cyrilzakka/clinical-trials huggingface dataset:
Quitting Matters Human Immunodeficiency Virus Hybrid Trial

The purpose of this study is to compare the advantages and disadvantages of two approaches for quitting smoking among people living with HIV (PWH). Participants will complete a 24- week (\~6-month) study where the Participants will be assigned to one of two smartphone apps to help with quitting smoking. Regardless of the group participants are assigned to, they will also receive a combination of nicotine replacement therapy (patches and gums) that have been shown to help people quit smoking. The main questions this study aims to answer are:

Participants will complete 5 video call visits over about 6 months. Participants will install their assigned smoking cessation app onto their phone and will be asked to use the app for the duration of the study along with their provided Nicotine Replacement Therapy (NRT) products. During the study visits, participants will meet with study staff to complete questionnaires and interviews. Participants may be asked to provide breath and saliva samples to measure the level of carbon monoxide and nicotine.

Tobacco use has alarmingly high rates among people with Human Immunodeficiency Virus (HIV) (PWH), 43% compared with 15% in the general population. Due to the development of highly effective treatments for HIV and the resulting increased longevity among PWH, this population now loses more life years to smoking than to HIV infection itself. Novel and effective models to deliver wider reaching smoking cessation interventions for PWH are highly needed and indicated as a priority for National Institute of Health. Digital therapeutics (DTx) may be a novel, scalable, and highly available approach for engaging and treating smoking in this population. However, although DTx for smoking cessation have been shown effective in the general population, no large trial to date has examined the effectiveness of a tailored DTx for smoking cessation in PWH, and no implementation science work has examined barriers and facilitators of implementation of DTx for smoking cessation in this population.

Eligibility Criteria:
Inclusion Criteria:

1. Self-reported daily cigarette smoking over the past 30 days
2. Self-reported HIV status
3. Age 18 or older
4. Desire to quit smoking
5. Willing and medically eligible to use NRT
6. Currently receiving HIV care
7. Currently owning an Android or iOS smartphone

Exclusion Criteria:

1. Current acute psychotic episode or unsafe to participate in the study
2. Pregnant or intending to become pregnant in the next 6 months
3. Currently receiving any pharmacological and/or behavioral intervention or counseling for smoking cessation
4. Any medical condition or medication that could compromise subject safety, as determined by the PIs and/or study physician
5. Not able to fluently speak and write in English
6. Hearing, comprehension, visual, speech, or motor limitations that preclude study participation
Terlipressin Given As I.V. Boluses Versus Terlipressin Given As Continuous Intravenous Infusion In Patients With Cirrhosis And Type 1 Hepatorenal Syndrome

It is well known that terlipressin and albumin improve renal function in patients with cirrhosis and type 1 HRS. In previous studies terlipressin has been used either as intravenous boluses moving from an initial dose of 0.5-1 mg/4 hr or as continuous intravenous infusion at the initial dose of 2 mg/24 h. Up to now the two schedules of i.v. administration of terlipressin have never been compared. Nevertheless, it has been hypothesized that continuous intravenous infusion assures a more steady profile of effect on portal pressure in patients with cirrhosis. Thus, the aim of the study will be to compare terlipressin given as i.v. bolus vs terlipressin given as continuous intravenous infusion in the treatment of type 1 HRS in patients with cirrhosis.


Eligibility Criteria:
Inclusion Criteria:

* Patients with cirrhosis and type 1 HRS

Exclusion Criteria:

* HCC beyond the Milan Criteria,septic shock (systolic arterial pressure \< 90 mmHg,
* Significant heart or respiratory failure,
* Peripheral arteriophaty clinically significant,
* Previous heart stroke or significant alteration of the ECG
Patient-Applied Pretreatment Analgesia for Intrauterine Device Placement

The goal of this clinical trial is to perform a pilot study looking at the benefit of topical anesthetic application to the cervix by tampon prior to intra-uterine device insertion. The main question it aims to answer are:

* Does patient tampon-applied local anesthetic prior to insertion of an intrauterine device (IUD) reduce procedural duration?
* Does patient tampon-applied local anesthetic prior to insertion of an intrauterine device (IUD) reduce pain and improve patient perceptions of the procedure? Participants will place a tampon after dipping the tampon into the study-supplied medication (aqueous lidocaine or saline). Researchers will compare treatment and control groups to see if there is any difference in procedure time, difficulty or patient perceptions.

