cyrilzakka/clinical-trials huggingface dataset:
The Effectiveness of a Classroom-based Intervention Promoting a Prosocial Classroom Climate in Children

The purpose of this study is to investigate whether a classroom-based program promoting a prosocial classroom climate is more effective than treatment-as-usual (control condition).

A positive, prosocial classroom climate is associated with improved social competence and academic achievement, as well as decreased internalizing and externalizing problems and antisocial behavior in children. It is expected that motivation to behave prosocially is needed to achieve a prosocial climate in the classroom, and that such motivation can be enhanced through three components of self-determination theory (SDT): competence, relatedness, and autonomy. The goal of this study is to examine the effectiveness of a classroom-based program based on SDT that aims to promote prosocial classroom climate, through a cluster Randomized Controlled Trial (RCT). SterkWerk is hypothesized to be more effective than treatment-as-usual (TAU) in creating more prosocial classrooms, through improving prosocial (intrinsic) motivation and behavior, social autonomy, social competence, and social relatedness.

The design of the current study is a cluster Randomized Controlled Trial (RCT) with two conditions: the intervention condition and a waitlist control condition (TAU: treatment-as-usual). Schools in the intervention condition receive the materials and training to implement the intervention in the school year 2023/2024. Schools in the control group do not receive the intervention (do not receive material or training), and function as normal (TAU). Control schools are requested to not start any social-emotional program during the school year 2023/2024.

Eligibility Criteria:
Inclusion Criteria:

* Primary school children of grades 5-8 (mostly aged between 8-12 years)
* Teachers and school leaders of participating schools (no age limit)

Exclusion Criteria:

* No exclusion criteria
An Observational Study of Pegasys (Peginterferon Alfa-2a) in Patients With HbeAg-negative Chronic Hepatitis B (Perseas)

This observational, multi-center, open-label study will evaluate the prognostic factors of long-term-response and the safety of Pegasys (peginterferon alfa-2a) in patients with HbeAg-negative chronic hepatitis B. Data will be collected for 96 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/=18 years of age
* Diagnosis of HBeAg-negative chronic hepatitis B with compensated hepatic disease, virus multiplication, raised alanine amino transferase results and/or fibrosis

Exclusion Criteria:

* Co-infection with hepatitis A, C or D
* Co-infection with human immunodeficiency virus (HIV)
* Severe hepatic dysfunction or decompensated liver disease
Study to Evaluate the Safety, Pharmacokinetics, Tissue Distribution, Metabolism and Dosimetry of Two Prostate Cancer Imaging Agents

This is a single blinded, randomized, cross-over design. Up to 12 patients will be randomly administered a single 10.0 mCi dose of 123I-MIP-1072 or 123I-MIP-1095 (study drugs). The second (alternate) study drug will be administered approximately 14 days after the first. A final follow-up visit will occur approximately 2 weeks after the injection of the alternate study drug.


Eligibility Criteria:
Inclusion Criteria:

* Have a prior histological diagnosis of prostate cancer.
* Have evidence of recurrent metastatic disease demonstrated by an abnormal bone scan, CT scan or MRI plus:

  1. PSA\> 1.0 if patient is post prostatectomy or post ablative radiotherapy, or
  2. PSA\> 20 if intact prostate
* Have platelet count of \> 50,000/mm3
* Have neutrophil count of \> 1,000/mm3
* Provide written informed consent and willing to comply with protocol requirements
* Greater than or equal to 18 years of age
* Can be on hormonal therapy if dose stable for \> 90 days

Exclusion Criteria:

* Karnofsky performance status of \<60
* Inadequate venous access (two antecubital or equivalent venous access sites are required for study drug injection and PK blood sampling, respectively)
* Patient received a permanent prostate brachytherapy implant within the last 3 months (for Pd-103 implants) or 12 months (for I-125 implants).
* Patient received external beam therapy or chemotherapy within the last 30 days
* Administered a radioisotope within 5 physical half lives prior to study enrollment
* Serum creatinine \> 3.5 mg/dL
* Total bilirubin \> 2.5 times the upper limit of normal
* Liver transaminases greater than 5x the upper limit of normal
* Received an investigational compound and/or medical device or is part of an investigational study within the past 30 days before enrollment into this study
* Have any medical condition or other circumstances which, in the opinion of the Investigator, would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post dose follow-up examinations
* Is determined by the Investigator that the patient is clinically unsuitable for the study
* Have had any other malignancies within 5 years other than basal or squamous cell carcinoma of the skin.
Clinical Trial With Combination of Dienogest/Ethytnilestradiol and Drosperidona/Ethyniestradiol

