cyrilzakka/clinical-trials huggingface dataset:
A Phase 2 Study to Evaluate the Efficacy and Safety of AMG531 in Aplastic Anemia

The present study will be conducted to evaluate the efficacy and safety of AMG531 and to determine the recommended initial dose of AMG531 on the basis of its efficacy and safety when it is administered subcutaneously (SC) to the Aplastic Anemia (AA) patients with immunosuppressive-therapy refractory thrombocytopenia and also to assess the pharmacokinetics of this product. Its efficacy and safety during the extension period beyond one year will also be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Patient who is diagnosed as AA and refractory to immunosuppressive therapy
* Platelet ≤ 30,000/μL

Exclusion Criteria:

* Concurrent active infection not adequately responding to appropriate therapy
* HIV positivity
* Bone marrow reticulin grade of \> 1
* Clinically significant cardiac disease
* Arterial or venous thrombosis within the last 1 year before enrollment
* Other cause of thrombocytopenia
* AA with hemolytic predominant paroxysmal nocturnal hemoglobinuria (PNH)
* Uncontrolled diabetes
* Receiving any agent used to treat AA, including antithymocyte globulin (ATG) or ATG + cyclosporine within 6 months before starting study treatment and/or cyclosporine or anabolic hormone within 6 weeks before starting the study treatment
* History of PEG-rHuMGDF, recombinant human thrombopoietin, AMG531, and other thrombopoietin (TPO)-receptor agonist
* Who plans to conduct hematopoietic stem cell transplantation within 1 year
Sarcopenia and Short Bowel Syndrome

Sarcopenia or the loss of skeletal muscle is highly prevalent in many diseases, including short bowel syndrome (SBS). While adaptation is more likely in SBS patients with a colon-in-continuity, the consequences and underlying mechanisms are unclear. An overabundance of fecal Lactobacillus was found but not yet linked to adaptation or sarcopenia. The objectives are to study the evolution of sarcopenia and the link with intestinal adaptation in SBS.

Patients with short bowel syndrome (SBS) will be screened and included in longitudinal or cross-sectional studies if eligible.

The longitudinal study will follow patients with type 1 SBS (enterostomy) before and every 3 months after continuity surgery for 1 year. Cross-sectional studies will follow patients with type 2 or 3 SBS (jejunocolonic or -ileal anastomosis) for 1 year (every 3 months during the first 2 years after continuity surgery or every 6 months after).

Study visits will include clinical examination, nutritional assessment, endoscopy with biopsies and/or intestinal absorption assessment planned as part of routine follow-up. In addition, questionnaires will be completed (GPAQ, SarQoL, EQ-5D -3L, SF36), with collection of stool (for routine and research) and urine samples (for research).

The objective are to study the evolution of sarcopenia and the link with intestinal adaptation in SBS. The results may identify metabolic or microbial biomarkers and predictors of nutritional optimisation in SBS, which is a complex and costly orphan disease.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years old
* SBS diagnosis validated by small bowel length and either type 1 (enterostomy), type 2 or 3 (jejuno-colic or -ileal anastomosis)
* Patient not objecting to the collection of personal data as part of the study

Exclusion Criteria:

* Pregnancy

  * Remaining hail length unknown
  * Patient expressing opposition to participating in the cohort
  * Patients who are unable to express themselves
Intermittent Therapy in HIV-1 Infected Patients With Successful Viral Suppression Under Highly Active Antiretroviral Therapy (HAART)

Although lifelong continuous therapy with HAART remains the standard of care of HIV infection, allowing to achieve undetectable plasma viral RNA, restore CD4 cell count and provide substantial decline in HIV-related morbidity and mortality, long-term toxicity associated with antiretroviral therapy is a real concern. The purpose of this study is to compare an intermittent therapy strategy to a continuous treatment in patients with chronic and well controlled HIV-1 infection.

Although lifelong continuous therapy with HAART remains the standard of care of HIV infection, allowing to achieve undetectable plasma viral RNA, restore CD4 cell count and provide substantial decline in HIV-related morbidity and mortality, long-term toxicity associated with antiretroviral therapy is a real concern.

