cyrilzakka/clinical-trials huggingface dataset:
Combination of Thrombopoietin Mimetic and Immunosuppressive Therapy in Aplastic Anaemia

To the investigator's Knowledge this is the first study that will assess Treatment with thrombopoietin Mimetic plus immunosuppressiveTherapy in Egyptian Patients with Aplastic Anaemia.

Aim of the work :

1. To evaluate the efficacy, tolerability and toxicity of the combination of thrombopoietin mimetic and immunosuppressive therapy in Egyptian patients with AA.
2. To study the influence of this combination on patients' quality of life.
3. To access evolution to paroxysmal nocturnal hemoglobinuria (PNH), myelodysplastic syndrome , acute leukemia or development of fibrosis

Aplastic anemia (AA) is a bone marrow failure syndrome that, although benign in nature, it influences patients' quality of life and carries poor prognosis.The pathophysiological basis of development of acquired AA include immune-mediated attack, inherent hematopoietic stem cell insufficiency and telomere defects. Bone marrow transplantation (BMT) is the only curative treatment for AA. Unfortunately it is unavailable for many patients due to lack of matched donors furthermore others are ineligible for BMT due to old age or co-morbid conditions. Immunosuppressive therapy was the mainstay of treatment for AA for many years, however many patients developed resistance or refractoriness. Immunosuppressive therapy was in the form of antithymocyte globulin (ATG) which gave hematologic response in nearly 50% of patients , adding cyclosporin A increases this response to 70%. Why some patients became resistant to immunosuppressive therapy ? The answer is not known.

Thrombopoietin mimetic (Eltrombopag) was firstly FDA approved for treatment of immune thrombocytopenic purpura. Numerous clinical trials proved the efficacy of anthropometric mimetic in patients with refractory severe AA, leading to its FDA approval for this group of patients. Some researchers proven the efficacy of thrombopoietin mimetic in patients with moderate aplastic anemia.

This study aimed to asses the combination of thrombopoietin mimetic and immunosuppressive therapy in patients with AA.

Eligibility Criteria:
Inclusion Criteria:

* Eligible for treatment with thrombopoietin mimetic.
* Willing to participate in the study and signed informed consent.
* Unavailability of BMT -

Exclusion Criteria:

* Patient with inherited aplastic anemia
* Underlying immune deficiency
* Contra indication to cyclosporin A
* Endstage hepatic or renal disease
* Pregnancy and lactation
Sorbact TM: Effect of a Microbial Binding Dressing on Wound Healing After Pilonidal Sinus Excision

Sinus pilonidal concern 26/100 000 young adults. It manifests after puberty, presenting as an acute abscess in approximately 50% of patients or as a discharging painful sinus. Patients may experience lengthy healing times resulting in considerable morbidity and disruption to a young adult's life. Eradication of pilonidal sinus is based on a wide surgical excision and at the end of the procedure, the wound is dressed with an alginate dressing (Algosteril®).

The objective is to show a better efficiency of Sorbact TM (trademark) dressings compared to Alginates that are standardized dressings after pilonidal sinus excision during a period of 75 days. The main objective is to show a difference of 20% of wounds completely healed in 75 days between the two types of dressing: 50% of wounds healed with Algosteril TM compared to 70% of wounds healed with Sorbact TM.


Eligibility Criteria:
Inclusion Criteria:

* Man or woman over 18 years old
* Informed consent signed by the participant
* Affiliation to social security system
* Having a pilonidal sinus:

  * Asymptomatic or discovered by the patient during a routine examination
  * With chronic recurrent infection and skin rupture

Exclusion Criteria:

* Patients with concomitant pathology:

  * cancer treated by chemotherapy
  * Hypertension uncontrolled systolic blood pressure\>180 mmHg or diastolic\> 110 mmHg
  * Severe comorbidity with reduced life expectancy less than 12 months
  * Acute cardiovascular disease (myocardial infarction, stroke, recent heart surgery) within 3 months before inclusion
* Patients participating in another clinical trial
* Known for intolerance to one of the dressings
* Known pregnancy
* Uncontrolled diabetes (fasting glucose \>2g/l)
Description of the Safety and Functionality of a Rectoscope (P201630551)

Most patients with rectal cancer receive neoadjuvant therapy. This usually causes a decrease in tumor size. In approximately 20% of patients who receive neoadjuvant therapy, the tumor disappears completely (complete pathological response), showing as a scar on the rectal mucosa, not noticeable from the rectal serosa, from outside the rectum, difficulting the identification of the tumor location by the surgeon.

