle proprioception, balance, dynamic balance, vertical jump, and electromyographical muscle activity in basketball players with FF.

Methods: Eighty-four basketball players with chronic ankle instability were distributed to three groups (28 with flexible FF, 28 with rigid FF, and 28 without FF). The outcome measures will include static and dynamic balance, knee and ankle proprioception, vertical jump, and electromyography (EMG) of ankle muscles (including gastrocnemius (GE), soleus (SOL), tibialis anterior (TA), and peroneus longus (PL) muscles)

Eligibility Criteria:
Inclusion Criteria:

* The presence of flatfoot in the dominant leg.
* The presence of chonic ankle instability

Exclusion Criteria:

* The exclusion criteria were the existence of limited hallux dorsiflexion
* previous hip, pelvis, knee, or foot surgeries within the last year; obesity or pregnancy; leg-length discrepancies;
* Had any vestibular disorder neurological disorder, brain concussion within the last 3 months that may cause balance impairment; or administering any drugs that could disturb alertness or balance
Evaluation of Geistlich Fibro-Gide® + CAF in Comparison to CTG + CAF for the Treatment of Recession Defects at 6 Months

This double blind, randomized, split mouth study evaluates the non-inferiority of Geistlich Fibro-Gide® in comparison to connective tissue graft for the treatment of Miller Class I or II recession defects at 6 months post treatment.

This double blind, randomized, split mouth study evaluates the non-inferiority of Geistlich Fibro-Gide® in comparison to connective tissue graft for the treatment of Miller Class I or II recession defects at 6 months post treatment.

A total sample size of 30 subjects (n=30) will be evaluated at 3 centers with 4 investigators. Power analysis based on 80% power and past McGuire/ Scheyer matched-pair defect recession coverage studies, with one-sided confidence interval 0.025, indicates that in order to detect a 12% difference in root coverage with ± 15% standard deviation a patient sample of 25 should be used . Given the multi-center nature of this study and the intention to follow patients long-term, with normal attrition, 30 subjects will ensure adequate long-term follow-up and provide a "power buffer" for any outcome differences that might be seen between centers.

30 Patients with Miller Class I or II recession defects on bilateral sites will be treated randomly with coronally advanced flap (CAF) in combination with either Geistlich Fibro-Gide (GFG =Test) on one side, and Connective Tissue Graft (CTG = Control) on the contralateral side of the mouth. Follow-up visits after visit 2 surgery will be conducted at week 1,2, 4,12 and 24 and in the long term after 1,3 and 5 years.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 75 years of age, inclusive.
* Subjects must have at least two teeth with buccal Miller Class I or II recession type defects, 3 mm deep and 3 mm wide on the same tooth in the contralateral quadrant of the same jaw
* Defects should be similar in size and morphology
* Teeth with root canals should be asymptomatic, completed at least 6 months prior
* At least 1mm KT
* Subjects with parafunctional habits must wear a bite guard to be included.

Exclusion Criteria:

* Participation within the previous 30 days in other investigational clinical trials.
* Class V restorations or abfractions that obliterate the CEJ.
* Subjects whose teeth have extremely prominent root surfaces -greater than 2mm facially to the adjacent teeth measured at the level of the CEJ.
* Systemic conditions that could influence wound healing or any other conditions that would preclude periodontal surgery.
* Taking medications that compromise wound healing.
* Acute infectious lesions in the areas intended for surgery.
* Untreated moderate to severe periodontal disease.
* Weekly or more frequent use of nicotine products within the past 6 months.
* Females who are pregnant or lactating, or sexually active female subjects who are of childbearing potential and who are not using hormonal or barrier methods of birth control.
* Subjects who require sedation in order to undergo surgery.
* Molars, teeth with axial mobility or interproximal loss of attachment, or full coverage crowns or veneers do not qualify.
Risk Factors for Sub Mucosal Fibrosis During Achalasia Cardia: A Prospective Study

Classification for Stasis Esophagitis:

Grade I Grade II Grade III Vascular pattern Obscured Obscured Obscured Mucosal thickening No Yes Yes Ulceration No Yes Yes Nodularity No No Yes

Predictors of Submucosal Fibrosis:

Various factors were analysed for prediction of SMF including age, gender, stasis esophagitis, type of achalasia, duration of disease, lower esophageal sphincter pressure (LESP), height of barium column on barium esophagogram and severity of symptoms (Eckardt score). Esophageal mucosa was graded for the severity of stasis esophagitis (grade I to grade III) based on vascular pattern, mucosal thickening, ulceration and nodularity. SMF was graded (I minimal, II moderate, III severe) according to mucosal lift, difficulty in entry, density of SM fibers, separation of mucosa and muscle.

