cyrilzakka/clinical-trials huggingface dataset:
Soy Derivatives for Control of Hot Flashes in Men on Androgen Deprivation Therapy

To determine the efficacy of soy/isoflavone supplementation on hot flashes in men who are being treated with luteinizing hormone-releasing hormone (LHRH) agonist therapy for control of advanced prostate cancer

Literature has shown that low dose estrogens can control hot flashes in men on androgen deprivation but with a high risk of thromboembolic events. Soy derivatives that contain isoflavones, a type of phytoestrogen, have been evaluated in peri-menopausal women as a possible safer alternative to synthetic estrogens but there has not been a similar study performed on their effect in men on androgen deprivation therapy for prostate cancer.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven adenocarcinoma of prostate with treatment of prostate cancer (radical prostatectomy, radiation therapy, etc.)
* had biochemical/clinical relapse and started on antiandrogens
* have documented history of hot flashes

Exclusion Criteria:

* History of MI, DVT, CVA
* peanut allergy
* untreated hypothyroidism
* must be off other medical treatment for hot flashes for 2 weeks before enrollment in this study
Pemetrexed/Cisplatin Intercalating Gefitinib Treating EGFR Wild NSCLC

To investigate the curative effect between Pemetrexed/Cisplatin and Pemetrexed/Cisplatin intercalating Gefitinib Treating EGFR Wild NSCLC

In preclinical data, it is identified that pemetrexed combined with erlotinib could achieve good response than pemetrexed because EGFR-TKI (erlotinib) could enhance the sensitivity of pemetrexed. So we design the trial to investigate curative effect between Pemetrexed/Cisplatin and Pemetrexed/Cisplatin intercalating Gefitinib Treating EGFR Wild NSCLC.

Eligibility Criteria:
Inclusion Criteria:

1.Histological or cytological diagnosis of small-cll lung cancer histology

2.18 years or older

3.Eastern Cooperative Oncology Group (ECOG) Performance Status no more than 2

4.Local stage SCLC without distant metastases

5.After 1st-line chemotherapy (EP or IP) at least 4 cycles

6.After radical radiotherapy for primary tumor and lymph node drainage area:including concurrent or sequence chemoradiotherapy

7.CR or PR assessment by RECIST(1.0) before randomized

8.Haemoglobin 10.0 g/dl, Absolute neutrophil count (ANC) 1.5\^9/L, platelets 100 x 10\^9/L

9.Total bilirubin 1.5 x upper limit of normal (ULN) alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 2.5 x ULN in the absence of liver metastases, or \< 5 x ULN in case of liver metastases

10.Creatinine clearance 60ml/min (calculated according to Cockcroft-gault formula)

Exclusion Criteria:

1. Mixed non-small cell lung cancer histology
2. Neck and supraclavicular lymph node metastasis
3. Be allergic to temozolomide or intolerable to radiotherapy
4. Any unstable systemic disease
5. Pregnant or lactating women
Lutonix® Drug Coated Balloon vs. Standard Balloon Angioplasty for Treatment of Femoropopliteal In-Stent Restenosis

To assess the safety and efficacy of the Lutonix Drug Coated Balloon for treatment of femoropopliteal artery (SFA) in-stent restenosis (ISR).


Eligibility Criteria:
Key Inclusion Criteria:

1. Male or non-pregnant female ≥18 years of age
2. Rutherford Clinical Category 2-4
3. Significant (≥ 50%) restenosis of a previous bare (not covered and not drug-eluting) nitinol stent(s) in the femoropopliteal artery
4. Lesion measures between 4 and 18 cm
5. Target vessel diameter between ≥4 and ≤6 mm and able to be treated with available device size matrix
6. A patent inflow artery free from significant lesion (≥50% stenosis) as confirmed by angiography
7. Successful crossing and predilatation of the target lesion with a guidewire
8. At least one patent native outflow artery to the ankle, free from significant (≥50%) stenosis as confirmed by angiography that has not previously been (nor planned to be) revascularized
9. No other prior vascular or surgical interventions within 2 weeks before and/or planned 30 days after the protocol treatment

Key Exclusion Criteria:

