cyrilzakka/clinical-trials huggingface dataset:
Antigravity Treadmill With Alter G on the Postural Stability of Traumatic Lower Limb Injuries

This prospective randomised study aimed to test the investigators's hypothesis that anti-gravity treadmill therapy has beneficial effects on postural stability tests over a standard rehabilitation protocol in patients who have suffered traumatic injuries of the lower limb, demonstrating an improvement in the Biodex platform's values.

The total of 30 patients participated in this study (n=30). There were 15 subjects in control group and 15 in experimental group.

This prospective, randomised, controlled, longitudinal and triple-blind masked clinical design was performed in patients derived to the rehabilitation service of Fremap Sevilla Hospital after an laboral accident with surgery and not surgery traumatic injuries.

After that, participants were questioned about their personal data and the inclusion and exclusion criteria. All agreed to participate and provided signed informed consent prior to data collection.

Participants were allocated according to the inclusion and exclusion criteria into an intervention and a control group. The intervention was performed in two weeks. Patients were randomised into the intervention (anti-gravity treadmill) or control (standard protocol) rehabilitation group.

Previous data is taken from the "Postural Stability", "Stability Limits" and " m-CTSIB" tests on the Biodex Balance System SD platform.

The control group will perform the hospital's standard protocol for these injuries while the experimental group will also be added the anti-gravity treadmill in Alter G once a day.

At 2 week post-treatment, subjects were tested again. All patients were able to complete all rehabilitation sessions and balance tests.

Sample size assessment: accepting an alpha risk of 0.05 and a beta risk of 0.1 in a bilateral contrast, 15 subjects in each group are needed to detect a minimum difference of 15% between two groups, assuming that there are 2 groups and a standard deviation of 12%. A 10% rate of loss of insurance has been estimated.

Statistical analysis plan: the statistical analysis will be carried out using IBM-SPSS Statistics 24 software. The Kolmogorov-Smirnov test will be applied to test the distribution of the data. Student's t-test will be applied for paired variables when the data have a parametric distribution. The Mann-Whitney U test will be used to analyse data with a non-parametric distribution. The Chi-Squared will be used to compared qualitative variables. The confidence level used will be 95% (0.05) and the power of the study will be 90% (0.1).

Eligibility Criteria:
Inclusion Criteria:

* Age between 25 and 55
* Sex male and female
* Surgical or non-surgical subacute knee, ankle, and foot traumatic injuries

Exclusion Criteria:

* Vestibular pathology
* Important dysmetry
* Neurological pathology
* Acute inflammatory diseases.
* Important degenerative diseases.
* Autoimmune diseases.
* Severe visual deficits.
* Tumor pathology.
The Cognitive Effects of Lorazepam in Healthy Older Individuals With TOMM40 Variable-length Polymorphisms

The investigators' goal is to determine if certain tests of memory and attention, performed while sleepiness is induced by a single dose of lorazepam, can predict whether or not an individual is at risk for developing Alzheimer's disease.


Eligibility Criteria:
Inclusion criteria:

* Mini-Mental State Examination (MMSE) score of 28-30
* Hamilton Depression Rating Scale score of less than 10
* participants in longitudinal study of aging and have a TOMM40 genotype of S/S, VL/VL, S/VL, L/S or L/VL.

Exclusion criteria:

* Alzheimer's Disease or Mild Cognitive Impairment
* any significant medical, psychiatric, and neurological illnesses, e.g., impaired liver or kidney function, prior stroke, traumatic brain injury, memory impairment, cognitive impairment, parkinsonism, a lifetime history of schizophrenia, bipolar disorder, a psychoactive substance use disorder, or current major depression.
* known allergy to benzodiazepines
* current use (within the previous four weeks) of benzodiazepines or other medications known to interact with lorazepam, current use of sedating antihistamines, or current use of stimulant medications
Effects of Soy Compounds on Breast Cancer, Prostate Cancer, and Bone Health

This study will determine the effects of soy products on in vitro surrogate cancer markers as well as bone density markers and quality of life parameters in men and women. This study will also determine concentrations of isoflavones (naturally occurring plant compounds that act like estrogen in the body) in prostate tissue that has been removed during prostatectomy, as well as in the blood.

