cyrilzakka/clinical-trials huggingface dataset:
Endoluminale Obliteration Der Stammvene Mit Dem 1470nm Laser Versus VNUS Closure Fast

There is a difference concerning obliteration rate and postoperative pain after treatment of the saphenous vein with 1470nm laser or VNUS Closure Fast (=radiofrequency method) .

The endovenous treatment of the insufficient saphenous vein (large saphenous vein and small saphenous vein) is a standard procedure for years. There are different methods that cause an obliteration of the vein using heat. The adventage of these methods are low rates of minor and major complications compared to classic open surgery. There are also advantages concerning cosmetic and recurrence of varicous veins. Actually there are two different methods for the endovenous obliteration of the saphenous vein - lasers with wavelength of 1470nm or 1320nm and the radiofrequency method. The objective of this study is to compare these two different methods concerning postoperative pain, obliteration rate and the rate of pleased patients in 140 patients. All patients get an venous ultrasound investigation to determine the stadium of venous insufficiency. There are consecutive ultrasound investigations 10 days, 3 months and 12 months after surgical treatment.

In this study there are no additional risk factors for the included study patients except the risk of surgery.

Eligibility Criteria:
Inclusion Criteria:

* varicosis of great saphenous vein Hach-classification II-III (CEAP-classification: C3-4EPAS2-3PR and/or varicosis of small saphenous vein der Hach-classification I-III CEAP-classification: C3-4EPAS4PR)
* maximum diameter of the great saphenous vein of 15mm maximum diameter of the small saphenous vein of 12mm

Exclusion Criteria:

* surgical treatment of the saphenous vein in the past
* sclerotherapy of the saphenous vein in the past
* phlebitis or thrombosis of the saphenous vein
* surgical treatment of an venous ulcer in the past
* postthrombotic syndrome
* erysipelas of the leg in the past
* chronic treatment with pain-killers or chronic alcoholism
* pregnancy
* drug allergy against painkillers that are used in this study
* spinal anesthesia not possible
* compression bandage not possible
* patients with polyneuropathy
* patients with chronic pain
* persons that do have a connection or persons that are working for one of the jused companies (Laser or VNUS Closure Fast)
* participation on an other clinical trial that can interfere with this clinical trial
* missing written informed consent
Digital Support Intervention for Pregnant People with Opioid Use Disorders

The goal of this pilot randomized feasibility study is to explore the benefits of providing parenting and recovery support for pregnant people with Opioid Use Disorders through digital technology (e.g. smartphones). The main question it aims to answer is:

• What is the feasibility of providing customized digital parenting and recovery supports to pregnant people with Opioid Use Disorders residing in natural communities?

o Feasibility data includes data on study interest, eligibility, time to enroll, participant training on digital app usage, attrition;

Secondary outcome exploratory data will include MOUD treatment retention, missed follow up prenatal and early postpartum appointments, drug usage, and parenting outcomes (i.e., scores on the Parental sense of competency scale, Self-rated abilities for health practices scale, and Self-efficacy in infant care scale) through self-report; The intervention group only will also be observed regarding app usage, frequency of use, resources accessed, thoughts about the app, and what was found to be helpful.

Researchers will compare the bibliotherapy control group to determine clinical differences in secondary outcomes.

Participants will complete the following tasks:

* Schedule an online meeting with the research team to receive more information about the study. Once consented to participate, the participant will be randomly assigned to one of the groups.
* Complete survey questions within one week after agreeing to participate in the study, after 6 weeks, and 12 weeks. The surveys include questions about drug usage, missed follow-up medical appointments, and parenting outcomes. The total time to complete the survey after consenting to be in the study will take approximately 40 minutes. The total time to complete the surveys after the six week and 12-week study period should take no more than 30 minutes.
* Complete a one-hour virtual interview at three months post-delivery (by phone or computer) about the study experience.


Eligibility Criteria:
Inclusion Criteria:

Female, pregnant, greater 13 weeks gestational age

* Opioid Dominant Use Disorder and Primary Phenotype
* Residing in natural home environment
* minimum of 18 years of age
* Able to speak and understand English
* Able to understand and provide informed consent

Exclusion Criteria:

* Not pregnant, has active illicit opioid use and not currently in treatment
* a violent criminal history
* cannot read and communicate in English
Use of Bispectral Index (BIS) for Monitoring of Total Intravenous Anaesthesia in Pediatric Patients

The objective of the study is to determine wether the use of the Bispectral Index Monitor (BIS) as a method to guide anaesthesia for children in different groups of age, undergoing ear nose and throat surgery anaesthetized with an infusion of Propofol and Remifentanil with an high dose of Remifentanil (0,5-2 mcg/kg/min), can lead to a reduction in the time needed for extubation and in the amount of anesthetics used.

