cyrilzakka/clinical-trials huggingface dataset:
Reduced Intensity AlloTransplant For Osteopetrosis

We believe that hematopoietic stem cell transplantation (HSCT) will help subjects with Osteopetrosis generate functioning osteoclasts, and by so doing assist in the resolution of the abnormal bone architecture, and the anemia and bone marrow failure that is also characteristic of this disease. However, we have found in past studies that approximately 30% of Osteopetrosis patients do not engraft. Therefore, in this study, we plan to use a different combination of pre-transplant drugs to try to make transplants safer for this disease, as well as to provide a second infusion of stem cells in patients with matched related or unrelated donors. The purpose of this research is to find a safer and more effective means of performing stem cell transplantation in patients with Osteopetrosis, using chemotherapy and radiation designed to bring about engraftment and lessen transplant mortality.

This transplant protocol will test the following: 1) the ability to achieve engraftment with the reduced intensity protocol, 2) the mortality associated with transplant by day 100, 3) patient outcomes, based on differential imaging and biologic evaluations prior to transplantation and at designated points after transplantation (day 100, 6 months, 1, 2 and 5 years). Additional biologic studies will include microarray analysis, Campath levels just prior to the administration of the graft, and establishment of mesenchymal stem cell lines. In older patients, studies to evaluation osteoclast differentiation and function will also be offered.

Eligibility Criteria:
Inclusion Criteria:

* Patients eligible for transplantation under this protocol will be \<45 years of age, and will be diagnosed with severe osteopetrosis. This will be defined as having the following manifestations of the disease.
* Bones that are uniformly markedly dense based on skeletal survey
* No history that would suggest autosomal dominant inheritance
* Evidence of hematologic changes that are attributed to the underlying disease, including the need for ongoing transfusions, OR
* the presence of progressive anemia or thrombocytopenia, OR a white blood cell differential with a predominance of immature forms and evidence of extramedullary hematopoiesis, OR
* persistence of serious infectious complications that are thought to be due to the abnormal architecture of the bone that are resistant to surgical and medical interventions.

Exclusion Criteria:

* Patients \>45 years of age
* Evidence of hepatic failure
* pulmonary dysfunction sufficient to substantially increase the risk of transplant
* Renal dysfunction with glomerular filtration rate (GFR) \<30% of predicted.
* Cardiac compromise sufficient to substantially increase the risk of transplantation
* Severe, stable neurologic impairment.
* Human immunodeficiency virus (HIV) positivity.
* Pregnant or lactating females
Myeloproliferative Neoplasms (MPN) and COVID-19

An increased risk of both venous and arterial thromboembolism was noted in reports from SARS-CoV-2-infected patients in China and has been confirmed in autopsy findings from patients who experienced sudden death. Myeloproliferative Neoplasms (MPNs), which encompass polycythemia vera, essential thrombocythemia and primary myelofibrosis, are thrombophilic disorders with a natural propensity to thrombosis that is fuelled by the intrinsic activation of inflammatory cytokines. It therefore follows that an underlying diagnosis of MPN may increase the risk of worse clinical outcomes and death during periods of active Covid-19 disease. This ambispective, observational study aims to elucidate the key factors which affect the clinical course of patients with MPN who develop Covid-19 disease.

This is an European multicenter observational study that will include around 550 MPN patients with a confirmed diagnosis of Covid-19 will be followed for at least one month. Detailed information on the clinical characteristics of these patients and their disease outcomes will be retrospectively and prospectively collected in a specific eCRF, including MPN characteristics, treatment and comorbidities pre-Covid-19, time of Covid-19 diagnosis, drugs/device used for the treatment of Covid-19, any change in MPN therapy, antithrombotic prophylaxis employed during the period of infection and - for hospitalised patients only - key blood and laboratory parameters. A particular focus will be on exploring final outcomes for patients in this study, most notably the incidence of fatal and non-fatal thrombotic events. Statistical analyses will also be performed looking for any independent factors that can significantly predict patient outcomes after Covid-19 diagnosis.

