cyrilzakka/clinical-trials huggingface dataset:
The Effect of Zumba Dance on Primary Dysmenorrhea

the objective of this study is to investigate the effect of practising Zumba exercise in decreasing menstrual pain in young women with primary dysmenorrhea.

primary dysmenorrhea or painful menstruation without pelvic pathology is one of the most common complaints in women's medicine. The pain begins with the onset of menstrual bleeding and lasts for 72-12 h. Pain is usually in the middle line of the highest severity. Dysmenorrhea pain is often described as cramped and intermittent. Zumba is a dance-based fitness class that originated in Colombia in the 1990s and is now extremely popular worldwide. the aim of this study is to investigate the effect of 8 weeks of regular Zumba exercise on the severity of primary dysmenorrhea.

Eligibility Criteria:
Inclusion Criteria:

* having regular menstrual cycles (30-35 days) and bleeding time of 3-10 days.
* history of primary dysmenorrhea(PD) which had affected daily activities in at least 50% of their cycles through the past 6 months; and pain intensity over 4 cm, based on the 10-cm visual analog scale score.
* having a pain score for PD on the visual analog scale (VAS) of 4-7 cm
* Age: 18-25 years.

Exclusion Criteria:

* Pregnancy
* known diseases of the genitourinary system (e.g., pelvic inflammatory disease and urinary tract infections) or secondary dysmenorrhea and chronic diseases (heart disease, respiratory, kidney, blood pressure, asthma, diabetes, epilepsy, migraine, thyroid, anemia, nervous disorders).
* Previous Zumba fitness practice.
* irregular menstrual cycles; the use of intra-uterine devices and oral contraceptive pills.
* musculoskeletal injuries and metabolic/cardiorespiratory contraindications to physical exercise
Effect of Oxygen During Percutaneous Coronary Intervention for Pain Relief

Nasal oxygen is widely used as pain relief against ischemic pain during Percutaneous Coronary Intervention (PCI). However, to our knowledge no randomised clinical trials have tested this. In contrast, oxygen causes coronary artery vasoconstriction in man. Furthermore, a recent Cochrane meta-analysis has shown no evidence of beneficial effect of oxygen for patients with acute myocardial infarction (with normal blood saturation. The investigators therefore wanted to examine if oxygen reduces ischemic pain during PCI for stable angina or NSTEMI.


Eligibility Criteria:
Inclusion Criteria:

* Stable angina or NST-ACS undergoing PCI

Exclusion Criteria:

* Blood oxygen \<95%
* Cognitive dysfunction
* STEMI
* Intubation
Health Services Implications of a Teledermatology Consult System

We have previously shown (IIR 95-045) that teledermatology, using store and forward technology, can result in reliable and accurate diagnostic outcomes when compared to clinic-based dermatology consultations. This investigation builds on that fundamental diagnostic information by assessing the health services implications of a teledermatology consult system.

Background:

We have previously shown (IIR 95-045) that teledermatology, using store and forward technology, can result in reliable and accurate diagnostic outcomes when compared to clinic-based dermatology consultations. This investigation builds on that fundamental diagnostic information by assessing the health services implications of a teledermatology consult system.

Objectives:

To investigate health services outcomes related to teledermatology implementation. Outcomes of interest were time to diagnosis and treatment initiation, the proportion of patients that avoided the need for a clinic-based encounter, and an economic analysis.

Methods:

Patients referred from the primary care clinics to the dermatology consult service were randomized to either usual care or a teledermatology consultation. A usual care consultation consisted a conventional text-based electronic consult request. A teledermatology consultation included digital images and a standardized history, in addition to the electronic text-based consult. Consultant dermatologists, reviewing the consult requests for both modalities, decided when, and if, a referral required a clinic-based evaluation.

Status:

Final report has been prepared and is in the review process at this time.

Eligibility Criteria:
Inclusion Criteria:

Patients referred to Dermatology Consult Service.

