cyrilzakka/clinical-trials huggingface dataset:
Safety Study of Gene Modified Donor T Cell Infusion After Stem Cell Transplant for Non-Malignant Diseases

The purpose of this study is to determine a safe dose of BPX-501 gene modified T cells infused after a haplo-identical stem cell transplant to facilitate engraftment and the safety of Rimiducid (AP1903) on day 7 to prevent GVHD.

This is a single arm dose finding study evaluating the safety and efficacy of a BPX 501 infusion (T cells genetically modified with the inducible Caspase 9 suicide gene) of 3x10E6 to 1X10E7 cells/kg followed by a Rimiducid infusion on day 7 after a partially mismatched, related, T cell-depleted hematopoietic cell transplantation (HCT) in patients with non-malignant diseases. The purpose of this clinical trial is to determine the dose of BPX 501 T cell infusion with subsequent planned infusion of Rimiducid which can facilitate engraftment and prevent the occurrence of GVHD.

Eligibility Criteria:
Inclusion Criteria:

1. Patient must meet eligibility criteria for allogeneic transplantation
2. Lack of suitable conventional donor (10/10 allele matched related or unrelated donor) or presence of rapidly progressive disease not permitting time to identify an unrelated donor
3. Males or females
4. Age \< 55 years old and \> 4 months
5. Diagnosis of a nonmalignant disorder considered treatable by HCT.
6. HLA typing will be performed at high resolution (allele level) for the HLA-A, -B, Cw, DRBl, and DQB1 loci.

   i. A minimum match of 5/10 is required. ii. The donor and recipient must be identical, as determined by high resolution typing, in at least one allele of each of the following
7. If capable of reproduction, patient must agree to use contraception or abstinence to prevent pregnancy during the first year of enrollment and treatment.
8. Informed consent signed by patient (if ≥18 years old) or parent/guardian (if \<18 years old).
9. Fanconi anemia patients ONLY i) Patients must meet one of the following criteria to be eligible for this study:

   1. Any patient with Fanconi anemia and bone marrow failure involving 2 of the following 3 lineages: granulocyte count \<0.5 x 109/L, platelet count \<20 x 109/L, or hemoglobin \<8 g/dL.
   2. Any patient with Fanconi anemia who requires red blood cell or platelet transfusions because of marrow failure
   3. Any patient with Fanconi anemia who has a life-threatening bone marrow failure involving a single hematopoietic lineage.

Exclusion Criteria:

1. Serious organ dysfunction
2. Pregnant or breast-feeding
3. Evidence of HIV infection
4. Bovine product allergy
5. Patients with an active infectious disease
6. Patients with Fanconi anemia with AML/MDS.
Direct Anterior Approach Versus Direct Lateral Approach in Total Hip Arthroplasty

The purpose of this study is to compare the direct anterior approach and the direct lateral approach in primary total hip arthroplasty, regarding the postoperative function and pain, complications, radiological finds (X-ray), postoperative hemorrhage, markers for muscle damage (i.e creatine kinase (CK), lactate dehydrogenase(LDH/LD) , aspartate aminotransferase(AST), C-reactive protein (CRP),Troponin and Myoglobin) or other clinical outcomes.

This is a prospective randomised controlled clinical trial and follow-up study comparing primary total hip arthroplasty performed either through a direct anterior approach or a lateral approach. At our hospital(i.e. Emergency County Hospital Cluj-Napoca), the lateral transgluteal approach was standard for more than 40 years. Starting 2008,the minimally invasive anterior approach was gradually implemented with the aim to facilitate early rehabilitation and improve functional results. Reduced blood loss, earlier functional recovery, low dislocation rates and shorter stays in hospital have been attributed to the muscle-sparing properties of the anterior approach.

Eligibility Criteria:
Inclusion Criteria:

* Clinical and radiological diagnosis of coxarthrosis
* Those deemed capable of giving informed consent, understanding the aims of the study and expressing willingness to comply with the post-operative review programme.