Ultimately, this project will provide important insights into disease severity and progression in patients with MPN and Covid-19 and uncover the key clinical factors which drive outcomes and mortality. Results may help clinicians better understand how patient characteristics and management decisions can impact on disease trajectory when MPN and Covid-19 collide.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Confirmed diagnosed of MPN according to WHO criteria
* Diagnosis of COVID-19 based by the positivity of oropharyngeal swab performed between 15 February 2020 up to 15 February 2022
* Signed informed consent

Exclusion Criteria:

* None
Prevalence of Disruptive Behavior in Children With Attention Deficit Hyperactivity Disorder(ADHD)

Identification of prevalence and Risk factors for disruptive behavior in children with Attention Deficit Hyperactivity Disorder and Early recognition of disruptive behavior in children with ADHD

ADHD is asustaible pattern of inattention Hyperactivity and lmpulsive behavior which can have harmful consequences for the patients social life it was called childhood hyperkinetic reaction before it is estimated that 3 to 5 percent of children show symptoms in primary school in addition to the role of genetic factor in the incidence of this mental disorder ,family imbalance and other anxiety factors play arole in the continuity of disorder.disruptive behavior with a prevalence of 1 to 10percent is a prevalent disorder in primary school similar to ADHD it is 4 to 12 times more frequent among boys compared with girls . disruptive behavior characterized by aggression and violating others rights . This study is screening survey questionnaire study will be done in Assuit University children hospital Neuro psychiatric outpatient clinic in all children under 18 years old have ADHD and exclude other psychiatric problems as :Autism , depression , Schizophrenia or mental retardation . investigator will take full history : personal history : name , date of birth ,age,sex ,age of onset of ADHD ,type of ADHD,severity of ADHD ,type of disruptive behavior , history of treatment,Family history : sibling have ADHD,smoking of parents,drug use parents,social problems: divorce or death of parents . Investigator will use DSM V criteria as adignostic criteria and screening data evaluated by ADHD symptoms check list -4 (ADHD -sc4 scale scores) : symptoms count scores and symptoms severity scores . All for detect outcome of the patient with ADHD .

Eligibility Criteria:
Inclusion Criteria:

* All children under 18 years old with ADHD at Neuro pyshictric outpatient clinic

Exclusion Criteria:

* Any psychiatric problems other than ADHD like :Autism, depression, schizophrenia or mental retardation
Gua Sha Therapy for Chronic Low Back Pain

Chronic low back pain is a major public health burden with only limited evidence of effectiveness for complementary and traditional therapies. Gua Sha is a traditional East Asian therapy traditionally used in the treatment of spinal pain. This study aimed to test the efficacy of Gua Sha therapy in patients with chronic low back pain A total of 50 patients with chronic low back pain were randomized to either two Gua Sha treatments (n=25) or a waitlist control group (n=25). Primary outcome measure was current pain intensity on a 100-mm visual analog scale; secondary outcome measures included back-related function (Oswestry Disability Index), movement-related pain (modified Pain on Movement Questionnaire), as well as pressure pain threshold, mechanical detection threshold, and vibration detection threshold.

Chronic low back pain is a major public health burden with only limited evidence of effectiveness for complementary and traditional therapies. Gua Sha is a traditional East Asian therapy traditionally used in the treatment of spinal pain. This study aimed to test the efficacy of Gua Sha therapy in patients with chronic low back pain A total of 50 patients with chronic low back pain were randomized to either two Gua Sha treatments (n=25) or a waitlist control group (n=25). Primary outcome measure was current pain intensity on a 100-mm visual analog scale; secondary outcome measures included back-related function (Oswestry Disability Index), movement-related pain (modified Pain on Movement Questionnaire), as well as pressure pain threshold, mechanical detection threshold, and vibration detection threshold.

