cyrilzakka/clinical-trials huggingface dataset:
Verification of Novel Survival Prediction Algorithm for Patients With NSCLC Spinal Metastasis

The purpose of this study is to learn whether our own made predictive algorithm can be used as a clinical practical decision support for patients with NSCLC spinal metastasis. The scoring system consists of the use of EGFR-TKI, KPS, Age, SCC, CA125 and smoking history. By predicting survival doctors could determine which patients are suitable for palliative therapy.

Investigators have performed a retrospective study on 176 patients with NSCLC spinal metastasis under the oversight of hospital's ethics committee, and investigators found that the use of EGFR-TKI, KPS, Age, SCC, CA125 and smoking history had significant association with survival. Then investigators built a simple, easy to use scoring system based on the features mentioned above. The score was calculated as 1 (for patients didn't receive EGFR-TKI), +2 (for KPS \<50%), +1 (for KPS 50-70%), +1 (Age \>60years), 2 (SCC ≥1.5ng/ml), +3 (CA125 ≥35 U/ml), +1 (smoking history 1-10/day), +2 (smoking history \>10/day), and 0 otherwise. This algorithm was used to divide the patients into low risk (0-3), intermediate risk (4-6), high risk groups (7-10) to predict survival and determine which patients are suitable for palliative therapy. Now investigators wish to register this study to do a further research, in order to verify the accuracy and sensitivity of this algorithm.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis by biopsy: Non-small-cell lung cancer, including non-squamous carcinoma and squamous cell carcinoma.
* Diagnosis through both nucleotide bone scan and MRI or PET-CT: spinal metastasis.
* Age 18-75 years.
* Have been or is about to be treated according to NCCN panel recommendation.

Exclusion Criteria:

* Diagnosis by biopsy: other tumors.
* Irregular follow-up and lost follow-up
* Withdraw from the study for any reason
Postpartum Initiation of Long-acting Reversible Contraceptives: Knowledge Attitude and Practice Study (KAP)

Comparing Knowledge, attitude and Practice of clients and service providers about the regular (6 weeks) versus earlier initiation of LARC, through a structured questionnaire prepared in English and translated to local language i.e. Arabic.

Family planning is a behavior that allows individuals and couples to anticipate and attain their desired number of children, at the spacing and timing of their births. It is achieved through the use of contraceptive methods and treatment of involuntary infertility.

Postpartum family planning is the prevention of unintended and closely spaced pregnancies during the first 12 months following childbirth. Short interval pregnancies are associated with increased maternal morbidities such as anemia, bleeding disorders, premature rupture of membranes, puerperal endometritis and mortality .

Postpartum family planning (PPFP) has long been recognized as an important component of maternal health care. Through birth spacing and prevention of high-risk and unwanted pregnancies, PPFP helps women who have recently delivered to avoid exposure to the risks of maternal death. Likewise, the importance of the interplay between maternal health services and use of contraception in the postpartum period has been recognized for decades.

Globally, more than 90 percent of women during the first year postpartum want to either delay or avoid future pregnancies . An increase in contraceptive use during the postpartum period should substantially reduce rates of maternal and infant mortality by preventing unplanned and unwanted pregnancies and by spacing new pregnancies at least two years after the previous birth .

Eligibility Criteria:
Inclusion Criteria:

Client's group All clients who were attending family planning centers in public health facilities at the study period if they have had a postpartum LARC method (Copper IUD, Progestin-releasing IUS, Subdermal implant) or willing to use it in the first year after delivery.

Service provider group:

All service providers who are working in primary health care units \& hospitals, including general practitioners, ob/gyn. specialists, nurses, and social workers.

Exclusion Criteria:

* Clients and service providers who refused to participate in the study
* Clients who are currently using or willing to use a method other than LARC
Effect of High-calcium Intake on Appetite, Insulinemia and Incretins

The purpose of this study is to investigate the appetite, insulin and incretin hormone responses to a high-calcium meal.

Participants will be provided with control and high-calcium meals. Insulin, appetite, glucagon-like peptide-1 and glucose-dependent insulinotropic peptide responses will be assessed, along with rates of substrate oxidation.

