cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Impact of Stopping Treatment for the Prevention of Pneumonia in HIV-Positive Patients Receiving Anti-HIV Drugs Who Have Increased CD4 Cell Counts

The purpose of this study is to see how often Pneumocystis carinii pneumonia (PCP) occurs in HIV-positive patients who have stopped taking medications that help prevent PCP.

The risk of developing PCP may be decreased when an HIV-positive patient's CD4 cell counts (cells of the immune system which fight infection) are more than 200 cells/mm3. This study looks at whether it is acceptable to stop PCP prevention treatment in these patients.

The risk of developing PCP may be decreased with treatment-induced recovery of CD4 counts to \> 200 cells/mm3. Few data exist to confirm or negate the continued necessity of PCP prophylaxis for such patients. This study will assess the effects of discontinuing therapy.

Subjects are asked to discontinue PCP prophylaxis if antiretroviral therapy has resulted in a sustained CD4 increase greater than 200 cells/mm3 on two measurements at least 12 weeks apart. They will be evaluated for symptoms and CD4 counts every 8 weeks as well as plasma for HIV-RNA every 16 weeks for 18 months. Subjects whose CD4 count falls to less than 150 cells/mm3 or between 150 and 200 cells/mm3 will have the CD4 count re-evaluated immediately or within 4 weeks. If the second CD4 count is less than 200 cells/mm3 for either case, conventional PCP prophylaxis will be resumed and the subject will be followed on study. Subjects will be followed during study by physical exams and laboratory tests at Weeks 4, 8, and every 8 weeks thereafter.

Eligibility Criteria:
Inclusion Criteria

You may be eligible for this study if you:

* Are HIV-positive.
* Have had 1 CD4 cell count of less than 100 cells/mm3 and have never had PCP, or have had at least 2 CD4 cell counts over 200 cells/mm3 and have had PCP within 6 months prior to study entry.
* Have received PCP prevention medication within 3 months of study entry.
* Are at least 13 years old (need consent if under 18).
* Are taking anti-HIV (antiretroviral) medication at study entry.

Exclusion Criteria

You will not be eligible for this study if you:

* Have active PCP or symptoms of PCP within 2 weeks of study entry.
* Have a fever lasting more than 2 weeks.
* Have oral candidiasis (thrush).
Effectiveness of Bowen Technique vs Muscle Energy Technique in Neck Pain.

Mechanical neck pain, also known as non-specific neck pain, is a prevalent ailment that results from problems with spine and surrounding tissue function. Trauma, degenerative changes, strained muscles, and bad posture are among the causes. The range of symptoms includes headaches, stiffness, and mild to severe pain. The goal of treatment is to strengthen the muscles and improve posture. The diagnosis is clinical. The Bowen Technique is a type of gentle bodywork therapy that promotes relaxation and overall rebalancing by using specific movements to activate the autonomic nerve system. It is sought for the improvement of general well-being, pain alleviation, and stress reduction. Patients undergoing manual treatment will be asked to actively contract their muscles against regulated resistance using the Muscle Energy Technique (MET). It addresses problems including joint limitations and attempts to return muscles and joints to their normal functions.

The research, will last for ten months at the Limit Institute of Health Sciences in Sahiwal, is a randomized controlled trial. With 10 participants in each group using a non-probability convenient sampling procedure, the sample size includes 10% attrition. Computer users between the ages of 18 and 35 who work five to seven hours a day meet the inclusion criteria, but recent musculoskeletal injuries and a history of head or spine trauma are the exclusion criteria. One instrument used to collect data is the Neck Disability Index (NDI). There are two established study groups: Group B will receive Muscle Energy Technique (MET) and traditional physiotherapy, while Group A will receive Bowen therapy and conventional physiotherapy. Blinding will be used, and the study will adhere to a recruitment, enrollment, and randomization procedure. SPSS version 23 will be used to analyze the data, and descriptive statistics, change over temporal analysis as well as tests of group comparison. The purpose of the study is to evaluate how the interventions affect people who use computers for extended periods in terms of their functional results and mechanical neck discomfort.

