cyrilzakka/clinical-trials huggingface dataset:
Pain and Suction Curettage

Aim of the study was to investigate the analgesic efficacy of preoperative oral dexketoprofen trometamol, intravenous paracetamol, lidocaine spray and paracervical block with ultracaine on curettage procedure.


Eligibility Criteria:
Inclusion Criteria:

* pregnant participants between 35-48 days of gestation (5 to 7 weeks of gestation) pregnant participants with a single viable intrauterine pregnancy requesting termination of pregnancy.

Exclusion Criteria:

incomplete abortions, diabetes mellitus, tendency to bleed such as thrombocytopenia, factor deficiency and functional disorders of platelets... etc, pelvic infection, known cervical stenosis, significantly impaired respiratory or cardiac conduction functions, active liver disease, renal disease, previous adverse reaction to any of the drugs used in the study, and patients who are unable to understand how to score a 10-cm visual analog scale (VAS) pain score. Moreover, patients who described chronic pelvic pain prior to the study or patients who rated their pain level on a continuous 100-mm VAS different from 0 (no pain) just before the study were not included into study.
Proximal Row Carpectomy vs Four-corner Fusion for Osteoarthritis of the Wrist

Study purpose is to compare the outcome after proximal row carpectomy (PRC) vs four-corner fusion (FCA) for SLAC/SNAC II-III type osteoarthritis (OA) in a double-blinded randomized controlled study setting.

Patients with radiologically and clinically confirmed OA are randomized (1:1 computer generated sequence with random block size) to two parallel groups and will undergo either PRC or FCA. The study will be patient and assessor blinded.

Baseline data is collected preoperatively and is followed by a follow-up visits at 2 and 6 weeks, 3, 6, 12 months, and 5, 10 years after the intervention. Unveiling of the allocation is at 12 months post-intervention.


Eligibility Criteria:
Inclusion Criteria:

* SLAC/SNAC II-III
* Age 18 - 75
* Symptom duration \> 3 months
* American Society of Anaesthesiologists physical status (ASA) I-II

Exclusion Criteria:

* Patient eligible for SL reconstruction or scaphoid
* Ulnocarpal/pancarpal arthritis
* Lunate fossa, proximal lunate arthrosis or both
* Age \<18 or \>75 years
* Rheumatoid arthritis
* Heavy smoking (\> 20 cigarettes per day)
* Condition or medication affecting bony healing (eg diabetes mellitus with poor glycemic control, malnutrition, use of per oral corticosteroids)
* Alcohol or drug abuse
* Neurological condition affecting upper limb function
CDK4/6 Inhibitor Plus Camrelizumab for PD-1 Inhibitor Refractory R/M NPC

Because most patients with R/M NPC have received long-term maintenance of immunotherapy at the time of initial treatment and the first-line treatment, there are a large number of PD-1 inhibitor refractory patients. How to deal with the ICIs resistance is an urgent problem in clinical practice.


Eligibility Criteria:
Inclusion Criteria:

1. Had histopathologically confirmed nonkeratinizing recurrent/metastatic NPC.
2. ECOG performance status of 0 or 1.
3. Progression after previous treatment with platinum-based dual-drug chemotherapy.
4. Progression after previous treatment with PD-1 inhibitors.
5. Experieced at least 1 line systemic therapy.
6. Subjects enrolled must have measurable lesion(s) according to response evaluation criteria in solid (RECIST) v1.1.
7. Adequate organ function assessed by laboratory parameters during the screening period.
8. Life expectancy more than 12 weeks.
9. Able to understand and sign an informed consent form (ICF).
10. Able to swallow the pill.