Eligibility Criteria:
Inclusion Criteria:

* recreationally active
* male

Exclusion Criteria:

* food intolerances/allergies
Effects of Mechanical Insufflation-Exsufflation in Preventing Respiratory Failure After Extubation

Weaning protocols that include the use of noninvasive ventilation (NIV), decreases the incidence of re-intubation and ICU length of stay. However, the role of NIV in post-extubation failure is still not clear. Impaired airway clearance is associated with NIV failure. Mechanical Insufflation-Exsufflation (MI-E) is an assisted coughing technique that has been proven to be very effective in patients under NIV.

In this study the investigators assess the efficacy of MI-E as part of a protocol for patients that develop respiratory failure after extubation.

Patients under mechanical ventilation (MV) for more than 48 hours with specific inclusion criteria, who successfully tolerated an spontaneous breathing trial (SBT) were randomly allocated before extubation, either for (A) conventional extubation protocol (control group) or (B) MI-E extubation protocol (study group). Re-intubation rates, ICU length of stay and NIV failure rates were analyzed.

Inclusion of MI-E in post-extubation failure may reduce re-intubation rates with consequent reduction in post-extubation ICU length of stay. This technique seems to be efficient in improving the efficacy of NIV in this patient population.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years and under mechanical ventilation, for more than 48 hours, for acute hypoxemic and/or hypercapnic respiratory failure from a specific etiology

Exclusion Criteria:

* facial or cranial trauma, tracheostomy, active upper gastrointestinal bleeding, neurologic instability (inability to respond to direct simple orders), hemodynamic instability, lack of cooperation and confirmed diagnosis of neuromuscular disease.
High-intensity Interval Training in Overweight/Obese

Purpose: The purpose of this study would be to evaluate the effects of interval training on cardiovascular health, lipid profile and body composition in overweight and obese men and women.

A secondary purpose will be to compare lab based measurements of body composition \[4-compartment model (4C)) with portable equipment \[bioelectrical impedance spectroscopy (BIS) and ultrasound (US)\]

Participants: Seventy-six men and women (age 18-55 yrs; BMI 25-45 kg/m2) will be randomly assigned to a high-intensity short interval group (SIT), high-intensity long interval group (HIT) or a control group (CON). Procedures (methods): Participants will be assessed for peak oxygen utilization (VO2peak), blood lipids, glucose and insulin levels. Body composition will also be measured using a 4C model, as measured from dual energy x-ray absorptiometry (DEXA), air displacement plethysmography (BodPod), and BIS, in comparison to US values. Participants assigned to either training group will undergo 3 weeks of interval training, 3 days per week. SIT will complete 10 bouts of a series of 1 min cycling with 1 min rest periods at 90% of the power output obtained during VO2peak;in comparison HIT will complete 5 bouts of the same protocol: 2 min bouts with 1 min recovery at varying intensities of VO2peak (80-100% power output).


Eligibility Criteria:
Inclusion Criteria:

* written and dated informed consent to participate in the study.
* willing and able to comply with the protocol.
* good health as determined by a health and exercise status questionnaire
* normal electrocardiogram (ECG), and physical.
* body mass index of 25-45 kg/m 2.
* has been cleared for participation by a physician (either study or personal).

Exclusion Criteria:

* participating in another clinical trial or have received an investigational product within thirty days prior to enrollment.
* has lost ten or more pounds during the previous three months and maintained the weight loss.
* significant history or current presence of untreated high blood pressure (BP) \[systolic BP\> 140 mmHg and/or diastolic BP\> 90 mmHg\], thyroid disease, tachyarrhythmia, heart disease, kidney disease, or liver disease. Subject currently suffers from/or has a known history of (or is currently being treated for) clinical depression or an eating disorder(s).
* has any medical condition or uses any medication, nutritional product, dietary supplement or program, which in the opinion of the investigator, might interfere with the conduct of the study or place the subject at risk.
* are identified as moderate to high risk individuals by the American College of Sports Medicine will be excluded from the study.
Trial to Assess the Efficacy of Midostaurin (PKC412) in Patients With c-KIT or FLT3-ITD Mutated t(8;21) AML

To assess the efficacy of tyrosine-kinase inhibitor midostaurin in c-KIT or FLT3-ITD mutated t(8;21) AML. To assess the efficacy of midostaurin depending on the type of c-KIT mutation

AML patients displaying t(8;21) have a relatively favourable outcome. Nevertheless, only approximately 50% of patients carrying this cytogenetic aberration are alive at 5 years. This suggests that some patients have more aggressive leukemic phenotypes and indicates the need for treatment optimization with novel therapies.