Exclusion Criteria:

* Previous surgery on affected hip
* The patient has inflammatory arthritis.
* The patient has any type of infection.
* The subject has a known metal allergy.
* Patients with co-existent ipsilateral knee disease or back problems
* Those with a known co-existent medical condition where death is anticipated within five years due to the pre-existing medical condition.
* Patients requiring bilateral hip replacement.
* Patient with active major psychiatric illness
* Patients whose body mass index (BMI; kg/m2) \>35.
* Patients with active or suspected infection or sepsis.
* Patients with renal failure and/or renal insufficiency.
Low-dose Pentavalent Antimony Treatment of Cutaneous Leishmaniasis in Old Age Patients

This study was designed to evaluate the effect of low doses of pentavalent antimony (meglumine antimoniate) to treat cutaneous leishmaniasis ulcers in patients older than 65 years. The hypothesis is that older patients may have a positive response with a lower dose of pentavalent antimony, avoiding the frequent adverse events observed with the standard dose. The design is that of an open uncontrolled trial enrolling 20 patients infected with the parasite Leishmania braziliensis in an endemic area of the State of Bahia, Brazil. The endpoint of cure or therapeutic failure will be evaluated at the third month of follow-up after treatment to avoid the impact of spontaneous cure as a confounding factor.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 65 years
* Permanent residence in the endemic area
* Availability of a caregiver for dependent patients

Exclusion Criteria:

* Mucosal disease caused by leishmaniasis
* Disseminated cutaneous disease
* Severe cardiac, renal or hepatic disorders
* Active cancer
* Active tuberculosis
* Leprosy
* HIV positive
* Total bilirubin \> 1.5mg/dL
* Urea and creatinin \> 1.5 times the upper normal level
* Alkaline phosphatase and aminotransferases \> 2.5 times the upper normal level
* Lipase and amylase \> 1.5 the upper normal level
* Hemoglobin \< 5 g/dL of
ACP-204 in Adults With Alzheimer's Disease Psychosis Open Label Extension Study

This 52-week, open-label extension study is to evaluate the long-term safety and tolerability of ACP-204 in subjects with ADP.


Eligibility Criteria:
Inclusion Criteria:

* Subject has successfully completed ACP-204-006 study
* Male or female (age 55 to 95 years old): female must be of non-childbearing potential, male must take appropriate contraceptive method if partner has childbearing potential
* Subject has a designated study partner/caregiver
* Subjects are able to complete all study visits with a study partner/caregiver
* Signed inform consent form with a caregiver or legal representative

Exclusion Criteria:

* Requires treatment with a medication prohibited by the protocol
* Is in hospice and receiving end-of-life palliative care, or has become bedridden
* Female who is pregnant or breastfeeding
* Unstable clinically significant medical condition other than AD
* Any medical condition that in the opinion of the investigator may affect safety or ability to complete the study

Additional inclusion/exclusion criteria apply. Subjects will be evaluated at screening to ensure that all criteria for study participation are met.
Remdesivir- Ivermectin Combination Therapy in Severe Covid-19

Recent study reported in vitro synergistic interaction between two FDA approved drugs, remdesivir (RDV) and ivermectin (IVM) resulting in enhanced antiviral activity against SARS-CoV-2, the causative pathogen of COVID-19. The aim of the current study is comparing the efficacy and safety of combining remdesivir and ivermectin versus using remdesivir alone in patients with severe COVID-19.


Eligibility Criteria:
Inclusion Criteria:

* Adult, hospitalized severe COVID-19 patients; both genders; given informed consent (COVID-19 infection confirmed by PCR, severe illness is defined as patients with SpO2 ≤94% on room air, including patients on supplemental oxygen).

Exclusion Criteria:

* patients under 18 years old, pregnant ladies, advanced renal diseases (cr. Clearance \< 30 ml/hr), raised liver enzymes\> 3 folds of normal, arrhythmia.
Tapentadol Versus Tramadol Analgesia Post Cardiac Surgery

The aim of this randomized one-blinded study will be to evaluate the efficacy and tolerability of two different oral doses of tapentadol and compare it to tramadol (an opioid commonly used to treat post-surgical pain) in cardiac surgery patients

Management of post-surgical pain is a daily challenge for every anaesthetist. Undertreated post-surgical pain can result in cardiovascular, pulmonary and gastrointestinal complications, as well as chronic pain and negative psychological effects. A negative impact may be seen on immune function, coagulation and wound healing. Opioids have been the cornerstone in the treatment of pain after cardiac surgery. However, opioids have a number of adverse effects such as respiratory depression, gastrointestinal alterations, dizziness, delirium, addiction.

