cyrilzakka/clinical-trials huggingface dataset:
Nurses' Health Study and Health Professionals Follow-Up Study (Dermatological Component)

To determine the relationships of dietary factors with the subsequent risk of dermatological diseases (such as skin cancers and inflammatory or autoimmune dermatoses) in a cohort of female registered nurses and male health professionals.

The study population consisted of two ongoing cohorts: the Nurses' Health Study (NHS) and Health Professionals Follow-Up Study (HPFS). The NHS began in 1976 when 121,700 female nurses aged 33-55 years and residing in the United States responded to a baseline questionnaire. The HPFS began in 1986 when 51,529 male health professionals aged 40-75 years and residing in the United States completed a similar baseline questionnaire. Study investigators sent follow-up questionnaires biennially to participants to update information on past medical history as well as lifestyle factors.

Follow up was started in 1984 for the NHS and 1986 for the HPFS when diet was measured with an expanded food frequency questionnaire (FFQ). Participants in the NHS responded to an \~130 item semi-quantitative FFQ in 1984, 1986, and then every four years thereafter, while those in the HPFS responded to a similar FFQ in 1986 and then every four years thereafter. The FFQ collected information on average intake of each food item over the past year. It also specified a common serving size for each item. Participants could select from one of nine intake frequency choices, ranging from less than once per month to six or more times per day. Participants also provided information on current use and dose of multivitamins and use of other vitamin supplements.

For both cohorts, investigators repeatedly collected and updated information on several anthropometric and lifestyle factors such as weight, smoking status, alcohol use, coffee intake, and physical activity level. Information was also collected on several major risk factors for skin disease such as family history of melanoma, number of arm moles, natural hair color, sunburn susceptibility as a child or adolescent, number of lifetime blistering sunburns, type of tan after repeated sun exposure as a child or adolescent, and cumulative ultraviolet flux since baseline.

Study subjects reported new diagnoses biennially. After obtaining permission from participants, their medical and pathological records were acquired. Study physicians blinded to questionnaire information reviewed these records to confirm diagnoses

The study was approved by the institutional review boards of both Brigham and Women's Hospital and Harvard T.H Chan School of Public Health.

Eligibility Criteria:
Inclusion Criteria:

-Participants of these two cohorts

Exclusion Criteria:

* Participants with missing data on dietary intake at baseline
* Participants with a prior history of cancer (except non-melanoma skin cancer)
* For skin cancer, non-white participants because of low risk of skin cancer (such as melanoma) and small numbers.
* For melanoma, participants with in-situ melanomas, which comprise tumours restricted to the epidermis of the skin.
Investigation on Differences in Skin Sodium Content Between Normal Subjects and ICU-patients

This study investigates the differens in sodium storage in skin between normal subjects, patients after cardiac surgery and septic patients.

According to the current paradigm ICU-acquired hypernatremia is mainly an iatrogenic problem, caused by sodium overload or water deficit. In spite of several interventions to reduce sodium intake and optimize fluid balance, critically ill patients still develop hypernatremia. These patients also seem to have an inability to excrete sodium, hence develop a positive sodium balance. In animals sodium storage in the third compartment was found. Our hypothesis is that sodium storage in the third compartment is different in critically ill patients and this difference could play a role in the development of ICU-acquired hypernatremia.

Eligibility Criteria:
Inclusion Criteria:

* 50-80 years (septic patients), 45-85 years (CABG and hip replacement-patients)
* Patients undergoing hip replacement: no relevant medical history (i.e. chronic and/or systemic diseases with a suspected influence on sodium / sodium handling)
* Septic patients: fulfilling the criteria for the systemic inflammatory response syndrome in the presence of a(n expected) new infection

Exclusion Criteria:

* Absence of both upper legs
* Skin disease that makes skin biopsies in healthy skin impossible
* Subjects with in their history formation of exaggerated scar tissue
* Subjects suffering from psoriasis or lichen ruber
* Use of skin corticosteroids on all skin of both upper legs \< 2 weeks before inclusion
* Tattoos covering the whole surface of both upper legs
* Use of diuretics in the past month
* Current renal replacement therapy
* Septic patients: not being sedated
* Patients undergoing hip replacement: hip replacement because of an inflammatory disease
Drug-drug Interaction Following Oral Administration of Telmisartan/Amlodipine and Atorvastatin in Healthy Adult Volunteers

study to evaluate drug-drug interaction following oral administration of telmisartan/amlodipine and atorvastatin in healthy adult volunteers


Eligibility Criteria:
Inclusion Criteria:

* 19\~55 years healthy male
* The result of Body Mass Index(BMI) is not less than 19 kg/m2 , no more than 27 kg/m2
* Subjects who agree to keep contraceptive methods during the clinical trial.