The participants to the study are patients undergoing the following operations: Tonsillectomy, Adenoidectomy, Microlaryngoscopy, Bronchoscopy, Esophagoscopy, Myringoplasty, Myringotomy with positioning of a tube.

All these procedures are performed with the patient receiving a general anesthesia with and infusion of Propofol and Remifentanil. Muscle relaxants and inhaled anesthetics are not used.

The patients undergoing a Tonsillectomy will receive a supplementary opioid analgesic (Inj. Fentanyl iv, 3mcg/kg) at the end of the surgical procedure. Patients undergoing the other operations receive intraoperative Paracetamol and NSAID for postoperative pain treatment.

Stratification by age (1-3y, 4-11y, 12-17y, 18-65y) will be performed to ensure balanced allocation of age groups and allow for identification of age and weight specific effects. Stratification by operation type will be performed to ensure the identification of the effects of the duration of anaesthesia and of the use of longer acting opioids (Fentanyl) on outcome parameters.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status 1 or 2
* General anesthesia for the following operations: Tonsillectomy, Adenoidectomy, Myringoplasty, Myringotomy with tube placement, microlaryngoscopy, bronchoscopy and esophagoscopy.

Exclusion Criteria:

* Psychiatric disorder
* Use of psychotherapeutic, antiepileptic, antiarrhythmic drugs
* Chronic use of opioids
* Intake of more than 21 alcoholic drinks/week
* Missing informed consent
Prediction and Prevention of Twin Premature Birth 2021

Research Objectives:

1. Establish a prediction and scoring system for twin premature birth.
2. To investigate the curative effect of 200mg,400mg and 600mg of vaginal progesterone in the prevention of twin premature birth.
3. To investigate the effect of stress cervical ligation in preventing premature delivery of twins.
4. The optimal dose of atosiban for the treatment of twin premature birth.
5. The influence of delivery mode on twin premature infants under 32 weeks.

Research Objectives:

1. Establish a prediction and scoring system for twin premature birth.
2. To investigate the curative effect of 200mg,400mg and 600mg of vaginal progesterone in the prevention of twin premature birth.
3. To investigate the effect of stress cervical ligation in preventing premature delivery of twins.
4. The optimal dose of atosiban for the treatment of twin premature birth.
5. The influence of delivery mode on twin premature infants under 32 weeks. It has now entered the second phase: clinical data collection

Eligibility Criteria:
Inclusion Criteria:

twins with cervical length ≤ 25 mm by vaginal ultrasound at 14-32 weeks no contractions, abdominal pain and vaginal bleeding No complicated twin complications occurred during pregnancy

Exclusion Criteria:

Patients undergoing selective cervical ligation before 14 weeks of gestation history of liver problems or cholestasis during pregnancy Abnormal liver enzymes Abnormal renal function Local allergy to trace natural progesterone Recurrent vaginal bleeding Recurrent vaginal infection Ultrasound diagnosis of fetal abnormality Intrauterine treatment for fetal abnormalities
The Addition of Inhaled Furosemide to Standard Treatment of COPD Exacerbation

The goal of this randomized controlled trial is to determine the effect of adding inhaled furosemide to the known treatment of patient with Chronic obstructive pulmonary disease (COPD) exacerbation. It primarily aims at studying its effect on:

1. Relief of dyspnea sensation
2. Length of hospital stay

Participants will be receiving the standard therapy of COPD exacerbation plus either inhaled furosemide or inhaled saline over 3 days. They will be asked to:

* Perform spirometry
* Fill in dyspnea score
* Do arterial blood gases (ABGs)


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Diagnosed with COPD
* Presenting with COPD exacerbation
* Requiring hospitalization

Exclusion Criteria:

* Hemodynamically instability (systolic blood pressure ≤ 90mmHg, heart rate ≥ 120 or ≤ 50 Bpm)
* Decreased level of consciousness
* Non-invasive mechanical ventilation or intubation at the time of recruitment
* \>5 liters of oxygen at the time of recruitment
* Pregnant patients
* Other primary pulmonary disease or heart failure exacerbation
Evaluation of the Efficacy of Varenicline on Cognition, Safety, Tolerability and Pharmacokinetics in Subjects With Mild-to-Moderate Alzheimer's Disease

1. Assess the efficacy of varenicline, relative to placebo, on a performance based measure of cognition in patients with mild to moderate Alzheimer's disease
2. Evaluate the effects of varenicline on clinically relevant measures including attention and executive function, behavior, and clinician rated global change.
3. Evaluate the safety and tolerability of varenicline, relative to placebo, in patients with mild to moderate Alzheimer's disease
4. Evaluate the pharmacokinetics of varenicline in patients with mild to moderate Alzheimer's disease.


Eligibility Criteria:
Inclusion Criteria:

* Males or females, age 55-85
* Diagnosis of probable Alzheimer's disease, consistent with criteria from both: 1) National Institute of Neurological and Communicable Disease and Stroke and Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) and 2) Diagnostic and Statistical Manual of Mental Disorders (DSM IV)
* Mini-mental status exam score of 14-26 inclusive
* Rosen-Modified Hachinski Ischemia Score of \< or = 4

Exclusion Criteria:

* Diagnosis or history of other dementia or neurodegenerative disorders
* Diagnosis or history of clinically significant cerebrovascular or cardiovascular disease
* Subjects with pulmonary disease or evidence of clinically significant pulmonary symptoms
Examination of Plasma Concentrations and Safety in Chronic Kidney Disease Patients Undergoing Hemodialysis

This study is to assess the safety, tolerability, plasma concentration and pharmacodynamics of ASP7991 after oral administration to patients with chronic kidney disease undergoing hemodialysis.

To examine the pharmacokinetics, pharmacodynamics and safety in patients with chronic kidney disease undergoing hemodialysis.

* To assess the pharmacokinetics (PK), pharmacodynamics (PD), safety and the effect of hemodialysis on PK of single oral administration of ASP7991 in Part 1.
* To assess the safety, PK and PD of repeated oral administration of ASP7991 in part 2.

Eligibility Criteria:
Inclusion Criteria:

* Patients on stable chronic maintenance dialysis who are receiving hemodialysis therapy 3 times/week for more than 12 weeks (84 days) and are also scheduled to undergo the regimen of 3 times/week hemodialysis during the study period
* Patients who have secondary hyperparathyroidism;

  1. Receiving Active vitamin D or Cinacalcet hydrochloride
  2. OR iPTH values ≥ 180 pg/mL at screening in case patients receive no medication for secondary hyperparathyroidism.
* Corrected serum Ca at screening：≥ 8.4 mg/dL
* No changes in items below at least 7 days before screening and do not have a plan to change something in the items below during the trial.

  1. Dose and type of Active Vitamin D, Calcitonin preparation, Phosphate binder.
  2. Ca concentration of the dialysate, membrane area of the dialyzer and dialysis time of each week(possible to change within ±10%)

Exclusion Criteria:

* Patients who underwent parathyroid intervention within 24 weeks prior to the informed consent
* Patients who have primary hyperparathyroidism
* Having a history of gastric/intestinal resection considered influential on the absorption of the drug in the gastrointestinal tract
* Patients with uncontrolled hypertension (systolic blood pressure ≥ 180 mmHg and diastolic blood pressure ≥ 120 mmHg are showed at the previous three points at the initiation of dialysis including the screening assessment)
* Complicated by severe heart disorder \[congestive cardiac failure (NYHA classification III or higher), or wide range of old myocardial infarction\], or having a history of hospitalization for cerebro-vascular disease or heart disorder within 12 weeks(84 days) before obtaining the informed consent.
* Concurrent serious hepatic disease (acute and active chronic hepatitis, hepatic cirrhosis)
* History of malignant tumor
* History of serious drug allergy including anaphylactic shock
* Potentially child-bearing, lactating, those who do not comply with the instructed contraceptive measures
* Patients who were involved in an assessment of other clinical trial within 12 weeks(84 days) prior to the informed consent
* Patients who is an employee of the sponsor, CRO, SMO, or sites related to the study.
* Patients who have been judged ineligible to participate in the study by the investigator / sub investigator.
High-dose Vitamin D Supplementation for ADT-induced Side Effects