Eligibility Criteria:
Inclusion Criteria:

* non-specific low back pain at least once weekly for at least the previous 3 months
* average back pain intensity hat least 40mm on a 100mm visual analog scale (VAS)

Exclusion Criteria:

* specific low back pain due to trauma, disc protrusion, whiplash, congenital deformity of the spine, spinal stenosis, neoplasm, inflammatory rheumatic disease, or oncologic disease
* dystonia
* pregnancy
* invasive treatment of the spine or spinal surgery within the previous 4 weeks
* oral steroids or anticoagulants
* hemophilia or a skin condition in the area to be treated
* started a new treatment for low back pain within the previous month or planning to start a new treatment within the next month
COVID-19 Pandemic Response Network

Coronavirus Disease 19 (COVID-19) represents an unprecedented challenge to the operations and population health management efforts of health care systems around the world. The "Pandemic Research Network (PRN): Duke Community Health Watch" study leverages technology, clinical research, epidemiology, telemedicine, and population health management capabilities to understand how to safely COVID-19. The target population is individuals in the Duke Health region as well as individuals beyond the Duke Health region who have flu-like symptoms, a viral test order for COVID-19, confirmed COVID-19, or concern for exposure to COVID-19. A subgroup of particular interest within the target population is health care workers (HCW) and families of HCW. Community members will enroll in the study electronically and for 28 days will be reminded via email or SMS to submit signs and symptoms related to COVID-19. Participants who report symptoms will be provided information about COVID-19 testing (if needed) and established mechanisms to seek care within Duke Health. Instructions for telemedicine and in-person visits, which is available publicly at https://www.dukehealth.org/covid-19-update, will be presented to participants. Participants who are unable to report symptoms independently may be contacted via telephone by Population Health Management Office (PHMO) or Clinical Events Classification (CEC) team members. Data collected through the "Pandemic Response Network (PRN): Duke Community Health Watch" study will be used for three objectives.

* First, to characterize the epidemiological features of COVID-19. Specifically, we will have a high-risk subgroup of HCW and families of HCW that we enroll.
* Second, to develop models that predict deterioration and the need for inpatient care, intensive care, and mechanical ventilation.
* Third, to develop forecast models to estimate the volume of inpatient and outpatient resources needed to manage a COVID-19 population.

The primary risk to study participants is loss of protected health information. To address this concern, all data will be stored in Duke's REDCap instance and the Duke Protected Analytics Compute Environment (PACE).


Eligibility Criteria:
Inclusion Criteria:

* flu-like symptoms
* a viral test order for COVID-19
* confirmed COVID-19
* concern for exposure to COVID-19

Exclusion Criteria:

- None
Use of Novel High-protein Food Products To Reduce Insulin Resistance

This controlled weight loss trial in adults at cardiometabolic risk (elevated triglyceride/HDL ratio) followed a randomized, cross-over design and utilized novel, high-protein pasta and cereal to examine the physiological impact of stealth substitution of dietary carbohydrate with protein derived from soy concentrates, wheat protein isolates, and dried egg whites. Pasta dishes were prepared using high-protein orzo and fusilli pasta (Zone PastaRxTM) or conventional, gluten-free pasta, and high-protein flaked cereal (ZoneTM cereal) was matched with conventional flaked cereal. Participants were instructed to follow an energy restricted diet (-500 kcal/d) and incorporate a test food into each of three meals over a 24-hour period. The diet-induced changes in body mass and lean body mass were tracked as well as changes in in insulin sensitivity and common blood biomarkers.


Eligibility Criteria:
Inclusion Criteria:

* 20-75 years of age
* BMI 23-42 kg/m2

Exclusion Criteria:

* food allergies
* diet restrictions (e.g., vegetarian, gluten or lactose intolerant)
* insulin use
* cigarette use
* active disease states including diagnosed diabetes
* anticipated changes to diet or physical activity levels
* recent weight gain or loss (±10 pounds)
* current or recent pregnancy or lactation
* prescription medication use by participants was allowed if use had been consistent
SKB445 for Injection in Solid Tumors

This is a multicenter, open-label, multiple-dose dose finding and expansion study to evaluate the safety, tolerability, pharmacokinetic(PK) profile, and anti-tumor efficacy of SKB445 for injection in patients with advanced solid tumors.

This is an open-label, dose-escalation, multicenter study to evaluate the safety, tolerability, PK characteristics, immunogenicity, and preliminary anti-tumor activity of SKB445 monotherapy in patients with advanced solid tumors.