Exclusion Criteria:

* Subjects who are allergic to investigational drug.
* Subjects who have a medical history which can affect the clinical trial.
* Hypertension(Systolic BP ≥ 150mmHG or Diastolic BP ≥ 100mmHg), Hypotension(Systolic BP ≤ 100mmHg or Diastolic BP ≤ 70mmHg)
* Liver enzyme (AST, ALT) level exceeds the maximum normal range more than one and a half times.
Effects of Mulligan Technique With or Without Diclofenac Phonophoresis on Patellofemoral Pain Syndrome.

The patellofemoral pain syndrome (PFPS) is a common cause for "anterior knee pain" and mainly affects young women. the effectiveness of Mulligan technique with or without diclofenac phonophoresis on pain, range of motion and functional disability of knee joint in patients with patellofemoral pain syndrome is known little. This study, ethically approved, focused on patients with anterior knee pain referred to the Physical Therapy Department from Lahore General Hospital. After eligibility assessments and consent, participants were randomly assigned to Group A (Experimental) or Group B (Control). Over four weeks, three sessions per week, routine physiotherapy and specific exercises will be administered, with Group A receiving additional Phonophoresis using ultrasound and diclofenac gel. Outcome variables (Numeric Pain Rating Scale, KOOS-PF, Universal Goniometer) will be assessed by a blinded assessor at baseline and study completion.

Background: The patellofemoral pain syndrome (PFPS) is a common cause for "anterior knee pain" and mainly affects young women without any structural changes such as increased Q-angle or significant pathological changes in articular cartilage.

Objective: To evaluate the effectiveness of Mulligan technique with or without diclofenac phonopheresis on pain, range of motion and functional disability of knee joint in patients with patellofemoral pain syndrome.

Methodology: This study, ethically approved, focused on patients with anterior knee pain referred to the Physical Therapy Department from Lahore General Hospital. After eligibility assessments and consent, participants were randomly assigned to Group A (Experimental) or Group B (Control). Over four weeks, three sessions per week, routine physiotherapy and specific exercises were administered, with Group A receiving additional Phonophoresis using ultrasound and diclofenac gel. Outcome variables (Numeric Pain Rating Scale, KOOS-PF, Universal Goniometer) were assessed by a blinded assessor at baseline and study completion.

Eligibility Criteria:
Inclusion Criteria:

* • Patients of age range 20-45 years and both genders (Rehman, 2021 #171)

  * Unilateral anterior knee pain persisting for over two months, referred by orthopedic (Rehman, 2021 #171)
  * Pain scoring rate on numeric pain rating scale (NPRS) \>3 during at least two activities (Rehman, 2021 #171)
  * Patients with positive Clarke's test/ Patellar grind test (Rehman, 2021 #171)
  * Pain while going up and down stairs, when sitting with knees flexed and with squatting, kneeling or returning from squat. (Powers, 2017 #172)

Exclusion Criteria:

* • Patients with other knee pathologies; meniscus tears, bursitis, patellar tendon injury, ligamentous injury

  * Degenerative joint disorders; knee osteoarthritis, rheumatoid arthritis etc.
  * Patellofemoral dislocation and / or frequent subluxation.
  * Patients having undergone lower extremity surgery
  * Those taking any pain medications
Quantifying Patellar Tendon Microstructure Using DTI

The goal of this observational study is to understand how diffusion tensor imaging (DTI) relates to other traditional measures and knee function. The main question it aims to answer is:

Will regions of known patellar tendon pathology present with smaller DTI scalar parameters, shorter fiber length, and lower fiber density compared to the contralateral tendon and healthy regions in the ipsilateral tendon.