Rectoscope (p201630551) allows the surgeon to view the illuminated rectum from the patient's abdomen, determining the appropriate point of section of the rectum.


Eligibility Criteria:
Inclusion Criteria:

* Men and women over 18 years old.
* Patients with rectal cancer (15 cm or less from the anal margin), whether or not they have received neoadjuvant treatment, in whom cancer surgery is to be performed through the anterior (abdominal) route, whether laparoscopic or not.
* Patients who accept their participation in this study, after explaining the study details.
* Patients who sign the informed consent.

Exclusion Criteria:

* Patients who are going to undergo an abdominoperineal amputation or transanal surgery for rectal cancer.
* Patients who do not accept their participation in this study.
Restylane® Lyft Filler Injection for Hand Rejuvenation on First Impressions

The purpose of this research is to determine the effects of Restylane® Lyft Filler injection into the back of the hand on first impressions.


Eligibility Criteria:
Inclusion Criteria:

1. Males and females of ages 28 and above.
2. Subjects will be required not to have had previous filler fat injections, or other cosmetic treatments to their hands within the last 12 months.
3. Subjects that understand the purpose and aspects of the study, freely sign the consent and complete the required treatment and follow up visit. -

Exclusion Criteria:

1. Males and females below age of 28.
2. Subjects who have had previous filler, fat injections, or other cosmetic treatments to their hands within the last 12 months.
3. Subjects who are pregnant or nursing.
4. Subjects with a known allergy or sensitivity to any component of the study ingredients.
5. Any history of bleeding disorders (iatrogenic or otherwise). This includes persons who have undergone therapy with thrombolytics, anticoagulants, or inhibitors of platelet aggregation in the preceding 3 weeks.
6. Anyone taking aspirin, ibuprofen, St. John's Wort, or high doses of Vitamin E supplements in the last 3 weeks.
7. Subjects with diseases, injuries, or disabilities of the hand, including those with autoimmune disease affecting the hand, hand implants, Dupuytren's contracture, history of hand tumor, vascular malformations, Raynaud's disease and patients at risk for tendon rupture.
8. Subjects that do not understand the purpose and aspects of the study, do not sign the consent and do not complete the required treatment and follow up visit will also be excluded. -
Aerosolized Versus Intravenous Colistin-based Antimicrobial Regimens in Hospitalized COVID-19 Patients With Bacterial Coinfection: A Randomized Controlled Trial

Secondary bacterial pathogen infection has been demonstrated to aggravate COVID-19 clinical outcomes. Bacterial infections acquired during a hospital stay are likely resistant to several antimicrobial medicines, making COVID-19 patient management difficult. As a result, it is believed that aerosolized colistin might be a viable choice for treating secondary bacterial infections caused by gram-negative resistant strains in individuals who also have COVID-19 infection.


Eligibility Criteria:
Inclusion Criteria:

* Covid-19 patients with secondary gram-negative bacterial infections

Exclusion Criteria:

* Patients with resistant bacterial strains to polymyxins
* patients less than 18 years
Descriptive Study of Strength Training Exercises to Activate the Muscles of the Operated Leg After Total Knee Replacement

Background:

In the early phase after a total knee replacement (TKA), patients experience multi-level weakness in the operated leg, which is caused primarily by reduced central (CNS) activation failure of the muscles - especially the knee extensors. This considerable loss of muscle strength relates to reduced functional performance. The investigators recently reported that early-commenced physiotherapy, including progressive strength training performed in machines, seems feasible after TKA. The question is, if neuromuscular activity of the muscles in the operated leg, elicited during strength training in machines, can be reached during strength training in more simple forms? Many clinicians are faced with the problem of not having strength training equipment at their institution, or having to prescribe simple strength training exercises for home-based training.

Purpose and hypothesis:

The purpose of this study is to determine which strength training exercises that activate the muscles in the operated leg the most after TKA. The hypothesis is that strength training exercises performed in machines is more effective compared to strength training performed in more simple forms (using elastic bands or own body weight, etc.).

