cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of CBT in Improving Psycho-Neuro-Endocrine Factors in Women Following In Vitro Fertilization Program

The goal of this clinical trial is to learn if Cognitive Behavioral Therapy (CBT) can improve psychological, neurological, and hormonal aspects in women undergoing In Vitro Fertilization (IVF). The main questions it aims to answer are:

* Is CBT effective in improving psychological aspects (anxiety, depression, and coping mechanism) in women undergoing IVF?
* Is CBT effective in improving neuroendocrine aspects (cortisol levels, neuroepinephrine levels, free trioodothyronine levels) in women underoing IVF?

Researchers will compare CBT to no intervention to see if CBT is effective in improving psychoneuroendocrine aspects.

Participants will

* attend 8 appointments once a week, during which they will be given CBT or no intervention
* have their anxiety score, depression score, and dominant coping mechanism assessed before the first appointment and during appointment 3, 6, and 8
* have their cortisol levels, norepinephrine levels, and free triiodothyronine levels assessed before the first appointment and during appointment 3, 6, and 8

Eligibility Criteria:
Inclusion Criteria:

* Women with primary infertility
* Aged 25-42 at the start of the study
* Willing to participate in the study and willing to sign informed consent form
* Minimum education of high school, able to read, write and understand Bahasa Indonesia

Exclusion Criteria:

* Having one or multiple psychotic disorder(s)
A Study to Evaluate the Use of Cidofovir (an Experimental Drug) for the Treatment of Progressive Multifocal Leukoencephalopathy (PML) in AIDS Patients

The purpose of this study is to evaluate the safety, tolerance, and overall effectiveness of cidovir to treat PML in AIDS patients.

PML is an opportunistic infection (HIV-associated, due to weak immune system) caused by a virus that attacks the brain. Cidovir has been used effectively to treat cytomegalovirus (CMV) of the eye. Cidovir could be an effective treatment for PML as well.

PML is a demyelinating disease of the brain's white matter, occurring when the JC virus infects the brain of patients infected with HIV-1. Cidofovir is known to be an effective treatment for cytomegalovirus of the eye and, in laboratory and animal testing, has also been shown to be effective against several other viruses. However, cidofovir is considered investigational as a treatment for PML.

In this multicenter, open-label study 24 patients receive cidofovir iv over 1 hr on days 0, 7, then every 2 wk for a total of 13 doses.

Oral probenecid is given 3h prior to and 2h and 8h following cidofovir administration. Nucleoside and non-nucleoside reverse transcriptors are withheld on days of probenecid administration. Protease inhibitors are continued during probenecid administration.

Eligibility Criteria:
Inclusion Criteria

You may be eligible for this study if you:

* Are HIV-positive.
* Have had symptoms of PML for no more than 90 days before study entry, or have had abnormal neurological exams related to PML.
* Have negative tests for bacterial or fungal infections.
* Agree to practice abstinence or use effective methods of birth control during the study.
* Are at least 18 years old.
* Have a life expectancy of at least 6 months.

Exclusion Criteria

You will not be eligible for this study if you:

* Have a history of uveitis.
* Are allergic to sulfa drugs or probenecid.
* Have had active opportunistic infections other than Kaposi's sarcoma within 30 days before study entry.
* Have sickle cell anemia or trait.
* Are pregnant or breast-feeding.
Conducting Outreach to Improve Cervical Cancer Screening Rates Among Underscreened Patients

The purpose of this project is to determine whether outreach to HIV-negative patients who are overdue for a Pap smear at a New England urban community health center can increase cervical cancer screening rates. It additionally seeks to determine which form of outreach - via letter, email, phone, or a mixture of those modalities- is most effective among these patients.

To the investigators' knowledge, this study will be the first to assess the efficacy of email in cervical cancer screening outreach in a randomized controlled trial. It will also be one of the few randomized controlled trials to directly compare different outreach media directly, as opposed to different variations within a single medium (e.g. two different types of letters). Lastly, given the unique patient demographic makeup at Fenway, including a significant number of lesbian, bisexual and transgender patients, secondary subanalyses have the potential to significantly add to the investigators' knowledge of what media work best in conducting cervical cancer screening outreach with sexual and gender minorities, who are disproportionately underscreened compared to heterosexual cis-gendered women.

