cyrilzakka/clinical-trials huggingface dataset:
Gemcitabine Plus Carboplatin Versus Carboplatin Monotherapy in Patients With Advanced Ovarian Cancer

The primary objective of this study is to compare the time to progressive disease in patients treated with gemcitabine plus carboplatin versus carboplatin monotherapy. Patients will have advanced epithelial ovarian cancer and have failed first-line platinum-containing therapy 6 months after treatment discontinuation.

Carboplatin is commonly used for the treatment of ovarian cancer in first- and second-line therapy. The efficacy of gemcitabine in ovarian carcinoma was researched in various Phase 2 studies.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven ovarian cancer with evidence of recurrence or progression
* Failed first-line platinum containing therapy after 6 months of treatment discontinuation
* Documented lesion as evidenced by appropriate computerized tomography (CT), magnetic resonance imaging (MRI) scan, chest x-ray, or ultrasound.
* Previous hormonal therapy or radiotherapy must be terminated at least 3 weeks before study drug administration
* Adequate bone marrow reserve: neutrophils ≥ 1.5 x 10\^9/L and platelets ≥ 100 x 10\^9/L

Exclusion Criteria:

* Receiving concomitant cytotoxic or other antineoplastic treatment. Hormone replacement therapy is allowed, as are steroid antiemetics
* Clinical evidence of central nervous system metastases
* Active infection
* Cannot adequately be followed up for the duration of the study
* A second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin)
* Use of any investigational agent in the 3 weeks prior to inclusion
* Serious concomitant systematic disorders incompatible with the study
* Received more than one previous chemotherapy regimen or had prior gemcitabine treatment
* Patients with tumor of borderline malignancy
* Patients with estimated GFR ≤ 50 mL/min
Effectiveness of Counseling on Use of Postpartum Family Planning.

Family planning (FP) is the most supported, reasonable public health service to prevent both maternal and newborn mortality and decrease the risk of adverse maternal, perinatal, and infant outcomes. The World Health Organization's (WHO) recommend of waiting at least 2 years after a live birth before attempting the next pregnancy as short interval between pregnancies increase risk of preterm labor; low birth weight; fetal, early neonatal and infant death; and serious maternal outcomes.

So WHO recommends postpartum family planning (PPFP) for healthy birth spacing. PPFP is divided into three stages immediate: within 48 hours following delivery, early: within the first 6 weeks after delivery, late: within 12 months postpartum. Fertility can return as soon as 45 days after delivery for non-breastfeeding women, and among women who are not breastfeeding exclusively, fertility can return before the return of menses. Providing PPFP instantaneously following delivery may be likeable for women who prefer effective postpartum protection as the return of fertility may be hard to expect. So Promoting PPFP use was documented in different communities, interventions included conversational, SMS, brochure and video-based contraceptive education in antenatal or postnatal visits. However, the unmet need for FP is high in the postpartum period, ranging from 32 to 62% in low and middle-income countries depending on the definition used. that is why WHO recommends that all women should be offered counselling within 6 weeks postpartum so we will study the impact of post-partum counselling pre and post-discharge on intent and use of a reliable family planning method.

Eligibility Criteria:
Inclusion Criteria:

1. Women who delivered in Women's Health hospitals, Assiut university hospitals.
2. Women in reproductive age (15 - 49 years).
3. Accepting to share in our study.

Exclusion Criteria:

1. Women diagnosed with mental problems or postpartum psychosis
2. Women with unstable hemodynamic status.
3. Women after Peripartum hysterectomy or tubal ligation.
Mindfulness Meditation Format Pilot Study

The purpose of this study is to assess feasibility of an internet and individual format of mindfulness meditation in people with posttraumatic stress disorder (PTSD) and depression symptoms

Internet and individual formats of mindfulness meditation have not been previously evaluated. In order establish feasibility of such formats a pilot study is need. The current study will randomize up to 20 people with PTSD and depression symptoms and evaluate changes in PTSD and depression symptoms from before to after the internet and individual mindfulness meditation interventions.