Exclusion Criteria:

1. Recurrent lesions suitable for radical treatment (radiotherapy or surgery).
2. Previous treatment over 3 lines.
3. Prior use of CDK4/6 inhibitors.
4. Patients with other malignancies.
5. Patients with known or suspected autoimmune diseases including dementia and seizures.
6. Multiple factors affecting the absorption of oral medications (e.g., dysphagia, chronic diarrhea, and bowel obstruction).
7. An excessive dose of glucocorticoids given within 4 weeks before enrollment.
8. Complications requiring long-term use of immunosuppressive drugs or systemic or local use of immunosuppressive-dose corticosteroids.
9. Patients with active pulmonary tuberculosis (TB) receiving anti-TB treatment or who have received anti-TB treatment within 1 year prior to screening.
10. HIV positive; HBsAg positive and HBV DNA copy number positive (quantitative detection ≥ 1000 cps/ml); chronic hepatitis C with blood screening positive (HCV antibody positive).
11. Any anti-infective vaccines such as influenza vaccine, varicella vaccine, etc., within 4 weeks before enrollment.
12. Women of childbearing age with a positive pregnancy test and lactating women.
Safety and Efficacy of Fidaxomicin Versus Placebo for Prophylaxis Against Clostridium Difficile-Associated Diarrhea in Adults Undergoing Hematopoietic Stem Cell Transplantation (MK-5119-001)

The objective of this study is to demonstrate the efficacy and safety of Fidaxomicin versus placebo for prophylaxis against Clostridium difficile-Associated Diarrhea (CDAD) in adult participants undergoing hematopoietic stem cell transplantation (HSCT). The primary hypothesis is that Fidaxomicin is superior to placebo in preventing CDAD in participants undergoing HSCT.


Eligibility Criteria:
Inclusion Criteria:

* Male or female 18 years of age or older.
* Females of childbearing potential must be using an adequate and reliable method of contraception (e.g., abstinence, barrier with additional spermicide foam or jelly, intrauterine device, hormonal contraception). Males and females must agree to avoid conception during treatment and for four weeks following the end of study treatment.
* Is undergoing HSCT with planned Fluoroquinolone prophylaxis.
* Informed consent is provided.

Exclusion Criteria:

* Ongoing active CDAD infection (as evidenced by clinical signs of diarrhea along with the presence of either toxin A and/or B \[or their respective genes, tcdA and/or tcdB\] of C. difficile in the stool) or current treatment for CDAD.
* Undergoing cord blood transplants.
* Has fulminant colitis, toxic megacolon, or ileus.
* A history of inflammatory bowel disease (ulcerative colitis or Crohn's disease).
* Women who are pregnant or are actively breast feeding (all women of childbearing potential must have a negative pregnancy test result prior to dosing study drug).
* Use of any drugs potentially useful in the treatment of CDAD (e.g. oral Vancomycin, Metronidazole, oral Bacitracin, Fusidic Acid, Rifaximin, and Nitazoxanide).
* Any other condition that, in the opinion of the investigator, would jeopardize the safety or rights of the participant in the study, would make it unlikely for the participant to complete the study, or would confound the results of the study.
* Participation in other clinical research studies utilizing an investigational agent within one month prior to screening and during the study treatment period.
Quality of Life in Cutaneous Lymphoma Patients Using the Skindex29

This study assesses the quality of life in patients with cutaneous lymphoma diagnosis as it relates to their personal, clinical, and therapeutic information using the Skindex29 questionnaire and also assesses patients' understanding of their diagnosis and need for resources related to their care. Cutaneous lymphomas are a rare type of blood cancers (non-Hodgkin lymphoma) that present in the skin. The information gained from this study, may help researchers improve quality of life in cutaneous lymphoma patients.

PRIMARY OBJECTIVES:

I. To prospectively assess quality of life (QoL) in adult patients with cutaneous lymphoma (CL) via use of a validated questionnaire (Skindex-29) and identify the psychosocial needs of our patient population.

II. To prospectively evaluate the burden of pruritus in patients with CL via use of 10-point pruritus scale and compare to QoL.

III. To evaluate QoL for any correlation with demographic and clinical information, specifically, age, gender, race/ethnicity, type of CL, stage of mycosis fungoides (MF)/Sezary syndrome (SS), treatment regimen, and social work involvement.

IV. To track changes in QoL and burden of pruritus as they relate to therapeutic strategies used to manage disease, including social work involvement.