1. Life expectancy of \<1 year
2. Patient is currently participating in an investigational drug or other device study or previously enrolled in this study NOTE: Enrollment in another drug or device clinical trial during the follow up period is not allowed
3. History of stroke within 3 months
4. History of MI, thrombolysis or angina within 2 weeks of enrollment
5. Prior vascular surgery of the index limb, with the exception of remote common femoral patch angioplasty separated by at least 2 cm from the target lesion
6. Target lesion involves a previously placed covered stent or drug-eluting stent
7. Grade 4 or 5 stent fracture (mal-aligned components or trans-axial spiral configuration) in the restenotic stent
8. Inability to take required study medications or allergy to contrast that cannot be adequately managed with pre- and post-procedure medication
9. Known inadequate distal outflow (\>50 % stenosis of distal popliteal and/or all three tibial vessels), or planned future treatment of vascular disease distal to the target lesion
10. Intended use of adjunctive treatment modalities (i.e. laser, atherectomy, cryoplasty, scoring/cutting balloon, stents, etc.)
Study of UB-312 in Healthy Participants and Parkinson's Disease Patients

This is a 44-week, randomized, placebo-controlled, double-blind, single-center, phase 1 clinical trial consisting of a dose-escalation Part A study in healthy participants, followed by a Part B in participants with Parkinson's disease with a selected doses from Part A.

This is a first-in-human Phase 1 study to determine the safety, tolerability, and immunogenicity of UB-312 in healthy participants and in participants with Parkinson's disease (PD). UB-312 is a UBITh®-enhanced synthetic peptide-based vaccine and may provide an active immunotherapy option for treating synucleinopathies including the most prevalent form, PD.

The study consists of two parts. Part A of the study with healthy participants will consist of dose escalation and cohort staggering for up to seven planned dose levels or placebo. Part B of the study will consist of two cohorts of participants with Parkinson's disease (PD). Dosing for Part B will be based on safety, tolerability and immunogenicity from Part A. All eligible participants will be enrolled in a 44-week study consisting of 20 weeks of treatment and 24 weeks of follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 40 to 85 years old, inclusive at screening
* Expected to be able to undergo all study procedures
* Other inclusion criteria apply

For Part B only:

* A diagnosis of PD, confirmed by a neurologist
* Hoehn \&Yahr Stage ≤ III at Screening
* Stable treatment of permitted antiparkinsonian medications from 30 days prior to first study drug administration or 60 days for MAO-B inhibitors, and expected to remain stable throughout the study

Exclusion Criteria:

* Clinically significant abnormalities, as judged by the investigator
* History of medical, neurological or psychiatric conditions which in the opinion of the investigator may compromise participant's safety or scientific value of the study
* Acute or chronic infection as judged by the investigator, for positive human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis B virus (HBV)
* History or evidence of an autoimmune disorder
* History of anergy.
* Participated/participating in any clinical trial with monoclonal antibodies or vaccines directed at aSyn
* Other exclusion criteria apply

For Part B only:

* Other known or suspected cause of Parkinsonism other than idiopathic PD
* History or evidence at Screening of PD-related freezing episodes, falls, or orthostatic hypotension
* Dopamine transporter single-photon emission computerized tomography scan (DaTscan) inconsistent with dopamine transporter deficit.
* Clinically significant neurological disease other than PD
Physical Exercise on Physiological Adaptation Capacity and Chronic Pain in Individuals With Cardiovascular Risk

This research focuses on studying the effects of a 12-week exercise program on the health of individuals at risk of heart disease. The program includes High-Intensity Interval Training (HIIT) and Muscle Endurance Resistance Exercise (ERE). The researchers aim to observe the impact of these exercises on physiological adaptability, physical capacity, cardiovascular risk factors, metabolism, body composition, and chronic pain.

The participants will be inactive adults with a Body Mass Index (BMI) between 25 and 39.9, who are enrolled in a cardiovascular health program. Individuals with certain serious conditions, such as bone or heart problems, pulmonary diseases, cancer, or those who do not adequately understand instructions or Spanish, are ineligible to participate.

Patients will be selected by the program team and divided into three groups: one will perform HIIT, another will engage in ERE, and a control group will continue their usual treatment. Participants will be assessed at different times: before starting, at 4 weeks, at 8 weeks, and at the end of the program. Various health aspects will be measured, including physical activity, quality of life, physical capacity, cardiovascular risk factors, metabolism, body composition, and pain level.