Exclusion Criteria:
Safety and Efficacy Study of Pitavastatin in Patient With a Metabolic Syndrome

We will identify the influence of long-term treatment of Pitavastatin compared to non-treatment control group on the metabolic syndrome by evaluation of a change of metabolic syndrome component score. And we will additionally observe the changes of CVD risk factors like lipid profile, abdominal fat, insulin resistance and so on.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 18 and 75
* Patients with LDL ≥ 100mg/dL
* Patients with metabolic syndrome

  1. IFG: Fasting glucose ≥ 100mg/dL
  2. Abdominal Obesity: Waist circumference: men≥90cm,women≥85cm
  3. 1 or more of the following

     1. Triglyceride ≥ 150mg/dL
     2. HDL-C: men \< 40mg/dL, women \< 50mg/dL
     3. Blood pressure: SBP ≥ 130mmHg or DBP ≥ 85mmHg or subject receiving anti-hypertensive treatment

Exclusion Criteria:

* uncontrolled hypertension (DBP ≥ 95mmHg)
* taking diabetic drugs or with HbA1c \> 8%
* LDL ≥ 190mg/dL or Triglyceride ≥ 400mg/dL
* coronary heart disease or other diseases caused by artherosclerosis
* malignancy within 6 months
* Serum creatinine ≥ 2.0mg/dL
* ALT or AST ≥ ULN\*2.5
* CPK ≥ ULN\*2
* hypothyroidism
Interleukin-12 Gene in Treating Patients With Liver Metastases Secondary to Colorectal Cancer

RATIONALE: Inserting the interleukin-12 gene into a person's cancer cells may make the body build an immune response to kill tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of interleukin-12 gene when injected into the tumors of patients with liver metastases secondary to colorectal cancer.

OBJECTIVES:

* Determine the toxicity and maximum tolerated dose of intratumoral adenoviral vector-delivered interleukin-12 gene in patients with liver metastases secondary to colorectal cancer .
* Determine the tumor response in patients treated with this regimen.
* Determine the immune response in patients treated with this regimen.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed\* colorectal adenocarcinoma metastatic to the liver

  * Solitary or multiple metastatic tumors in the liver

    * Metastatic involvement of the liver no greater than 40% of estimated liver volume NOTE: \*Must be from the hepatic tumor designated for study injection
* Metastatic liver tumors must be bidimensionally measurable by CT scan or MRI
* At least 1 metastatic liver tumor measuring at least 2.0 cm must be visualized by ultrasound (US) and accessible for US-guided percutaneous injection
* Extrahepatic metastases allowed
* No prior or current ascites
* Ineligible for hepatic resection

PATIENT CHARACTERISTICS:

Age

* Adult

Performance status

* Karnofsky 70-100%

Life expectancy

* At least 16 weeks

Hematopoietic

* Granulocyte count at least 1,500/mm\^3
* Hemoglobin at least 9.0 g/dL
* Platelet count at least 100,000/mm\^3

Hepatic

* No clinical evidence of other severe liver disease (e.g., portosystemic encephalopathy)
* PT no greater than 14 seconds
* Bilirubin no greater than 2.0 times upper limit of normal (ULN)
* Transaminases no greater than 2.5 times ULN

Renal

* Creatinine no greater than 1.5 mg/dL OR
* Creatinine clearance at least 45 mL/min

Other

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective nonhormonal contraception during and for at least 2 months after study participation
* HIV negative
* No active infection
* No other concurrent serious medical illness
* No other malignancy within the past 5 years except inactive nonmelanoma skin cancer, carcinoma in situ of the cervix, or grade 1 papillary bladder cancer
* Oriented and rational
* Weight at least 30 kg

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)

Endocrine therapy

* At least 2 months since prior corticosteroids

Radiotherapy

* Not specified

Surgery

* Not specified

Other

* At least 2 months since prior systemic immunosuppressive drugs
* No concurrent immunosuppressive drugs
* No concurrent anticoagulant therapy with heparin or warfarin
Ergon Technique Versus PNF Stretching on Hamstring Flexibility in Knee Osteoarthritis

