cyrilzakka/clinical-trials huggingface dataset:
Post-marketing Safety Study to Assess the Risk of Spontaneous Abortions in Women Exposed to Cervarix Residing in UK

This study will assess the risk of spontaneous abortion during weeks 1-23 and weeks 1-19 of gestation, respectively, and other pregnancy outcomes, in an exposed cohort, i.e. women with last menstrual period (LMP) between 30 days before and 45 days after, or 30 days before and 90 days after any dose of Cervarix, when compared to a non-exposed cohort, i.e. women with LMP between 120 days and 18 months after the last Cervarix dose. The data collected in the Clinical Practice Research Datalink General Practitioner OnLine Database (CPRD GOLD) in the UK, will be analysed in this study.

Convenience sampling will be used in this study. It is planned to include all eligible pregnant women (included in CPRD GOLD and who fulfil to the inclusion/exclusion criteria) in each of the two cohorts.

Eligibility Criteria:
Inclusion Criteria:

For the exposed cohort:

All subjects must satisfy all of the following criteria at entry into the exposed cohort:

* Full date of first day of LMP available in the database or calculated from Estimated date of delivery (EDD).
* Female, aged between, and including, 15 and 25 years of age at LMP.
* Recorded in the CPRD GOLD for at least 12 months at LMP.
* First day of LMP available in the database or calculated from EDD between September 1st 2008 and June 30th 2011.
* At least one dose of Cervarix received between September 1st 2008 and June 30th 2011.
* Full date of Cervarix vaccination(s) available.
* First day of LMP available in the database or calculated from EDD between 30 days before and 90 days after any dose of Cervarix.
* Subject defined as acceptable in CPRD GOLD.

For the non-exposed cohort:

All subjects must satisfy all of the following criteria at entry into the non-exposed cohort:

* Full date of first day of LMP available in the database or calculated from EDD.
* Female, aged between, and including, 15 and 25 years of age at LMP.
* Recorded in the CPRD GOLD since at least 12 months at LMP.
* First day of LMP available in the database or calculated from EDD between September 1st 2008 and June 30th 2011.
* At least one dose of Cervarix received between September 1st 2008 and June 30th 2011.
* Full date of Cervarix vaccination(s) available.
* First day of LMP available in the database or calculated from EDD between 120 days and 18 months after the last dose of Cervarix.
* Subject defined as acceptable in CPRD GOLD.

Exclusion Criteria:

For the exposed cohort:

• Female with the first day LMP between 30 days before and 90 days after at least one dose of unspecified Human Papillomavirus vaccine and/or Gardasil.

For the non-exposed cohort:

* Female with the first day LMP between 30 days before and 90 days after at least one dose of unspecified Human Papillomavirus vaccine and/or Gardasil.
* Female included for a previous pregnancy in the exposed cohort.
Effects Of Latissimus Dorsi Stretching On Functional Disability Related To Chronic Low Back Pain

The main objective of the study is to determine effects of latissimus dorsi stretching on functional disability related to chronic low back pain

A single-blinded,randomized clinical trial will be conducted in /multiple rehabilitation centers of Rawalpindi and Islamabad, after taking approval from ERB/IRB respective centers. The study duration will be 3 months. the study participants will be having mechanical low back pain.

The intervention will be included latissmus dorsi stretching along with spinal stabilization exercises in one group and in comparative group spinal stabilization exercises alone. Oswestry Disability Index (ODI) will be used to measure the disability related to the chronic low back pain.

Eligibility Criteria:
Inclusion Criteria:

* male and female
* 20 to 60 years
* chronic mechanical low back pain

Exclusion Criteria:

* patients who had any type of injury or fracture which limits rehabilitation
* patients with the symptoms of radiating pain
* who had disc pathology and spinal cord injury
* patients with medical conditions
Strongest Families (Formerly Family Help Program): Pediatric Disruptive Behaviour Disorder

The purpose of the Strongest Families (formerly Family Help Program)is to evaluate the effectiveness of the Strongest Families distance intervention compared to usual or standard care that is typically provided to children with mild to moderate Disruptive Behaviour symptomology. This is a single-centre trial based at the IWK Health Centre. The primary outcome is change in diagnosis.

