cyrilzakka/clinical-trials huggingface dataset:
Responsiveness and Minimal Clinically Important Difference (MCID) of Knee Injury and Osteoarthritis (KOOS-12) in (OA)

Osteoarthritis (OA) is a common and disabling constant Musculoskeletal Disorder that causes significant weight on individual, Health Care Systems, and social economy. With the maturing of the populace and the commonness of undesirable way of life practices, the predominance and disease burden of OA are expanding day by day. Different non-surgical interventions have been introduced worldwide for the treatment of knee OA. The aim of this study is to determine the responsiveness and minimal clinically important difference for knee injury and osteoarthritis outcome score-12 in knee OA patients respectively.


Eligibility Criteria:
Inclusion Criteria:

* An Age group of 50-65 years will be included in study.
* both males and females will be included.
* Patients with Unilateral knee OA with K-L grade II-III involving medial side will be a part of study.
* Following ACR (American college of rheumatology) guidelines Patient with knee pain must have 3 or more than 3 of the following symptoms i.e. age \>50 years, morning stiffness \<30 minutes, crepitus on movement, tenderness, bony enlargements, no palpable warmth will also be a part of study.
* patient having pain ranging from 5-8 on Numeral Pain Rating Scale (NPRS) will be included

Exclusion Criteria:

* participants with Traumatic knee injuries (cruciate injuries, meniscal injuries etc.) will be excluded.
* Osteonecrosis patients will be excluded.
* Patient with Neurological problems won't be a part of this study.
* People having Metastasis or neoplasm will be omitted.
* Knee or hip fractures
* Rheumatoid arthritis, Systemic lupus erythematosus (SLE) or other autoimmune disease people will be listed out.
Prediction of Chronic Postsurgical Pain in Adults

This research will be a prospective single-centre observational cohort study in Denmark spanning approximately one year. The objective of this study is to develop a clinically applicable and generalizable prediction model for postsurgical pain in adults.


Eligibility Criteria:
Inclusion Criteria:

* Consenting Danish-speaking adults aged 18 years and older
* Patients who undergo common inpatient or outpatient surgical procedures

Exclusion Criteria:

* Patients with cognitive impairment
* Patients who refuse or unable to provide informed consent
* Patients who undergo re-operation within 3 months of their initial surgery
Day-Case Closure of Loop Ileostomy in Rectal Cancer

The aim of this study is to investigate if day-case closure of ileostomy is feasible and safe.

For all patients that match the inclusion criteria a registration-protocol is completed. Then the patients are operated and a surgery-protocol is completed. The patients are observed for maximum 24 h and discharged if they meet the discharge-criteria. 30 days post-operative the investigators do a follow-up of complications.

Eligibility Criteria:
Inclusion Criteria:

* Adults not older than 80 planed for closure of ileostomy
* The patient should not have had the ileostomy for more than 1 year
* Informed written consent should be given
* The patient should have a phone
* Should have an adult supervision at home for the first 24 hours after discharge
* American Society of Anesthesiologists (ASA) classification 1-2

Exclusion Criteria:

* ASA classification 3 and above
* The pre-operative investigation have shown anastomosis leakage or stricture
* Dementia or other cognitive dysfunction
* The need of an interpreter
* Patients assessed not being able to manage themselves at home post-operative
* Insulin treated diabetes
* Coagulopathy
* Other organ dysfunction
* Bleeding more than 300 ml
* If converted to laparatomy
* Other intraoperative difficulties leading to suspected increased risk of complication

Discharge criteria:

* Stable vital parameters regarding circulation and respiration
* No sign of bleeding
* Pain relief possible through per oral administration
* Emptied urinary bladder
* Able to maintain per oral nutrition
* Mobilization possible
* Obtained oral and written information about symptoms of sepsis and bowel obstruction
* Obtained telephone number of a contact-nurse
* Obtained time for wound-inspection at the surgical unit
Mapping of the Epileptic Brain

This study aims improving the outcome after brain resective surgery of epileptic patients by improving presurgical evaluations. In particular the specific goal is to evaluate the ability of non invasive neuroimaging (functional magnetic resonance imaging and electroencephalography) to provide presurgical maps of the functional areas of the brain and of the epileptogenic networks.