Eligibility Criteria:
Inclusion Criteria:

1. At the time of signing the ICF: age between 18 -75 years, male or female.
2. subjects with histologically or cytologically confirmed locally advanced or metastatic solid tumors who have failed/are intolerant/ineligible to or do not have standard therapy, and have at least one measurable lesion meeting Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
3. Eastern Cooperative Oncology Group (ECOG) score of 0 to 1.
4. Expected survival ≥ 3 months.
5. Subjects with adequate organ and bone marrow function confirmed by laboratory results
6. Subjects of childbearing potential (male or female) must use effective medical contraception during the study
7. Ability to understand and willingness to sign ICF, and will be able to comply with the protocol-specified visits and relevant procedures.

Exclusion Criteria:

1. Has received anti-tumor therapy, including chemotherapy, targeted therapy, tumor immunotherapy, and traditional Chinese medicinal products with anti-tumor indications, within 4 weeks prior to the first dose or within 5 half-lives of known drugs (whichever is shorter).
2. Has had major surgery within 4 weeks prior to the first dose.
3. Has known history of allergy to any component of SKB445 or SKB445.
4. Has a known previous or concurrent other malignancies within 3 years prior to first dose.
5. Presence of active central nervous system (CNS) metastases.
6. Has uncontrolled or severe cardiovascular disease.
7. Has uncontrolled systemic diseases.
8. Has human immunodeficiency virus (HIV) infection; has any active viral hepatitis.
9. Subjects with a known history of psychiatric illness or drug abuse that would preclude the subject from complying with the study.
10. Has prior autologous/allogeneic hematopoietic stem cell transplantation or solid organ transplantation.
11. Has any other conditions such as medical history, treatment and laboratory abnormalities that may confound the study results, interfere with the subject's compliance, or impair the subject's interests, as assessed by the investigator or the sponsor.
Effects of Customized Silicone Digital Orthoses in People With Diabetic Neuropathy

The present study aims to evaluate the efficacy and safety of the use of customized silicone digital orthoses for six months in the distribution of plantar pressure, in the reduction of pre-ulcerative lesions and plantar ulcers in the forefoot, foot deformities, quality of life and foot health and functionality in people with diabetes and neuropathy with risk category 2 and 3 for ulcers, according to the International Working Group on Diabetic Foot.

The present study aims to evaluate the effects and safety of the use of customized silicone digital orthoses for six months in the plantar pressure distribution during gait, in the reduction of pre-ulcerative lesions and plantar ulcers at forefoot, in functional balance, foot deformities, quality of life and foot health and functionality in people with diabetes and and diabetic neuropathy with risk category 2 and 3, according to the International Working Group on Diabetic Foot.

The sample will consist of 60 participants, who will be randomly allocated, in a randomized controlled clinical trial, in the control or intervention groups and evaluated at baseline, 3 and 6 months of follow up. The assessment includes (1) classification of the risk of foot ulceration, (2) analysis of plantar pressure during gait, (3) quality of life, (4) foot deformities, (5) pre-ulcerative lesions, (6) functionality and general health of the feet.

The hypothesis of this study is that the intervention group will present a reduction in the peak pressures during gait, a reduction in hyperkeratosis at forefoot, a reduction in the incidence and recurrence of forefoot ulcerations, and improved quality of life and in the functionality and health of the foot, when compared to the control group after six months of use of silicone digital orthoses.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed type 1 or 2 diabetes, with diabetic peripheral neuropathy confirmed by loss of sensitivity measured by 10 g Semmes-Weinstein monofilament or 128Hz tuning fork and by the fuzzy score (www.usp.br/labimph/fuzzy);
* Presence of 1 or more deformities at the forefoot region (claw toes, hammer toes, mallet toes, overlapping toes, hallux valgus, prominence of the metatarsal heads or reduction/displacement of the fat pad);
* Ability to walk independently with or without the aid of a walking device;

Exclusion Criteria:

* Presence of other diagnosed neurological diseases;
* Presence of dementia or inability to give consistent information;
* Presence of major vascular complications;
* Receiving any physiotherapy intervention;
* Major vascular complications (ischemia)
* Presence of an active ulcer at the time of baseline assessment;
* Major amputations;
* Minor amputations, except toes.
A Study to Evaluate the Effect of Nandrolone Decanoate in Women With HIV-Associated Weight Loss

The purpose of this study is to see if giving nandrolone decanoate (a hormonal drug) will cause weight gain in HIV-positive women who have HIV-associated weight loss (wasting).