This trial will study the percentage of women with at least one occurrence of intracyclic bleeding (bleeding and/or spotting) during the cycles 2 and 3 of treatment with test or reference drug.


Eligibility Criteria:
Inclusion Criteria:

* Sign, initial and date the informed consent form;
* Female patients, with child bearing potential, aged 18 to 35 years;
* Have indication to receive progesterone and estrogen-based low oral hormone treatment for at least 7 cycles (approximately 7 months) for birth control;
* Be able to comply with the study protocol;
* Show normal result in cervical-vaginal cytology conducted up to 3 months before study enrollment or be willing to repeat the screening visit test, which result must also be normal;
* Be willing to use one of the study drugs

Exclusion Criteria:

* Is pregnant or breastfeeding, suspecting to be or planning to get pregnant;
* Patients currently using oral contraceptives with drospirenone 3 mg/ ethynilestradiol 30 mcg or dianogest 2 mg/ ethynilestradiol 30 mcg.
* Have history of gynecologic surgery such as hysterectomy, total oophorectomy or tubal ligation;
* Smoke over 10 cigarettes a day;
* Have any severe comorbidities (at the investigator's criteria), including bowel inflammatory disease
* Have hypertension, showing at least one of the following conditions:

Systolic pressure \>140 mm Hg or diastolic pressure \>90 mm Hg in sitting position;

* Current use of pharmacological treatment for hypertension;
* Show history or currently have venous or arterial thromboembolism;
* History of breast or genital cancer;
* Have obesity (BMI \>30 kg/m2);
* Have liver disease or changed lab values;
* Currently have dysplasia or malignancy in cervical-vaginal cytology;
* Concomitantly use CYP3A4 metabolizing drugs or drugs causing drug interaction with other study drugs;
* History of abortion one (1) month before study enrollment;
* History of childbirth or breastfeeding 3 months before study enrollment;
* Have hypersensitivity to any of the study drug components;
* Patients with long-term disability, who have undergone a major surgery or any surgery in legs or major traumatism in the last 6 months;
* Have current diagnosis of sexually transmitted disease;
* Have used injectable hormones 3 months before study enrollment;
* Have used hormone implant 6 months before study enrollment;
* Have participated in another clinical trial in the last 12 months.
Danazol in Treating Patients With Advanced or Recurrent Endometrial Cancer

RATIONALE: Hormone therapy may be an effective treatment for endometrial cancer.

PURPOSE: Phase II trial to study the effectiveness of danazol in treating patients with advanced or recurrent endometrial cancer.

OBJECTIVES: I. Assess the antitumor activity of danazol in patients with advanced or recurrent endometrial cancer. II. Determine the nature and toxicity of danazol in these patients.

OUTLINE: Patients receive oral danazol 4 times per day for at least 4 weeks. Patients with partial response, complete response, or stable disease continue treatment in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 23-56 patients will be accrued for this study within 26 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven advanced or recurrent endometrial cancer that is not amenable to curative surgery or radiotherapy Measurable disease Tumor at least 1.0 cm by 1.0 cm per x-ray or physical exam OR Tumor at least 2.0 cm by 2.0 cm per CT scan, MRI, or ultrasound

PATIENT CHARACTERISTICS: Age: Not specified Performance status: GOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3000/mm3 Platelet count at least 100,000/mm3 No history of porphyria Hepatic: Bilirubin no greater than 1.5 times normal SGOT no greater than 3 times normal Alkaline phosphatase no greater than 3 times normal Renal: Creatinine no greater than 2 mg/dL Other: No concurrent or prior malignancy within past 5 years (except nonmelanoma skin cancer) or for which patient received chemotherapy Not pregnant or nursing Fertile patients must use effective contraception Must have tissue available for estrogen receptor/ progesterone receptor analysis