The purpose of this study is to test the efficacy of a high-dose vitamin D supplementation regimen in reducing androgen deprivation therapy (ADT)-related side effects in older prostate cancer patients on ADT. The proposed study is a randomized, double-blind, 2-arm, controlled clinical trial that will accrue 76 prostate cancer patients without severe bone loss, aged 60 and older, beginning ADT, and scheduled to receive at least 6 months more of ADT. Participants will be randomized to: 1) weekly high-dose vitamin D3 (50,000 IU) or 2) vitamin D placebo only for a period of 24 weeks. Both groups will also receive a daily multivitamin and calcium supplement.

The investigators hypothesize high-dose vitamin D supplementation will reduce androgen deprivation therapy (ADT)-related side effects including ADT-induced bone loss, decreased muscle mass, falls, reduced muscle strength, and diminished physical performance in older prostate cancer patients. The vitamin D supplementation is aimed at reducing fracture risk by maintaining proper bone density, thereby preventing osteoporotic/osteopenic conditions and increasing muscle mass. Both vitamin D and exercise are efficacious in maintaining proper bone health and muscle mass among the general population, but little research has been done on prostate cancer patients and survivors. Vitamin D could reduce fracture risk among prostate cancer survivors.

Eligibility Criteria:
Inclusion Criteria:

* Have a confirmed diagnosis of stage I-IIIA prostate cancer
* Within 6 months of starting ADT with an additional 6 more months planned.
* Participants must have sub-optimal vitamin D levels of \<32 ng/ml.
* Participants must agree not to take calcium and/or vitamin D supplements for the duration of the intervention other than those provided.
* Participants must have an ionized serum calcium level within normal limits (1.19-1.29mmol/L) and a total corrected serum calcium of ≤10.5 mg/dl.
* No contraindications for fitness testing and no physical limitations (e.g. cardiorespiratory, orthopedic, nervous system) as assessed by their physician.
* Able to read English (since the assessment materials are in printed format).
* Able to swallow medication and provide written informed consent.
* 60 years of age or older.

Exclusion Criteria:

* Previously verified diagnosis of osteoporosis (any t-score ≤ -2.5).
* Patients on antiresorptive drugs (i.e. bisphosphonates) within the past year.
* Patients with hypercalcemia (corrected serum Ca \> 10.5 mg/dl) or a history of hypercalcemia or vitamin D toxicity/sensitivity.
* Patients with impaired renal function (CrCl \< 60 mL/min) or who had kidney stones (calcium salt) within the past 5 years.
* Myocardial infarction within the past year.
Weight Management in Rural Communities

The goal of this study is to evaluate the effect of three weight management interventions (group phone conference calls, individual phone calls, and enhanced usual care) on weight across 18 months in overweight and obese adults recruited through and treated by rural primary care clinics.

The rates of overweight/obesity are significantly higher among residents of rural areas compared to their urban counterparts. Recent focus to provide whole-person health care suggests that rural primary care clinics may provide an ideal setting for delivery of weight management.

This study is a 3 group randomized trial to evaluate intervention delivery. The investigators will randomize 200 overweight/obese adult residents of rural towns (town population \< 50,000) who obtain health care at primary care clinics to one of three groups for an 18 month trial (6 month weight loss; 12 month weight maintenance).

Group 1) Group phone (GP)/Portion-Controlled Meals (PCM)

Group 2) Individual phone (IP)/PCM

Group 3) Enhanced usual care (EUC)/Conventional Diet (CD)

All participants will receive a progressive physical activity program. Physical activity will progress from 45 min/wk in month 1 to 225 min/wk in month 4 and remain at 225 min/wk for the duration of the 18 month study for Group 1 \& 2. Physical activity will progress from 45 min/wk in month 1 to 150 min/wk in month 4 and remain at 150 min/wk for the duration of the 18 month study for Group 3.

Participants on the CD will be asked to consume a nutritionally balanced, reduced energy, high volume, lower fat (fat= 20-30% energy) diet recommended by the Academy of Nutrition and Dietetics and the USDA's MyPlate approach. Examples of meal plans consisting of suggested servings of proteins, grains, fruits and vegetables, dairy and fats based on individuals energy needs will be provided. Participants using PCM will consume PCMs with the addition of 5 fruits and vegetables per day during weight loss.