The study will be a randomized control trial and will be conducted in Pakistan Railway Hospital Rawalpindi. A sample of 60 participants will be taken. Patients will be divided into two groups (A\&B) of 30 participants in each group by sealed envelope method. Hot pack will be applied to both groups for 15 minutes at the start of intervention. ERGON Technique(IASTM) will be applied to group A along with strengthening exercise. Proprioceptive Neuromuscular Facilitation (PNF) stretching will be given to group B along with strengthening exercise. A 35 minute session will be given to the patients and 3 sessions will be given once a week. Intervention will be given for 6 weeks. The outcome measure will be Visual analog Scale (VAS), Western Ontario and McMaster Universities Arthritis Index (WOMAC), and Active Knee Extension Test (AKE) will be measured at baseline and at the end of 6th week. Data will be analyzed by SPSS 22.


Eligibility Criteria:
Inclusion Criteria:

* Unilateral/bilateral osteoarthritis
* Participants with unilateral/bilateral hamstring tightness
* 200 from Active Knee Extension test
* Grade 1 and 2 in Kellgren and Lawrence criteria for knee osteoarthritis

Exclusion Criteria:

* Participant failing to fall in the category below will be excluded from the study:
* Any lower extremity injury in past 3 months
* Any fracture or surgery done for pelvis, hip or knee.
* Any neurological symptoms.
* Any recent knee reconstructive surgery
* Burns of lower extremities
* Other musculoskeletal disorders associated with knee joint, Iliotibial band, adductor muscle and Sartorius muscle tightness
DAILIES TOTAL1® Lens Centration in a Japanese Population

The purpose of this study is to compare the lens centration of DAILIES TOTAL1® (DT1) contact lenses to 1-DAY ACUVUE® Tru-Eye® (1DAVTE) contact lenses in a Japanese population after 7 ± 2 days of wearing of each product.


Eligibility Criteria:
Inclusion Criteria:

* Sign Informed Consent document.
* Habitually wear soft contact lenses on a daily disposable or weekly/monthly replacement basis.
* Symptoms of contact lens discomfort as defined by protocol.
* Require contact lenses within the power range of -0.50 diopter (D) to -10.00 D.
* Cylinder, if present, less or equal to 0.75D in either eyes at Visit 1.
* Vision correctable to 20/25 or 0.1 (logMAR) or better in each eye at distance with pre-study lenses at Visit 1.
* Acceptable contact lens fit with both study contact lenses.
* Willing to wear lenses every day for at least for a minimum of five days per week six hours per day, every day if possible and attend all study visits.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Currently wearing DT1 or 1DAVTE.
* Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear.
* Use of systemic or ocular medications which contact lens wear could be contraindicated as determined by the investigator.
* Eye injury or surgery within twelve weeks immediately prior to enrollment for this trial.
* Any moderate or severe ocular condition observed during the slit-lamp examination at the enrollment visit.
* History of herpetic keratitis, ocular surgery or irregular cornea.
* Prior refractive surgery (e.g. LASIK, PRK, etc).
* Monocular subjects (only one eye with functional vision) or subjects fit with only one lens.
* Judged ineligible as a patient in this clinical study by the investigator.
* Other protocol-defined exclusion criteria may apply.
Masitinib in the Treatment of Patients With Severe Uncontrolled Asthma and Elevated Eosinophil Levels

The purpose of this study is to assess the safety and efficacy of masitinib (6 mg/kg/day) in severe persistent asthma, uncontrolled with high dose of inhaled corticosteroid and with elevated eosinophil levels.

Masitinib is a selective tyrosine kinase inhibitor. It is known that activation of inflammatory cells, such as mast cells, and fibrous tissue remodeling are associated with c-Kit, Lyn and PDGFR kinase signaling pathways; all key targets of masitinib. This is a multicenter, double-blind, randomized, parallel-group (ascending dose titration of masitinib to 6.0 mg/kg/day and matching placebo), comparative study of oral masitinib in the treatment of patients with severe asthma, uncontrolled with high dose of inhaled corticosteroid and with elevated eosinophil levels. Eligible patients will be treated during at least 48 weeks.