Eligibility Criteria:
Inclusion Criteria:

* Computer users who work 5-7 hours daily.
* Age between 18 to 35 will be included.
* Both genders

Exclusion Criteria:

* Any recent musculoskeletal injury of upper limb or spine.
* History of any trauma of spine or head
Early Access Program of the Safety of Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Active Rheumatoid Arthritis

Multicenter Early Access Program of the Safety of Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects with Active Rheumatoid Arthritis


Eligibility Criteria:
Inclusion Criteria:

* Eighteen years or older
* Females - post-menopausal for at least 1 year, surgically sterile or practicing an acceptable method of birth control
* Females - negative pregnancy test at screening
* Confirmed diagnosis of active RA \>= 6 swollen joints and \>= 9 tender joints
* Met ACR criteria for diagnosis of RA for at least 3 months
* Active RA defined by a DAS \>= 3.2 at study entry

Exclusion Criteria:

* Subject had prior treatment with cyclophosphamide or chlorambucil
* Subjects previously treated with total lymphoid irradiation or anti-CD4 or CAMPATH 1H monoclonal antibodies resulting in CD4 lymphopenia
* Prior treatment with intravenous immunoglobulin or investigational agent in with 30 days or 5 half-lives of adalimumab
* Subject with history of cancer within the past 10 years other than resected basal cell or squamous cell carcinoma of the skin
A Dose Finding Study Followed by a Safety and Efficacy Study for Patients With Multiple Myeloma or Lymphoma

The Phase 1 portion of this study will determine the safety of TAS4464 and the most appropriate dose for patients with Multiple Myeloma or Lymphoma.

The trial was put on Clinical Hold prior to Phase 2 due to cases of drug induced liver injury meeting the criteria for Hy's Law.

Background and Rationale:

• TAS4464 is an investigational NEDD8 activating enzyme (NAE) inhibitor, a compound which may affect cancer cell growth and survival. Thus, TAS4464 may help in the treatment of cancer.

Phase 1:

Primary:

* To investigate the safety and tolerability of TAS4464
* To identify a tolerated dose of TAS4464

Secondary:

* To investigate the preliminary efficacy of TAS4464
* To investigate the pharmacokinetics (PK) and the pharmacogenomics (PGx) of TAS4464
* To investigate the pharmacodynamics of TAS4464

Eligibility Criteria:
Inclusion Criteria:

1. Provide written informed consent
2. Women of child-bearing potential must have a negative pregnancy test

Multiple Myeloma:

Confirmed diagnosis of Multiple Myeloma with measurable disease, having been treated with at least two prior lines of therapy.

Lymphoma:

Confirmed diagnosis of Non-Hodgkin Lymphoma with measurable disease, having been treated with at least one anthracycline-based therapy, with relapse or progression since the last treatment received.

Exclusion Criteria:

1. Any of the following treatments, within the specified time frame, prior to the first dose of TAS4464:

   1. Major surgery within 28 days
   2. Radiation/chemotherapy within 21 days
   3. Monoclonal antibodies within 28 days
   4. Corticosteroid administration \>20 mg/day of prednisone or equivalent within 14 days
   5. Proteasome inhibitors within 14 days
   6. Immunomodulatory agents within 7 days
   7. Stem cell transplant within 3 months
   8. Current immunosuppressive treatment for graft versus host disease
   9. Current use of an investigational agent
2. Active graft versus host disease
3. Known serious illness or medical condition
4. Prior treatment with TAS4464 or known hypersensitivity to any of its inactive ingredients or drugs similar in class
5. Pregnant or breast-feeding female
The Utility of Next-generation Sequencing for the Diagnosis of Periprosthetic Joint Infection

This is a prospective multicenter study. All patients presenting for revision hip or knee arthroplasty for all indications under the respective surgeon's care may be eligible. Per standard of care preoperatively, all patients must have blood drawn for erythrocyte sedimentation rate(ESR), C-reactive protein(CRP) and D-dimer. Aspiration of the joint in question may be performed at the discretion of the treating surgeon and results documented. Intraoperative samples will also be collected and sent for NGS analysis

Pre-operative D-dimer testing should be performed if this is in keeping with the local institutional standard of care. Otherwise, D-dimer testing will be omitted from the pre-operative panel of tests collected.