Wasting has become an AIDS-defining condition. In the past, most studies that examined wasting treatments were limited to men. However, it appears that wasting in HIV-positive men is linked to levels of testosterone (a hormone which affects men's bodies more than women's). This study has been designed for women only, in order to best treat wasting in HIV-positive women.

Body wasting is an increasingly frequent AIDS-defining condition and it is becoming evident that women are not exempt from this complication of HIV. Although multicenter trials of megestrol acetate, dronabinol and growth hormone have not specifically excluded women, women have generally been underrepresented in these trials. This study hopes to generate data that will be substantial enough to perform an analysis that might determine whether there are gender-based differences in anabolic potential.

Patients will be randomized to receive either nandrolone decanoate or placebo every 2 weeks for 12 weeks of the study. All patients who complete the first 12 weeks of the study will be eligible to receive open-label nandrolone for the subsequent 12 weeks.

Eligibility Criteria:
Inclusion Criteria

You may be eligible for this study if you:

* Are an HIV-positive woman over 13 years old (need consent if under 18).
* Have lost weight over the past 12 months.
* Are able to eat almost enough to maintain your current weight.
* Agree to practice abstinence or use effective methods of birth control.
* Are on a stable anti-HIV drug regimen or have not been on any anti-HIV drug regimen for the past 30 days.

Exclusion Criteria

You will not be eligible for this study if you:

* Are allergic to nandrolone.
* Have a history of cervical cancer, diabetes, cardiomyopathy or congestive heart failure, or are taking certain medications.
* Have an active opportunistic (HIV-associated) infection or another major illness within 30 days of study entry.
* Have an abnormal PAP smear.
* Have difficulty eating (are on tube-feeding, for example).
* Have severe nausea, vomiting, or diarrhea.
* Have Kaposi's sarcoma (unless stable) or are receiving chemotherapy or radiation for any type of cancer.
* Are pregnant or breast-feeding.
A Study of ARRY-334543 and Docetaxel in Patients With Advanced Cancer

This is a Phase 1 study during which patients with advanced/metastatic solid tumors will receive investigational study drug ARRY-334543 and docetaxel (with prophylactic growth factor support). Patients will receive increasing doses of study drug in combination with docetaxel in order to achieve the highest dose of study drug possible that will not cause unacceptable side effects. Patients will be followed to see what side effects the combination causes and what effectiveness the combination has, if any, in treating the cancer. Approximately 30 patients from the US will be enrolled in this study.


Eligibility Criteria:
Key Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of any advanced/metastatic solid tumor suitable for treatment with docetaxel.
* Tumor recurred or progressed following at least one line of chemotherapy, except if no standard of care exists or if the patient refuses standard of care treatment.
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2.
* Must be able to take and retain oral medications.
* Other criteria exist.

Key Exclusion Criteria:

* Active concomitant malignancies.
* Uncontrolled or symptomatic brain metastases (if a patient has brain metastases and is on steroids, the steroid dose must be stable for at least 30 days prior to study start).
* Known positive serology for the human immunodeficiency virus (HIV), hepatitis B and/or hepatitis C.
* Requiring intravenous (IV) alimentation.
* Pregnancy or lactation.
* Chemotherapy, anticancer immunotherapy, monoclonal antibodies or biologics within 21 days prior to first dose of study drug.
* Anti-ErbB1 and/or ErbB2 targeted therapy or anticancer hormonal therapy within 14 days prior to first dose of study drug.
* History of hypersensitivity to or intolerance of docetaxel.
* Other criteria exist.