Eligibility Criteria:
Main inclusion criteria include:

* Patients with a physician diagnosis of persistent asthma for at least 12 months based on Global Initiative for Asthma (GINA) 2009 Guidelines whose asthma is partially controlled or uncontrolled on inhaled corticosteroids (ICS) / long-acting beta2-agonists (LABA) combination therapy.
* Patient with elevated eosinophil level related to asthma at baseline: ≥0.15 K/uL or patient with eosinophil level ≥0.15 K/uL related to asthma demonstrated in the year prior to screening
* Non-smoker patient for at least one year and with a prior tobacco consumption \<10 packs/year

Main exclusion criteria include:

* Female patient who is pregnant or lactating
* Asthmatic patient still exposed to allergens or to triggering factors influencing asthma control
* Chronic obstructive pulmonary disease and/or other lung diseases impairing Pulmonary Function Tests
* Within 12 weeks prior to screening, patient who received oral corticosteroids for any other reason than to treat severe asthma exacerbation (patients needing long term corticosteroids intake to control basal asthma condition)
* Patient with history of acute infectious sinusitis or respiratory tract infection within 4 weeks prior to screening visit
* Patient with active lung disease other than asthma (e.g. chronic bronchitis)
A Study to Evaluate the Effectiveness of Imiquimod 5% Cream for Basal Cell Carcinoma Recurrence

The primary objective of this study is to assess whether basal cell carcinoma (BCC) lesions surgically treated with curettage, followed by imiquimod 5% cream as postsurgical adjuvant therapy, will have an improved cure rate over the ED/C historical norm of approximately 70% at 1-year posttreatment follow-up. A secondary objective is to assess cosmetic outcome.

This was an open-label, phase IIIb, multicenter, single arm, historical-controlled study. Biopsy-confirmed BCC lesions (1 per subject) were excised by curettage, with no electrodessication. Approximately 1 week later, treatment with imiquimod 5% cream was initiated. Imiquimod was applied to the target BCC once daily, 5 times per week (5x/week) for up to 6 weeks. Rest periods were allowed as needed. Subjects reported to the study center at treatment weeks 1, 2, and 6, and posttreatment at weeks 12, 26, and 52. At treatment week 6 and all posttreatment visits, the investigator clinically assessed the target site for tumor clearance and cosmetic outcome. A template made at initiation and created from clear plastic overlay aided in locating the target tumor site. If the investigator identified a lesion that had occurred or recurred at the target site, the subject was discontinued from the study and counted as a recurrence/persistence (R/P).

Eligibility Criteria:
Inclusion Criteria:

* Basal cell carcinoma

Exclusion Criteria:

* Psoriasis
Internet-Based Interventions for Bipolar Disorder

The investigators hope to learn whether access to online support and education can help people with Bipolar Disorder (BD) better manage their symptoms of depression.

This study will examine if there is a benefit of an online intervention for persons with bipolar diagnoses, and what components appear to be useful. Specifically, the study will examine (1) whether exposure to the MoodSwings 2.0 intervention results in decreased depressive symptoms as measured by the Montgomery Asberg Rating Scale for Depression (MADRS) and (2) whether there is an association between graduated levels of involvement (Level I, 2, or 3) and resulting improvement? We expect that those participants assigned to the control condition (Level 1, peer discussion board only), will have fewer positive outcomes than those in Level 2 (discussion board and psychoeducation) or 3 (discussion board, psychoeducation, and interactive psychosocial tools) conditions.

Eligibility Criteria:
Inclusion Criteria:

* Current diagnosis of bipolar I disorder, bipolar II disorder, or bipolar disorder NOS verified with the Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders (SCID) Mood disorder module.
* Age 21-65.
* Access to a computer with internet access. Access to a printer is preferable, but not required.
* Able to speak and read English proficiently.
* Some degree of medical supervision of bipolar disorder (sees a health professional at least twice a year to discuss symptoms and treatment needs) and local access to emergency care.