Eligibility Criteria:
Inclusion Criteria:

* Patients (between 18 to 75 years of age) who underwent POEM for achalasia or other esophageal motility disorders.
* Had a diagnosis of esophageal achalasia confirmed by High Resolution Manometry, barium esophagogram.

Exclusion Criteria:

* Patients who underwent treatment other than achalasia
* Lost to follow up patients.
* Incomplete clinical record patients
* Patients not willing to participate in the study
Efficacy and Tolerability of BAF312 in Patients With Polymyositis and Dermatomyositis

This study determined the efficacy, safety, tolerability and the PK profile of BAF312, a novel immunomodulator, in polymyositis and dermatomyositis patients who were not responsive to traditional immunosuppressive and/or corticosteroid therapy. The study consisted of a 12 week, randomized, placebo controlled period, followed by another 12 weeks where all subjects received BAF312 treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients with disease at least 3 months before study
* Muscle weakness
* Received corticosteroids with or with out disease modifying antirheumatic drugs at least 3 months before study however not responding to this therapy

Exclusion Criteria:

* Other idiopathic inflammatory myopathies
* Myopathy other than polymyositis and dermatomyositis
* Patients with late stages of disease
The Association Between Asparaginase Enzyme Activity Levels and Toxicities in Childhood Acute Lymphoblastic Leukaemia in NOPHOALL 2008

Evaluation of the association between risk and severity of asparaginase associated toxicities and asparaginase enzyme activity levels in children with Acute Lymphoblastic Leukemia treated in the NOPHO-ALL 2008 protocol.

Asparaginase treatment in acute lymphoblastic leukemia in children is jeopardized by a huge toxicity burden and the toxicities are often preventing further treatment. The most common asparaginase associated toxicities are hypersensitivity, pancreatitis, thromboembolism and osteonecrosis.

In the NOPHO ALL2008 protocol asparaginase associated toxicities have been registered since the protocol opened in July 2008. In addition asparaginase enzyme activity measurements have been done before every asparaginase administration and analyzed retrospectively.

This study evaluate the association between risk and severity of asparaginase associated toxicities and asparaginase enzyme activity levels in children with ALL treated in the NOPHO-ALL 2008 protocol.

Eligibility Criteria:
Inclusion Criteria:

* ALL, standard or intermediate risk
* Included in the NOPHO ALL2008 protocol (July 2016 - February 2016)
* Children (1-17,9 years at diagnosis)

Exclusion Criteria:

* ALL: high risk disease, ph-, genetic predisposition, bilinear ALL
* \< 2 samples for asparaginase enzyme activity measurements
Ease-it Spray for the Treatment of Fire Ant Stings

The application of Ease-it Spray will alleviate pain secondary to fire ant stings more quickly than placebo.


Eligibility Criteria:
Inclusion Criteria:

* AD soldier in US Army
* Ages 18-60
* Volunteer
* Absence of serious medical condition
* Past allergic reactions
* Asthma
* History of (h/o) IFA sting

Exclusion Criteria:

* Inability to provide informed consent
* Known h/o hymenoptera allergic reaction
* Allergy to any component of the treatments
* Inability to follow-up
* Active medical condition
* Pregnancy
Impact of 5-Fluorouracil (5-FU) on Cancer Cells From Liver Metastases of Colon Cancer

Analyze the dynamics of incorporation of 5-fluorouracil into cancer cell ribosomes from liver metastases of patient with metastatic colon cancer.

This is a monocentric, prospective, non-interventional cohort study in adult patients with metastatic colon cancer with hepatics metastasis.

Tumour samples collected for this study include:

* A fragment of the previously operated primary tumor: FFIP block and/or archived frozen tumor if available.
* A fragment of the liver metastasis(s) performed as part of standard metastasis surgery, this fragment will include a tumor area and a healthy area within the margin of excision. These samples collected in a fresh state will be analyzed immediately.