Participants and methods:

Twenty participants with a unilateral TKA, operated between 4 to 8 weeks prior to the first investigation, will be included. The participants are investigated twice. During the first investigation, the absolute load (kilograms) corresponding to 10 Repetition Maximum (RM) (a load that can be lifted exactly 10 times) will be determined for all the exercises. At least 72 hours later, the participants will undergo an electromyographic analysis, which determines the neuromuscular activity of the thigh muscles in the operated leg.

Ethical issues:

From a pilot study, the investigators found that strength training exercises commenced early after TKA seems feasible as the exercises did not increase knee joint swelling or knee pain. None of the financial supporters, or any of the authors, have any potential conflicts of interest with regard to the study.


Eligibility Criteria:
Inclusion Criteria:

* Unilateral primary TKA
* Between the age of 18 to 80 years
* Understand and speak Danish
* Informed consent
* 4 to 8 weeks after TKA

Exclusion Criteria:

* Disease/Musculoskeletal disorder, which requires a special rehabilitation modality
* Alcohol and drug abuse
* Lack of wish to participate or unwillingness to sign an informed consent
Edwards CLASP TR EFS

Early feasibility study to assess the safety and performance of the Edwards PASCAL Transcatheter Valve Repair System in tricuspid regurgitation

The study is a multi-center, prospective, single-arm, and non-randomized study designed to evaluate the safety and performance of the Edwards PASCAL Transcatheter Valve Repair System

Eligibility Criteria:
Inclusion Criteria:

* Severe functional or degenerative TR
* Symptomatic despite medical therapy
* The local site Heart Team determines that the patient is appropriate for transcatheter tricuspid valve repair

Exclusion Criteria:

* Unsuitable anatomy
* Previous tricuspid valve repair or replacement
* Co-morbid condition(s) that, in the opinion of the investigator, could limit the patient's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study
A Study to Assess the Safety and Effectiveness of Tacrolimus Cream in the Treatment of Psoriasis

A study to assess the safety and effectiveness of tacrolimus cream in the treatment of psoriasis


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of plaque psoriasis

Exclusion Criteria:

* Skin disorder other than plaque psoriasis in the areas to be treated.
* Disease on only elbows, knees, and scalp
Ulnar Wrist Pain Treatment With Dextrose Prolotherapy

Participants who have failed therapy for chronic wrist pain on the little finger side of the wrist will recieve dextrose prolotherapy. Their results will be compared to a cohort of consecutive participants who have not failed therapy, and receive 4 weeks of usual care.


Eligibility Criteria:
Inclusion criteria

* Pain on the ulnar side of the wrist.
* PRWE greater than 40

Exclusion criteria

* Radioulnar instability more than moderate as determined by a positive ulna fovea sign or ulna grinding test
* Surgery in the wrist area
* Infection in the wrist area
* Other wrist pathology on examination
* Other pain area that is constant, interferes with sleep, or is as bad, or worse, than shoulder pain.
* Diabetes or other peripheral neuropathy
* Radiculopathy
* Unstable psychiatric function.
* Current opioid use.
* Vulnerable patients
* Pregnancy
A Study of Aripiprazole in Children and Adolescents With Aspergers and Pervasive Developmental Disorder.

The purpose of this study is to develop a better tolerated and more effective pharmacologic treatment for individuals with Asperger's Disorder and Pervasive Developmental Disorder. This is an open-label investigation of aripiprazole in the management of the maladaptive behaviors of autistic disorder. We hypothesize that aripiprazole will be effective for reducing aggression and repetitive behavior.

Pervasive developmental disorders (PDD) are characterized be severe impairments in social interaction and communication in addition to restricted patterns of interests and activities. Research suggests that a dysregulation of the dopamine and serotonin systems contributes to these interfering behaviors in individuals with PDD. After benefits of typical neuroleptics were reported in subjects with PDD's, research shifted to the atypical antipsychotics, which have been shown to be better tolerated and effective in this population. However, the atypical antipsychotics have also been associated with adverse effects. Thus there remains a need for a novel pharmacotherapy that would be safe and effective for children and adolescents with PDD's including Asperger's disorder and PDD Not Otherwise Specified (PDD NOS). We hypothesize that aripiprazole will be effective for reducing aggression and repetitive behavior. We also hypothesize that aripiprazole will be well tolerated, with low risk for extrapyramidal symptoms, hyperprolactinemia, weight gain, or corrected QT interval (QTc) prolongation. In addition, this open-label study will serve to stimulate more definitive, controlled research.