Exclusion Criteria:

* Current psychosis, as assessed in screening phone interview with the SCID psychosis module.
* Acutely suicidal (defined as having a HAM-D item 3, score of ≥3).
* Current mania, assessed using mania module of the SCID mood disorders module.
Variance of HRD From Paired Ovarian Cancer

Homologous recombination deficiency (HRD) is an important biomarker of poly (ADP-ribose) polymerase inhibitor (PARPi) in patients with high-grade serous ovarian cancer (HGSOC). The stability of HRD in the recurrent HGSOC and its primary pair remains unknown.

This study intends to perform HRD testing of ovarian cancer in the recurrent HGSOC and its primary pair, furtherly correlate HRD status and clinical characteristics in the recurited population.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects join the study voluntarily and sign informed consent;
2. Female subjects are older than 18 years;
3. ECOG(Eastern Cooperative Oncology Group) physical status score is 0-2;
4. Life expectancy≥3 months;
5. Histologically confirmed FIGO(International Federation of Gynecology and Obstetrics ) III/IV ovarian cancer, fallopian tube cancer, or primary peritoneal cancer; Participants must have high-grade serous histology

Exclusion Criteria:

1. Personnel involved in the formulation or implementation of the research plan;
2. The subjects had other malignant diseases in past 2 years, except skin squamous cell carcinoma, basal-like carcinoma, breast intraductal carcinoma in situ, or cervical carcinoma in situ;
Computerized Cognitive Training for Childhood Cancer Survivors

Specific Aim 1: To assess the feasibility and acceptability of a home-based, computerized attention training program with survivors of central nervous system (CNS) impacting pediatric cancer (e.g. acute lymphocyte leukemia \[ALL\], brain tumors).

Specific Aim 2: To estimate the effect size of this attention training program with survivors of childhood cancer to determine whether a larger-scale clinical trial is warranted.

Pediatric patients meeting initial eligibility criteria will be identified through the databases for each clinic (n = approximately 50 survivors in each clinic). A letter explaining the purpose of the study will then be sent to the parents of these patients. Interested parents will be invited to contact study personnel by phone or email for a thorough review of the study and to schedule a screening appointment.

After obtaining written informed consent and assent (from parents and child, respectively), screening procedures will include administration of an abbreviated intellectual test battery, two working memory tasks, and a computerized attention measure to the survivor. Parents will complete questionnaire measures regarding their child's adaptive, behavioral, emotional, and attentional functioning; follow-up interviewing will be conducted to clarify any potential problems identified on the questionnaires. The entire screening procedure is estimated to take approximately 60 minutes for the survivor and 30-45 minutes for parents. To maximize efficiency, a research assistant will complete testing with the child and a psychologist will explain the questionnaire measures to the parent and conduct any follow-up interviewing.

Eligibility Criteria:
Inclusion Criteria:

1. A T-score greater than the 75th percentile on either the Cognitive Problems/Inattention or the DSM-IV Inattention subscales of the Conners' Parent Rating Scale
2. One or more standard deviations below the mean on the Working Memory Index of the WISC-IV or a Working Memory Index that is one or more standard deviations below the participant's estimated IQ.

These criteria are based on the eligibility criteria used in the largest trial to date of psychostimulant methylphenidate (MPH; commonly known as Ritalin) with survivors of childhood cancer.

Exclusion Criteria:

1. Estimated IQ ≤ 70
2. Motor, visual, or auditory handicap that prevents computer use
3. A diagnosis of attention-deficit hyperactivity disorder (ADHD), oppositional defiant disorder (ODD), depression, autism, or pervasive developmental disorder (PDD)
4. Insufficient fluency in English.

Participants who are currently taking stimulant medications (stable dose for at least 30 days) for attentional difficulties, but who meet inclusion criteria will be allowed to participate.