The purpose of the Strongest Families (formerly Family Help Program): is to deliver, primary care mental health services to children and their families in the comfort and privacy of their own home. Approximately 60 children (3-7 years of age)suffering from mild to moderate (but clinically significant) symptoms of pediatric behavior disorder will be randomized.

The intervention is delivered from a distance, using educational materials (manuals, video-tapes, audio-tapes) and telephone consultation with a trained paraprofessional "coach" who is supervised by a licensed health care professional. The telephone coach delivers consistent care based on written protocols, with on-going evaluation by a professional team.

Fifty percent of the eligible participants will receive Family Help Program telephone-based treatment and 50% will be referred back to their family physician to receive standard care as determined by that physician. Those receiving standard care will be evaluated for outcome results and then compared to the Strongest Families treated participants. It is anticipated that Strongest Families treatment will be proven to be as or more effective than standard care.

Eligibility Criteria:
Inclusion Criteria:

* child 3 to 7 years of age
* child had behavioural problems for 6 months or longer
* access to a telephone in the home
* speak and write english
* mild to moderate disruptive behaviour symptomology

Exclusion Criteria:

* severe disruptive behaviour symptomology
* received similar intervention within past 6 months
* Autism or Schizophrenia
* child has intellectual impairment
Pharmacokinetics, Safety, Tolerability and Efficacy of Intravenous Doses of ZGN-433 in Obese Female Volunteers

The purpose of this study is to assess whether multiple doses of ZGN-433 are safe and effective.

This protocol is designed to test the safety and efficacy of a drug called Beloranib (ZGN-433). It is to be tested for its ability to reduce weight in obese female subjects who are of non-childbearing potential. The study will provide information on how much ZGN-433 gets into the blood, how long it stays in the body, and how it affects other biological markers.

Eligibility Criteria:
Inclusion Criteria:

* Obese but otherwise healthy females
* Non-childbearing potential (surgically sterile, post-menopausal, or receiving implanted or injectable contraceptive for at least 3 months)
* BMI ≥ 30 and ≤ 50 kg/m2
* Stable body weight during the past month

Exclusion Criteria:

* Use of weight loss agents in the past month
* History of eating disorder
* History of gastric bypass surgery
* Current smokers
Comparison of the Effect of Intravenous and Perineural Dexmedetomidine in Gastric Cancer Surgery

Using random case assignment to investigate the analgesic and sedative effect of intravenous dexmedetomidine and dexmedetomidine as a local anesthetic adjuvant in ultrasound-guided subcostal TAP block in gastric cancer patient undergoing gastrectomy or partial gastrectomy.

The process of the experiment (brief describe) The participant patients will be randomly allocated into three groups: the intravenous dexmedetomidine group (Dex_iv group), dexmedetomidine adding to local anesthetic as an adjuvant for subcostal TAP block (Dex_adj group), and Control group. All patients receive gastrectomy or partial gastrectomy in general anesthesia as standard. Thirty minutes before the end of surgery, the patients in Dex_iv group receive 0.5mcg/kg dexmedetomidine infusion for 30 minutes, while the patients in Dex_adj group and control group receive 0.125ml/kg 0.9% normal saline IV infusion for 30 minutes. All patients have ultrasound-guided TAP block single injection after the end of surgery and before the tracheal tube extubation. The block agents in Dex_adj group is 40 ml of 0.375% ropivacaine with 0.5mcg/kg dexmedetomidine, while in Dex_iv group and control group are only 40ml of 0.375% ropivacaine. The IV PCA pump will be set up before patients awaken in the post-anesthesia care unit. All patients are assessed for the signs of emergence agitation with Riker sedation-agitation scale in the post-anesthesia care unit. The numerical rating scale (NRS) for pain intensity assessment, the opioid consumption via IV PCA pump, and the patients satisfaction will be documented for postoperative 3 days for the impact evaluation of dexmedetomidine in postoperative analgesia in patients undergoing gastric cancer surgery with subcostal TAP block.