Eligibility Criteria:
Inclusion Criteria:

* Good general health
* Age 25-65
* Access to internet
* PTSD symptoms (score \>14 on PTSD screen)
* Depression symptoms (endorsement of one question on depression screen)
* Stable on medications six weeks prior to the study
* Willing to be stable on medications during study

Exclusion Criteria:

* Significant potentially life-limiting acute medical illness
* Risk for suicide
* \>2 drinks/day of alcohol and street drug use besides marijuana
* Current daily meditation practice
Dismantling Mindfulness: Contributions of Attention vs. Acceptance

This study addresses NCCAM's request for research that investigates the neuropsychological mechanisms underlying mind-body therapies, and for precise criteria and better delineation of meditation practices.

The purpose of this study is to assess the clinical efficacy and mechanism of action of 2 component practices of "mindfulness meditation", i.e. focused awareness (FA) and open monitoring (OM) in comparison to each other and to the standard package, Mindfulness-Based Cognitive Therapy (MBCT).

Meditation, particularly mindfulness meditation, is one of the most popular Complementary and Alternative Medicine (CAM) therapies for alleviating emotional stress, depression and anxiety. While standardized meditation-based treatment packages like Mindfulness Based Stress Reduction (MBSR) and Mindfulness-based Cognitive Therapy (MBCT) have reliably shown sustained improvements in emotional disturbances and wellbeing, they contain so many different components and practices that the active ingredient cannot be ascertained. What is commonly called "Mindfulness" meditation is actually comprised of two separate practices: 1) focused awareness practice (FA), and 2) open-monitoring practice (OM). This project aims to create separate 8 week programs for FA and OM meditations, compare their clinical efficacy and investigate their separate mechanisms of action in individuals with clinically significant levels of persistent negative affect and depression. The clinical benefit and mechanism of action of focused awareness (FA) vs open-monitoring (OM) vs MBCT will be examined with a 3-armed randomized control trial of these 8 week interventions. Outcome variables include negative affect (depression, anxiety, stress) and wellbeing. Hypothesized mediating processes include objectively measured attention, emotion regulation and the basic wakefulness on which they depend.

Eligibility Criteria:
Inclusion Criteria:

* English-speaking
* ages 18-65
* mild-severe levels of depression or high level of negative affect

Exclusion Criteria:

* Current:

  * age \<18 or \>65
  * inability to read and write in English
  * Extremely severe levels of depression
  * active suicidal ideation
  * presence of Axis I personality disorder
  * panic disorder
  * post-traumatic stress disorder
  * obsessive-compulsive disorder
  * eating disorder, or substance abuse/dependence
  * current psychotherapy
  * change in antidepressant medication type or dosage in the last 8 weeks.

Lifetime history exclusions:

* bipolar disorder
* psychotic disorders
* persistent antisocial behavior or repeated self-harm,
* borderline personality disorder,
* organic brain damage
* regular meditation practice
Treating Depression in Patients With De Quervain's Tenosynovitis; An Integrated Web Based Skills Intervention

This study evaluates a Decision Aid to help patients with de Quervain's tenosynovitis decide how to treat their condition.

For patients with symptoms of depression, half the participants will receive a psychological intervention (Toolkit) to improve depression and pain from de Quervain's tenosynovitis.

The investigators hypothesize that both the Decision Aid and the Toolkit will be feasible, and that the Toolkit will improve pain and function compared to usual care.

The investigators are doing this research to see if they can improve the management of patients with de Quervain's tendinopathy. In the first part of this study, a Decision Aid (DA) has been developed to help participants make choices about their treatment.

Decision aids are designed to provide patients with balanced, complete, and understandable information about their options for management of their condition, as well as risks and benefits, in order to help them determine their preferences according to their values. Research has shown that patients felt more knowledgeable and better informed with a more active role in decision making after using DAs.

Additionally, research has shown that depression affects pain and disability experienced by patients with de Quervain's tenosynovitis. In the second part of our study, the investigators want to see whether a web based skills intervention (Toolkit) is more effective than usual medical care in improving pain and disability in patients with de Quervain's tenosynovitis and symptoms of depression.

The Toolkit is delivered online and can be accessed at home. Similar skills interventions in patients with musculoskeletal injury have been shown to improve pain and function.