In the United States, consumption of soy products has dramatically increased in the past several years. Foods made from soy are high in isoflavones and evidence suggests that these isoflavones, genistein in particular, have many beneficial properties such as alleviating menopausal side effects and reducing the risk of osteoporosis, breast cancer, and prostate cancer. However, this data has been derived largely from studies with animal or cell models; human trials are limited. This study will determine the effects of soy isoflavones on quality of life and cancer and bone density markers.

While isoflavones have been purported to inhibit the proliferation of cancer cells, the concentrations required for this anti-cancer effect were determined to be much higher than the concentrations that can be achieved in plasma after intake of isoflavones. Recent animal studies have suggested that isoflavones may be concentrated 10-fold in tissue compared to blood concentrations. If this is true, then the higher concentration would be in the range found in the cancer cell line research to be protective of cancer. This study will determine whether tissue concentrations are similar to, higher than, or different than blood concentrations.

This study will last 5 years and will comprise three populations: men with prostate cancer on androgen ablation therapy, postmenopausal women on hormone replacement therapy (HRT), and postmenopausal women not on HRT. Participants will be randomly assigned to receive either isoflavone or placebo for two to four weeks. Participants' serum and serum extracts will be incubated with cultured human cell lines (prostate cancer, breast cancer and osteoblasts) and estrogenic and non-estrogenic mechanisms of action investigated. The human sera data will be complemented by parallel studies of direct addition of crystalline isoflavones (genistein, daidzein and equol) to the same cultured human cell lines. Participant's serum and urine also will be tested for markers of bone resorption and formation. Quality of life issues will be assessed with questionnaires.

Eligibility Criteria:
Inclusion Criteria

* Scheduled for prostatectomy
* Willing and able to consume study tablets for at least 2 weeks prior to surgery
* Willing to accept random assignment
* Signed informed consent

Exclusion Criteria

* Unwilling to avoid soy intake during the study period
* Currently taking antibiotics
Dose of Spinal Manipulation for Chronic Low Back Pain

This study will determine the number of visits to a chiropractor for spinal manipulation, light massage, and ultrasound necessary for optimal relief of chronic low back pain. The study will also determine the effectiveness of spinal manipulation.


Eligibility Criteria:
Inclusion Criteria:

* Current episode of low back pain
* mechanical origin
* Threshold low back pain level

Exclusion Criteria:

* Contraindications to spinal manipulation or massage
* Complicating conditions that could confound clinical outcome
* Prophylactic use of prescription medication
* Health-related litigation, claims, or disability compensation
Assessing the Efficacy of a Serotonin and Norepinephrine Reuptake Inhibitor for Improving Meniere's Disease Outcomes

As of yet, the cause of Meniere's disease is uncertain and there is no cure. Given the lack of high level evidence for treatments, we seek to perform a randomized, placebo-controlled, double-blind, crossover, pilot trial of venlafaxine for treating Meniere's disease. Venlafaxine is a safe and well-tolerated medication. It has never been trialed in Meniere's disease, but there is evidence that it could be effective in helping with vertigo attacks and other aspects of the disorder.


Eligibility Criteria:
Study subjects will be prospectively recruited from the population of patients presenting with dizziness to our tertiary, multidisciplinary, vestibular-focused, neurotology clinic. Subjects must meet the following inclusion criteria:

* be 18 years of age or older;
* have definite MD as defined by the Barany Society 2015 international consensus statement;
* have active MD with at least 2 vertigo episodes in the month prior to enrollment; and score at least 36 on the Dizziness Handicap Inventory (DHI), representing at least moderate handicap.