NGS results will be made available to the Investigator. Treatment will remain within keeping with the Investigator's standard of care. NGS results may be used at the discretion of the treating surgeon in guiding patient treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Patients undergoing primary total hip or knee arthroplasty with no history of prior surgery
2. Patients undergoing revision hip or knee arthroplasty for septic or aseptic indication.

Exclusion Criteria:

1. Patients undergoing second stage re-implantation surgery for PJI.
Study of Arginine and Nitric Oxide in Patients With Diabetes

This study will test the effect of citrulline versus placebo supplementation in ketosis-prone diabetes (KPD) patients on arginine and nitric oxide production and on glucose- and arginine-stimulated insulin secretion and arterial flow-mediated dilation.

Both arginine and its derivative nitric oxide (NO) have been implicated in the regulation of glucose homeostasis. Arginine is a β cell secretagogue, potentiating glucose stimulated insulin secretion. Further, it has been shown that glucose can stimulate NO production in primary β cells, and NO then enhances insulin secretion.

On the other hand, because the only known fate of citrulline is its conversion to arginine, citrulline supplementation could be a more efficient and safe way to increase intracellular arginine. Compared to enteral arginine, citrulline administration to healthy humans elicited a greater increase in plasma arginine and NO products, suggesting a greater increase in cellular arginine availability for NO synthesis. Therefore dietary citrulline supplementation will result in greater arginine availability and NO synthesis than arginine supplementation per se in KPD patients. In addition, because the consequences of diminished NO production in usual type 2 diabetes includes vascular dysfunction, an overall increase in NO production in response to citrulline supplementation will result in an improvement in vascular function assessed by arterial flow-mediated dilation

Eligibility Criteria:
Inclusion Criteria:

* New onset (defined as receiving a diagnosis within the past 1 year) diagnosis of unprovoked" A-β+ ketosis-prone diabetes
* Aged 20-65 years
* In good health except for diabetes without clinical evidence of micro- or macrovascular complications by history, physical exam and blood chemistries

Exclusion Criteria:

* Chronic or acute illness
* History of myocardial infarction or coronary artery disease or stroke,
* Renal insufficiency (eGFR \<90mL/min/1.73m2; \<30 mg albumin / g creatinine in urine)
* Abnormal liver, thyroid, gonadal or adrenal functions
* On medications other than metformin,
* On any hormonal replacement therapy
* Pregnancy
Vasculogenic Mimicry in Urothelial Carcinoma

In this study, the investigators aim at:

1. Evaluate the presence of vasculogenic mimicry in urothelial carcinomas by CD31-PAS double staining.
2. Correlate the presence of vasculogenic mimicry with the clinicopathologic features as age, sex, TNM stage, pathological grade, recurrence, carcinoma in situ, lymphovascular emboli, lymph node metastasis, necrosis, surgical margin, multifocality and tumor size in urothelial carcinoma.

Bladder cancer is the ninth most common cancer worldwide which seriously affects human health. In Egypt, it is the third common malignant tumor.

Urothelial carcinoma (UC) is considered the most common histologic type of bladder cancer.

It is well recognized that the biological behavior of several cancers is closely related to their blood supply. Tumor progression and metastasis have been long associated with tumor angiogenesis. However, several studies demonstrated that vascular targeting drugs which induce endothelial cell apoptosis have a little effect. So, it has been suggested that novel tumor microcirculation patterns may exist in these neoplasms.