The mutated KIT gene as well as the FLT3-ITD mutation have recently been identified as factors most likely to explain the heterogeneous clinical outcomes within the group of t(8;21) AML. The FLT3 and c-KIT genes encode type III receptor tyrosine kinases (RTK) with important and partly redundant functions in early hematopoietic stem cells. Various activating mutations have been described for both genes. For c-KIT, the incidence ranges from 17 to 48% depending on the source population and type of mutations determined. It has been consistently shown that in AMLs with t(8;21), mutated c-KIT is associated with a dramatically increased risk of relapse and reduced overall survival compared to their unmutated counterparts. The FLT3-ITD mutation has a similar negative effect on prognosis in the patient group of t(8;21) mutated AMLs as c-KIT.

PKC412 (midostaurin) is known to inhibit the c-KIT RTK activity as well as the FLT3 kinase, both in patients with ITD and TKD mutations. It should therefore be possible to abrogate the negative impact of pathologically increased c-KIT or FLT3-ITD activity on relapse and overall survival by using midostaurin in this patient population. Aim of the proposed clinical trial is to prove the efficacy of midostaurin in c-KIT or FLT3-ITD mutated t(8;21)- AMLs in an open-label one-arm design.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of c-KIT mutated t(8;21) AML i.e.

  1. \>20% myeloid blasts in bone marrow and/or peripheral blood at initial diagnosis
  2. Plus cytogenetic diagnosis of aberration t(8;21)/AML1-ETO
  3. Plus mutation of c-KIT gene (mut-KIT17 or mut-KIT8) or FLT3-ITD mutation or both c-KIT and FLT3-ITD mutations
* Chemoresponsive disease as determined by early bone marrow assessment on day 14-16 after first cycle of induction therapy with cytarabine in combination with daunorubicine or idarubicine, or mitoxantrone- Fit for further intensive chemotherapy
* Age 18-65 years
* ECOG performance status of 0-2
* Life expectancy of at least 12 weeks

Exclusion Criteria:

* Primary refractory or previously relapsed AML
* Non-eligibility for high-dose cytarabine based consolidation, e.g. intolerance to cytarabine
* Inability to swallow oral medications
* Symptomatic congestive heart failure
* Bilirubin \>2.5 x upper limit of normal
Ischemic Conditioning as an Intervention to Improve Motor Function in Chronic Stroke

The investigators will test whether an intervention called ischemic conditioning can improve paretic leg motor function in chronic stroke subjects.

This study will study ischemic conditioning (IC) as an intervention to improve motor function post-stroke. IC is a well studied, well tolerated intervention which has been shown to improve regional blood flow, motor neuron excitability and muscle function in multiple patient groups and in young, healthy subjects. Because IC targets three physiological systems which are all affected by stroke, the investigators hypothesize that repeated bouts of IC will result in improved motor function of the paretic leg.

Eligibility Criteria:
Inclusion Criteria:

1. be between the ages of 18-85
2. able to give informed consent
3. be ≥ 6 months post diagnosis of unilateral cortical stroke and
4. have residual leg paresis.

Exclusion Criteria:

1. chronic low back or hip pain
2. substance abuse
3. head trauma in last 6 months
4. neurodegenerative disorder
5. any uncontrolled medical condition
6. any condition where knee extension contractions are contraindicated
7. people who are unable to follow multi step commands.
8. people who cannot walk ≥ 10 ft without physical assistance.
9. history of major psychiatric disorder
10. participant has had a myocardial infarction in the last year
11. participant has uncontrolled hypertension
12. participant is unable to contract knee muscles
Cognitive Behavioural Therapy in Dissociative Seizures

The purpose of this study is to determine whether adults with disoociative (psychogenic non-epileptic) seizures receiving cognitive behavioural therapy (CBT) show a greater reduction in seizures and health service use and greater improvement in employment status and overall psychosocial functioning than patients who receive standard care.