Eligibility Criteria:
Inclusion Criteria:

* Patient with metastatic colon cancer operated on and followed up at the Centre Leon Berard for liver metastasis.
* Patient affiliated to social security

Exclusion Criteria:

* Other pathologies that may interfere with biological evaluation, in particular known hepatic cirrhosis, whatever its origin, other liver overload diseases (hemochromatosis, Wilson's disease), but excluding steatosis (which can be chemo-induced).
Clinical Study to Evaluate Efficacy and Safety of ASC and Fibringlue or Fibringlue in Patients With Crohn's Fistula

This is a phase III study to evaluate the efficacy and safety of ASC(Autologous Adipose-derived Stem Cells) and Fibringlue or Fibringlue in Patients With Crohn's Fistula.

Experimental: ASC(Autologous Adipose-derived Stem Cells) and Fibringlue, Comparator: Fibringlue, Study type: Interventional, Study design: Randomized

Eligibility Criteria:
Inclusion Criteria:

1. Patient who has obtained the consent of their legal representative if they are over 18 years of age and under 20 years of age.
2. Patient is diagnosed with Crohn's disease.
3. Patient who has one or more Crohn's fistulas .
4. In the case of women of childbearing potential, patient who is negative for beta-HCG pregnancy tests at the screening visit.
5. Patient is able to give written informed consent prior to study start and willing to comply with the study requirements.

Exclusion Criteria:

1. Patient who participated in other clinical trials within 30 days prior to the start of this clinical trial, or who has not passed a period equal to five times of the half-life of the drug dosed in other clinical trials.
2. Patient with a medical history or family history of Variant Creutzfeld Jakob Disease or related to this disease.
3. Patient who is sensitive to anesthetic drugs or bovine-derived materials.
4. Patient with autoimmune disease except for Crohn's disease.
5. Patient with infectious diseases such as HBV, HCV and HIV.
6. Patient with signs of Septicemia.
7. Patient with Active Tuberculosis.(Including patient with Anal Tuberculosis)
8. Pregnant or breast-feeding.
9. . Is unwilling to use an acceptable method of birth control during the whole study.
10. Patient with Inflammatory Bowel disease except for Crohn's disease.
11. Patient who is sensitive to Fibringlue.
12. Patient with a clinically relevant history of alcohol or drugs abuse, habitual smoking.
13. Patient whose adipose tissue obtained by liposuction is insufficient to manufacture the Investigational product at the intended dose.
14. Patient who is not able to understand the objective of the study or to comply with the study requirements.
15. Patient who is considered by the investigator to have a significant disease which might impact the study.
16. Patient who is considered not suitable for the study by investigator.
17. Patient who is Active Crohn's disease with CDAI 450 or higher.
18. Patient with medical history of surgery for malignant cancer in the past 5 years.(Except for carcinoma in situ)
19. Patient who exceeds 2 cm in the longest diameter of fistula.
20. Patient who dosed anti-TNF formulations such as infliximab, adalimumab, certolizumab within 3 months prior to injection.
Safety and Immunogenicity of GSK Biologicals' Investigational Malaria Vaccine in HIV Infected Infants and Children

The purpose of this study is to assess the safety and immunogenicity of the candidate malaria vaccine in HIV-infected infants and children

This protocol posting has been updated due to protocol Amendment 2.

Eligibility Criteria:
Inclusion Criteria:

All subjects must satisfy ALL the following criteria at study entry:

* A male or female infant or child between and including 6 weeks to 17 months of age, at the time of first vaccination.
* Signed or thumb-printed informed consent obtained from the parent(s)/LAR(s) of the infant or child. Where parents/LARs are illiterate, the consent form will be countersigned by a witness.
* Subjects who the investigator believes that their parents/LARs can and will comply with the requirements of the protocol should be enrolled in the study.
* Subjects who are known to be HIV-infected (documented positive DNA PCR), whether taking HIV antiretroviral treatment (ART) or not.
* Subjects who are born following a normal gestation period.