Participants will:

* undergo MRI and ultrasound imaging
* perform knee function test
* complete questionnaires

Patellar tendon injuries are commonly accompanied by macrostructural alterations captured on common imaging modalities, and the extent of these alterations correlate to knee joint function. Evidence for using tendon macrostructure for diagnosis and prognosis of tendon injuries is not as clear, suggesting that these imaging modalities are not providing a complete picture of the alterations. Diffusion tensor imaging (DTI) tractography can quantify tendon microstructures that underlie the alterations in pathological tendons and shows promising results in healthy tendons. This study is the first step in evaluating whether tendon microstructure captured using DTI technology can be applied as a biomarker to optimize treatment for patellar tendon injuries.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Have patellar tendon injury as confirmed through subjective report, clinical examination, and ultrasound by an experienced physical therapist
* Patellar tendinopathy group must present with current symptoms of patellar tendinopathy
* Control group must have no history of patellar tendon injury

Exclusion Criteria:

* Participants with a history of invasive procedures other than bone-patellar tendon-bone (BPTB) autograft harvest to the patellar tendon or extensor mechanism
* Participants with history of contralateral BPTB autograft harvest, or ACLR using any other graft type
* Participants with contraindications to MRI
* Participants with contraindications to NMES
Treatment of Symptoms After Stent Placement for Urinary Tract Obstruction

The purpose of this study is to determine whether combination therapy with Tolterodine ER and Tamsulosin is more effective than monotherapy with tamsulosin alone in reducing stent symptoms. The second purpose is to determine if people have less stent discomfort if they take these medications starting 2 weeks before the stent is placed

The investigators hope to show that the addition of Tolterodine ER to Tamsulosin will provide added benefits in reducing stent symptoms in patients who have had unilateral placement of a ureteral stent.

The investigators aim to show that the addition of Tolterodine ER to Tamsulosin will provide added benefits in ameliorating stent-related symptoms in participants who have had unilateral placement of a ureteral stent for urolithiasis. This objective will be assessed by determining the mean difference in the urinary symptom index domain of the Urinary Stent Symptom Questionnaire, which is a validated tool used to assess stent symptoms. The investigators suggest that a 15% further decrease in the index score in the experimental group, compared to the control group would represent a clinically significant improvement in urinary symptoms, based on the prior studies evaluating lower urinary tract symptoms in patients with stents. The investigators hypothesize that combination therapy with Tamsulosin and Tolterodine ER will yield greater symptom relief than tamsulosin alone.

Initially, a 7-day design (medical starts 7 days before stent insertion) was conducted to determine whether combination therapy with Tolterodine ER and Tamsulosin is more effective than monotherapy with tamsulosin alone in reducing stent symptoms.

Previous studies showed that tolterodine ER therapy significantly reduces urinary symptoms by week 4 of medication therapy. Given the evidence that tolterodine ER requires a longer duration to have maximum benefit, in the second phase, investigators increased the duration of medication to start 2 weeks prior to surgery and continued for 7 days after surgery, for a total of 21 days of medication, to test whether combination therapy is more effective than monotherapy in reducing stent symptoms

Eligibility Criteria:
Inclusion Criteria:

* Patients with unilateral ureteral stent placement for urolithiasis

Exclusion Criteria:

1. Pre-existing lower urinary tract symptoms
2. Active urinary tract infection
3. Contraindication to anticholinergic medication

   1. Prior hypersensitivity or allergy to tolterodine
   2. Patients with severe hepatic impairment (Child-Pugh Class C)
   3. Patients with uncontrolled close (narrow) angle glaucoma
   4. Patients with urinary retention
4. Current anticholinergic use
5. Chronic pelvic pain syndromes (e.g. acute/chronic prostatitis, interstitial cystitis)
6. Women who are pregnant or nursing
7. Under 18 years of age
8. Prior hypersensitivity or allergy to tolterodine
9. Patients with severe hepatic impairment (Child-Pugh Class C)
10. Patients with uncontrolled close (narrow) angle glaucoma
11. Patients with urinary retention
12. Unable to provide informed consent
Woman Centred Childbirth Care Training

Woman centred childbirth care has become more meaningful and important in today's conditions. Although women-centred childbirth care is frequently mentioned in the literature, it is thought that there are no studies on this subject and it will be beneficial to train midwives on this subject. In this study, it is aimed to examine the effect of online education that will be given to midwives based on the Midwifery Model of Women-Centred Childbirth Care, on both patient-centred care competency and job satisfaction levels.