Eligibility Criteria:
Inclusion Criteria:

* gastric cancer patients undergoing gastrectomy or partial gastrectomy, who receive ultrasound-guided subcostal TAP block and PCA for postoperative analgesia

Exclusion Criteria:

* surgery involved other visceral organ (eg. combined splenectomy or partial hepatectomy), patients with histories of adverse drug reaction to dexmedetomidine, bradycardia (baseline heart rate \<60 beats/min), any type of atrioventricular block in electrocardiogram (EKG), heart failure, significant renal or hepatic impairment, severe bronchopulmonary disease, any coagulant disorder, and pregnant or breast-feeding woman.
The Effect of 3% Diquafosol Ophthalmic Solution on Visual Display Terminal-associated Dry Eye

This study aims to evaluate the efficacy and safety of 3% Diquafosol Ophthalmic Solution for visual display terminal (VDT)-associated dry eye and to investigate the mechanism of treatment.

The treatment period is 12 weeks. The day after subjects who meet the inclusion criteria undergo baseline examination is the day starting the medication. The dosing frequency was six times daily for 3% Diquafosol Ophthalmic Solution. The follow-up time points are 2, 4, 8, 12 weeks, and the investigator will evaluate the symptoms and signs of Dry Eye.

Eligibility Criteria:
Inclusion Criteria:

* Male or female with a diagnosis dry eye based on Chinese Dry Eye Diagnosis Standard (2020)；
* Working in the offices with VDTs more than 4h daily；
* Working in the offices with VDTs at least five days per week；
* Provision of written informed consent.

Exclusion Criteria:

* Known allergy to any eye drops
* Ocular therapies other than artificial tears
* Presence of any of the following conditions: active ocular infection, ocular inflammation, active ocular allergy, contact lens wear, ocular surgical history, laser treatment in the last 3 months, Meibomian gland dysfunction (MGD) over grade 2 (the grade is according to the report of the International Workshop on MGD in 2011), severe blepharitis or obvious inflammation of the eyelid margin, which in the judgment of the investigator may interfere with the interpretation of the study results
* Pregnant and lactating women, or those planning a pregnancy over the course of the study
* Uncontrolled systemic disease
* Hypersensitivity or intolerance to diquafosol(DQS)
* Subjects with a history of anxiety and depression
Preventing Youth Suicide in Primary Care: A Family Model

The purpose of the study is to test the efficacy of a brief family therapy (Attachment-Based Family Therapy) for youth presenting in primary care with suicidal ideation and depressed mood.

Youth suicide is a serious public health problem and clinical challenge for medical and behavioral health providers, yet few preventive interventions have been tested for this population. This project addresses this deficit by testing the efficacy of a brief family therapy for adolescents presenting with serious risk for suicide in a primary care setting. Several innovations characterize the study. First, patients will be identified and treated directly in the primary care setting. Integrating behavioral health services into primary care may a) reduce burden on physicians by promoting parents as safety monitors, b) increase behavioral health treatment adherence, and c) address many underlying family problems associated with suicide. Second, to identify seriously at risk adolescents, we will assess for severe and persistent suicidal ideation and co-occurring depression. Patients will need to score above clinical cutoffs on both ideation (SIQ-JR \> 31) and depression (BDI-II \>20) at two consecutive appointments (generally within 3 days of each other). Third, treatment will target two of the most critical suicide risk factors: depression and family conflict. Depression is the most consistently associated risk factor for suicide and family conflict is the most common precipitant of completed suicide (20%) and non-fatal suicidal episodes (50%). Fourth, we will use Attachment Based Family Therapy (ABFT; Diamond et al., 2002) as the intervention approach, an efficacious and manualized family therapy model specifically designed for adolescent depression. ABFT has been successful in reducing suicidal ideation, hopelessness, depression, anxiety, and family conflict. Participants will be recruited from the primary care centers at The Children's Hospital of Philadelphia. Eighty-seven percent of patients are African American and 60% are girls. One hundred adolescents will be randomized to 6 to 10 weeks of either ABFT or Enhanced Usual Care (EUC). Patients will be evaluated at baseline 6, 12, 24, and 52 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Suicidal ideation (SIQ-JR \> 30)
* Moderate depressed mood (BDI-II \> 19)
* At least one parent/caregiver willing to participate

Exclusion Criteria:

* Psychosis
* Mental retardation or other significant cognitive impairment
Clinical Study to Evaluate the Body Fat Reducing Effects of Heat-Treated Green Tea Extract Complex

This clinical study was designed to evaluate the efficacy and safety of body fat reduction in obese adults by treatment of heat-treated green tea extract complex

This study is a 12-week, randomized, double-blind, placebo-controlled clinical trial. 100 subjects were ranromly assigned to heat-treated green tea extract(HTGT) group and placebo group. The changes in the efficacy endpoint were evaluated after treatment of 2 capsules of HTGT once daiy for 12 weeks.