The purpose of this study is to compare an intermittent therapy (IT) strategy (8 weeks off / 8 weeks on) to a continuous treatment (CT) in patients with chronic and well controlled HIV-1 infection (CD4 over 450/µl and plasma HIV1-RNA below 200 cp/ml) under HAART, over a 96-week study period.

The study hypothesis is that intermittent therapy is not inferior to continuous therapy in maintaining a CD4 cell above 300/µl. It will compare the proportions of and time to immunological failure (CD4 count below 300/µl confirmed by a retest 14 days later) in the IT and CT groups.

Eligibility Criteria:
Inclusion Criteria:

* HIV-1 infection
* CD4 cell count over 450/µl for at least 6 months prior to screening
* Plasma HIV1-RNA below 200 cop/ml for at least 6 months prior to screening
* Stable and well tolerated ART for at least 6 months prior to screening
* Acceptable methods of contraception
* Patient able to comply with the protocol
* Informed consent signed prior to (or at) screening

Exclusion Criteria:

* CD4 nadir below 100/µl
* Abacavir or nevirapine in the current ART
* Hepatitis B with 3-TC, adefovir or tenofovir current therapy
* Current or upcoming treatment with interferon for hepatitis B or C
* History of AIDS-defining event in the 18 months prior to screening
* Pregnancy or breast feeding
Conjoined Twins: a Report of Four Cases.

The present study aims to report our experience in conjoined twin separation surgery in Assuit university and pediatric hospital, Assiut university, Assiut, Egypt over a period of 20 years.

A conjoined twin is a subset of monozygotic twin gestation. It's a rare phenomenon with an incidence of 1 in 50,000 to 1:100,000 births with the higher incidence in Africa and Southwest Asia. Based on the terminology proposed by Spencer and colleagues, conjoined twins are classified according to the most prominent site of conjunction into three major groups; First, twins with a ventral union; \[cephalopagus (head), thoracopagus (Thorax), omphalopagus (Abdomen) and ischiopagus (pelvis)\]. Second; twins with a dorsal union; \[pygopagus (sacrum), rachipagus (spine, back) and craniopagus (cranium)\] and lastly; twins with a lateral union that is referred to as parapagus (side). Depending on the aspect of the embryonic disc, the most common types are thoracopagus (19%).

Surgical separation of conjoined twins is extremely challenging taking in consideration the high perioperative risk. The low incidence of such surgeries and anatomical variations in each type of conjoined twins makes each separation surgery a unique experience.

Eligibility Criteria:
Inclusion Criteria:

* conjoined twins
* symmetrical or
* asymmetrical.

Exclusion Criteria:

* conjoined twins incompatible with life
* conjoined twins with decapitating medical illness.
Otago Exercises and Otago Exercise Effects on Elderly Population

Study aims to investigate the profound impact of exer gaming on normal aged individuals within our society. Additionally, to compare the effects of exer gaming-based exercises and Otago exercises on crucial aspects such as balance, physical performance, and gait pattern among the normal aged population. This study holds immense significance as it has the potential to greatly improve the health and wellbeing of the elderly population. By identifying an efficacious physical therapy intervention to address the complications associated with balance, physical performance, and gait pattern, we can effectively mitigate further dysfunctions in this demographic.


Eligibility Criteria:
Inclusion Criteria:

* Both genders
* Age \> 55 Years
* Berg balance scale score 21-40
* Moca \>24
* Urinary bowel continence

Exclusion Criteria:

* Having history of other neurological conditions (i.e. Dementia, Parkinson's disease)
* Having contagious or inflammatory conditions.
* Having orthopedic limitations such as fractures
* Unable to comply with the training or currently participating in another interfering therapy
* With Vision problems
* Having uncontrolled cardiac conditions such as uncontrolled hypertension
Study on the Biomarker of First-line Immunotherapy Combined With Chemotherapy in Advanced Esophageal Cancer

This study intends to explore the predictive biomarkers by Next-generation sequencing (NGS) and multiple immunohistochemistry (mIHC) for the treatment of SHR-1210 in combination with paclitaxel and platinum in advanced esophageal cancer.


Eligibility Criteria:
Inclusion Criteria:

* Unresectable locally advanced/ recurrent or distant metastatic esophageal squamous cell carcinoma confirmed by histology or cytology;
* Not received any previous systematic antitumor therapy.
* Eastern Cooperative Oncology Group (ECOG) fitness status score was 0 or 1 within 3 days before the first administration of the intervention.
* 8-10 tumor tissue samples can be provided.
* Demonstrate good organ and bone marrow function.
* Consent to participate in the contraceptive methods related to clinical research.