Patients with the following will be excluded:

* other concurrent vestibular or balance disorder (especially those with vestibular migraine-related vertigo episodes despite not meeting diagnostic criteria for vestibular migraine);
* currently taking venlafaxine, SSRIs, or SNRIs;
* history of medical (e.g. gentamicin) or surgical (e.g. labyrinthectomy) vestibular ablative treatment;
* history of otologic, lateral skull base, or brain surgery;
* history of radiation to the head or neck;
* known neurologic disorder affecting cognition;
* currently taking another serotonin modulating medication;
* seizures;
* stroke;
* myocardial infarction;
* hepatic or renal impairment;
* hyperlipidemia;
* coagulopathy;
* psychiatric disorder other than anxiety or depression;
* glaucoma;
* uncontrolled hypertension;
* pregnancy or intention of pregnancy.
Pharmacokinetic Interactions of Valsartan and Hydrochlorothiazide

This study was conducted to compare the rate and extent of absorption of valsartan and hydrochlorothiazide following oral administration as a fixed dose combination tablet and concomitant administration of the individual drugs under fasting conditions in healthy Egyptian subjects. The study was extended to investigate any potential reaction between VAL and HCT.

This study comprised 2 separate parts, I and II; each was a single-dose, open-label, 4-crossover periods separated by a 2 weeks washout, and 4-Treatments. Part I consisted of Treatments A (VAL 160 mg alone), B (HCT 12.5 mg alone), C (VAL 160 mg + HCT 12.5 mg) and D (VAL / HCT 160 mg/12.5mg) and Part II consisted of Treatments E (VAL 320 mg alone), F (HCT 25 mg alone), G (VAL 320 mg + HCT 25 mg) and H (VAL / HCT 320 mg/25 mg). Blood samples were collected up to 48 hours postdose and plasma was analyzed for VAL and HCT concentrations using HPLC. The pharmacokinetic properties of each drug after co-administration of VAL and HCT were compared with those of each drug administered alone.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old and not more than 45 healthy male volunteers
* Actual weight no more than ± 30% from ideal body weight based on sex, height, and body frame
* Who had passed all the screening parameters
* Free of any drug exposure known to interfere with the pharmacokinetics or assay of fexofenadine for at least 10 days prior to the study
* Who had to be able to communicate effectively with study personnel, be literate, and able to give consent.

Exclusion Criteria:

* A clinically significant abnormal physical exam, medical history, or laboratory studies
* If they showed a sitting SBP of \>140 or \<100 mmHg, DBP \> 90 or \<60mm Hg, or a pulse rate of \> 95 or \< 50 beats/min at screening
* A history of serious intolerance, allergy, or sensitivity to fexofenadine
* The use of any prescription drug within the previous month or use of any over-the-counter medication (with the exception of acetaminophen) within the past 14 days
* A history of blood dyscrasias
* A history of alcohol or drug abuse within the past year
* Donation of blood during the 8 weeks prior to the study or plans to donate blood during or within 8 weeks of completing the study
* Unable to tolerate vein puncture and multiple blood samplings
* Any surgical/medical condition that might alter drug absorption, distribution, metabolism, or excretion
* Cannot follow instructions, in the opinion of the investigator.
TWICE (Ezetimibe Together With Any Statin Cholesterol Enhancement)(0653-060)

In patients with primary hypercholesterolemia treated with a statin and with ldl-c above the recommended target goal (esc 2003 recommendations ldl\>=1.15 g/l) to compare the efficacy and the safety of ezetrol added to ongoing statin and non drug therapeutic intervention (patient motivation on diet or physical activities or both).


Eligibility Criteria:
Inclusion Criteria:

* Primary hypercholesterolemia treated with any statin at any dose, for at least 3 months with a ldl cholesterol above 115 mg/dl (esc 2003 recommendations).

Exclusion Criteria:

* pregnant or breast feeding women
* Lipid-lowering agents including hmg-coa reductase inhibitors other than the current statin, fish oils, cholestyramin, niacin (\>200 mg/day) and fibrates taken within the 3 months preceding visit 1.
A Phase 2 Study of MM-141 Plus Nab-paclitaxel and Gemcitabine in Front-line Metastatic Pancreatic Cancer

The purpose of this study is to determine whether the combination of MM-141 plus nab-paclitaxel and gemcitabine is more effective than nab-paclitaxel and gemcitabine alone based on Progression Free Survival (PFS) in front-line metastatic pancreatic cancer patients with high serum levels of free IGF-1.