Vasculogenic mimicry (VM), is a novel tumor microcirculation system. Maniotis et al initially discovered VM in melanoma and defined these channels to be composed of tumor basement membrane lined externally by tumor cells, lacking blood vessel endothelium and containing plasma and red blood cells. So VM can be distinguished using immunohistochemical (IHC) staining and histochemical double staining. VM is CD31- or CD34-negative (endothelial markers) and periodic acid-Schiff (PAS) positive.

Vasculogenic mimicry was detected in several malignant tumors. Several studies reported that VM can promote tumor progression and metastasis and it is positively associated with pathological grade, stage, recurrence and drug resistance. Previous studies which evaluate, the role of VM in urothelial carcinoma yield controversial results. So, the value of VM in urothelial carcinomas and its relation to the clinicopathologic parameters remains to be elucidated.

Eligibility Criteria:
Inclusion Criteria:

* - Specimens of urothelial carcinoma.

Exclusion Criteria:

* - Any criteria that not fulfill the inclusion criteria such as resected urinary bladder tumors other than urothelial carcinoma.
f Adding Ketamine to Propofol For Drug-induced Sleep Endoscopy in Adult Patients With Obstructive Sleep Apnea

The investigator compared the sedative effects of propofol alone and ketamine added to propofol in drug induced sleep endoscopy

Propofol and ketamineare commonly used intravenous anesthetic drug used for procedural sedation.

The investigator compared the effect of propofol and propofol ketamine in patients undergoing drug induced sleep endoscopy.

Eligibility Criteria:
Inclusion Criteria

* Age \> 18 years old.
* American society of anesthesiologists (ASA) physical status I or II. I / II

Exclusion Criteria:

* patient refusal
* American society of anesthesiologists (ASA) physical status \> III
* known or suspected allergy to the studied drugs or its components, allergy to eggs or soy beans
* morbid obesity
* patients with moderate to severe chronic obstructive pulmonary disease or uncontrolled asthma, congestive e heart failure ,seizures ,or cerebrovascular disease
* pregnancy
Phosphate Binder-combination Study of KHK7791 in Hyperphosphatemia Patients on Hemodialysis

To evaluate the efficacy of KHK7791 in combination with phosphate binders by comparing changes in serum phosphorus levels between hemodialysis patients with hyperphosphatemia receiving repeated administration of KHK7791 30 mg in combination with phosphate binders for 6 weeks and those receiving placebo in combination with phosphate binders.


Eligibility Criteria:
Inclusion Criteria:

1. Has voluntarily provided written informed consent to participate in the study.
2. Aged ≥ 20 years (expressed in completed years) at the time of providing informed consent.
3. Stable chronic renal failure patients who have undergone hemodialysis 3 times per week for at least 12 weeks until screening examination.
4. Dialysis conditions, excluding dry weight, should have been unchanged during the last 2 weeks before screening examination.
5. The prescribed drug and dosage regimen should have been unchanged during the last 4 weeks before screening examination.
6. Serum phosphorus levels should be in the range of ≥ 3.5 and ≤ 6.0 mg/dL at screening examination.
7. If on any vitamin D, calcimimetics regimen, bisphosphonate,calcitonin preparations, selective estrogen receptor modulators or teriparatide preparations then the prescribed drug and dosage regimen should have been unchanged for the last 4 weeks before screening examination.
8. Kt/V urea ≥ 1.2 at the most recent test in routine medical practice before screening examination.