V. To prospectively assess patients' knowledge and understanding of their cancer diagnosis, prognosis, and overall survival; and to track changes in their knowledge and understanding, and assess for any correlation to QoL.

VI. To prospectively evaluate our patients' need for resources, and our ability to meet those needs; and to assess for any correlation to demographic or clinical category, or QoL.

OUTLINE:

Patients complete quality of life questionnaires over 10-20 minutes about symptoms, emotions, and functioning related to diagnosis of cutaneous lymphoma.

Eligibility Criteria:
Inclusion Criteria:

* Agreement to participate in the research study
* Presumed or confirmed diagnosis of CL
A Study to Evaluate the Safety and Effectiveness of Topiramate Compared to Placebo in the Treatment of Patients With Bipolar I Disorder

The purpose of this study is to determine the safety and efficacy of topiramate in adolescents with manic or mixed episodes of Bipolar I Disorder.

This is a 4-week study to evaluate the safety and effectiveness of topiramate compared to placebo in the treatment of Bipolar I Disorder with an optional 6-month open-label (OL) extension for qualified patients following completion of the study. On Days 1-28 patients will receive placebo or topiramate 2x/day by mouth except for the 1st and last doses which will be a single evening dose and a single morning dose, respectively. Study drug will be titrated in 100-mg increments to 400 mg/day and patients maintained on a stable dose through Day 28. During the OL extension phase, topiramate will be titrated over 5 days to 200 mg/day. After Day 7, topiramate may be tapered down to 100 mg/day or up to 600 mg/day, as clinically indicated.

Eligibility Criteria:
Inclusion Criteria:

* DSM-IV diagnosis of Bipolar I Disorder (confirmed by the Kiddie-Schedule for Affective Disorders and Schizophrenia-Present and Lifetime version \[K-SADS-P/L\])
* YMRS score greater than or equal to 20
* General good health as determined by medical history, physical examination, and laboratory evaluations
* Ability to swallow tablets
* Patient's parent or guardian must be fully capable of monitoring the patient's disease process and compliance to treatment
* Parent(s) or legal guardian(s) must read and sign the informed consent form after the nature of the study has been fully explained and assent must be obtained from patients

Exclusion Criteria:

* DSM-IV Axis I disorder diagnoses of autistic disorder, schizophrenia, schizoaffective disorder, or other psychotic disorders not otherwise specified (NOS)
* DSM-IV diagnosis of alcohol or substance dependence, with the exception of nicotine or caffeine dependence, within the 3 months prior to baseline. Acute or intermittent substance abuse prior to screening will not be exclusionary, depending upon the clinical judgment of the investigator
* Chronic antidepressant treatment within 4 weeks of randomization (5 weeks for fluoxetine), use of psychostimulants in the 7 days prior to baseline, use of any other psychotropic medications within 3 days or 5 half-lives, whichever is less, prior to baseline, or requirement for treatment with other psychotropic drugs on an ongoing basis
* Weight less than 33 kg or current or past history of anorexia nervosa
* Serious or unstable medical or neurological conditions
Effect of Mother DHA Supplementation on Premature Newborn.

To date, the investigations in the field of the supplementation with DHA in premature babies have been focused on the study of neuronal and visual development, giving place to contradictory and ambiguous results, because they did not consider in many cases important aspects of this supplementation, such as the mother´s diet, dose, duration, etc., and precise studies have not been performed in the field of the oxidative damage, inflammation and bone development in this population.

Hypothesis: If the composition of the mother´s milk is modified on the basis of her diet, a mother supplementation with high doses of DHA will increase proportionally the levels of this fatty acid in her milk, fact that will allows the premature newborn child receive a major dose of this fatty acid, and therefore this way, we will manage to improve the neuronal and visual development and to take part on the inflammatory process, oxidative damage and its evolution, together with the development or bone mass increase in the premature baby.

Aims: Overall we aim to evaluate in a multidisciplinary way the effect of a mother supplementation during the lactation with high doses of DHA on the development and wellness of the premature newborn children. We try to deepen into the effect on the neuronal and visual development and to study, for the first time, the effect on the oxidative damage, pro- and antiinflammatory citoquines activity and bone metabolism in this group of newborn babies.