This is a randomized, double-blind, placebo-controlled Phase 2 study of MM-141 plus nab-paclitaxel and gemcitabine or placebo plus nab-paclitaxel and gemcitabine in front-line metastatic pancreatic cancer. All patients will be initially screened for free IGF-1 status. Eligible patients with high free IGF-1 will be randomized to receive MM-141 plus nab-paclitaxel and gemcitabine or placebo plus nab-paclitaxel and gemcitabine and patients. Patients with low free IGF-1 or patients who have high free IGF-1 but are not otherwise eligible will be followed in an observational group.

Eligibility Criteria:
Inclusion Criteria:

* Metastatic adenocarcinoma of the pancreas. Patients with islet cell neoplasms are not eligible.
* Patient must have received no prior radiotherapy, surgery, chemotherapy, or investigational therapy for the treatment of metastatic disease.
* Blood sample sent for free IGF-1 testing
* ECOG performance status (PS) of 0 or 1

Exclusion Criteria:

* Patients who only present with localized disease
* Patients with CNS malignancies (primary or metastatic)
* Clinically significant cardiac disease
Modified Enhanced Recovery After Oblique Lateral Interbody Fusion Surgery

The goal of this randomized clinical trial is to investigate whether modified enhanced recovery after surgery (ERAS) in oblique lumbar interbody fusion (OLIF) can shorten the postoperative hospital stay among patients with lumbar degenerative disease.

The main questions it aims to answer are:

Whether ERAS can shorten the postoperative hospital stay. Whether modified ERAS can improve postoperative functional recovery, improve functional score and pain score, reduce hospitalization costs, improve mental state, and improve abdominal indicators, etc.

Participants will be randomized into modified ERAS group, or control group.

The main questions it aims to answer are:

Whether ERAS can shorten the postoperative hospital stay. Whether modified ERAS can improve postoperative functional recovery, improve functional score and pain score, reduce hospitalization costs, improve mental state, and improve abdominal indicators, etc.

Participants will be randomized into modified ERAS group, or control group.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-80 years old;
* Lumbar degenerative diseases that meet the indications of fusion surgery;
* Patients who are suitable for OLIF surgery;
* Patients who have actually completed OLIF surgery;
* The number of fusion segments is less than or equal to two;
* There was no basis for serious diseases of brain, lung, kidney and other important organs, and preoperative American Society of Anesthesiologists (ASA) score was I-III;
* Agree to participate in the study and sign the informed consent form.

Exclusion Criteria:

* Patients undergoing lumbar fusion surgery due to spinal trauma;
* Patients undergoing lumbar fusion surgery due to spinal tumor resection;
* Revision surgery;
* The number of fused segments is more than 2;
* Simultaneous lumbar fusion via other approaches, such as transforaminal lumbar interbody fusion (TLIF), posterior lumbar interbody fusion (PLIF), anterior lumbar interbody fusion (ALIF), etc.;
* Pregnancy or perinatal period;
* Blood system diseases lead to coagulation dysfunction;
* Combined with other diseases, life expectancy less than 2 years;
* Patients is participating in other clinical trials.
DynaCleft® Effects on Soft Tissues and on Quality of Life for Incomplete Unilateral Cleft Lip Infants

The purpose of this study is to examine the effectiveness of the DynaCleft® system on soft tissues of infants with unilateral incomplete cleft lip and to assess influences on quality of life for infants who underwent DynaCleft® and that of their families.


Eligibility Criteria:
Inclusion Criteria:

Retrospective Group:

* Unilateral cleft lip with or without cleft palate
* Patients of a single surgeon (Matthew Greives, MD)
* Patients with complete photographs:

  * After birth, first visit
  * At cleft lip repair (3-4 months)
  * Post-operative cleft repair (about 1 year of age)

Prospective Group:

* Patients with incomplete unilateral cleft lip with or without cleft palate
* Patients of any surgeon

Exclusion Criteria:

Retrospective Group:

* Bilateral cleft lip or complete unilateral cleft lip
* Patients operated on by other primary surgeons
* Patients with incomplete photo records will be evaluated to determine if the patient should be excluded

Prospective Group:

* Patients with bilateral cleft lip or complete unilateral cleft lip
* Patients whose parents refuse to consent to inclusion
* Patients with tape allergies to the adhesive of the DynaCleft®
* Patients with syndromic craniofacial conditions or Tessier type facial clefts
Resection Versus Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma With Solitary Huge Tumor

This clinical trial aims to compare hepatectomy with Transarterial Chemoembolization (TACE) for Hepatic Cellular Cancer With Solitary Huge Tumor (≥5cm). All patients will be divided into two group.One group will receive hepatic resection, while an another equivalent group patients will be treated with Transarterial Chemoembolization.