Exclusion Criteria:

* Have a history of allergy to monoclonal antibodies, any component of SHR-1210, albumin-paclitaxel, carboplatin, and other platinum drugs;
* Weight loss \> 20% in the past 3 months.
* Major surgery within 28 days prior to enrollment.
* Have received systemic chemotherapy or radiation therapy for esophageal cancer.
* Had a myocardial infarction within the past 6 months.
* Have any medical history or current evidence, treatment, or laboratory abnormalities that prevent the subject from participating fully in the study with the investigator's opinion.
* Prior treatment with immunotherapy drugs.
* Received live vaccine within 30 days prior to initial administration of the investigational drug.
* Have been diagnosed with immunodeficiency or are receiving immunosuppressive treatment.
* Another malignancy is known to exist.
* Have active infections that require systemic treatment.
* Pregnant or lactating, or planning to become pregnant or become a father during the study period (180 days for lactating subjects receiving carboplatin) from the beginning of the screening visit until 120 days after the last dose of the study intervention.
Subacute Thyroiditis in the SARS-CoV-2 Era

Many cases of subacute thyroiditis (SAT) have been described related to SARS-CoV-2 infection, but no prospective data about follow-up is known. This prospective, longitudinal, 3-year, multicentre study is aimed at exploring clinical peculiarities and outcome of SAT in relation to SARS-CoV-2 infection, ascertained with antibody dosage.

All patients receiving SAT diagnosis from November 2020 to May 2022 were enrolled. Multicentre study. Data about anamnesis, physical examination, blood tests (TSH, freeT4, freeT3, thyroglobulin, anti-thyroid antibodies, C-reactive protein, erythrocyte sedimentation rate, complete blood count), and thyroid ultrasound were collected. At baseline, the presence of IgG against the SARS-CoV-2 spike protein or nucleocapside was investigated. Patients were evaluated after 1, 3, 6, 12 months.

A multicentre, longitudinal, prospective study was conducted, enrolling all patients diagnosed with SAT at the participating centres between November 2020 and May 2022. The following Italian centres participated: Endocrinology Unit of Azienda Ospedaliero-Universitaria of Modena (Coordinating center); Endocrinology Unit of IRCCS Ca' Granda Ospedale Maggiore Policlinico of Milano; Endocrinology and Diabetes Prevention and Care Unit of the IRCCS Azienda Ospedaliero-Universitaria Policlinico of Bologna. These Units were involved through a call launched by the coordinating center to the young Italian members of the Club EnGioI (Endocrinologia Giovane in Italia) of the Italian Society of Endocrinology (SIE).

Five visits were planned: at diagnosis (V0) and after 1, 3, 6 and 12 months (V1, V2, V3 and V4, respectively). At each visit, subjects were evaluated with anamnesis, physical examination, thyroid ultrasound and blood tests. Patients were treated according to the clinical presentation and to the current guidelines. Nonsteroidal anti-inflammatory drugs (NSAIDs) were preferred in patients with mild symptoms and mild laboratory findings; steroid therapy was preferred in those with severe symptoms and/or those who did not respond to NSAIDs within 1 to 2 weeks. Beta-blockers were prescribed as symptomatic treatment in case of tachycardia. During the follow-up phase, the therapeutic approach and any change of it were recorded.

Finally, the treatment responsiveness and outcomes of transient hypothyroidism, permanent hypothyroidism, or recurrence during the follow-up period were all documented.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of subacute thyroiditis
* age ≥ 18 years
* willingness to sign an informed consent

Exclusion Criteria:

* ongoing pregnancy
* alcohol abuse.
Music and VR Effects on Pain, Anxiety, and Fear During Oral Mucositis Care in Leukaemic Children