Eligibility Criteria:
Inclusion Criteria:

* Physically inactive: Not engaging in 300 minutes of moderate or 150 minutes of vigorous physical activity per week, measured with the IPAQ questionnaire.
* BMI between 25 and 39.9 kg/m².
* Belonging to the cardiovascular health program of External Family Health Center Valdivia.
* Presenting or not presenting chronic non-cancerous pain.

Exclusion Criteria:

* Bone disease.
* Ischemic disease or arrhythmia.
* Chronic obstructive pulmonary disease (COPD) or asthma.
* Uncontrolled chronic diseases.
* Individuals unable to understand instructions.
* Individuals who do not speak Spanish.
* History of previous oncological disease or under investigation for suspected neoplastic disease in any part of the body.
Recommendations for Monitoring Clinical Experience Following Implantation of the AcrySof® Toric

To allow surgeons to obtain clinical experience on the postoperative uncorrected and best distance corrected visual acuities (UCVA and BDCVA) and corneal and refractive cylinder of the AcrySof Toric IOL.


Eligibility Criteria:
Inclusion Criteria:

* 40-80 years old; of any race and gender; diagnosed with bilateral cataracts; require cataract extraction followed by implantation of a posterior chamber IOL; patients have between 0.75 -2.5 D of astigmatism preoperatively as measured by K readings.

Exclusion Criteria:

* Females of child bearing potential;irregular corneal astigmatism;keratopathy/Keratectasia; cornea inflammation or edema;previous corneal reshaping,dystrophy or transplant;amblyopia;glaucoma;RPE/Macular changes;diabetic retinopathy.
Study on Akin Osteotomy: Fixation Versus Non-fixation (Fixakin)

We hypothesize that the Akin screw fixation osteotomy technique provides better postoperative mobility of the metatarsophalangeal hallux joint compared to the non-fixation technique.

Compare the screw fixation technique of Akin's osteotomy, compared to the technique without fixation, on the postoperative mobility of the metatarsophalangeal joint of the hallux at one year postoperatively in patients ( patients operated on for an isolated hallux valgus, that is to say without any associated lateral movement, by percutaneous technique (MICA or PERC).

Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years-old
* Patient undergoing percutaneous surgery for Hallux valgus with first hybrid and / or percutaneous ray procedure without rotation disorder,
* First line surgery,
* Absence of metatarsophalangeal osteoarthritis,
* Persistence of mobility of the hallux metatarsophalangeal gland,
* Subject benefiting from a social protection insurance
* Patient having signed the free and informed consent / Patient having given his express consent / Patient having been informed and not opposing this research.

Exclusion Criteria:

* Rotation disorder,
* Rheumatoid foot,
* Hallux rigidus.
* Patient participating in another clinical study
* Minors:
* Adults under guardianship, curatorship or other legal protection, deprived of their liberty by judicial or administrative decision;
* Pregnant, breastfeeding or parturient woman;
* Hospitalized without consent.
Addressing Patients' Expectations of Total Knee Arthroplasty in a Randomized Trial

The goals of this study are to develop and test an educational intervention to address patients' expectations of long-term outcomes of total knee arthroplasty.

The first goal of this study is to develop an educational intervention to address patients' expectations of long-term outcomes of total knee arthroplasty. The intervention will be structured according to the expectations listed in the Hospital for Special Surgery Total Knee Replacement Expectations Survey. The second goal is to test the intervention in a randomized trial. An additional goal is to compare patients' self-reported knee symptoms with radiographic findings.

Eligibility Criteria:
Inclusion Criteria:

* Patients will be eligible for this study if they are 40 years of age or older and are scheduled for primary total knee arthroplasty at the Hospital for Special Surgery.

Exclusion Criteria:

* Patients will be excluded from this study for the following reasons: if they are not fluent in English; if they are not going to attend the preoperative knee replacement class; if they are unable to complete the surveys; if they refuse to participate.
ERAS After Bariatric Surgery in Morbidly Obese

Recently, the number of bariatric surgery is increasing but ERAS (Enhanced Recovery After Surgery) protocol for bariatric surgery needs revision with evidence. So we investigated usefulness of ERAS protocol for bariatric surgery in morbidly obese patients.

Patients undergoing elective laparoscopic bariatric surgery are going to be recruited and divided into 2 groups: Group E will receive ERAS protocol, and Group C will receive standard perioperative care.