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 3 weeks since prior radiotherapy and recovered Surgery: At least 3 weeks since prior surgery and recovered
ELDOA Technique Versus Lumbar SNAGS With Motor Control Exercises

Study will be a Randomized clinical trial to check the effects of ELDOA technique versus lumbar SNAGS with motor control exercises on pain, function and mobility in patients with chronic low back pain. Duration of study will be 8 months, non probability convenience sampling technique will be used, subject following eligibility criteria from District Headquarters Hospital Okara will be randomly allocated in two groups using computer random number generator. baseline assessment will be done. Group A participants will be given baseline treatment along with ELDOA exercises, Group B participants will be given baseline treatment along with Lumbar SNAGS and motor control exercises for 3 weeks. Assessment will be done by using Numeric Pain Rating Scale, Oswestry Disability Index and Inclinometer at baseline, at 3 weeks and a follow up will be taken at 6 weeks. 3 sessions per week will be given, data will be analyzed by using SPSS version 21.

LBP is a significant global health problem, and its impact is still great. In 2019, there were 6972.5 (95% UI 6190.5 to 7860.5) age-standardized point prevalence estimates for LBP worldwide, with 568.4 million (95% UI 505.0 to 640.6 million) prevalent cases. The GBD research also revealed that LBP has a worldwide point prevalence of 9.4%, with men having a greater prevalence than women (8.7% vs. 10.1%). Back discomfort might arise as a result of mobility disorders, musculoskeletal sprains, incorrect spine positioning, or nucleus pulposus degeneration. There is huge literature regarding the management of low back pain and yet after the decades of research there are gaps in treatment options. The current study will compare the ELDOA technique to Lumbar SNAGS with motor control exercises. The current study is novel in a way that there is very limited evidence avialbale on ELDOA Technique and Motor Control Exercises. This study will provide vital insights into their efficacy and can help to guide clinical decision making for individuals with low back pain. Furthermore, this study can add to the expanding body of information regarding low back pain treatment and will help to improve patient outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-30
* Patients of both genders.
* Patients having chronic Low Back Pain ( \>3 months duration)
* Patients with restricted range of motion (patients will be examined for active lumbar range of motion)
* Patients with lumbar straightening based on referral from orthopedic

Exclusion Criteria:

* History of neurological condition of hip and lumbar region.
* Medical red flag history (tumor, metabolic diseases, rheumatoid arthritis, osteoporosis or Infection)
* Medical record of severe disabling chronic cardiovascular and pulmonary disease.
* Prescribed history of epidural steroidal injection for pain.
INF108F in Infants With Food Protein Induced Proctocolitis

Single-center, randomized, double-blind, placebo-controlled trail evaluating INF108F in breastfed infants with FPIAP

This is a single-center, randomized, double-blind, placebo-controlled trial with two arms evaluating IBF108F in breastfed infants with FPIAP. Assessments will be conducted over a 4-week study period with assessment of blood in stool, infant stooling, sleep, feeding, and growth. Safety will be evaluated through collection adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Infants, male or female, of all ethnic/racial groups, with a gestational period of 37 to 42 weeks
* Infants aged 1 - 90 days old with a documented FPIAP with either gross blood or microscopic blood in without other possible causes
* Infants must be exclusively breastfed or at least half of oral intake is from breast feeding or from expressed breast milk
* A willing parent or legal guardian will sign the consent form either electronically or with a wet ink signature

Exclusion Criteria:

* Infants born earlier than 37 weeks of gestation
* Infants who are exclusively formula-fed or less than half of oral intake is from breastfeeding or from expressed breast milk at the time of enrollment
* Infants born with medical complications (i.e., neurological, cerebral palsy, confirmed food allergies)
* Diagnosis of other severe or complicating medical problems, including autoimmune or chronic immune inflammatory conditions, gastrointestinal inflammatory conditions, or renal insufficiency
* History of abdominal surgery or congenital abnormalities of the GI track, the cardiovascular system, the pulmonary system or the renal system
* Antibiotic use (oral or systemic) within 7 days prior to enrollment
* Mother's intent to feed non-study probiotics or solid food to their infant at any time during the study
* Mothers with substance use disorder (SUD) or on Nicotine replacement therapy (NRT)
* Infants who have consumed any B. infantis-containing probiotics since birth
Time Performance of Scoop Stretcher Versus Vacuum Mattress for Prehospital Spinal Stabilization

A simulation-based randomized controlled trial was designed with the objective to assess the time needed to achieve spinal stabilization using a scoop stretcher compared to a vacuum mattress.

A simulation-based randomized controlled trial was designed with the objective to assess the time needed to achieve spinal stabilization using a scoop stretcher compared to a vacuum mattress. The participants will be recruited among healthcare workers from one Emergency Medical Service. Then, the participants will first act as patient and undergo spinal stabilization from an other team, afterwards they will have to complete a spinal stabilization either using a scoop stretcher or a vacuum mattress, depending on allocation regarding randomization. The sessions will be video recorded to allow subsequent assessment.

Eligibility Criteria:
Inclusion Criteria:

* registered paramedics or emergency medical technician (EMT) actually working in the ambulance service.

Exclusion Criteria:

* member of study investigators
Effect of Computer-based Cognitive Training on Attention and Executive Functions in Patients With Parkinson's Disease

The current study adresses the effect of two different computer-based cognitive trianing programmes on attention and executive functions in patients with Parkinson's disease.

The current study adresses the effect of two different computer-based cognitive training programmes (Brain+ Evolution and Scientific Brain Training PRO) on attention and executive functions in patients with Parkinson's disease. The patients are assigned to one of three groups. Two training groups with each their programme, and a control Group. The training groups will train at home for 8 weeks with follow-ups every second week. The control group will not train at home, but will also receive a follow-up with computer-based stimuli (computerized Card game) every second week, to minimize the possibility that a possible effect is due to the follow-up's with a professional, and not due to the computer training at home.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Parkinson's disease AND
* Montreal cognitive assesment (MOCA)-score between 22-28
* Motorically cabable of using an iPad
* Not receiving antipsychotic medicine
* No comorbid diseases which might influence the level of executive functioning, for an example ADHD or acquired brain damage

Exclusion Criteria:

* People without Parkinson's disease
* Parkinson's patients not included in the above inclusion criteria
Rapid Rehabilitation to Treat Lower Extremity Trauma

The purpose of this study is to find out if an advance balance perturbation training program can enhance the rehabilitation process by increasing weight-bearing strategies on the prosthetic or injured limb, and, help reduce stumbles and falls.


Eligibility Criteria:
Inclusion Criteria:

* Research participants will be eligible active duty service members and retired veterans.
* Having lower limb trauma (transtibial and transfemoral amputations, bilateral amputations, and limb salvage).
* Are enrolled in conventional rehabilitation at the participating military treatment centers.
* Subjects with dysvascular disease will be excluded because compromised lower limb somatosensation and circulation are independently linked with poor postural stability and a history of frequent falls.
* For subjects with amputations, the individual must be a community ambulator (i.e., K-Level 3 or 4).
* For subjects with limb salvage, they will need to have an IDEO and be entered into the Return-to-Run training program.

Exclusion Criteria:

- Subjects must not have excessive pain or other neuromuscular problems that preclude them from performing the test protocol.
Clinical Performance of Self-cured Universal Adhesive for Restoring Cervical Lesions in Geriatric Patients

the study is conducted to evaluate the clinical performance of PALFIQUE universal adhesive (Tokuyama self-cure universal adhesive), Versus 3m ESPE™ single bond Universal Adhesive, for restoring cervical lesions in geriatric patients over one year.