Eligibility Criteria:
Inclusion Criteria:

* Female or female-to-male transgender patients with a cervix
* HIV-negative
* Medical appointment at Fenway Community Health during calendar year 2012 who have not had a Pap smear in the past 3 years (since January 2010)

Exclusion Criteria:

* HIV-positive (due to different Pap testing guidelines)
* Male-to-female transgender patients
* Patients with a history of a hysterectomy, unless specified as partial or supracervical
* Patients aged 30-64 who had a negative Pap test in the past 5 years with simultaneous negative Human papillomavirus infection (HPV) co-testing
Physical Exercise Therapy in Pediatric Stem Cell Transplantation

The purpose of this randomized controlled two-part study examines the effects of a structured sports intervention before, during and after hematopoetic stem cell transplantation (hsct) in children and adolescents.

The main aspects in the sports groups are resistance, endurance and flexibility training. The control group performs a mental training as well as relaxation exercises.


Eligibility Criteria:
Inclusion Criteria:

* Indication for hsct
* Informed consent signed

Exclusion Criteria:

* Contraindication for exercise
* Age \< 5 years
* Insuperable language barrier
* Orthopeadical, cardiological or neurological indication for physical therapy
A Multicenter, Post-Market Clinical Follow-up Study of Subjects With the REDAPT™ System Monolithic Sleeveless/Sleeved Stem and/or Fully Porous Acetabular Shell With XLPE Liner and/or Modular Shell Components Previously Implanted

The primary purpose of this study is to demonstrate cumulative revision rate of the REDAPT System Monolithic Sleeveless/Sleeved Stem, Fully Porous Acetabular Shell with XLPE liner, and Modular Shell Components (with or without Staple, Slice and Blade Augments) at 10 years.

Retrospective-prospective, single arm, multicenter study of subjects previously implanted with the REDAPT System Monolithic Sleeveless/Sleeved Stem and/or Fully Porous Acetabular Shell with XLPE liner and/or Modular Shell Components (with or without Staple, Slice and Blade Augments).

Eligibility Criteria:
Inclusion Criteria:

Subjects must meet all of the inclusion criteria to enroll in the study:

1. Subject was considered skeletally mature at the time of surgery and was at least 18 years of age.
2. Subject has undergone hip arthroplasty with the REDAPT Fully Porous Acetabular Shell with XLPE liner or REDAPT Modular Cup Components (with or without Staple, Slice and Blade Augments), and/or Monolithic Sleeveless Stem, and/or Monolithic Sleeved Stem and are at least 3 months post-implantation at this site.
3. Subject required surgery with REDAPT device chosen for one of the following indications:

   1. Advanced degeneration of the hip joint as result of osteoarthritis, avascular necrosis, posttraumatic arthritis, rheumatoid arthritis, or dysplasia (or any of the composites of these conditions).
   2. Fracture-dislocation of the hip, femoral neck fracture or trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
   3. Revision THA
4. Subject is willing to consent to and to follow the study visit schedule (as defined in the study protocol and ICF), by signing the IRB/IEC approved ICF.
5. Subject is willing and able to participate in required follow-up visits at the investigational site and to complete study procedures.

Exclusion Criteria:

Subjects meeting any of the following exclusion criteria will be excluded from study participation:

1. Subject had an active infection - systemic or at the site of surgery.
2. Subject, in the opinion of the PI, has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study including mental illness, mental retardation, drug or alcohol abuse.
3. Subject is known to be at risk for loss to follow-up or failure to return for scheduled visits.
4. Subject is incarcerated or is pending incarceration.
5. Subject is enrolled in another clinical study that would affect the endpoints of the study.
Occlusal Forces and Muscle Activity in Fixed Versus Removable Mandibular Implant Supported Overdenture

22 Patients having lower completely edentulous mandible aged 55-60 years were selected from the outpatient dental clinic of the Medical Excellence Centre of the National Research (NRC) Cairo, Egypt. Six dental implants were inserted in the mandible of each patient.

The patients were randomly categorized into two groups according to the final restoration.

Group I: received a complete removable mandibular implant supported overdenture. While Group II: received implant supported fixed bridge.

Occlusal equilibrations, Muscle activities, and oral health-related quality of life (OHRQoL) were assessed by at the time of prosthesis insertion, after one and three month.