Eligibility Criteria:
Inclusion Criteria:

* Adults (≥18 years) diagnosed with de Quervain's tenosynovitis
* English fluency and literacy
* Ability to give informed consent

Exclusion Criteria:

* Inability or unwillingness to participate in decision aid (DA) and/or Toolkit-depression
* Major medical comorbidity expected to worsen in the next 6 months
* Comorbid chronic pain condition
* Antidepressant medications changes in the past 6 months
* Severe and untreated mental health conditions or active substance dependence
* Secondary gains such as litigations or worker compensation procedures that may interfere with patients' motivation for treatment
* No online device available to use the DA and Toolkit-depression
A Trial of the Safety, Tolerability, and Pharmacodynamics of CVL-871 in Subjects With Dementia-Related Apathy

The purpose of this study is to determine whether CVL-871 is safe and tolerable in patients with Dementia-Related Apathy and if CVL-871 shows changes in clinical measurements of apathy.


Eligibility Criteria:
Inclusion Criteria:

* Meets diagnostic criteria for apathy in neurocognitive disorders
* Clinically significant apathy
* Mild to Moderate Dementia (AD, FTD, VAD, or DLB)

Exclusion Criteria:

* Other significant psychiatric disorder(s)
* Other neurological disorders (other than AD, FTD, VAD, or DLB)
Promoting Smoking Cessation in the Community Via QTW 2015

Although smoking prevalence is decreasing in Hong Kong, there are still 648,800 daily smokers 10.8% (Census and Statistics Department, 2013) and half will be killed by smoking (Lam, 2012) which accounts for over 7,000 deaths per year (Lam, Ho, Hedley, Mak, \& Peto, 2001). Smoking also accounts for a large amount of medical cost, long-term care and productivity loss of US$688 million (0.6% Hong Kong GDP) (Census \& Statistics Department, 2001; McGhee et al., 2006) . Smoking is a highly addictive behavior and it is difficult for smokers with strong nicotine dependence to quit without assistance. On the other hand, reaching and helping the many smokers who have no intention to quit is a challenge, because they are unlikely to seek professional help from smoking cessation services.

The Quit and Win programme provides an opportunity to reach and encourage a large group of smokers to make quit attempt and maintain abstinence. The Quit and Win model posits that smokers participating in the contest will have higher motivation to quit with incentives and better social support (Cahill \& Perera, 2011). Studies have found that such quitting contests or incentive programs appeared to reach a large number of smokers and demonstrated a significantly higher quit rate for the quit and win group than for the control group (Cahill \& Perera, 2008).

Smoking cessation services in Hong Kong are under-used with more than half (60.9%) adult daily smokers who had never used smoking cessation services (Census and Statistics Department, 2013). Among these smokers only 9.6% were willing to use the services. Existing services mostly require self-initiation to seek the services but smokers general lack the will power of initiation. Active referral will help overcome the barriers of self-initiation. There is preliminary evidence that active referral of smokers to smoking cessation hotline services may increase likelihood of smoking abstinence at 12-month follow-up compared with no active referrals (Borland et al., 2008). A recent study has also reported that individuals who used the community-based referral were also more likely to quit than those who did not (43.6% vs 15.3%, P\<0.001) (Haas et al., 2015).

Therefore, the present study will examine (1) effectiveness of the active referral and AWARD approaches, (2) explore the use of CBPR model to build capacity and to engage community partners in taking on this important public health issue for sustainability in the community. In addition, process evaluation will be conducted to assess the effectiveness of the recruitment activity and how it is linked with the overall program outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Hong Kong residents aged 18 or above
* Smoke at least 1 cigarette per day in the past 3 months
* Able to communicate in Cantonese
* Exhaled carbon monoxide (CO) 4 ppm or above, assessed by a validated CO smokerlyzer
* Have Intention to quit

Exclusion Criteria:

* Smokers who have difficulties (either physical or cognitive condition) to communicate
* Currently following other smoking cessation programs
Comparison of Two Rehabilitation Programs in Patients With Mild to Moderate Parkinson's Disease.

Parkinson's disease is a major source of handicap, for which physical treatments are often underutilized with respect to chemical or surgical treatments. Yet, dopaminergic treatments alone prove unable to stop or control the gradual worsening of motor disability after a few years.

The training program that this study sets out to evaluate aims to restore balance between agonist extensors and antagonist flexors in Parkinson's disease.