Eligibility Criteria:
Inclusion Criteria:

* Mental age of 18 months
* Diagnosis of Asperger's Disorder or Pervasive Developmental Disorder
* Good health overall
* Free of all psychotropic medication for 2 weeks

Exclusion Criteria:

* Weight less than 15kg
* Subjects who have received an adequate trial of aripiprazole
* An active seizure disorder
* A significant medical condition
* History of neuroleptic malignant syndrome
* Females with positive Beta human chorionic gonadotropin(HCG) pregnancy test
DOZE Sleep App for Youth With Sleep Disturbance

Insomnia is a highly prevalent problem among adolescents and young adults (AYAs) with mental health issues. Although evidence-based treatments to quickly address insomnia exist, access to such treatments is limited and there is very little research in AYAs. Furthermore, some of the sleep problems of AYA are unique (e.g., voluntary sleep restriction, circadian phase delay, very poor sleep hygiene), so pediatric and adult programs are not suitable for this age group. This study will test an innovative program that consists of an integrated smart phone application (app) and web self-management system ("DOZE") to help adolescents and young adults sleep better. The first phase of this project, now completed, involved interviewing primary stakeholders of the app (AYAs) to evaluate a low-fidelity prototype of the app and to gather information regarding their opinion about what tools participants would use to improve their health and/or sleep. Using the data from phase I, the investigators have created an app that is acceptable, useful and easy to use while meeting the needs of AYAs experiencing sleep problems. In this study, the investigators will conduct an open trial of the app with 145 AYAs to evaluate usability, acceptability, and sleep and corollary outcomes using a mixed methods design.

The investigators hypothesize:

1. That participants (AYAs) will find the app satisfactory and credible;
2. DOZE will effect sleep-related behaviour change;
3. DOZE will contribute to improvements in energy, mood, and perceived quality of life.

Exploratory analyses will also be conducted to evaluate which aspects of DOZE participants (AYAs) found most helpful.


Eligibility Criteria:
Inclusion Criteria:

* Age between 15 and 24 years
* Experiencing sleep disturbance

Exclusion Criteria:

* None
The Efficacy of Prophylactic Antibiotic Administration During Breast Cancer Surgery in Overweight Patients.

This is a single center trial to compare the rate of surgical site infection (SSI) in normal (BMI equal to or less than 25; Control Group)) and overweight (BMI over 25) women who are undergoing breast cancer surgery. The overweight patients are further randomized into two groups; in one group patients receive prophylactic antibiotics (ampicillin/sulbactam; Prophylaxis Group), in the other they do not (No Prophylaxis Group).

CONTEXT Although breast surgery is regarded as clean surgery, the actual SSI rate is well above accepted range in various series. Retrospective studies showed BMI as one of the factors which may have caused increased SSI rate after breast cancer surgery. Yet, no prospective randomized study assessed the efficacy of chemoprophylaxis during breast surgery in overweight patients.

OBJECTIVE To compare the SSI rate between three groups of early stage breast cancer patients in which two are assigned according to randomization. First, patients are grouped into two according to their BMI. All patients (Control Group) with BMI equal to or below 25 do not receive any antibiotics as prophylaxis. Patients with a BMI above 25 are randomly assigned to receive a single dose prophylactic ampicillin /sulbactam combination before surgery (Prophylaxis Group) or not to receive chemoprophylaxis (No Prophylaxis Group).

DESIGN, SETTING AND PATIENTS Patient recruitment is still continuing after the study started in October 2003 in order to reach a sample size of 360 patients with BMI over 25. Advanced or distant metastatic stage, receiving neoadjuvant therapy, history of receiving antibiotics within prior 3 months, history of immunodeficiency, having a remote infection and history of reaction to treatment antibiotics are within the exclusion criteria.

INTERVENTIONS All patients are followed for 30 days postoperatively (once in a week at the original surgical unit). Patients and the investigator who inspects all wounds are blinded. Cost of SSI-related prophylaxis and treatments (including additional hospital visits after discharge, physician charges, additional antibiotics, wound management, other drugs and interventions etc) is calculated in each study group and compared with each other.