Exclusion Criteria:

1. Peritoneal dialysis was performed within 12 weeks before screening examination.
2. iPTH \>600 pg/mL (should be based on the most recent value from the patients' medical records, etc. before pre-enrollment)
3. Having concurrent or a history of inflammatory bowel disease (IBD) or diarrhea-predominant irritable bowel syndrome
4. History of gastrectomy or enterectomy or having undergone gastrointestinal tract surgery within 3 months before screening examination.
5. Subjects who used anti RANKL preparations within 6 weeks before screening examination.
6. Subjects who used anti-sclerostin antibody preparations within 12 weeks before screening examination.
7. Having concurrent severe heart disease or hepatic impairment.
8. Developed cerebrovascular disease requiring hospitalization within 6 months before screening examination.
9. Uncontrollable hypertension or diabetes.
10. Scheduled for living donor kidney transplant, change in the mode of dialysis, home hemodialysis, or change in the dialysis center (relocate to another hospital/clinic) during the study period.
11. Any diagnosis of and treatment of malignancy within 5 years before screening examination (excluding basal cell carcinoma or surgically resected intraepithelial carcinoma of uterine cervix).
Communication Tool Evaluation on Intensive Care Patients.

The present study evaluate the impact of a communication tool "PICT'REA" on patients in reanimation units, equipped with ventilation systems, preventing them from speaking.

The app consists of simple pictograms allowing simple communication between patients and the reanimation care team.

The study will assess the quality of communication before and after the introduction of the communication tool in the reanimation unit.

Invasive mechanical ventilation is commonly used in intensive care, in sedated patients but also in perfectly conscious patients, and this on a daily basis.

For these patients, the resulting deprivation of oral expression is a major source of stress and discomfort. On the side of the caregivers, the difficulty of comprehension is a source of frustration on a daily basis.

Thus PICT'REA has been developped in order to help patients and caregivers to better understand each other during invasive ventilation.

PICT'REA is a tool in the form of a mobile app with simple pictograms allowing simple communication (Yes/No/Pain chart...).

The study will analyze the quality of communication between patients and caregivers before and after the introduction of the application:

* Before setting up the tool: control group

  * Over a period of 6 months
  * In the multi-purpose resuscitations of Cardio Vascular Surgery and Neurosurgery.
* After setting up the tool:

  * Over a period of 6 months
  * In the same departments.

The analyses consists of various questionnaires :

* the modified Ease of Communication Scale,
* a Short questionnaire in 3 questions for caregivers,
* IPREA questionnaire for patients,
* Evaluation of the usability of the system by System Usability Scale questionnaire,
* Evaluation of the attractiveness of the system by Attrackdiff questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized in intensive care or intensive care
* ventilated on a tracheostomy or an orotracheal intubation tube for\> 24 hours
* not too agitated or too sedated (RASS -1 to +2) for\> 24 hours
* Confusion Assessment Method (CAM) ICU negative
* Speak or read French

Exclusion Criteria:

Inability to use the device:

* Blind or visually impaired
* Severe paresis of the upper limbs
* No understanding of the tool.
Androgen Deprivation Therapy, External Beam Radiotherapy and Stereotactic Radiosurgery Boost for Prostate Cancer

For the treatment for intermediate- and high-risk prostate cancer, Cyberknife boost will be used after 4 weeks of intensity modulated radiotherapy to pelvis. The boost doses are 18 Gy and 21 Gy in 3 fractions, respectively. The investigators plan to evaluate the toxicity of two dose groups and decide the appropriate dose for Cyberknife boost. Also, PSA control will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed intermediate- or high-risk prostate cancer within 6 months after enrollment
* ECOG performance status 0-1
* Appropriate values of blood tests within 6 months after enrollment Absolute neutrophil count (ANC) ≥ 1500 cells/mm3 Platelets ≥ 50,000 cells/mm3 Hemoglobin ≥ 8.0 g/dl
* Appropriate values of kidney function within 6 months after enrollment Creatinine \< 2.0 ng/dL
* Appropriate values of liver function within 6 months after enrollment total bilirubin \< 1.5 X maximum normal value alanine aminotransferase or aspartate aminotransferase \< 2.5 X maximum normal value

Exclusion Criteria:

* Presence of distant metastasis
* Presence of pelvic LN metastasis
* History of androgen deprivation therapy within 6 months after enrollment
* History of definitive treatment for prostate cancer (e.g., radical prostatectomy)
* History of pelvic irradiation
* Double primary cancer other than skin/thyroid cancer