Eligibility Criteria:
Inclusion Criteria:

* Epilepsy

Exclusion Criteria:

* MRI incompatible
* Pregnancy
Cyclophosphamide Plus Topotecan in Treating Patients With Refractory or Relapsed Acute Myelogenous Leukemia

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of cyclophosphamide plus topotecan in treating patients who have refractory or relapsed acute myelogenous leukemia.

OBJECTIVES: I. Evaluate the efficacy of cyclophosphamide followed by topotecan in patients with relapsed or refractory acute myelogenous leukemia. II. Confirm safety and tolerability of this combination on this schedule in these patients.

OUTLINE: Patients receive cyclophosphamide intravenously over 1 hour on day 1 followed by topotecan as a continuous 120 hour infusion starting 12 hours after completion of cyclophosphamide. Treatment may be repeated every 3-6 weeks for at least 2 courses.

PROJECTED ACCRUAL: A total of 26 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven acute myelogenous leukemia by bone marrow aspirate or biopsy Clear evidence of relapse or residual disease with greater than 5% blasts on bone marrow examination or greater than 30% peripheral blasts No active CNS leukemia Not eligible for potentially curative allogeneic or autologous bone marrow transplantation without further surgery Must have failed to achieve a complete remission with conventional chemotherapy (cytarabine based) or have relapsed within 12 months after initial remission

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 6 weeks Hematopoietic: See Disease Characteristics Hepatic: Bilirubin less than 1.6 mg/dL (unless due to disease) Renal: Creatinine less than 1.6 mg/dL (unless due to disease) No prior hemorrhagic cystitis Other: Not pregnant Fertile patients must use effective contraception No active uncontrolled infection

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: See Disease Characteristics Recovered from prior chemotherapy No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: Must have recovered from prior radiotherapy Surgery: Not specified
Triple Negative Breast Cancer: Study of Molecular and Genetic Factors

Breast cancer triples negatives (TN; 15 % of the cases) are characterized by a high histoprognostic grade, a strong proliferation, a strong metastatic power, and a worse prognosis than the other forms of breast cancer. It is however a heterogenous group for histological and molecular level, but also for evolution. Most of the TN is part of the basal breast cancer subcategory. Until now, the medical treatment is based on chemotherapy.

Breast cancers by constitutional mutation of BRCA1 / BRCA2 (5 % of breast cancers) are mostly of basal type and their prognostic seems better that what could be expected from high grade tumours and without hormonal receptors. They would be much more frequent in the TN group. However, at this day, no prospective study was led to estimate this incidence, or to study the intervention of other genes of predisposition, as well to analyse the links between this phenotype and their consequences at the germinal or somatic level, in terms of associated molecular changes and prognosis.

The purpose of this study is, on a prospective study, to lead a joined analysis at the germinal level, in search of mutations of the main genes of breast cancer predisposition (BRCA1/2, PALB2, PTEN, PALB2), and at the tumour level (tissue micro-array and transcriptome), by correlating these results to the main clinical parameters.

The 5 years relapse-free survival will also be estimated.


Eligibility Criteria:
Inclusion Criteria:

* women \> 18
* non metastatic breast cancer
* triple negative
* 5 years follow-up
* signed informed consent

Exclusion Criteria:

* other cancer (except in situ)
* metastases at diagnosis
* impossibility of follow-up
Feasibility Testing and Evaluation of an Online Toolkit for Male Spouses of Women With Breast Cancer

Male partners of women with breast cancer experience distress, so we want to develop a way to support them so they, in turn, can care for their wives. The purpose is to pilot test an online male spouse transition toolkit (MaTT) that the research team has developed. The specific aims are to: a) evaluate the Toolkit for ease of use, acceptability, and feasibility, and; b) collect preliminary data to determine potential effectiveness of the Toolkit in increasing hope, general self-efficacy and quality of life, and its potential effectiveness in decreasing guilt scores for male partners of women with breast cancer (stages 1-3).