EUC will meet with a health educator every 6 months to discuss weight management topics. GP \& IP will receive the weight management intervention over the phone weekly during weight loss and biweekly during weight maintenance tracking diet and physical activity and will submit the results to a health educator prior to every meeting.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index 25 to 45 kg/m2
* Clearance from primary care physician

Exclusion Criteria:

* Unable to participate in moderate intensity physical activity
* Participation in weight loss or physical activity program in previous 6 months
* Greater than 3, 30-min bouts of planned exercise/week
* Not weight stable (+/-4.6 kg) for 3 months prior to intake
* Unwilling to be randomized to 1 of the 3 study groups
* Report being pregnant during the previous 6 months or planned pregnancy in the following 18 months
* Serious medical risk such as cancer, recent cardiac event
* Current use of antipsychotics or untreated depression
* Adherence to specialized diet regimens (food allergy, vegetarian, macrobiotic)
* Binge eating disorder
* Planning to movie to a location and no longer having access to rural clinic site
Comparison of Cervical Cerclage by Vaginal and by Laparoscopic Transabdominal Routes in the Periconceptional Period

The goal of this observational study is to compare two different surgical techniques of performing elective cervical cerclage in the prevention of preterm delivery, both of which are already widely used in common clinical practice: elective cervical cerclage by the vaginal route and laparoscopic transabdominal elective cervical cerclage.

For the purpose of this study, no study-specific visits are planned. Data will be collected in a pseudo-anonymized manner, assigning each participant a sequence number.

For patients who undergo elective vaginal cervical cerclage at the division of Obstetrics and Prenatal Age Medicine or laparoscopic cerclage at the division of Gynecology and Human Reproductive Pathophysiology, the normal care pathway does not include additional follow-up visits for outpatient follow-up visits.

Regarding data collected in the past as part of the normal care pathway, patients will be asked to give informed consent in the context of a follow-up visit at which a practice staff member will be present.

Eligibility Criteria:
Inclusion Criteria:

* Patients with unfavorable obstetric history, i.e., at least two previous preterm deliveries or second-trimester abortions who underwent elective prophylactic cervical cerclage (vaginal or laparoscopic) between 01/01/2002 and 31/12/2020
* Age ≥18 years
* Obtaining informed consent form
* Availability of clinical-demographic data

Exclusion Criteria:

* Multiple pregnancy
Study Evaluating DVS-233 SR In Adult Outpatients With Major Depressive Disorder

Primary Objective: To compare the antidepressant efficacy and safety of subjects receiving DVS-233 SR versus subjects receiving placebo.

Secondary Objective: To assess the response of subjects receiving DVS-233 SR for the clinical global evaluation, functionality, general wellbeing, pain, and absence of symptoms (Hamilton Psychiatric Rating Scale for Depression, 17-item \[HAM-D17\] less than or equal to 7) versus those subjects receiving placebo.


Eligibility Criteria:
Inclusion Criteria:

* Outpatients
* Sexually active women participating in the study must use a medically acceptable form of contraception
* Subjects must have a primary diagnosis of major depressive disorder of 4 on Clinical Global Impressions-Severity scale (CGI-S)

Exclusion Criteria:

* Treatment with DVS-233 SR at any time in the past
* Treatment with venlafaxine (immediate release \[IR\] or extended release \[ER\]) within 90 days of study day 1
* Known hypersensitivity to venlafaxine (IR or ER)
Investigation of Factors Affecting Children's Attitudes Towards Peers With Disability

Children with disabilities can be exposed to stigma and discrimination because of poor attitudes. The role of peer is crucial for development of disabled children.

The aim of the study was to investigate the attitudes of children towards their peers with disabilities and to identify factors associated with them.

1305 elementary school students included to the study. The students participating in the study, 48.9% (534) were female, 51.1% (558) were male. The Chedoke-McMaster Attitudes towards Children with Handicaps (CATCH) scale was used to investigate the children's attitudes.

* Being important in terms of epidemiological investigation.
* Giving new results from society with different cultural and national characteristics.
* Investigating the three components of the CATCH.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria were being a student of elementary school, being aged between 11-15 years and being volunteer.

Exclusion Criteria:

* Students who had a congenital or acquired disability or a handicap and who did not complete the scale were excluded.