There is indeed in Parkinson's disease an imbalance between weak flexors and weaker extensors, with excessive predominance of the flexors. The hypothesis of the study is that a motor strengthening program targeting extensor muscles specifically will improve body posture and restore motor function better than a conventional physical therapy program, in mild to moderate Parkinson's disease.

This is a parallel-group, single blind, randomized trial (investigators will be kept unaware of the physical treatment followed by study subjects).

The duration of patient participation is 5 months: 2-month intervention and 3-month follow-up following the intervention.


Eligibility Criteria:
Inclusion Criteria

* Patient diagnosed with Parkinson's disease on UKPDSBB criteria.
* Hoehn \& Yahr stage 2, 3 in "OFF" state
* Age ≥18 years
* Patient who agreed to sign an informed consent to participate in this study.

Exclusion Criteria

* Patients who cannot or do not wish to follow a motor rehabilitation program for two months with a subsequent follow-up 3 months
* Intercurrent severe condition jeopardizing the vital or functional prognosis or the ability to participate in rehabilitation sessions.
* Cognitive dysfunction making effective communication or participation in a rehabilitation program impossible
* Person not benefiting from French State Health Insurance
* Current participation in another research protocol
Protein Kinase 2 (HIPK2) Polymorphisms on rs2058265, rs6464214, and rs7456421

In the present study investigators aimed to investigate whether homeodomain interacting protein kinase 2 (HIPK2) polymorphism is associated with renal stone formation in Turkish population or not.

One hundred and twenty nine participants with calcium nephrolithiasis and 67 sex and age-matched healthy controls were enrolled in this study. For analysis of HIPK2 polymorphism, the real-time PCR amplification was performed in a final volume of 20μL reaction mixture, including 10 ng of genomic DNA, 5 µL of TaqMan® Universal PCR Master Mix, and 0.5 µL of 40X TaqMan® assay. The Rotor-Gene Q Series Software Version Q 2.3.1 (Rotor-Gene Q Series, Ziagen) was used for allelic discrimination. Chi square test was utilized to compare the differences of the genotype and allele frequencies between patients and controls.

Kidney stone incidence depends on geographical, climatic, ethnic, dietary and genetic factors. Thus the prevalence rates for urinary stones change from 1% to 20%. 1,2 Genetic polymorphism also causes nephrolithiasis. The most known polymorphic genes are the calcium-sensing receptor (CASR), vitamin D receptor (VDR), and matrix gla protein (MGP), plasminogen activator, urokinase (PLAU). 3,4 Furthermore, the concordance rate of the stone disease in monozygotic twins is substantially higher than in dizygotic ones (32.4% vs. 17.3%) demonstrating that genetic factors play a vital role in the formation of nephrolithiasis. 5 Homeodomain interacting protein kinase 2 (HIPK2) has been shown to be a new androgen receptor regulator. HIPK2 and androgen were demonstrated to mediate kidney tubular epithelial cell injury and apoptosis.

Informations on HIPK2 polymorphism about renal stone formation are newfound and inconclusive. Therefore, in this study, authors aimed to investigate whether HIPK2 polymorphism is associated with renal stone formation in Turkish population or not.

Eligibility Criteria:
Inclusion Criteria:

Patients with nephrolithiasis

Exclusion Criteria:

* Patients had a history of chronic urinary tract infection
* renal failure
* gastrointestinal diseases
* increased levels of vitamin D
* sarcoidosis
* primary hyperoxaluria
* polycystic kidney disease, gout, renal tubular acidosis, primary and secondary hyperparathyroidism.
Upstate New York Infant Development Screening Program

The goal of the Upstate KIDS Study is to track the growth, development and long-term health of children given the increasing use of infertility treatment, occurrence of maternal obesity and pregnancy complications, and rising maternal age at birth.

The Upstate KIDS Study aims to determine if there are differences in health measures between children conceived by infertility treatment and children conceived naturally. In the first phase of the study, the focus was on growth and development through age 3 years. In the second phase of the study, the focus is turning to cardiometabolic factors through age 9 years. Infertility treatments include assisted reproductive technologies (ART) such as in vitro fertilization (IVF), controlled ovarian hyperstimulation (COH) and ovulation induction (OI). The study was originally designed as a matched exposure cohort. Specifically, singletons whose birth certificates indicated the use of infertility treatment were considered 'exposed' singleton infants and subsequently frequency-matched on perinatal region of birth at a ratio of 1:3 to 'unexposed' singletons. Twins and higher order multiples were invited to participate regardless of mode of conception. Mothers and their newborns were recruited approximately 2-4 months postpartum. The first phase of the study was completed in 2014 and main findings can be found under publications.