Eligibility Criteria:
Inclusion Criteria:

* male
* 18 years of age or older
* living with a spouse who has breast cancer (Stage 1, 2, or 3)
* English speaking.

Exclusion Criteria:

* persons who are non-autonomous adults
* cognitively impaired as determined by the Registered Nurse (RN) researcher
* unable to participate, in the opinion of the RN researcher
* non-English speaking
* does not have a spouse who is diagnosed with having breast cancer (State 1, 2, or 3)
Megestrol Acetate in Treating Weight Loss or Anorexia in Young Patients With Malignancies Who Are Undergoing Radiation Therapy and/or Chemotherapy

RATIONALE: Megestrol acetate may help improve appetite and lessen weight loss caused by cancer. PURPOSE: This clinical trial studies megestrol acetate in treating weight loss or anorexia in young patients with malignancies who are undergoing radiation therapy and/or chemotherapy.

PRIMARY OBJECTIVES:Proportion of Patients Who Maintain Weight or Experience Weight Gain.

SECONDARY OBJECTIVES:BMI Trends, Caloric Intake, Weight Maintenance Over Time, Toxicity Profile as Assessed by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v.4.

OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM A: Patients receive oral megestrol acetate 1-2 times (10 mg/kg dose if once daily or 5 mg/kg dose if twice daily) daily for 4 weeks. ARM B (control): Patients are observed for weight loss and gain for 4 weeks. After completion of study treatment, patients are followed up for 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Any pediatric patient with an underlying diagnosis of a malignancy (excluding hematological malignancies like leukemias and lymphomas)
* ≥5% weight loss from diagnosis of primary malignancy (must be currently on chemotherapy and/or radiation therapy or scheduled to receive cancer therapy OR ≥5% weight loss following bone marrow transplant (autologous or allogeneic blood/bone marrow) and not actively receiving corticosteroid therapy
* Negative pregnancy test done =\< 7 days prior to registration for women of childbearing potential only

Exclusion Criteria:

* Receiving tube feedings or parenteral nutrition
* Evidence of ascites
* Current (within the past 28 days) or planned treatment with adrenal steroids (short-term use of dexamethasone around days of intravenous chemotherapy is allowed for protection against emesis), androgens, progestational agents, or appetite stimulants (e.g., dronabinol)
* Known mechanical obstruction of the alimentary tract, malabsorption, or intractable vomiting (\> 5 episodes/week)
* History of unresectable brain tumor or cancer metastatic to the brain
* History of thromboembolic disease
* Insulin-requiring diabetes
* Congestive heart failure and/or uncontrolled hypertension
* Anticoagulation
* Previous history of thrombosis (personal and immediate family)
* Concurrent corticosteroid therapy (except as an antiemetic)
Nimotuzumab in Children With HGG

Determination of efficiency of nimotuzumab in children with high grade glioma.

High grade malignant gliomas are tumors grade III and IV according to WHO classification, that originate from oligodendroglia and astrocytes, where the latter are also known as anaplastic astrocytoma(WHO grade III) and glioblastoma(WHO grade IV). This also includes intrinsic pontine gliomas of adolescents, which are usually not documented histologically due to their localisation, but they have a similar clinical progress when compared to high grade malignant astrocytic tumors. Among various molecular alterations, malignant gliomas overexpress EGFR (epidermal growth factor) in nearly 50% of cases, which is particularly pronounced in glioblastoma.(Schlegel 2003) Standard therapy consists of radical surgery as extensive as medically responsible followed by radiotherapy dose of 60 Gy, which is aimed at the area with a safety margin. The long-term efficacy of additional chemotherapy has been a subject for controversy for several decades. The combination of all three treatment modalities in grade III tumors can lead to median survival times of 3-5 years in adults.