ERAS protocol comprises 8 hours of fasting and ingestion of oral carbohydrate 2 hour before surgery, TIVA(Total intra-venous anesthesia), TAP(transversus abdominis plane) block and IV-PCA using NSAIDs after surgery, and resumption of oral intake 2 hour after surgery.

Conventional anesthesia is composed of 8 hours of fasting, inhalation anesthesia, IV-PCA using NSAIDs, and resumption oral intake 6 hour after surgery.

In both groups, gastric ultrasonography will be used to measure gastric volume before surgery.

Functional hospital stay will be recorded from the end of surgery until all discharge criteria had been met. Pain scores will be recorded at 30 minutes, 4 hours, and 24 hours after surgery. Also, nausea and vomiting, time to ambulation, will be documented. After the patients are discharged, their charts are going to be reviewed and their medical expenses will be documented.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists grade 1 \~ 3
* BMI(Body Mass Index) ≥30
* Scheduled for elective laparoscopic bariatric surgery

Exclusion Criteria:

* American Society of Anesthesiologists grade 4 or 5
* History of abdominal surgery
Quality of Life Analysis of Treatment in Patients With Prostate Cancer on Adjuvant Zoladex Therapy

This is an open label, non-interventional quality of life analysis for Zoladex treated prostate cancer patients by investigator's questionnaire


Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent
* Early or locally-advanced prostate cancer patients on androgen deprivation therapy
* Investigators are requested to recruit patients only with at least 1 month prior Zoladex treatment.

Exclusion Criteria:

* Allergy to substance of medication
* Prostate cancer patients with advanced disease
Does the Hyoscine N-Butylbromide Administered During Colonoscopy Increase the Adenoma Detection Rate?

The primary aim of the study was to test if the administration of Hyoscine Butyl Bromide, at time of caecal intubation, increases the adenoma detection rate.

Outpatients referred for colonoscopy were screened for possible enrollment. Exclusion criteria included: glaucoma, benign prostatic hyperplasia or urinary obstruction, previous intestinal resection, ongoing therapy with tricyclic antidepressants, chronic renal failure and history of IBD. Eligible patients were randomized to receive either 20 mg/2ml of HBB i.v. or 2ml of saline i.v.; both the endoscopist and the patient were blind to the administered drug. The endoscopist was asked to inspect the right, transverse and left colon for at least 2 min for each segment. The number, size and location of polyps were recorded as well as the occurrence episodes of tachycardia (defined as bpm\>140). As indirect estimation of the amount of air retained in the abdomen at the end of the procedure, the DAC (difference in the abdominal circumference measured before and after colonoscopy) was also calculated. At discharge (at least 1 hour after colonoscopy) the bloating perceived by the patient was measured by means of a VA scale (range 0-100).

Eligibility Criteria:
Inclusion Criteria:

* outpatients referred for colonoscopy

Exclusion Criteria:

* glaucoma
* benign prostatic hyperplasia or urinary obstruction
* previous intestinal resection,
* ongoing therapy with tricyclic antidepressants
* chronic renal failure
* history of IBD
* participation other studies
* unsedated colonoscopy
Does Increasing Auditory Cueing Affect Gait Parameters in Children With Cerebral Palsy During a Functional Task?

To determine the clinical efficacy of auditory cueing using a cross over design to investigate whether increasing auditory cueing frequency by 20% above self paced cadence affects gait parameters in children with Cerebral Palsy when performing a functional task.

Introduction: Cerebral Palsy is a non progressive disorder occurring in early brain development, resulting in inefficient ambulatory pattern. The use of sensory cues to facilitate loco-motor activity has been suggested as providing the necessary trigger to synchronise movement with greater beneficial outcomes observed at higher frequency intensities within the adult population. Thus auditory cueing could have the potential to alter gait parameters during a functional task.

Aim: To explore if increasing auditory cueing frequency (AC20) affects gait during a functional task compared to auditory cueing at self-paced cadence (ACSC).

Method: Nineteen children with CP levels 1 and 2 on the Gross Motor Function Classification Scale participated using paired analysis. Outcomes were compared to the mean values for temporal spatial gait data within the conditions using a cross over design. TS data was obtained by using the GAITRite® walkway system whilst walking holding a cup.