The second phase objectives are:

To determine whether infertility treatment is associated with differences in growth and development from age 6 to 8 years with particular focus on childhood cardio-metabolic outcomes by follow-up of children conceived by ART or other infertility treatments and children who were conceived without treatment. Secondarily, to assess epigenetic differences as measured by DNA methylation using collected biospecimens.

Eligibility Criteria:
Inclusion Criteria:

* Mothers delivering a live birth in New York State (excluding New York City).

Exclusion Criteria:

* Refused follow-up
Comparison of Suturing and Packing of Drained Abscesses

The standard treatment for skin abscesses in drainage followed by packing to prevent premature closure and reaccumulation of pus. Studies from the 1950s and later conducted outside of the US suggest that when drained abscesses are drained and sutured closed they actually heal faster without complications. The current study compares the time to healing and scar formation when drained abscesses are packed or sutured.


Eligibility Criteria:
Inclusion Criteria:

* Non complicated abscesses

Exclusion Criteria:

* Fever,
* Immunocompromise,
* Cellulitis,
* Perianal and
* Pilonidal abscesses
An Observational Study of Avastin and Conventional Chemotherapy in Patients >/= 70 Years of Age With Previously Untreated Metastatic Colorectal Cancer (AVAPLUS)

This observational study will evaluate the use of Avastin (bevacizumab) and conventional chemotherapy in patients \>/= 70 years of age with previously untreated metastatic colorectal cancer. Data will be collected from each patient from initiation of treatment until disease progression occurs (minimum follow-up 12 months).


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/ 70 years of age
* Previously untreated metastatic colorectal cancer
* Patient considered suitable to receive chemotherapy with or without Avastin

Exclusion Criteria:

* Participation in any other clinical trial or study with the exception of participation in registries
Influence of Age on Amyloid Load in Alzheimer's Disease and in Atypical Focal Cortical Alzheimer's Disease

The first objective is to asses influence of age on amyloid load measured by PET imaging using Pittsburgh B compound (PiB) radio-tracer, in Alzheimer's disease(AD). This will allow the determination of brains age-specific deterioration factors by comparing Early onset AD (EOAD), Late onset AD (LOAD)and atypical focal cortical AD (PCA and LPA). The amount of brain lesions in AD patients is estimated by:

1. measuring the rate of cortical brain atrophy,
2. FDG imaging of glucose metabolism reflecting neuronal activity, and
3. for patients who benefited from a lumbar puncture; Cortical-spinal fluid (CSF) amounts of amyloïd and tau proteins are measured.

Literature data suggests there are different types of AD depending on their age of onset, called EOAD and LOAD. These two categories are distinguished by the localization of brain atrophy : severe and 'posterior' in EOAD and more 'anterior' in LOAD. Neuro-pathologic data suggests some atypical focal cortical atrophy, characterized by a respect of episodic memory, may be classified within EOAD.

PiB-based PET imaging allows the in-vivo visualization and quantification of amyloïd load.

We want to answer the question whether the amount of amyloïd protein may be lower in LOAD than EOAD in patients showing the same level of dementia, and thus identify ageing-specific cognitive disorders and understand witch factors influence etio-pathology of typical and atypical Alzheimer's disease.

Eligibility Criteria:
Inclusion Criteria:

* AD patients: clinical dementia rating between 0.5 and 2 free and cued recall test (Grober and Buschke) cued-recall \< 18/48 and total recall \< 40/48
* atypical AD : i visual-spatial disorder and respect of episodic memory progressive evolution, Balint syndrome ii progressive language disorder constituted of logopenic aphasia respect of episodic memory
* controls: age over 30 MMSE over or equal to 27 normal neuropsychiatric state for age and education level

Exclusion Criteria:

* for every patients : psychiatric disorders age under18 absence of social security counter indication to MRI supposed or actual alcoholism or drug addiction pregnancy