Eligibility Criteria:
Inclusion Criteria:

* Women at any age with early stage breast cancer (stage I-II) and American Society of Anesthesiologists (ASA) score of I-II.

Exclusion Criteria:

* Ductal carcinoma in situ (DCIS; stage 0 cancer),
* Advanced or distant metastatic stage,
* Receiving any neoadjuvant therapy,
* History of receiving any antibiotics within prior 3 months,
* History of immunodeficiency,
* Having a remote infection,
* History of reaction to study antibiotics,
* Denial of signing the consent form.
A Study to Determine the Patient Preference Between Zosano Pharma Parathyroid Hormone (ZP-PTH) Patch and Forteo Pen

The purpose of this study is to determine which of two delivery methods of Parathyroid Hormone (PTH) is preferred by patients after 14 days of use for each.

The purpose of this study is to determine which of two delivery methods of PTH is preferred by patients after 14 days of use for each. Patient preference will be determined by means of patient questionnaires at the end of each treatment period and a final questionnaire after both treatment periods are complete. Adverse events will also be collected.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal with prior diagnosis of osteoporosis

Exclusion Criteria:

* Significant health issue
* previous use of teriparatide
* History of Paget's disease
Early Intervention to Promote Cardiovascular Health of Mothers and Children

Early Intervention to Promote Cardiovascular Health of Mothers and Children (ENRICH) is a cluster randomized clinical trial, funded by the National Heart Lung \& Blood Institute. The study is designed to test the effectiveness of home visiting intervention to promote cardiovascular health and reduce disparities in maternal and early childhood cardiovascular health. Sites, in partnership with evidence-based home visiting programs, are recruiting 6400 participants in total (i.e., 3200 parent-dyads which includes 3200 parents and 3200 children) from diverse community settings with a high burden of cardiovascular disease risk factors.


Eligibility Criteria:
Inclusion Criteria:

1. Be currently enrolled in an evidence-based home visiting program participating in ENRICH
2. Be pregnant, with a single or multifetal gestation, at or less than 34 weeks 0 days gestation (per self-report at time of consent)
3. Be 18 years of age or older
4. Speak English or Spanish

Exclusion Criteria: There are no exclusion criteria being applied in assessing eligibility for participation in ENRICH.
Effect of Cold Therapy Implementation on Multi-modal Postoperative Pain Management

This is a pilot randomized controlled trial examining post-operative pain scores and outcomes after laparoscopic hysterectomy in patients prescribed cold therapy as an adjunct to routine post-operative multi-modal analgesia, compared to those patients prescribed routine multi-modal analgesia without cold therapy. All patients scheduled for total laparoscopic hysterectomy (without robotic-assistance) will be screened for eligibility in the study. If eligible, patients will be invited to participate in the study and standardized informed consent process will ensue. After surgery is completed participants will be randomized to either the control group or the study group. The study group will be prescribed the use of cold therapy to their abdominal incisions through reusable cold gel packs. The cold therapy is to be applied to participants' incisions for the first three postoperative days, in addition to routine post-operative analgesia regimen. Investigators will then collect information on pain scores, narcotic use, quality of life and surgical recovery scores.

This study aims to examine if there is a difference in post-operative pain scores with the application of cold therapy to laparoscopic abdominal incisions following laparoscopic hysterectomy, when compared to no cold therapy. Secondarily, investigators will examine post-operative quality of life scores, postoperative surgical recovery scores, as well as narcotic use among the two groups. Investigators also aim to ascertain additional information regarding total quantity of narcotics used post-operatively to aid in prescribing patterns.


Eligibility Criteria:
Inclusion Criteria:

1. Patients can understand and voluntarily sign an informed consent form
2. Female gender ages 18-65
3. Scheduled for laparoscopic hysterectomy for benign indications, total or subtotal, without or without oophorectomy (standard of care involves bilateral salpingectomy)

Exclusion Criteria:

1. Conversion to laparotomy
2. Diagnosis of chronic pelvic pain
3. No access to freezer at home to keep reusable cold packs cold between uses
4. Contraindications to exposure to cold therapy (history of cold allergy, cold intolerance, Raynaud's disease, cold urticaria, cryoglobulinemia, or pyoderma gangrenosum)
5. Medical contraindication to NSAID use