Eligibility Criteria:
Inclusion Criteria:

* Children with Cerebral Palsy aged 5 to 11 years old who were scored as levels 1 to 2 on the Gross Motor Function Classification Scale.
* Cognitive status average or above on the Weschler Intelligence Scale for children.
* Able to hear without the use of a hearing aid.

Exclusion Criteria:

* Hearing impairment that results in the use of a hearing aid.
* Walking with assistance of a mobility aid.
* Cardiovascular problems or other associated health problems which limits the child waking multiple times over the GAITRite®.
Vitamin D, Genes and Colorectal Cancer

The aim of this study is to investigate the interaction between intake of vitamin D and polymorphisms in GC and CYP2R1 in relation to risk of colorectal cancer in a Danish prospective cohort study.

The association between vitamin D and incidence of colorectal cancer (CRC) has been thoroughly investigated in both observational and experimental studies, but the results are conflicting. Genetic epidemiology is an advantageous alternative to randomized, clinical trials for ethical and economic reasons.

The aim of this study is to investigate whether polymorphisms in GC and CYP2R1 that predicts 25-hydroxycholecalciferol (25(OH)D) concentrations after both ultraviolet B radiation and consumption of vitamin D3-fortified bread and milk in Danes are associated with risk of CRC; and further, to examine whether intake of vitamin D through diet and supplementation alter the risk of CRC.

Data are retrieved from the Danish prospective "Diet, Cancer and Health" study encompassing 57,053 persons which were recruited between 1993 to 1997. Between 1994 and 31th December 2009, 1038 CRC cases has been diagnosed. A sub-cohort of 1857 persons has been randomly selected within the full cohort at time of entry into the cohort. The study design is a nested case-cohort study.

Eligibility Criteria:
Inclusion Criteria:

* Born in Denmark
* No previous cancers at study entry
* Age between 50-64

Exclusion Criteria:

* Previous or present cancer(s) at study entry
Primary Dysmenorrhea Severity in Athletic vs. Non-Athletic Females

The aim of the study is to investigate the difference in the severity of primary dysmenorrhea between athletic and non-athletic females.

Primary dysmenorrhea is defined as colic pain in the lower abdomen which starts with the onset of menstruation. It is one of the most common gynecological disorders, an important cause of morbidity, and the most common cause of pelvic pain in menstruating girls and women it affects women in any age group. The prevalence varies widely, ranging from 17% to as high as 91%. Between 16% to 29% of women with dysmenorrhea have significant impairment in quality of life and the women's well-being. The rate of absenteeism from school, work, or other activities represents up to 15% of women with dysmenorrhea, dysmenorrhea is considered a source of considerable economic losses due to the costs of medications, medical care, and decreased productivity. Yoga, pilates, stretching, and other types of exercises have a noticeable effect on decreasing pain, and improving general health, and quality of sleep with different health conditions including primary dysmenorrhea. In addition, exercise and physical activity are used widely and proven to not only decrease pain but also improve quality of life, decrease stress, improve mental health, and in management of depression and stress.

For dysmenorrhea the mechanism that explained the effect of exercises on primary dysmenorrhea has been classified according to the intensity of the exercises; moderate -high-intensity exercise was believed to increase the anti-inflammatory cytokines, decrease the overall amount of prostaglandins released because of the decrease of the overall amount of menstrual flow. Low-intensity exercise reduces cortisol levels and prostaglandin synthesis

Eligibility Criteria:
Inclusion Criteria:

* Common inclusion criteria for athletic and non-athletic female.

  1. They had a regular menstrual cycle with a menstrual cycle length of 21-30 days.
  2. All females were virgins.
  3. Their ages ranged from 18 to 28 years old.
  4. Their BMI was ranged from 18.5 -29,9 kg/m2
  5. They did not use any pharmacological therapies for controlling pain during menstruation and during the application of the study.

Inclusion criteria athletic female:

1. They participated in the exercise for the last ≥ 6 months.
2. They did exercises for ≥ 3 days/ week.
3. They practiced (swimming, basketball, volleyball, ballet, gymnastics, judo, wrestling, karate, and boxing).

Exclusion Criteria:

1. History of pelvic pathology or any gynecological disease.
2. They had a history of chronic illness (eg: diabetes).
3. Their symptoms of dysmenorrhea became worse over time