Hepatocellular carcinoma (HCC) is the most common primary malignant tumor of the liver.For Barcelona Clinic Liver Cancer (BCLC) stage B patients，especially those with Solitary Huge Tumor (≥5cm) ，the better therapy between hepatic resection and transarterial chemoembolization remains controversial despite extensive studies。 From now on, we prospectively collected patients with solitary huge HCC who received hepatectomy or TACE. Of the 200 patients，100 patients were surgically treated and the others underwent TACE。After the treatment, patients received routine follow-up with physical examination, serum α-fetoprotein (AFP) level and ultrasonography at 3-month intervals for the first year and then every 6 months.The end of follow-up was determined as either the time of last follow-up (July 2019) or death. The overall survival，including 1, 2 and 3-year overall survival rates，will be analyse. All data are collected prospectively.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Hepatic cellular Carcinoma.
* Patients with Solitary Huge Tumor (≥5cm）of Hepatic cellular Carcinoma (HCC) detected by Serum Alpha Fetoprotein (AFP) and CT or MRI.
* Patients without Hepatic vein or bile duct invasion and extrahepatic metastasis.
* Patients without surgical contraindication.
* Patients with Child A or B liver function and indocyanine green retention rate at 15min (ICGR15) \< 10% before treatment.
* Laboratory examination: haemoglobin (Hb)\>100g/L, white blood cell (WBC) \> 3000/mL, blood platelet counts (PLT) \> 8×10\*10/L before treatment.
* Patients without severe esophagogastric varices before treatment.
* Patients with HBV，HBV DNA≤100, 000 copy/mL.
* All of the patients has written consent for this research.

Exclusion Criteria:

* Patients with multiple tumors or vascular or bile duct invasion or extrahepatic metastasis.
* Patients with surgical contraindication.
* Patients with Child C grade liver function before treatment.
* Patients with other malignancy.
* .Patients treated with hepatic resection or TACE before this treatment.
* Patients with severe esophagogastric varices or refractory ascites or coagulation dysfunction before treatment.
Laser Lithotripsy for Ureteral Stones

Objectives: To present the outcomes of retrograde and antegrade ureteroscopic laser lithotripsy in the treatment of proximal ureteral stones ranging in size from 10 to 20 millimeters in diameter.

Patients and methods: From March 2023 to December 2023, 70 patients were included in this prospective randomized double-arm interventional study. Patients were divided into two groups: Group 1: (35 patients) had semi-rigid retrograde ureteroscopic laser lithotripsy and group 2: (35 patients) had semi-rigid antegrade ureteroscopic laser lithotripsy.

The present study was conducted in Al-Azhar University Hospital (Damietta branch), urology department,at the period from March 2023 to December 2023. Seventy patients with symptomatic proximal medium sized ureteric stones were classified in two groups Retrograde Uretroscopic Laser Lithotripsy (group 1) and Antegrade Ureteroscopic Laser Lithotripsy (group 2) .

The preoperative-(patient- and stone-related), intraoperative- and postoperative- related parameters that might influence the perioperative course and short-term clinical outcomes were evaluated.

Eligibility Criteria:
Inclusion Criteria:

- Patients with medium-sized proximal ureteral stones (10-20 mm) situated between the ureteropelvic junction and the top edge of the L5 vertebral body; age 18-65 years

Exclusion Criteria:

* Pregnancy, bleeding disorders, morbid obesity (BMI \> 35), patients with stenosis of the ureter, history of previous surgery on the ipsilateral ureter, patients with a simultaneous kidney stone requiring surgery, and patients with an active urinary tract infection