Eligibility Criteria:
Inclusion Criteria:

* edentulous mandible with well-developed alveolar ridge
* free from temporomandibular joint disorder
* free from any chronic diseases.

Exclusion Criteria:

* smoker
* patients having systemically immunosuppressive diseases
* patients receiving radiotherapy.
Preventing Recurrent 'Idiopathic' Acute Pancreatitis Through Laparoscopic Cholecystectomy (PICUS-2)

Rationale: Annually, acute pancreatitis is diagnosed in 6,500 patients in the Netherlands. In up to 25% of patients no definitive cause can be determined after routine work-up including endoscopic ultrasound and this is deemed to be idiopathic acute pancreatitis (IAP). IAP is known for its high recurrence rate. It is hypothesized that microlithiasis, a type of biliary pancreatitis, is the most common cause of IAP. Laparoscopic cholecystectomy (LC) is highly effective in preventing recurrence of biliary pancreatitis. Currently no randomized trial has compared LC with conservative treatment in patients with IAP after adequate work-up including endoscopic ultrasound.

Objective: To assess the effectiveness of LC as compared to conservative treatment in patients after a first episode of 'EUS-negative' IAP.

Study design: Multicenter randomized controlled trial. Patients will be followed for one year after randomization.

Study population: Adults with a first episode of 'EUS-negative' IAP.

Intervention (if applicable): Laparoscopic cholecystectomy versus conservative treatment.

Main study parameters/endpoints: The primary endpoint is pancreatitis recurrence. Secondary endpoints include occurrence of biliary events, complications of LC, number and severity of recurrent episodes of pancreatitis, quality of life (QALY), costs (hospital and societal) and cost-effectiveness.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old
* Eligible for early (laparoscopic)\* cholecystectomy
* Full required diagnostic work-up of patient has been performed, including EUS
* First episode of 'EUS-negative' IAP
* Informed consent for participation was obtained \*if required open cholecystectomy is allowed

Exclusion Criteria:

* Recurrent acute pancreatitis
* Diagnosis of chronic pancreatitis
* Diagnosis of necrotizing pancreatitis
* Current pancreatic malignancy
* Prior cholecystectomy
* Documented etiology of acute pancreatitis
Intrapartum Ultrasound in Labor: Sonography Only, Few Internal Examinations

This is a prospective, randomized trial to determine whether the use of sonographic parameters during labor results in less intrapartum infection compared to traditional invasive examination. Other secondary outcomes include maternal satisfaction and overall birth outcomes.

It is a prospective, randomized trial to determine whether the use of sonographic parameters during childbirth results in less intrapartum infection compared to traditional invasive examination. Intrapartum non-invasive ultrasound has been established and validated as a method of assessing labor progress. Guidelines from international societies recommend the use of ultrasound to monitor labor and support decision-making during delivery. Despite its reproducibility and reliability, there is no comprehensive work to date demonstrating the potential benefit in reducing clinical chorioamnionitis compared to traditional invasive vaginal examination. With this in mind, the investigators set out to analyze the clinical benefit of using ultrasound alone using established non-invasive, intrapartum, translabial parameters (Angle of Progression, Head Perineum Distance, Midline Angle, Cervix Dilatation) to monitor birth outcomes compared to traditional invasive vaginal examinations.

Primary Outcome is the incidence of clinical chorioamnionitis. Secondary Outcome measures include mode of delivery and neonatal outcomes such as neonatal admission.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women of at least 18 years of age with a singleton in the cephalic position
* Spontaneous onset of labor; births after induction of labor with otherwise suitable inclusion and exclusion criteria are also permitted.

Exclusion Criteria:

* Emergency situations such as maternal or fetal bleeding
* Indication for urgent delivery by caesarean section
* Pathological cardiotocogram
* non-cephalic positions
* under 18 years of age
* women giving birth who are unable to give consent
The Prevalence and Impact of Depression and Anxiety Symptoms in Patients With Non-CF Bronchiectasis

Patients with chronic diseases are at great risk of depression and anxiety.It is known that depression and anxiety are one of the most common comorbidities associated with chronic lung diseases such as asthma and chronic obstructive pulmonary disease.

However,to date,little is known about the rates and risk factors of depression and anxiety symptoms in non-CF bronchiectasis;and no large-scale prospective studies have been performed to investigate the effect of depression and anxiety on the healthy outcomes(such as number of exacerbations and hospitalizations over the ensuing year).Our purpose is to fill these gaps.