Exclusion Criteria:

The following criteria should be checked at the time of study entry. If ANY exclusion criterion applies, the subject must not be included in the study:

* Acute disease at the time of enrolment. However, the presence of an illness listed as Grade I or Grade II (WHO pediatric AIDS clinical staging) will not of itself constitute an exclusion criterion. Enrolment should be deferred if axillary temperature is \>=37.5°C.
* Grade III or Grade IV abnormality on screening laboratory blood sample.
* Grade III or IV AIDS at the time of enrolment (WHO pediatric AIDS clinical staging).
* Major congenital defects.
* Planned administration/administration of a vaccine not foreseen by the study protocol prior to or within 7 days of study vaccine.
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine 30 days preceding Dose°1 of study vaccine, or planned use during the study period.
* Previous participation in any other malaria vaccine trial.
* Simultaneous participation in another clinical trial including administration of experimental treatment.
* Same sex twins.
* History of allergic reactions (significant IgE-mediated events) or anaphylaxis to previous immunizations.
* History of allergic disease or reactions likely to be exacerbated by any component of the study vaccine.
* Child in care.
Magnetic Resonance Imaging To Predict Outcomes In Aortic Aneurysms

The aorta is the main blood vessel that comes out of the heart and distributes blood to the whole body. In some people, the aorta becomes swollen (aneurysm) and bursts, especially as it passes through the abdomen. These 'abdominal aortic aneurysms' often occur without symptoms and can burst or rupture without warning. This usually leads to death and represents the thirteenth commonest cause of death in the United Kingdom. In this study, we are looking at a new technique that can look at the aortic aneurysm using magnetic resonance imaging; a technique that does not require x-rays or radiation. We have recently shown that, using magnetic resonance combined with a new imaging agent USPIO, we can detect 'hotspots' of activity in these aneurysms that seem to predict which aneurysms grow rapidly, and are therefore potentially at risk of rupture. We here propose to conduct a study in Edinburgh that will invite all patients who are under surveillance because of an aneurysm. We will image these patients using this novel technique and see if we can identify which patients burst their aneurysm, have an aneurysm that grows so large it needs to have surgery, or die. This will be important to establish as it will potentially lead to a new way of managing people that could ultimately save lives. This is particularly timely as national screening and surveillance programmes are currently being launched.

HYPOTHESIS We hypothesise that uptake of ultrasmall supraparamagnetic particles of iron oxide into the aortic wall will predict abdominal aortic aneurysm growth and clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

Patients with an abdominal aortic aneurysm \>40 mm

Exclusion Criteria:

1. Any medical history or clinically relevant abnormality identified on the screening medical examination, vital sign measurement, or clinical laboratory examination that is deemed by the principal investigator and/or designee to make the subject ineligible for inclusion.
2. Subjects with planned AAA surgery.
3. Renal impairment with eGFR of \<30 mls/min at screening, history of kidney transplant or history of contrast nephropathy.
4. Women of child-bearing potential without contraception,
5. Collagen-vascular disease.
6. Inability to undergo magnetic resonance or computed tomography scanning,
7. Contraindication to MRI scanning (as assessed by local MRI safety questionnaire) which includes but not limited to:

   * Intracranial aneurysm clips (except Sugita) or other metallic objects,
   * History of intra- orbital metal fragments that have not been removed,
   * Pacemakers, implantable cardiac defibrillators and non-MR compatible heart valves,
   * Inner ear implants,
   * History of claustrophobia in MR.
Premedication Dyclonine Improves Visibility During Bowel Cleansing for Colonoscopy

In this randomized controlled study, consecutive outpatients scheduled for elective colonoscopy were randomized into two groups. Group A patients (n = 300) used only 3L PEG before colonoscopy. Patients in group B (n = 300) were additionally advised to Dyclonine Hydrochloride Mucilage plus 3L PEG, The overall quality of colonoscopy cleaning was evaluated using the Boston Bowel Preparation Scale by a single endoscopist who was blinded to the intervention. Visibility was blindly assessed for the amount of air bubbles and adenoma detection rate (ADR). Difficulty of procedure, and adverse events were also evaluated.