Eligibility Criteria:
Inclusion Criteria:

* The patient had to be in good general health
* Geriatric patients
* Have an acceptable oral hygiene level
* Class V cavities in anterior and posterior teeth
* Males \& females included
* Anticipated availability for recalls (6 months and 12 months) through the 1-year study period

Exclusion Criteria:

* Lack of written informed consent to participate
* Poor oral hygiene,
* Severe bruxism
* Severe or chronic periodontitis
* Allergies to components of the materials used
* Underage patients
* Non vital pulp
Caffeine in Amblyopia Study

Prospective data on the visual acuity response in children treated by patching concurrently treated with caffeine and estimate the magnitude of effect that might be seen in a randomized trial (if no improvement in acuity is seen, this would be sufficient evidence to decide not to conduct a randomized, double blind trial).

Collect prospective data on the tolerability of caffeine in two dosages as an adjuvant treatment for amblyopia and provide limited data on its safety.

Evaluate the potential for a dietary intervention to enhance the acceptance and tolerability of patching on the child and family.

Demonstrate recruitment potential of subjects to participate in a dietary intervention study.


Eligibility Criteria:
Inclusion Criteria:

* Amblyopia from strabismus and amblyopia

Exclusion Criteria:

* Known intolerance to caffeine
* Diagnosis and/or treatment of attention deficit/hyperactivity disorder
* Presence of an ocular cause for reduced visual acuity
* Myopia with a special equivalent -6.00 diopters
* Current vision therapy or orthoptics - any type
* Ocular cause for reduced visual acuity
* Prior intraocular or refractive surgery
* History of narrow-angle glaucoma
* Strabismus surgery planned within 16 weeks
* Nystagmus per se does not exclude the subject if the above visual acuity criteria are met
* Known skin reactions to patch or bandage adhesives
* Known allergy or intolerance to food dyes
* Current treatment with topical atropine eyedrops
* Menarche, pregnancy or lactation
* Use of any of the following medications which may affect caffeine metabolism: nafcillin, verapamil, fluvoxamine, ciprofloxacin and other fluoroquinolones, modafinil, nafcillin, and omeprazole
Clinical Evaluation of Safety and Efficacy of Refrigeration Free Latanoprost

The purpose of this study is to:

* To evaluate the efficacy of Refrigeration-Free Latanoprost compared to Latanoprost stored at refrigeration temperature with respect to the diurnal intraocular pressure (IOP) change from baseline after 3 months of therapy in patients with open-angle glaucoma (OAG) or ocular hypertension.
* To evaluate the safety and tolerability of Refrigeration-Free Latanoprost in patients with open-angle glaucoma (OAG) or ocular hypertension.

Latanoprost refrigeration free formulation is developed to overcome difficulties on storing drugs at 2-8˚ C in consumer end and also to avoid risk during transition. This formulation has the best solubilizing agent cyclodextrin to increase the solubility and stability of latanoprost API. To find out the efficacy and safety due to this additional excipient in this formulation rather than the cold storage product the investigators have to perform clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* Patient between 18 and 80 years of age
* Newly diagnosed Primary Open-Angle Glaucoma, Pigmentary Glaucoma, Pseudoexfoliation, or Ocular hypertension.
* Patient has a mean (or median) IOP of 24 and 36 mmHg in at least one eye
* Patient has a best corrected ETDRS visual acuity score of +0.6 logMAR (Snellen equivalent of 20/80) or better in each eye.
* Patient should have the access / ability to refrigerate study drug.
* Residence with 60 kms of Madurai

Exclusion Criteria:

* Patient has a mean (or median) IOP \>36 mmHg in either eye at the Screening Visit.
* Patient has a history of or current abnormal corneal sensation or any abnormality in either eye preventing reliable Goldmann applanation tonometry
* Pupil in either eye that will not dilate sufficiently for adequate evaluation of the retina
* Patient has a history of retinal detachment, proliferative diabetic retinopathy, or any retinal disease in either eye that may be progressive during the study
* Patient who has significant ocular symptoms or signs such as photophobia, flashes or streaks of light, metamorphopsia, diplopia, or transient loss of vision in either eye.
* Patient has had intraocular surgery (e.g., cataract extraction) in either eye within 4months prior to Screening visit.
* Patient is aphakic or has, in the judgement of the investigator, risk for ocular inflammation