Non-CF bronchiectasis is a long-term condition which affects the lungs.It is characterized by chronic airway infection with periodic exacerbations which are associated with impaired lung function, reduced quality of life and increased healthcare costs.Depression and anxiety are common and are known to be associated with poor quality of life and exacerbations of other chronic respiratory diseases such as COPD.Studies in COPD have shown that psychological distress is increasingly elevated and common,with up to 55% of patients suffering from a clinical diagnosis of anxiety and/or depression;moreover,patients with anxiety and/or depression were at greater risk for COPD-related exacerbations.Unfortunately,there has been no systematic evaluation of symptoms of depression and anxiety in patients with non-CF bronchiectasis or their relationship to health outcomes.A study including 111 non-CF bronchiectasis patients,O'Leary and colleagues indentified that 34% of patients had elevated scores for anxiety, depression or both.In a recent study of 93 patients(including 43 with Cystic fibrosis)of bronchiectasis,20% patients had elevated depression-related scores and 38 % had elevated anxiety-related scores,both depression and anxiety symptoms predicted signiﬁcantly worse health-related quality of life.

To date,the studies of depression and anxiety symptoms in patients with non-CF bronchiectasis have been limited by small samples sizes;and no prospective studies have been conducted to investigate the impact of psychological distress on the health outcomes.Given the importance of identifying and treating these symptoms, and their implications for long-term health outcomes,we plan to determine the prevalence and risk factors of depression and anxiety in non-CF bronchiectasis.In addition,we investigate the effect of depression and anxiety on the risk of non-CF bronchiectasis exacerbations and hospitalizations.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years
2. HRCT diagnosed Bronchiectasis
3. No fever,no worsening of respiratory symptoms,and no medication change within the 4 weeks before recruitment.
4. Capable of providing written informed consent

Exclusion Criteria:

1. cystic fibrosis
2. Previous lung transplantation
Effects of Aliskiren in Elderly Hypertensive Chronic Kidney Disease (CKD) Patients

The purpose of this study is to determine whether aliskiren is effective in the treatment of blood pressure, hear function, renal function in elderly hypertensive chronic kidney disease (CKD) patients.

Chronic kidney disease (CKD) was reported to be affecting 11% of the all population. This number is much higher in the elderly population and may be as high as 30%. CKD is an independent risk factor of cardiovascular disease (CVD). This is called "Cardio-renal Continuum". The renin-angiotensin-aldosterone system (RAS) plays pivotal roles in both cardiovascular and renal functions.

The increased oxidative stress by activated RAS on vascular endothelium is one of important factor to development of Cardio-renal Continuum. The blockade of RAS by angiotensin I converting enzyme inhibitors (ACEIs) and/or angiotensin receptor blockers (ARBs) has been reported to ameliorate the renal disease and CVD; however,they do not completely suppress RAS, leading to a reactive rise in plasma renin activity (PRA). Aliskiren, an oral direct renin inhibitor, is effective against essential hypertension by reducing PRA, resulting in more complete suppression of RAS; however, little is known about the effects of aliskiren on heart and kidney functions in elderly hypertensive CKD patients. In this study, we assessed the efficacy of aliskiren on heart and kidney functions in elderly hypertensive CKD patients.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Chronic kidney disease
* Clinical diagnosis of Hypertension (Blood pressure \>=140/90mmHg)
* Elderly people(\>=65 years old)

Exclusion Criteria:

* The patients who are already taking aliskiren
* The patients who are receiving hemodialysis or peritoneal dialysis
* The patients who are taking cyclosporin
* The patients who have hyperkalemia(\>=5.5mEq/ml)
* Severe heart failure (\>=NYHA class III)
* Insulin dependent diabetic mellitus or poor controlled insulin independent diabetic mellitus (\>=HbA1c 9.0\&)
* Severe liver dysfunction (five folds increased AST or ALT than standard values)
Good Choice of pALliative Chemotherapy to Patient With Pancreatic Cancer ; GemcitAbine Therapy vs FOLFORINOX therapY

The study objectives are to find out: 1) palliative chemotherapy patterns and prognosis in patients with locally advanced or metastatic pancreatic cancer in Korea's real clinical settings, and 2) reasons adopted by clinicians in choosing therapeutic drugs.