Eligibility Criteria:
Inclusion Criteria:

1. Patients are between 18-75 years old
2. undergoing colonoscopy for diagnostic investigation, colorectal cancer screening or follow-up

Exclusion Criteria:

1. suspected gastrointestinal obstruction or perforation
2. severe acute inflammatory bowel disease
3. toxic megacolon
4. ileus or gastric retention, ileostomy,
5. hypersensitivity to any of the ingredients
6. pregnancy and lactation and/or at a risk of becoming pregnant
STRIPES Study: Study To Reduce Infection Post cEsarean Section

The objective of this study is to determine if the use of chlorhexidine gluconate cloths prior to cesarean section reduce the rate of infectious morbidity (i.e. surgical site infections, endometritis).

The study will be offered to women who present for a scheduled primary or repeat cesarean section at Mount Sinai Medical Center. The eligible women will be randomized to use of a 2% chlorhexidine gluconate (CHG) cloth or placebo cloth (a fragrance free cleansing cloth) the night before and the morning of their scheduled procedure. Participants will be blinded to the arm in which they have been assigned. This study intends to show that the use of 2% CHG cloths prior to cesarean section will reduce the rate of surgical site infections.

Chlorhexidine is a sterile, germ-free solution, which is regularly used to clean the skin immediately before surgery and works by killing or preventing the growth or spread of bacteria. Data exists in both the orthopedic and cardiac literature to show that an additional preoperative use of chlorhexidine further reduces the risk of post procedure infections. Limited data exists regarding the use of a preoperative use of chlorhexidine in patients undergoing Obstetric or Gynecologic procedures and there is no wash or cloth used prior to cesarean section as a standard of care. The hope for this study is to identify if an additional preoperative chlorhexidine wash will further decrease or prevent infection in women who deliver their babies via cesarean section.

All patients with a scheduled cesarean section surgery will be approached for enrollment during their pre-admission testing visit on the labor floor 2 days before the scheduled cesarean section, a visit that is standard procedure for this surgery. Once a patient is consented, she will be randomly assigned to one of the 2 arms of the study: the eligible women will be randomized to use of 2% chlorhexidine gluconate (CHG) cloths or placebo cloths (a fragrance free cleansing cloths) on the body the night before and the morning of their scheduled procedure. Participants will be blinded to the arm in which they have been assigned.

The purpose of this study is to determine if the use of 2% chlorhexidine gluconate cloths prior to cesarean section reduces the rate of surgical site wound infection and/or postpartum endometritis, which is an infection or inflammation of the endometrium (the inner lining of the uterus).

Eligibility Criteria:
Inclusion Criteria:

* women
* \> 24 weeks gestation
* scheduled for a primary or repeat cesarean section

Exclusion criteria:

* allergy to chlorhexidine
* unplanned or emergency cesarean section
Paper Applicator Acceptability Study

To assess the acceptability of a user-filled, paper, applicator for delivery of tenofovir (TFV) gel among women at high risk of acquiring human immunodeficiency virus (HIV) in rural KwaZulu-Natal, South Africa.

CAPRISA 070 is designed to enroll rural women who exit from CAPRISA 008 - an ongoing trial assessing implementation, effectiveness and safety of TFV gel in KwaZulu-Natal, South Africa. All study participants in CAPRISA 008 have also participated in CAPRISA 004 and thus have several years of experience using TFV gel with the prefilled, plastic applicator. CAPRISA 070 will allow us to assess acceptability of the user-filled, paper applicator among women who have had extensive experience with the pre-filled, plastic applicator and are well-positioned to provide feedback and comparisons on a new gel delivery method.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years and older
* Women who previously participated in CAPRISA 008
* Able and willing to provide first person informed consent to be screened for, and to enroll in, the study
* Allow access to their CAPRISA 008 data, including study exit data
* Able and willing to provide adequate locator information for study retention purposes
* Sexually active (at least one coital act in the last 3 months prior to screening)
* HIV negative
* Negative pregnancy test \*
* Agree to use a non-barrier form of contraceptive
* Agree to adhere to study visits and procedures

  * breastfeeding is not exclusionary but participants must be informed of the presence of TFV in breast milk in negligible amounts

Exclusion Criteria:

* Has creatinine clearance ,\<50ml/min, as estimated using the method of Cockcroft and Gault
* Has any other condition, that based on the opinion of the investigator or designee would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of the study outcome data, or otherwise interfere with achieving the study objectives