This Pilot Randomized Double Blind Clinical Trial study will assess the effectiveness of patient-applied aqueous lidocaine via tampon as a pre-treatment prior to intra-uterine device placement. Subjects will apply the lidocaine or a saline placebo to the end of a standard tampon with a plastic applicator and then place the tampon 1 hour prior to the procedure. The tampon will be removed as the subject prepares for the procedure.

The procedure team will measure the procedure time as well as the subject and provider impressions of the procedure. This data will be evaluated to compare the lidocaine to the control group.

Eligibility Criteria:
Inclusion Criteria:

* Request IUD insertion
* Age 18 or older
* Willingness to return for procedure after completing virtual study consent

Exclusion Criteria:

* Known allergy to viscous lidocaine or tampons
* Current vaginal or cervical injury
The Effect of Progressive Muscle Relaxation and Laughter Therapy on Women Undergoing In Vitro Fertilization

Purpose: This study was aimed to evaluate the effect of progressive muscle relaxation exercises and laughter therapy on the mental health and treatment outcomes of women receiving IVF treatment.

Design: Randomized controlled trial with two parallel groups Methods: Participants were randomly assigned to the intervention (IG; n = 71) and control group (CG; n = 70). The progressive muscle relaxation and laughter therapy was administered to women in the intervention group in the IVF center for 3-4 times and 40 minutes. The CG received routine care. Data were collected using baseline and oocyte retrieval day STAI and BDI.

Infertility, one of the important components of reproductive health, affects one in four couples in developing countries.The emergence of assisted reproductive techniques such as in vitro fertilization (IVF) gives infertile couples the opportunity to have both pregnancy and a baby. Couples are affected emotionally during IVF treatment and women experience more problems than men. The majority of women experience emotional problems such as anxiety and depression because of infertility, invasive treatment procedures, physiological effects of gonadotropin stimulation and positive outcome expectation.Considering the effect of anxiety and depression on infertile women, it is important to examine the effectiveness of progressive muscle relaxation exercises and laughter therapy as complementary therapy in psychosocial care.

Eligibility Criteria:
Inclusion Criteria:

* Women between the ages of 20 and 46,
* Literate in Turkish language,
* Diagnosed with infertility by an obstetrician or medical doctor
* Those with primary or secondary infertility

Exclusion Criteria:

* A diagnosed psychiatric disorder,
* prior experience in relaxation intervention,
* Lack of ovarian response in previous treatments
* Undergoing frozen embryo transfer.
Daratumumab-containing Induction Effects on Stem Cells Mobilization, colLection and Engraftment in Newly Diagnosed Multiple MyelomA Patients.

Daratumumab is a human first-in-class monoclonal antibody that targets a cluster of differentiation (CD) 38, a cell surface protein that is overexpressed on multiple myeloma (MM) cells, showing significant activity in relapsed/refractory disease. More recently, it was demonstrated that the addition of daratumumab to pre-autologous hematopoietic stem cell transplant (ASCT) induction regimens in newly diagnosed multiple myeloma increased the rate of complete responses and disease-free survival. However, in consideration of the expression of CD38 antigen also by stem cells, daratumumab could exert effects on their mobilization, collection, and engraftment. The primary objective of this retrospective/prospective observational study is to investigate the impact of adding daratumumab to standard induction regimens (VTD:bortezomib-thalidomide and dexamethasone, VD: bortezomib and dexamethasone) on stem cell mobilization in patients with newly diagnosed multiple myeloma (NDMM) who are candidates for ASCT.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* NDMM candidate to stem cell mobilization, collection, and ASCT who received a Daratumumab-containing induction regimen.
* Signed written informed consent to study participation.

Exclusion Criteria:

* Age \<18 y.o.
* Inability to obtain written informed consent.
* Patients not proceeding to stem cell mobilization because of disease progression.
* Patients not eligible for high-dose cyclophosphamide according to baseline cardiologic evaluation.
Treatment of Overweight in Children on Distance

The present study is a public health project with the aim to treat overweight in children 9-11 years of age. After the first consultation the children are randomized to either continue the treatment at The Child Obesity Clinic, Child Department or to have the following 2-3 consultations on distance with Lync. Last visit for all children is on the Child Obesity Clinic after approximately 12 months. Follow up after at least 1 years will be performed.