Experimental design: We will establish two groups of premature newborn children (\<34 weeks) (n=40). The mothers of one of the groups of premature newborn children will receive an oral supplementation by means of capsules with high dose of DHA (900 mg/day) during the lactation (minimum period of 3 months). In addition, all the groups will be underwent to a nutritional surveillance (a follow-up of 48 hours and a questionnaire of frequency of consumption) and will be given nutritionally-balanced diets, insisting especially in the suitable consumption of fish (4 portions/week). Blood samples will be obtained in all the groups at the birth moment, at the week 40 of gestational age corrected in the groups of premature babies and at the end of the lactation in all the groups (minimum 3 months).We will obtain samples of mother´s milk (colostrum, transition and mature milk). In these samples we will study bone turnover biomarkers, pro - and anti-inflammatory citoquines and markers of aggression oxidative damage. In addition, we will perform psychomotor and visual development tests in the newborn children.

Eligibility Criteria:
Inclusion Criteria:

* Preterm neonate, gestational age 30-34, PAEG (\>P10, \<P95), no pathologies.

Exclusion Criteria:

* Lactose intolerance, systemic illness, multiple gestation, cromosomopathies, antibacterial therapy.
Observational Trial of Cardiotoxicity in Patients Undergoing Chemotherapy.

Advances in treatment have led to improved survival of patients with cancer, but have also increased morbidity and mortality due to cancer treatment side effects. Cardiotoxicity is one the most frequent side effect which may lead to premature morbidity and death among cancer survivors. The most concerning cardiovascular complications of cancer therapy is myocardial dysfunction, leading to heart failure, and fatal arrhythmias, especially those induced by QT-prolonging drugs.

PROMETEY (PROspective Multidisciplinary obsErvational Trial of cardiotoxicity in patiEnts undergoing anticancer therapy) - is Russian multicenter observational study assessing cardiotoxicity and its clinical, biochemical and genetic factors in patients on cancer therapy.

The objectives of the study are:

* to reveal prevalence of cardiotoxic effects of cancer therapy in routine clinical practice in Russian Federation,
* to assess contribution of these effects to mortality of patients on cancer therapy,
* to evaluate clinical and economic consequences of cardiotoxicity in patients with cancer,
* to develop an individualized model of cardiotoxicity risk factors based on clinical and laboratory parameters.

Patients: 400 cancer patients with toxic cardiomyopathy and 100 patients with idiopathic or family dilated cardiomyopathy.

Study duration: 60 months. All patients will undergo complex examination after signing informed consent form(ICF): physical exam, echocardiography with speckle tracking analysis, ambulatory 48-hours ECG monitoring, biochemistry, analysis of biomarkers of myocardial injury, fibrosis and inflammation.

Primary endpoint: all-cause mortality, heart transplantation, cardioverter-defibrillator implantation, hospitalization with heart failure decompensation.

Secondary endpoints:

* thromboembolism,
* fatal/ nonfatal myocardial infarction, stroke,
* sudden cardiac death,
* surgical therapy of heart failure or arrhythmias,
* cardiovascular death,
* all-cause mortality,
* heart transplantation,
* cardioverter-defibrillator implantation.


Eligibility Criteria:
Inclusion Criteria:

* written informed consent form (ICF),
* Eastern Cooperative Oncology Group (ECOG) scale 0-3,
* patients with verified cancer on or planned to be on chemotherapy including anthracyclines,
* sufficient bone marrow function, including: absolute neutrophils \> 1.5\*10\^9/l, platelets \> 100\*10\^9/l, hemoglobin \> 9 g/dl,
* sufficient liver function, including: total bilirubin \< 1.5\*upper normal value, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 2.5 upper normal value,
* sufficient renal function, including: creatinine clearance \> 50 ml/min.

For control group:

* verified non-toxic dilated cardiomyopathy.