Research type: Semi-experimental research -Pre-test with control group, post-test designed- Population and sample selection: The universe of the study consists of all midwives who work in the childbirth unite. The effect rate of the intervention in the research, for which the studies on the job satisfaction level of midwives are descriptive in the literature, is unknown. Therefore, Cohen standard effect rate was used. According to the sample size analysis performed in the G-Power program for the sampling, a total of 48 volunteers will be included in the study, with the power of the research being 80%, the alpha of 0.05 and the Cohen standard effect ratio of 0.8, as 26 for the intervention group and 26 for the control group. It is planned to include 52 midwives.

Hypotheses

1. Hypothesis: H0: There is no difference in patient-centered care competence levels between midwives who attended the Women-Centred Midwifery Care Training Program and those who did not.

H1: The patient-centered care competence level of midwives participating in the Women-Centred Midwifery Care Training Program is higher than the control group.

Hypothesis 2:

H0: There is no difference in job satisfaction between midwives who attended the Women-Centred Midwifery Care Training Program and those who did not.

H1: Job satisfaction of midwives participating in the Women-Centred Midwifery Care Training Program is higher than the control group.

Eligibility Criteria:
Inclusion Criteria:

* Being midwife
* Working in a childbirth unit

Exclusion Criteria:

* Midwives having a Coronavirus Disease-19 (COVID-19) infection
Safety and Tolerability of Soy Fiber

This is a dose escalation trial in the elderly with obesity to determine the maximum tolerated dose of a novel dietary fiber from whole young soy pods (soy) delivered in foods.

The tolerability to 10 g, 20 g, and 30 g of soy will be tested. At each dose, eight subjects will incorporate the foods containing soy into their usual diet for one week. The tolerability to each dose will be evaluated and fecal short chain fatty acids will be measured as a biomarker of compliance. Subjects who satisfy the eligibility criteria and express willingness to consume the study foods will be enrolled.

Eligibility Criteria:
Inclusion Criteria:

* Adult (70 - 85 years).
* Body mass index between 30 and 40 kg/m2.
* No evidence of diabetes (fasting blood sugar \<126 mg/dL).
* No evidence of dementia (MMSE score \> 25).
* No evidence of depression. (Geriatric Depression Scale-15 \[GDS-15\] \< 6.
* Are weight stable (\< 3 kg weight change in the past three months).

Exclusion Criteria:

* Have type 1 or type 2 diabetes currently being treated by medication.
* Report clinically significant gastrointestinal malabsorption syndromes such as chronic diarrhea, or celiac disease.
* Are being treated with medications that have a significant effect on insulin resistance, obesity, and metabolic rate, or medications that significantly increase body weight such as antidepressants, second-generation antipsychotics, systemic glucocorticoids, and adrenergic blockers or stimulators (unless the dose and body weight have been stable for six months).
* Have serum triglyceride concentrations \> 400 mg/dl.
* Clinically significant abnormal laboratory markers (as determined by the medical investigator).
* Subjects with anticipated surgery during the study period.
* Subjects with a reported history of substance abuse or alcoholism or significant psychiatric disorder that would interfere with the ability to complete the study.
* Subjects who are current smokers or have smoked within the previous three months. Smoking is not permitted during the study.
* Subjects who are unable to provide a baseline blood or fecal sample or if they have any condition that impedes testing of the study hypothesis or makes it unsafe to consume the food being tested in the study (determined by the investigative team).
* Women on hormone replacement therapy unless weight has been stable over the last six months.
Laparoscopic "DA VINCI" Robot Assisted Abdominal Wall Hernia Repair

The aim of this study is to prove the superiority of the robotic assistance in laparoscopic repair of abdominal wall hernias .

In this monocentric randomized controlled trial, the use of the DA VINCI robot might reduce the post-operative pain of the patient resulting in a 40% reduction of morphine consumption.

Laparoscopic Robot Assisted abdominal wall hernia repair : a prospective randomized trial:

The main judgement criterion is post operative pain reflected by morphine consumption during the first 48 hours. Secondary criteria are morbidity, quality of life, duration of surgery, conversion rate, complications, the the length of stay and hospital costs.