Preliminary results from a pilot study demonstrated that cognitive behavioural therapy (CBT) is associated with a significant benefit for patients with dissociative seizures. The current study aims to extend these findings by conducting a randomised controlled trial comparing CBT with standard outpatient medical care. Standard outpatient care has been chosen as the comparison treatment as it most closely resembles what is currently offered to this group of patients by the National Health Service. The primary outcome measure will be seizure frequency. Secondary outcome measures will be work and social adjustment and health service use.

Our hypothesis is that CBT will be superior to standard outpatient care for patients with dissociative seizures as determined by the above measures.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of dissociative seizures
* diagnosis confirmed by video EEG telemetry where practicable
* aged 16 - 70

Exclusion Criteria:

* co existent diagnosis (past or present) of epilepsy
* seizure frequency of less than 2 seizures per month
* current alcohol or drug abuse
* benzodiazepine use exceeding the equivalent of 10mg diazepam per day.
Molecularly Tailored Therapy for Patients With Metastatic Cancer of the Esophagus and Stomach

The purpose of this study is to determine whether molecular profile-directed therapy (otherwise known as personalized treatment) can improve the effectiveness of standard chemotherapy combinations for patients with esophagogastric adenocarcinoma. A series of tests will be performed on a sample of tumor; based on the results of these tests, a patient will be assigned to a chemotherapy treatment.


Eligibility Criteria:
Inclusion Criteria:

* Advanced, measurable metastatic esophagogastric adenocarcinoma by RECIST criteria
* Patients who have had surgery or radiotherapy with or without neoadjuvant or adjuvant chemotherapy (the wash-out period will be at least 1 month)
* Patients who are not eligible for resection and are chemotherapy naïve
* Patients with HER2(-) status
* Patients who have tumor deposit(s) that are easily accessible by ultrasound or CT guidance
* Patients must have adequate organ function
* Patients must provide written informed consent

Exclusion Criteria:

* Active concurrent malignancy, other than superficial, non-squamous cell carcinoma of the skin or uterine cervix, within the past three years
* ECOG performance status worse than 2
* Prior oral or intravenous chemotherapy for metastatic disease
* Patients with comorbidities that prevent them from being able to receive the chemotherapy regimen
* cardiac ejection fraction 45% or greater
Efficacy of Group Life Skill Intervention to Enhance Well-Being Among Higher Education Students

The primary aim of this study is to investigate the Efficacy of Group life skills intervention designed to improve the well-being, Life skills, and Quality of life of higher education students. The study also identifies the feasibility of the Life skill intervention in the context of Pakistan. We will also compare these outcomes between two groups: one receiving the intervention and the other not receiving any treatment.

The primary aim of this study is to investigate the Efficacy of Group life skills intervention designed to improve the well-being, Life skills, and Quality of life of higher education students. The study also identifies the feasibility of the Life skill intervention in the context of Pakistan. We will also compare these outcomes between two groups: one receiving the intervention and the other not receiving any treatment.

Study Tasks:

Participants, who are University Students aged 21-30 years, were asked to provide informed consent to participate in the study. They completed questionnaires to assess their Life skills, Psychological distress, Well-being, and Quality of life as a pre-assessment.

Participants in the intervention group undergo the Life Skill Intervention, which includes activities like Team building skills, Leadership Skills, Self-respect and appreciation, Effective Communication Skills, Dealing with stress, Positive Thinking, Enhancing confidence, Volunteering, Decision Taking, Problem Solving, Conflict Resolution, Negotiating.

After the intervention, participants completed a post-assessment questionnaires to measure changes in Life skills, Psychological distress, Well-being, and Quality of life.

There will be a control group that does not receive any treatment.

Comparison Group:

Researchers compared the outcomes between the intervention group, who received the Life Skill Intervention and the control group, who did not receive any treatment. This will help us determine if the intervention had a significant impact on Life skills, Psychological distress, Well-being, and Quality of life outcomes for University students.

Eligibility Criteria:
Inclusion Criteria:

* Students of public sector university of Pakistan.
* Students aged 21-30.
* Students accessed with decreased psychological well-being.

Exclusion Criteria:

* Students of private universities in Pakistan
* Students with any physical disability.
* Students having a prior history of psychiatric illness.
Effect of Stress-management and Biofeedback on Craving in Smoking Abstinence: A Pilot Study

Craving is one of the most prominent reasons for relapse after smoking cessation. Mainly pharmacological aids (NRT, bupropion, varenicline) try to counter this condition. This project aims to evaluate the effect of stress-management and a short breathing technique, reinforced by means of visualisation , on the experience of craving in smokers who are prepared to stay abstinent for at least 3 hours before the start of the intervention. It is expected that this strategy can provide supplementary gains in craving control.