For this treatment group reports of 5 year recurrence free periods in 33-50% of cases have been reported in children and adolescents.

For glioblastoma(WHO grade IV) 5year recurrence free periods are 3% in elderly patients and 10-20% for adolescents.(Schlegel 2003) In German speaking territories chemotherapy with Cisplatin, Etoposid and Ifosfamid is used as a postoperative treatment option for adolescents and this disease.(Wolff HIT-GBM) In case of recurrence therapy choices are even more limited, thus if medically feasible the enrolment in clinical trials is an option.

In this study the aim is to use an antibody directed against the EGF-receptor to effect the proliferation of the tumor cells negatively. Pilot studies conducted in adults indicate that the median survival time for patients with malignant glioma can be prolonged by the antibody treatment.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of high grade glioma (WHO III und IV) \[not needed for intrinsic pontine glioma\]
* Progressive patients under primary therapy or first and second radiologically confirmed recurrence(MRI not older than 2 weeks) of high grade gliomas between the age of \> 3 years \< 20 years
* Lack of curative standard therapy which is currently under investigation in a national GPOH-therapy optimization study
* Sufficient haematological, renal and hepatic function (CTC Grad ≤ 2)
* Disease measurable radiologicaly in at least one dimension
* Life expectancy \> 4 Weeks
* Written declaration of consent of the parents/legal guardians and if possible of the child after prior information

Exclusion Criteria:

* Curative therapy with an alternative method after diagnosis of progression and during this study
* Prior administration of human or murine antibody
* Pregnancy in girls of child-bearing age
The Regulation of Pulmonary Vascular Resistance in Patients With Heart Failure

Peripheral blood and blood following a pulmonary wedge pressure will be obtained from patients undergoing right heart catheterizations.

It is well known that left sided heart disease can lead to pulmonary hypertension via a number of proposed mechanisms. The purpose in this study is to identify biomarkers in pulmonary hypertension to further understand the pathophysiology of this disease in patients with heart disease.Patients are recruited in the cardiac catheterization lab, which are undergoing right heart catheterization as per their plan of care established by their primary cardiologist. During the procedure, we will ask the performing cardiologist to obtain a blood sample of 40-50 milliliters from the catheter that they are using during the procedure. These blood samples will be sent for analysis of biomarkers. The patient will then have an echocardiogram done 1 year from their heart catheterization.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Ability to provide informed consent.
* Presenting for cardiac catheterization for evaluation of heart disease
* Ejection Fraction \> 50%

Exclusion Criteria:

* Unable to provide informed consent.
* Unable or unwilling to comply with the protocol and follow up.
* Infiltrative cardiomyopathy
* Constrictive pericarditis
* Severe valvular disease
* Comorbid status with life expectancy \<3 years
* Right ventricular dysplasia
* Congenital heart disease
* On immunosuppressive drugs.
* Patients who has heart transplant.
* Ejection Fraction \< 50%
* Mean Pulmonary Artery Pressure \<25
* Wedge pressure \<15
Effect of Caffeine Versus Probiotic on Preterm Neonates With Bronchopulmonary Dysplasia

The aim of this study is to evaluate the effectiveness of caffeine versus probiotics supplementation as adjuvant therapy for preterm neonates with Bronchopulmonary dysplasia (BPD).


Eligibility Criteria:
Inclusion Criteria:

* Male and female preterm neonates less than 37 weeks gestational age.
* Suffering from Bronchopulmonary dysplasia (BPD) diagnosed as follow:
* History: Preterm infant with persistence oxygen dependency up to 28 days of life.
* Clinical signs: increase work of breathing, increase oxygen requirements , increase in apnea , bradycardia and retraction.
* Laboratory: arterial blood gases and electrolytes.
* Radiology: streaky interstitial markings, patchy atelectasis , intermingled with cystic areas and severe lung hyperinflation.