Children undergoing leukaemia treatment are exposed to a wide range of chemotherapeutic agents and immunosuppressive therapies during treatment and are therefore at great risk for complications. Mucositis is one of the leading chemotherapy-related complications affecting the quality of life of the child. Although it varies according to the degree of mucositis, oral mucosal erythema, white plaques and ulcers are extremely painful and traumatising procedures for pediatric patients during mucositis care. The pain and fear they experience during the procedure may lead children to delay/not perform oral mucositis care or not allow their parents to do so. Since mucositis is a painful condition in children, it is recommended to use distracting nonpharmacological methods that can help reduce the pain and fear of children during mucositis care. In this context, the aim of this study was to determine the effects of music and virtual reality on pain, anxiety and fear during oral mucositis care in children aged 6-12 years receiving leukaemia treatment. Block randomisation (gender (F/M) and age groups (6-9/10-12) will be used to identify participants. Five minutes before the oral mucositis care procedure, all participants, regardless of group, will be assessed with the Child Anxiety Scale-Disposition (CAS-D), Child Fear Scale and Visual Analogue Scale (VAS). The study will be conducted in three groups as control group, VR group and music group. Descriptive characteristics of dependent and independent categorical variables will be given as number and percentage, numerical descriptive characteristics will be given as mean and standard deviation. In examining the relationship between dependent and independent variables, Mann Whitney-Kruskal Wallis or Student t-Anova analyses will be performed according to the result of the analysis of conformity to normal distribution. Bonferroni analysis will be used for pairwise comparisons and Covariance analysis will be used to investigate the effect of variables with children.


Eligibility Criteria:
Inclusion Criteria:

The participant child

* is between the ages of 6-12 years
* is being followed up as an inpatient in the Paediatric Haematology Clinic
* is receiving leukaemia treatment only
* has oral mucositis
* does not have a systemic infection
* willing to participate in the study
* speak Turkish and are open to communication
* has no visual and hearing problems (not using glasses or hearing aids)

Exclusion Criteria:

* Cases not fulfilling the inclusion criteria will be excluded from the study.
A Study to Assess the Safety and Efficacy of a Tacrolimus Based Immunosuppressive Regimen in Stable Kidney Transplant Recipients Converted From Cyclosporine Based Immunosuppressive Regimen

The objective of this study is to observe and evaluate the change in renal function following conversion from cyclosporine-based immunosuppressive regimen to tacrolimus-based one.


Eligibility Criteria:
Inclusion Criteria:

* Patients received a kidney transplant at least 12 months before enrollment.
* Patients whose dosage of previous immunosuppressants has not been changed and remained for at least 4 weeks before enrollment, and blood trough level of cyclosporine is 100 to 200 ng/mL.
* Patients who have the side effects (hypertension, hyperlipidemia, gingival hyperplasia and hypertrichosis/hirsutism) during use of cyclosporine.
* Serum creatinine \< 2.3 mg/dl at enrollment
* Female patients of childbearing potential must have a negative serum pregnancy test prior to enrollment, and agreed to use effective contraception during the trial.
* Patients considered clinically stable

Exclusion Criteria:

* Patients who have previously received an organ transplant other than a kidney.
* Patients who have had acute transplant rejection within 12 weeks, or acute transplant rejection requiring antilymphocyte therapy within 24 weeks prior to enrollment.
* Patients newly diagnosed malignant tumors after organ transplant, but the patients treated completely with basal or squamous cell carcinoma of the skin are excepted.
* Patients who have an underlying disease such as focal segmental glomerulosclerosis (FSGS) or type II membranoproliferative glomerulonephritis (Type II MPGN).
* Proteinuria \> 2 g/24 hrs.
* Patients who have "Creeping creatinine" (a 20% increase in their creatinine for six months before their enrollment).
* Patients whose Alanine Aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) is twice higher than the normal range in the center.
* Patients who have liver cirrhosis.
* Patients who are pregnant or breastfeeding.
* Patients who had been HIV-positive.
* Patients who have a known allergy to Prograf® or its ingredients, steroids or adjuvants.
* Patients who have an unstable medical condition that may affect the evaluation of the study's objectives.
* Patients who are receiving prohibited concomitant medications or who received those medications within 28 days of their enrollment.
* Patients who are currently participating in another clinical trial or who received the investigational drug in another trial within 28 days of their enrollment.
* Patients who are at the risk of drug abuse or mental disorders or communicate difficulties.
Phoenix Exoskeleton for SCI Users

This study will evaluate the Phoenix device for safety and effectiveness at allowing persons with SCI who are non-ambulatory or poorly ambulatory to stand up and walk under a variety of conditions.