This study is a domestic, multi-center, prospective, observational study designed for locally advanced or metastatic pancreatic cancer patients who plan to receive palliative chemotherapy. When patients voluntarily express their consent to provide their information to this study by signing a written agreement, their baseline information including demographics, comorbidities, pancreatic cancer-related information, medical treatment history, etc. shall be used for screening. When patients are judged eligible for study participation, they shall receive an appropriate palliative chemotherapy. After first-line chemotherapy (baseline), information review shall be conducted at month 2, 6 and 12 for chemotherapy currently in use (whether or not chemotherapy ended/discontinued and relevant reasons; type, frequency and duration of administered drugs), RECIST, quality of life (month 2 and 6), activity performance assessment, laboratory tests, tumor marker test, adverse drug reactions, etc. However, if first-line chemotherapy moves to second-line chemotherapy due to causes such as progressive disease (PD), information review shall be restricted to the relevant drug name and survival until the end of the study (month 12).

Eligibility Criteria:
Inclusion Criteria:

1. Patients are briefed about the study objectives and methodologies, and express their consent by signing a written agreement for the use of their personal information.
2. Male and female adults who are ≥ 19 years old at the time of enrollment.
3. Locally advanced or metastatic pancreatic cancer patients whose diagnosis was confirmed histologically or cytologically.
4. Patients who plan to receive palliative chemotherapy (e.g., FOLFIRINOX, Gemcitabine-based therapy, etc.)

Exclusion Criteria:

1. Patients who are diagnosed with any other primary cancer that may influence pancreatic cancer treatment or prognosis.
2. Patients who are currently or have a history of receiving palliative chemotherapy.
3. Female patients who are pregnant, have childbearing potential or are breastfeeding.
4. Patients who are currently participating in other clinical trials (clinical trials for drugs or medical devices) or are planning to participate in other clinical trials during the study period. However, patients participating in a non-interventional observational study or registry study can be enrolled.
5. Other patients who are judged by the investigator to be ineligible to participate in the study.
Clinical Trial to Evaluate the Visual Performance of Two Monofocal Intraocular Lenses

The main objective of the clinical study is to evaluate the performance of the CT LUCIA 601 PY for the monocular uncorrected distance visual acuity and compare it to the reference monofocal IOL Acrysof IQ SN60WF.


Eligibility Criteria:
Inclusion Criteria:

* Patient informed of the consequences and constraints of the protocol and who has given his/her written informed consent;
* Patients of any gender, aged 50 to 90 years;
* Senile cataract in at least 1 eye;
* Assured follow-up examinations;
* Healthy eyes besides clinically significant cataract
* Biometry measurement/cataract density compatible with the IOLMaster evaluation.

Post-operative inclusion criteria:

* IOL implanted in the capsular bag;
* The IOL model (CT LUCIA 601PY or Acrysof IQ SN60WF) has been implanted;
* No intraoperative complications; no damaged capsular bag, no intraocular hemorrhage; no can opener rhexis.

Exclusion Criteria:

* • Patients unable to meet the limitations of the protocol or likely of non-cooperation during the trial;

  * Patients whose freedom is impaired by administrative or legal order;
  * Current participation in another drug or device investigation;
  * Allergy to heparin
  * Monophthalmic patient
  * Ocular disorders, other than cataract, that could potentially cause future acuity loss to a level of 0.20 logMAR (best-corrected) or worse the operated eye
  * Any anterior segment pathology that could significantly affect outcomes (e.g. chronic uveitis, iritis, corneal dystrophy, etc.)
  * Diabetic retinopathy
  * Traumatic cataract
  * Aniridia
  * Microphthalmus
  * Amblyopia
  * Degenerative visual disorders (e.g. macular degeneration, optic nerve atrophy, or retinal disorders)
  * Patient expected to require retinal laser treatment before the end of the follow-up
  * Previous intraocular and corneal surgery
  * Expected postop. astigmatism greater than 1 D
  * Any type of corneal disorder
  * Dementia
  * Diabetes mellitus
  * Pseudoexfoliation syndrome (PXF)
  * Glaucoma or IOP higher than 24mmHg under ocular hypertension treatment
  * Any other pathology or condition presenting, according to the investigator opinion, a risk for the patient