This superiority study is a randomized trial with two independent treatment arms. The target for the enrollment is 50% in each of the two treatment groups.

With 60 patients in each group, the study has 80% statistical power at 5% significance level to detect an average difference between the treatment groups in the intra-individual change in the BMI Z-score that is 0.51 x the standard deviation in the intra-individual change. Previous data from the investigators own group suggest that a reasonable estimate of the standard deviation in the intra-individual change in the BMI Z-score following intervention is 0.42. Thus, the study has 80% statistical power at 5% significance level to detect a difference in the intra-individual change in the BMI Z-score that is 0.51 x 0.42 = 0.21 on average. The study will with the present funding end its follow up in June 2017.

Eligibility Criteria:
Inclusion Criteria:

- Children with overweight and not obese according to the definitions developed by Cole et al (4). It implies that we include children with the following age specific BMI Inclusion criteria

* 9 years = AGE \< 9 years, 6 months AND 19,0\< BMI\<23,0
* 9 years, 6 months =\> AGE \< 10 Years AND 19,5 \<BMI\<23,5
* 10 years = AGE \< 10 years, 6 months AND 20,0\<BMI\<24,0
* 10 years, 6 months=\>AGE\< 11 years AND 20,5\<BMI\<24,5
* 11 years = AGE \< 11 years, 6 months AND 21,0\<BMI\<25,5
* 11 years, 6 months =\>AGE\<12 years AND 21,5\<BMI\<25,5

Exclusion Criteria:

* Children and his/her parents not able to communicate in Swedish.
* Children with monogenic obesity
* Present less than 80% at school in the latest school year.
* No foster care for the child or his/her brothers or sisters
Safety and Efficacy of Boceprevir/Peginterferon Alfa-2a/Ribavirin in Interleukin-28B CC Allele-Positive Chronic Hepatitis C Virus (HCV) Genotype 1 Participants (P07755)

The primary purpose of this study is to compare the efficacy of two boceprevir (BOC)-containing therapeutic regimens in the treatment of naïve participants with chronic hepatitis C virus (HCV) genotype 1 who have the IL28B CC allele.

The regimens differ in the treatment for participants who achieve undetectable HCV ribonucleic acid (RNA) at the end of the peginterferon alfa-2a (peg-IFN) plus ribavirin (RBV) 4 week lead-in. Participants receive either peg-IFN + RBV (Arm 1) or BOC + peg-IFN + RBV (Arm 2). The hypothesis is that Arm 2 is noninferior to Arm 1 in the proportion of participants with undetectable HCV RNA at Follow-Up (FU) Week 24.


Eligibility Criteria:
Inclusion Criteria:

* Is ≥ 40 kg and ≤ 125 kg.
* Documented CHC genotype 1 with HCV RNA ≥10,000 International Units (IU)/mL
* Has IL-28B CC allele gene
* Has had a liver biopsy without evidence of cirrhosis and hepatocellular carcinoma (non-invasive fibroscan and Fibrotest can also be used for staging of liver disease).

Exclusion Criteria:

* Co-infection with the human immunodeficiency virus (HIV) or hepatitis B virus (Hepatitis B surface antigen \[HBsAg\] or HIV positive).
* Previously treated with an interferon and ribavirin regimen or HCV direct acting antiviral regimen.
* Treatment for hepatitis C with any investigational medication, or prior treatments with herbal remedies with known hepatotoxicity
* Receiving any medication(s) within 2 weeks prior to the Day 1 visit that are highly dependent on Cytochrome P450 3A4 (CYP3A4/5) for clearance, and for which elevated plasma concentrations could be associated with serious and/or life-threatening events
* Participation in any other clinical trial within 30 days of the screening visit in this trial or intention to participate in another clinical trial during participation in this trial.
* Evidence of decompensated liver disease or hepatocellular carcinoma (HCC)
* Is diabetic and/or hypertensive with significant retinopathy
* Has any known medical condition that could interfere with the participation in and completion of the trial including immunologically-mediated disease, chronic pulmonary disease, or current or history of any clinically significant cardiac abnormalities/dysfunction.
* Evidence of active or suspected malignancy, or a history of malignancy, within the last 5 years
* Hemoglobin \<12 g/dL for females and \<13 g/dL for males
* Neutrophils \<1,500/mm\^3, or \<1,200/mm\^3 for participants of African descent
* Platelets \<150,000/mm\^3
* Direct bilirubin \>1.5 x upper limit of normal (ULN) of the laboratory reference range.
HFCWO in Prolonged Mechanical Ventilation Patients

The effectiveness, safety and tolerance/comfort of high-frequency chest wall oscillation (HFCWO) in prolonged mechanical ventilation patients remain unknown. This study aimed to test the hypothesis that HFCWO could produce greater clearance volume of sputum, greater improvement rates in serial changes in the chest X-ray (CXR), and greater weaning success rates after extubation in Prolonged Mechanical Ventilation (PMV) patients with intra-tracheal intubation.