Eligibility Criteria:
* lt;Inclusion Criteria\&gt;

  * Males and females aged between 19 \~ 64 years
  * BMI 25.0 \~ 34.9 kg/m\^2
  * Waist circumferebce: 90cm or more for men, 85cm or more for women
  * Subjects who have fully understand the information provided about the study and voluntarily decided to participate
* lt;Exclusion Criteria\&gt;

  * Participants whose weight changed by more than 10% within the 3 months prior to visit 1
  * Individuals participated in a commercial weight loss program within 3 months prior to Visit 1
  * Participants who have undergone surgical procedures within 3 years
  * Participants who have taken obesity treatment medications within the last 3 months
  * Individuals who have taken medications affecting weight or dietary supplements for weight control within the last month
  * Subjects with uncontrolled hypertension
  * Subjects diagnosed with diabetes
  * TSH \&lt;0.1 uIU/ml or \&gt;10 uIU/ml
  * Creatinine \&gt;1.5mg/dL
  * AST or ALT \&gt; three times the upper normal limit
Preoperative Nutritional Assessment of The Patients Undergoing Major Gastrointestinal Surgery and Their Immediate Postoperative Outcome

It was a prospective observational study, where preoperative nutritional status and early postoperative complications \<30 days (infectious or noninfectious) were studied. The patients admitted between July 2015 to May 2017, who underwent major GI surgeries were included in the study. The study was designed to check if BMI and NRI can predict the postoperative outcomes in these patients.

It was a prospective observational study. This study was done at NAMS, Bir Hospital, Kathmandu, Nepal between July 2015 to May 2017. All the patients who underwent major GI surgery, under general anesthesia, were included in the study. Major was defined as surgery involving \>2hrs and excluded were an emergency major operation, gallstone disease operations, patients with cough, fever, and chest infections respectively. The sample size was calculated using the formula z2pq/d2. Twice the number of sample calculated was taken into consideration and the maximum tolerable error was taken as 5%. BMI and NRI were two independent categorical variables. The dependent variables were the postoperative outcome in terms of infectious and noninfectious complications. All the preoperative parameters were of the patients were recorded. The immediate postoperative complications were documented and categorized as infectious and noninfectious complications.

Eligibility Criteria:
Inclusion Criteria:

* All the patients who underwent major GI surgery, under general anesthesia, were included in the study. Major was defined as surgery involving \>2hrs and

Exclusion Criteria:

* Excluded were an emergency major operation, gallstone disease operations, patients with cough, fever, and chest infections respectively
A Master Protocol Study (LY900038) of Multiple Intervention-Specific-Appendices (ISAs) in Adult Participants With Obesity or Overweight

The purpose of this Phase-2 chronic weight management master protocol (CWMM) is to create a framework to evaluate the safety and efficacy of various investigational interventions for chronic weight management with intervention-specific appendices (ISAs). The CWMM establishes entry criteria for newly enrolled participants across the master and the ISAs. The ISAs may start independently of other ISAs as interventions become available for clinical testing. The results for the CWMM screening record will be reported when all the ISA's complete.


Eligibility Criteria:
Inclusion Criteria:

* Have a body mass index (BMI)
* ≥30 kilogram/square meter (kg/m²), or
* ≥27 kg/m² and \<30 kg/m²), or with at least 1 weight-releated comorbidity
* Have had a stable body weight for the 3 months prior to randomization (\<5%) body weight gain and/or loss.