Exclusion Criteria:

* Term and post term neonates
* Neonates with congenital infections
* Neonates with major congenital anomalies
The Effect of Glutamatergic Modulation on Cocaine Self-administration

Repeated drug consumption may progress to problematic use by triggering neuroplastic adaptations that attenuate sensitivity to natural rewards while increasing reactivity to craving and drug cues. Converging evidence suggests that glutamate modulation may work to correct these adaptations and rapidly restore motivation for delayed non-drug rewards relative to immediate drug use. Using an established laboratory model aimed at evaluating behavioral shifts in the salience of cocaine now vs. money later, the investigators will test the effect of CI-581a on cocaine self-administration as compared to the active control.


Eligibility Criteria:
Inclusion Criteria:

1. Active cocaine dependence with at least 8 days of use or at least 4 binges of large amounts (\>$200/occasion) over the past 30 days, and displaying at least one positive utox during screening
2. Physically healthy
3. No adverse reactions to study medications
4. 21-55 years of age
5. Capacity to consent and comply with study procedures, including sufficient proficiency in English
6. Not seeking treatment

Exclusion Criteria:

1. Meets DSM IV criteria for current major depression, bipolar disorder, schizophrenia, any psychotic illness, including substance induced psychosis, and current substance-induced mood disorder with HAMD score \> 12.
2. Physiological dependence on another substance, such as alcohol, opioids, or benzodiazepines, excluding caffeine, nicotine, and cannabis
3. Delirium, Dementia, Amnesia, Cognitive Disorders, or Dissociative disorders
4. Current suicide risk or a history of suicide attempt within the past year
5. Pregnant or interested in becoming pregnant during the study period
6. Any of the following cardiac conditions: clinically significant left ventricular hypertrophy, angina, clinically significant arrhythmia, or mitral valve prolapse
7. Unstable physical disorders which might make participation hazardous such as end-stage AIDS, hypertension (\>140/90), WBC \< 3.5, active hepatitis or other liver disease with elevated transaminase levels (\< 2-3 X upper limit of normal will be considered acceptable if PT/PTT is normal), renal failure (creat \> 2, BUN \>40), or untreated diabetes
8. Previous history of ketamine or midazolam misuse or abuse, and a history of an adverse reaction/experience with prior exposure to cocaine, ketamine or midazolam
9. Recent history of significant violence (past 2 years)
10. Abnormal pseudocholinesterase level
11. First degree relative with a psychotic disorder (bipolar disorder, schizophrenia, schizoaffective disorder, or psychosis NOS)
12. BMI \> 35, or a history of documented obstructive sleep apnea
13. On psychotropic or other medications whose effect could be disrupted by participation in the study
Midline Catheter Versus Long Peripheral Intravenous Catheter in Hospitalized Adult Patients

This research seeks to compare two types of vascular access (catheters that are inserted into the vein) for patient treatment during hospitalization. This research will evaluate how long each catheter lasts before presenting problems that may lead to its removal from the vein (the most common are swelling on the site of the catheter, clogging of the catheter, infections, or other less common problems. Each patient will be randomly selected to receive either catheter. In this study, we will also estimate how much each patient will spend if any of the problems mentioned occur.

This randomized, parallel, open, controlled, single-center clinical trial is blind to outcome analysis. The use of midline catheter will be compared, regarding duration of use without complications, to the use of long peripheral intravenous catheter during continuous our intermittent intravenous therapy in adult clinical patients who have been hospitalized for up to 30 days. The intervention group will consist of hospitalized adult clinical patients who were identified with difficult intravenous access (DIVA) and who received medical indication of continuous or intermittent intravenous therapy for more than five and a maximum of 30 days of treatment. These patients will receive PowerGlide ProTM Midline catheter. The control group will consist of patients with the same profile described as the intervention group and will receive the insertion of a long peripheral venous catheter Introcan Safety Deep Access. At the end of the study, an economic analysis will be carried out from the perspective of the public health system if the intervention group shows favorable results.

Eligibility Criteria:
* patients hospitalized in a clinical ward unit;
* indicated for continuous or intermittent intravenous therapy more than five days;
* identified with difficult intravenous access.