Exclusion Criteria:

* refusal of patient,
* sepsis,
* coma, delirium,
* mental disorders,
* left chest radiation therapy,
* metastases in central nervous system.
Post Stroke Aphasia Rehabilitation Using Computer-based Arabic Software Program: A Randomized Control Trial

Aphasia is a disorder of language processing caused by a lesion in particular brain regions. Treatment aims at improving or restoring impaired function or at compensating for deficits. More recently, computer technology has been integrated into treatment options. In this study, a detailed and comprehensive computerized software program for aphasia rehabilitation is designed for the treatment of Arabic speaking Egyptian aphasic patients.

Aim of the study: design a computerized software program for the rehabilitation of Arabic speaking Egyptian aphasic patients.

Aphasia is a disorder of language processing caused by a lesion in particular brain regions. Treatment aims at improving or restoring impaired function or at compensating for deficits. More recently, computer technology has been integrated into treatment options. In this study, a detailed and comprehensive computerized software program for aphasia rehabilitation is designed for the treatment of Arabic speaking Egyptian aphasic patients.

Aim of the study: design a computerized software program for the rehabilitation of Arabic speaking Egyptian aphasic patients.

Subjects: The study was conducted on 50 patients with aphasia who attend the unit of Phoniatrics during the period of one year, Department of Otorhinolaryngology, Alexandria Main University Hospitals.

Methodology: The training materials were designed as a software program. Each patient was subjected to assessment before and after the application of the rehabilitation program. Patients were randomized into two groups: group I who received therapy using the software aphasia rehabilitation program and group II who received conventional (traditional) language therapy. Therapy continued for 48 sessions over six months.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of aphasia
* Age 18 years or more

Exclusion Criteria:

* Intellectual disabilities.
* Visual impairment.
* Hearing impairment.
* Associated dysarthria and or apraxia of speech.
* Associated psychiatric disorders
Multidisciplinary Digital Therapeutics of Chronic Lower Back Pain Versus Usual Care

This randomized controlled pilot study will be evaluating an app, MORT-LBP app (ETH-02K), owned by EverEx, Inc., to examine safety and efficacy in individuals with chronic lower back pain.

This randomized controlled pilot study will enroll 46 participants, where half will be randomly assigned to the app, MORT-LBP (n = 23), and half will be assigned to treatment as usual (TAU) (n = 23), to examine safety and efficacy in individuals with chronic lower back pain. All subjects will be followed up in the study for a total of 12 weeks, 8-week courses of treatment with additional 4-week observation. The app provides multidisciplinary rehabilitation treatment, a combination of graded exercise therapy and cognitive behavioural therapy for patients with chronic lower back pain.

Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥ 19 and \<65 years of age
* Patients who have a history of lower back pain persisting for longer than 12 weeks
* Patients who have average back pain score of 3 or more on the numeric rating scale (NRS)
* Patients who can use application-based therapy with his/her smartphone
* Patients who signed a written informed consent form
* Patients who are able to comply with the plan, as determined by the study investigator.

Exclusion Criteria:

* Patients who have previous history of spinal surgery
* Patients who have previous history of spinal trauma within 3 months
* Patients with lower extremity radicular pain with sensory and motor dysfunction
* Patients with lower extremity muscle strength of 3 or less on a manual muscle test
* Patients with spondylolysis or spondylolisthesis
* Patients with other structural abnormalities of the spine, including scoliosis (Cobb's angle \> 10 degrees) or kyphosis (lordotic angle \< 0 degrees)
* Patients with red flag signs (paralyzing symptoms such as fecal impairment, sudden unexplained weight loss)
* Patients with tumors, infections, metabolic bone disease, cognitive impairment, fibromyalgia, and systemic inflammatory diseases
* Patients with other systemic disease conditions that limit exercise therapy, as determined by the study investigator
* Patients who are pregnant or breastfeeding
* Patients with known substance/alcohol use disorders
* Patients who are not able to participate in an exercise or strengthening program
* Patients taking opioid analgesic medications with a potency greater than or equal to tramadol for other conditions or low back pain