Eligibility Criteria:
Inclusion Criteria:

* smokers (at least 10 cigarettes/day);
* 18 years of age or older;
* prepared to stay abstinent for 3 hours before the start of the session;
* not prepared to stop smoking;
* Dutch speaking.

Exclusion Criteria:

* acute health related problems;
* psychiatric co-morbidities;
* quit attempts in the past 3 months;
* participation in other clinical trials.
Safety Study of Viaskin Peanut to Treat Peanut Allergy

This study evaluates the safety of Viaskin Peanut 250 mcg in the treatment of peanut allergy in children from 4 to 11 years of age. Subjects will receive either Viaskin Peanut 250 mcg or a placebo for a period of 6 months, after which all subjects will be receiving the active treatment up to a period of 3 years under active treatment.


Eligibility Criteria:
Inclusion Criteria:

* Physician-diagnosed peanut allergy;
* A peanut Skin Prick Test (SPT) with a wheal largest diameter ≥8 mm;
* A specific-peanut Immunoglobulin E (IgE) ≥14 kU/L;
* Subjects following a strict peanut-free diet.

Exclusion Criteria:

* Generalized dermatologic disease
* Spirometry forced expiratory volume in 1 second (FEV1) \<80% of the predicted value, or peak expiratory flow (PEF) \<80% of predicted value;
* Receiving β-blocking agents, angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers, calcium channel blockers or tricyclic antidepressant therapy; anti-tumor necrosis factor drugs or anti-IgE drugs (such as omalizumab) or any biologic immunomodulatory therapy;
* Prior or concomitant history of any immunotherapy to any food allergy (for example EPIT, OIT, SLIT, or specific oral tolerance induction).
Collagen Analysis and Genetic Analysis of Families With Tendency to Hernias

Analysis of collagen subtype subcutaneously and genetic analysis of patients from families with a tendency to hernias. Furthermore circulating biomarkers and biomarkers extracted from the subcutaneously tissue such as MMP's (matrix metallo proteinases) and TIMP's (tissue inhibitor of metallo proteinases) will be measured.

Research has shown relationship between hernias and collagen subtype I/III ratio, biomarkers such as MMP's TIMP's and other diseases such as Ehlers-Danlos, Marfans syndrome, AAA (abdominal aortic aneurysms), diverticulosis and rectal prolapse. Furthermore has research raised hypothesis about inheritance of hernias. The investigators are performing genetic examination combined with analysis of collagen and biomarkers on patients belonging to families with tendency to hernias.

Other examinations performed on the patients enrolled in this study:

* Ultrasound (US) examination of the abdominal aorta to discover possible abdominal aortic aneurysms.
* Beightons score to evaluate the degree of joint hypermobility.

Eligibility Criteria:
Inclusion Criteria:

* adults over 18 years
* adults must be members of a family where there are presence of hernias in minimum generation.

Exclusion Criteria:

* infections
* pregnant
* mentally ill patients
Metabolic Interventions to Resolve Non-alcoholic Steatohepatitis (NASH) With Fibrosis (MIRNA)

The study aims to evaluate two, orally administered, investigational agents - PF-06865571 (DGAT2 inhibitor) and the coadministration of PF-06865571 with PF-05221304 (ACC inhibitor). This study is specifically designed to evaluate the effect of a range of doses of DGAT2i alone, and DGAT2i + ACCi, on resolution of NASH or improvement in liver fibrosis, as assessed histologically (via liver biopsy).


Eligibility Criteria:
Inclusion Criteria:

* Biopsy proven NASH with either F2 or F3 fibrosis, per NASH CRN definition
* BMI \>/= 22.5kg/m2

Exclusion Criteria:

* Evidence of other causes of liver disease such as Alcoholic steatohepatitis, (de)compensated cirrhosis, active viral hepatitis
* Any condition possibly affecting drug absorption -Unstable concomitant medical conditions, based on medical history or screening laboratory results including-
* unstable liver function tests, recent cardiovascular event(s) significant malignancies,