Exclusion Criteria:

* Have a prior or planned surgical treatment for obesity, except prior liposuction or abdominoplasty, if performed \>1 year prior to screening.
* Have type 1 diabetes mellitus, latent autoimmune diabetes in adults, or history of ketoacidosis or hyperosmolar coma.
* Have poorly controlled hypertension.
* Have signs and symptoms of any liver disease other than nonalcoholic fatty liver disease.
* Have any of the following cardiovascular conditions within 3 months prior to screening:

  * acute myocardial infarction
  * cerebrovascular accident (stroke)
  * unstable angina, or
  * hospitalization due to congestive heart failure.
* Have a history of symptomatic gallbladder disease within the past 2 years.
* Have a lifetime history of suicide attempts.
Effect of Background Noise on Sleep Quality

Insufficient and low-quality sleep is a major public health problem that has been linked to motor vehicle crashes, industrial disasters, and medical and other occupational errors. Persons experiencing sleep insufficiency are also more likely to suffer from chronic diseases such as hypertension, diabetes, depression, and obesity, as well as from cancer, increased mortality, and reduced quality of life and productivity.

The number of people using sleep-inducing drugs to increase or improve sleep is steadily increasing in the last few decades; however, the side effects of these therapies often outweigh the benefits.

A few small trials and anecdotal findings suggest that continuous background (pink or white) noise overnight can improve sleep quality, increase acoustic arousal threshold, and reduce sleep onset latency.

In an attempt to find new, alternative solutions to increase sleep quality in people suffering from insomnia, the investigators would like to test the effect of surrounding filtered white noise on sleep onset latency and subjective sleep quality in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Age between 21 and 60

Exclusion Criteria:

* Any sleep disorder
* Use of hypnotics
A Standardized Meditation Technique "Body-scan", in the Management of Anxiety in Hospitalized Parkinsonian Patients

The aim of the study is to constitute a proof of concept study for a larger study investigating the effect of mindfulness on anxiety and agitation in Parkinson's disease (PD) based on the results of a preliminary feasibility.

Neuropsychiatric and behavioral non motor symptoms are common in PD often requiring hospitalization and/or specific drug management. Mindfulness-based stress reduction (MBSR) programs have proved to be efficacious in PD both for the management of motor and non-motor symptoms. This is however the case only in out-patients and by using standardized 8 weeks programs. The team has experienced in the hospitalization unit that methods derived from the MBSR program such as the "body scan", administered by the paramedical personnel, is of great help for the non-pharmacological management of anxiety and agitation in PD, avoiding physical contention in many cases. Based on this experience the study aims at evaluating the feasibility and preliminary efficacy of a simple and standardized administration of the "body scan" meditation in the management of anxiety and agitation in PD admitted in the unit since less than 48h.

Eligibility Criteria:
Inclusion Criteria:

* Parkinson's disease
* Age over 18
* Admitted in the unit since less than 3 days
* Presenting at least 3 symptoms with a severity rated \> 2 at the Hamilton anxiety scale (HAM-A)
* Patients with social security insurance
* Informed consent signed

Exclusion Criteria:

* Dementia, delusions or hallucination not permitting an informed consent or necessitating immediate and urgent sedation
* Patient under law protection
* Pregnant or breastfeeding women
Safety and Efficacy Study of R932348 Ophthalmic Solution in Chronic Ocular Graft Versus Host Disease Patients(DROPS-2)

* To assess the efficacy of R348 Ophthalmic Solutions administered for 12 weeks to subjects evaluated by objective and subjective measures.
* To investigate the safety and tolerability of R348 Ophthalmic Solutions administered for 12 weeks to subjects.


Eligibility Criteria:
Inclusion Criteria:

* Received an Allogeneic hematologic stem cell transplantation at least 3 months prior.
* Subjects with post Allogeneic hematologic stem cell transplantation onset or worsening of dry eye symptoms for at least 1 month prior.
* Use of over-the-counter and/or prescription eye drops for dry eye symptoms within 1 month.
* Corneal fluorescein staining score of ≥ 2 in 1 region and ≥ 1 in at least 1 other region.
* Total lissamine green conjunctival staining score (according to a modified National Eye Institute grading system) of ≥ 2.

Exclusion Criteria:

* Clinically unstable Graft versus Host Disease (requiring a change in immunosuppressive regimen), medical condition, or laboratory abnormality
* Used topical ophthalmic cyclosporine within 45 days.
* Used any topical ophthalmic steroid within 2 weeks.
* Used autologous serum eye drops within 2 weeks.