In this single centre study, inclusion criteria are age above 18, no previous repair of the hernia with a mesh and a diameter of the parietal defect of less than 10 cm. Contraindications are chronic use of pain drugs of level II or above and renal insufficiency (clearance \<30ml/min).

The robotic repair was described in a previous paper of our group and will be compared to our classical laparoscopic repair technique, and in both cases with the use of the same prosthetic mesh.

A total of 70 patients to be included in an 18 months period was calculated to prove a 40% reduction in morphine consumption during the postoperative 48h (α=5% and β=10%).

The total duration of the study is 30 months (12 months of follow-up for each patient).

Eligibility Criteria:
Inclusion Criteria:

* over 18 years
* with indication of hernia repair
* a collar with a diameter of less than 10cm
* no antecedent of hernia treatment with poses plate
* agreeing coelioscopy
* agreeing to participate the clinical study, having sign an informed consent
* agreeing a regular monitor

Exclusion Criteria:

* taking analgesic tier 2 or 3
* against indication to anesthetics or coelioscopy
* creatinine clearance less than 30 ml/min
* pregnant woman and protected persons
* no affiliation to social security
* unable to understand the information form
Female Urogenital Nutrition- Health Study

The purpose of this study is to assess nutrition and urinary tract bacterial activity during menstruation of approximately 15 female university Reserve Officer Training Corps (ROTC) cadets and Phoenix area police officers, firefighters, and military veterans.

Urinary tract infections (UTIs) disrupt tactical service women's obligations and health, which increases sexual transmitted infections (STIs), HPV, and cervical cancer risk if left untreated. Females are more susceptible to UTIs due to their unique anatomical features and hormone fluctuations affecting vaginal flora. During phase 1 of the menstrual cycle (i.e., onset of bleeding, menstrual cycle days 1-5), estrogen levels significantly decrease and inhibit the growth of lactobacilli (good bacteria), which is essential in warding off bad bacteria and infections, particularly UTIs. The uropathogenic bacterial growth in phase 1 could be heightened in phase 2 of the menstrual cycle (i.e., leading to ovulation), as increases in estrogen favors bacteria adhesion and arginine vasopressin (AVP) release that stimulates fluid retention, leading to less volume flow in the urinary tract. To reduce UTI onset, it is recommended to frequently urinate with sufficient urine void volume to facilitate washing out harmful bacteria from the urethra and bladder. While menstruating, increased fluid consumption to support urination frequency and void volume may be critical, as the urinary tract is more predisposed to infections, and the effects of estrogen on bacterial adhesion and AVP release in phase 2 could continue uropathogenic growth.

Question(s) 1: Are premenopausal tactical service women's current hydration status and behaviors (i.e., fluid intake and urination) sufficient? How many premenopausal tactical service women have a UTI history?

Question 2: Will increasing daily water intake of identified underhydrated tactical service women reduce uropathogenic bacterial activity during the first part (i.e., onset of bleeding through day 5) of the menstrual cycle?

Eligibility Criteria:
Inclusion Criteria:

* Female
* 18-34 years of age or older (premenopausal)
* Have a 21-35-day menstrual cycle
* No changes in hormonal contraceptives within the last three months
* No current UTI symptoms
* Sexual activity and inactivity

Exclusion Criteria:

* Males
* Under 18 years of age or over 34 years of age
* Pregnant or nursing
* Menstrual irregularities effecting having a menstrual cycle to be between 21-35 days
* Progesterone-only contraceptive use (combined estrogen-progesterone and non-hormonal IUDs are okay)
* Currently taking antibiotics
* On hormone replacement therapy
* Currently experiencing symptomatic vulvovaginitis
* Diagnosed with recurrent UTI
* Not volunteering to participate
Evaluation of Ultrasound of the Heart in Patients With Low Blood Pressure

Hypothesis: Goal-directed echocardiography by trained critical care physicians is equivalent to that of echocardiography technicians/cardiologists for the purpose of determining etiology (reason) of cardiopulmonary failure.


Eligibility Criteria:
Inclusion Criteria:

* Patients who present to the medical intensive care unit with cardiopulmonary failure

Exclusion Criteria:

* None