Eligibility Criteria:
Inclusion Criteria:

1. 18 Years of age or older in general good health
2. Weigh no more than 220lbs
3. Skin must be healthy where it touches the Phoenix
4. Able to stand using a device such as a standing frame
5. Have enough strength in your hands and shoulders to support yourself standing and walking using crutches or a walker
6. Have good control of upper body
7. Determined to have enough bone health to walk full weight bearing without risk of fracture. Meeting of this condition is at the discretion of your personal MD
8. Passive range of motion (PROM) at shoulders, trunk, upper extremities and lower extremities within functional limits for safe gait and use of appropriate assistive device/stability aid
9. Hip width no greater than 18" (46 cm) measured when sitting.
10. Femur length between 12.3 inches (31.3 cm) and 19.8 inches (50.2 cm) measured between centers of hip and knee joints.
11. Tibia length between 13.4 inches (33.9 cm) and 22 (55.9 cm) inches measured between the knee joint and bottom of the foot.
12. In general good health and able to tolerate moderate levels of activity.
13. Blood pressure and heart rate within established guidelines for locomotive training:

At rest; Systolic 150 or less Diastolic 90 or less and Heart rate 100 or less Exercise; Systolic 180 or less Diastolic 105 or less and Heart Rate 145 or less

Exclusion Criteria:

* 1. Pregnant or lactating females 2. Spinal cord injury level higher than T4 3. Severe muscle stiffness/tightness 4. Significant spasticity (Modified Ashworth Scale score of 3 or above) 5. Trunk or lower extremity pressure ulcer 6. Open Wounds 7. Unstable spine, un-healed limbs, or fractures 8. Severe sensitivity to touch 9. Presence of bone in soft tissue where bone normally does not exist (heterotopic ossification), limiting range of motion in the hip or knee joints 10. Joint instability, dislocation, moderate to severe hip dysplasia 11. Significant scoliosis (\>40 degrees) 12. Hardware, implant, or any external device impeding with safe fitting or use of Phoenix 13. Femoral or tibial rotation deformity (\>15 degrees) 14. Significant flexion contractures limited to 35º at the hip and 20º at the knee 15. Uncontrolled seizures, musculoskeletal injury, fracture or lower-limb surgery in past year.

  16. Known history of pulmonary disease limiting exercise tolerance or history of cardiac disease 17. Psychopathology, or other condition that the physician or investigator, in his or her clinical judgment, considers to be exclusionary to safely use an exoskeleton.

  18. Severe concurrent medical diseases, illness, systemic or peripheral infection 19. Dizziness or headache with standing 20. History of autonomic dysreflexia 21. Orthostatic Hypotension: Decrease in Systolic BP \> 20, Diastolic BP \> 10 upon standing from a seated position.
Study of Acetaminophen (ACM) in Post-operative Dental Pain

This is a Dental Pain Study which will evaluate the analgesic onset, efficacy and safety of 1000 mg acetaminophen as two Test acetaminophen 500 mg tablets, compared with commercial products of acetaminophen 1000 mg administered as two 500 mg caplets, and ibuprofen (IBU) 400 mg following third molar (wisdom tooth) extraction.

This is a single-dose, randomized, double-blind, triple-dummy, placebo- and active controlled, parallel-group study to evaluate the analgesic onset, efficacy, and safety profile of Test acetaminophen 1000 mg compared with two commercial products over a six-hour period after third-molar extractions. Subjects will undergo dental extraction of three or four third molars.

Eligibility Criteria:
Inclusion Criteria:

1. 17 years to 50 years old
2. Weight 100 lbs or greater with a body mass index (BMI) 18-30 inclusive
3. Dental extraction of three or four molars
4. Experience moderate to severe pain after extraction of third molars
5. Females of childbearing age must be willing to use acceptable method of birth control

Exclusion Criteria:

1. Currently pregnant or planning to be pregnant or nursing a baby
2. Known allergy to acetaminophen (ACM) or non-steroidal anti-inflammatory drugs (NSAIDS)
3. Inability to swallow whole large tablets or capsules
4. Have other conditions that the investigator feels may impact subject's safety and/or the integrity of the study