For over 20 years, studies have attempted to examine the effectiveness, safety and tolerance/comfort of HFCWO in the management of surgical and non-surgical patients who had impaired bronchial secretion clearance, including those with neuromuscular disorders, chronic obstructive pulmonary disease, cystic fibrosis, and blunt thoracic trauma, or those hospitalized for critical cardiac/abdominal/thoracic surgery. However, these outcomes of HFCWO on PMV patients remain unknown.

This parallel-design, randomized controlled trial aimed to test the hypothesis that HFCWO could produce greater clearance volume of sputum, greater improvement rates in serial changes in the chest X-ray (CXR), and greater weaning success rates after extubation in PMV patients with intra-tracheal intubation. Moreover, the safety and tolerance/comfort of HFCWO in PMV patients after removal of endotracheal tubes were also evaluated.

Eligibility Criteria:
Inclusion Criteria:

1. continuous intra-tracheal intubation and mechanical ventilator support for at least 21 days
2. age ≥20 year-old
3. having an acute or chronic pulmonary condition requiring secretion mobilization as judged by the physician
4. alert consciousness; completion of the Modified Borg Scale (MBS) and Hamilton Anxiety Scale (HAS)
5. scheduled extubation within 24 hours after enrollment
6. without any contraindication for HFCWO (i.e., recent spinal injuries which have not yet been stabilized and active hemorrhage with hemodynamic instability)

Exclusion Criteria:

1. those who had undergone tracheostomy
Evaluation Of Bilateral Tecnis Multifocal Versus ReSTOR 3D Intraocular Lenses

The purpose of this study is to compare the visual outcomes with bilateral implantation of Tecnis MF and ReSTOR intraocular lenses (IOLs) 6 months post cataract surgery.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or greater
* Bilateral cataracts for which phacoemulsification extraction and posterior IOL implantation has been planned for both eyes
* Visual potential of 20/30 or better in each eye after cataract removal and IOL implantation
* Preoperative best-corrected distance visual acuity (BSDVA) worse than 20/40 Snellen. If there is a glare component, glare testing which reduces the visual acuity to less than 20/40
* Naturally dilated pupil size (in dim light) \> 3.5 mm (with no dilation medications) for both eyes
* Preoperative corneal astigmatism of 1.0 D or less
* Clear intraocular media other than cataract
* Availability, willingness, and sufficient cognitive awareness to comply with examination procedures

Exclusion Criteria:

* Use of systemic or ocular medications that may affect vision
* Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus, immunocompromised, etc.)
* Subjects with diabetes mellitus
* Uncontrolled systemic or ocular disease
* History of ocular trauma or prior ocular surgery
* Amblyopia or strabismus
* Known pathology that may affect visual acuity; particularly retinal changes that affect vision (macular degeneration, cystoid macular edema, proliferative diabetic retinopathy, etc.)
* Diagnosed degenerative visual disorders (e.g. macular degeneration, or other retinal disorders) that are predicted to cause future acuity losses to a level of 20/30 or worse
* Subjects who may be expected to require retinal laser treatment or other surgical intervention
* Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome)
* Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils, or pupils that do not dilate at least 4.0 mm under mesopic/scotopic conditions)
* Contact lens usage within 6 months for polymethyl methacrylate (PMMA) contacts lenses, 1 month for gas permeable lenses or 1 week for extended-wear and daily-wear soft contact lenses
* Requiring an intraocular lens \<15.0 or \>26.0 diopters
Sd-RAB for the Diagnosis of PPLs

This is a single-center, prospective, and single-arm study. The purpose of this study is to evaluate the feasibility and safety of a new self-driving robotic-assisted bronchoscopic system for the diagnosis of peripheral pulmonary lesions.

Self-driving robotic-assisted bronchoscope (Shanghai MicroPort MedBot (Group) Corporation Limited, China) is a new robotic-assisted bronchoscopic system that can automatically advance through airway according to the preoperative planning path under the guidance of electromagnetic navigation. It can also be controlled manually by the operator. In this study, 30 patients will be prospectively enrolled to evaluate the feasibility and safety of this new self-driving robotic-assisted bronchoscopic system for the diagnosis of peripheral pulmonary lesions. The primary endpoint of this study is the complication rate. The secondary endpoints include navigation success rate, diagnostic yield, rate of rEBUS confirmation, total examination time, navigation time, and duration of finding lesions.

Eligibility Criteria:
Inclusion Criteria:

1. Patients older than 18 years old.
2. Chest imaging shows the presence of peripheral pulmonary lesions (defined as those lesions that are surrounded by pulmonary parenchyma and located below the segmental bronchus), which are suspected to be malignant and require a non-surgical biopsy.
3. Patients have good medical adherence and signed informed consent.

Exclusion Criteria:

1. Contraindications for bronchoscopy.
2. Presence of concomitant endobronchial lesion during the bronchoscopy procedure.
3. The investigators believe that patient has other conditions that are not suitable for the study.
Study for the Knowledge of Risk Factors Associated With Breast Cancer in Women

Breast cancer is the most frequent tumor in Western women. In Spain about 26,000 new breast cancers are diagnosed each year. This type of tumor is increasing worldwide with an increase in aggressive neoplasms in young women. There are some risk factors responsible for this global increase: lifestyle, diet and body weight especially in postmenopausal women.

Some cell mutations, especially in the BRCA1, BRCA2 and p53 genes, are associated with a very high risk of this type of cancer. Some authors have calculated the contribution of various modifiable risk factors to the global burden of breast cancer, and they concluded that 21% of all breast cancer deaths are attributable to alcohol consumption, overweight and obesity, and lack of physical activity. Nowadays, there aren't specific studies in the Community of Madrid designed to know the risk factors related to breast cancer.

For this reason, it is proposed to carry out an observational study that collects detailed information about dietary habits, genetic factors and life quality of a group of women with recent diagnosis in pre or post-surgical phase.

1. Storage of biological sample at the Hospital.
2. Patient's breast pathology characteristics.
3. Study of concomitant pathologies.
4. Dietary study: "Frequency of Food Consumption" questionnaire referring to the last year eating habits before having been breast cancer diagnosed.
5. Physical activity study in the year prior to the diagnosis of breast cancer.
6. Anthropometric study: weight, size, waist circumference and body composition (% Fat mass,% Lean mass,% Body water).
7. Study of other risk factors of breast cancer: age, family history, reproductive history, medications consumed...
8. Biochemical study: biochemical variables of the last blood analysis performed on the volunteer in the hospital center.
9. Saliva collection to proceed with the genetic analysis.
10. Collection of stool sample to carry out the microbiota study.

Eligibility Criteria:
Inclusion Criteria:

* Older women than 18 years old
* Newly diagnosed patients with a breast tumor (Phase I, II or III). Being in one of the following cases:

  1. Patient who has not yet received any treatment and the committee has decided that as a first treatment will receive chemo or radiotherapy.
  2. Patient who has just undergone surgery and is waiting to start adjuvant treatment with chemo or radiotherapy.
* Sign the informed consent.

Exclusion Criteria:

* Patients with stage IV disease.
* Associated Eating Disorders.
* Patients with dementia, mental illness or decreased cognitive function.
* Pregnant or lactating women.
A Multicenter Study of Retrospective Rehabilitation Medical Data for the Development for Medical Twins

Based on previous studies, when medical digital twin-based convergence medical contents are applied to degenerative musculoskeletal and central nervous system diseases, it is possible to more accurately evaluate the subject's motor function and neurological function to predict the subject's disease. In order to create an effective ICT application protocol and clinically apply a treatment program that can improve the subject's kinematic function and neurological function, etc.


Eligibility Criteria:
1. Inclusion Criteria:

   * Healthy subjects : who underwent imaging examination at Bundang CHA hospital from January 1, 2010 to December 31, 2021
   * Stroke patients : who underwent imaging examination at Bundang CHA hospital from January 1, 2010 to December 31, 2021
2. Exclusion criteria - Who cannot meet the inclusion criteria