Tapentadol is a new synthetic opioid with dual mechanism of action. It acts as a mu-receptor agonist, as well as norepinephrine reuptake inhibitor. It is used to treat moderate to severe pain and is associated with fewer adverse effects compared to other opioids.

The aim of this randomized one-blinded study will be to evaluate the efficacy and tolerability of two different oral doses of tapentadol and compare it to tramadol (an opioid commonly used to treat post-surgical pain).

Patients undergoing cardiac surgery and being discharged from ICU to ward within 30 hours of surgery, will be divided into 3 groups. Group A will receive tapentadol 50mg p.o 3 times daily for two days, group B will receive tapentadol 75 mg p.o 3 times daily for two days and group C will receive tramadol 100 mg p.o 3 times daily for two days. Pain level will be assessed with Numeric Rating Scale (NRS), before drug administration and two hours after drug administration. Overall patient satisfaction will be assessed with Likert scale. Brief Pain Inventory( short form) and DN4 questionnaire will be used to detect chronic pain and neuropathic pain respectively, 3 and 6 months after surgery.

Eligibility Criteria:
Inclusion Criteria:

* age \<75 years old
* patients discharged from Intensive Care Unit (ICU) in less than 30 hours
* elective cardiac surgery

Exclusion Criteria:

* hepatic failure (increased transaminase levels
* renal failure (creatinine\> 2 mg/dL)
* ileus
* emergency surgery (hemorrhage, tamponade, aortic dissection)
* readmission in ICU
* treatment with monoaminoxidase inhibitors, selective serotonine reuptake inhibitors or antiepileptics
* age\>75 years old
* communication or language barriers
* Lack of informed consent
CMV Retinitis Retreatment Trial

To assess the safety and efficacy of three therapeutic regimens (foscarnet, ganciclovir, or the combination) for recurrent or persistent AIDS-related cytomegalovirus (CMV) retinitis.

Although therapy with foscarnet or ganciclovir halts retinitis progression in 90 percent of patients treated, relapses are common and may accelerate due to development of drug resistance, deteriorating immune function, or other factors. Treatment strategies currently being investigated include switching patients from one drug to the other or combining the two drugs.

Although therapy with foscarnet or ganciclovir halts retinitis progression in 90 percent of patients treated, relapses are common and may accelerate due to development of drug resistance, deteriorating immune function, or other factors. Treatment strategies currently being investigated include switching patients from one drug to the other or combining the two drugs.

Patients are randomized to receive foscarnet, ganciclovir, or a combination of the two drugs (administered sequentially). Initially, patients undergo single or multiple cycles of induction therapy for 14 days followed by maintenance therapy. Patients in whom the retinitis continues to progress or who are intolerant of the initial treatment switch to the alternative drug for further cycles of induction and maintenance. Patients on the combination arm in whom retinitis continues to progress are given further cycles of the combination at an increased dose, or, if one drug is causing toxicity, are given further cycles with the alternative drug. Patients are followed monthly for 6 months and then every 3 months thereafter.

Eligibility Criteria:
Inclusion Criteria

Required:

* At least 28 days of prior foscarnet or ganciclovir.

Concurrent Medication:

Allowed:

* G-CSF.

Recommended:

* Antiretroviral therapy.

Patients must have:

* HIV infection or AIDS.
* Active CMV retinitis after 28 or more days of either foscarnet or ganciclovir therapy.
* At least one lesion with one-quarter disk area or more that can be photographed.
* Visual acuity of 3 or more letters on ETDRS chart (5/200 Snellen) in an affected eye.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

* Media opacity severe enough to preclude visualization of both fundi.
* Retinal detachment not scheduled for surgical repair.

Patients with the following prior conditions are excluded:

* History of intolerance to ganciclovir or foscarnet sufficient to contraindicate use.
* History of combination foscarnet/ganciclovir therapy.

Active drug or alcohol abuse sufficient to prevent compliance.
Prehabilitation to Overcome the Stress of Surgery: the Role of Nutrition in Enhancing Postoperative Functional Capacity

To determine the impact of nutritional supplementation with whey protein on postoperative functional capacity in patients undergoing colorectal surgery for cancer.It is hypothesized that, compared with a control group receiving nutrition counselling only, patients receiving nutritional counselling along with preoperative and postoperative nutritional supplements will have a significantly improved change in functional walking capacity from baseline to 8 weeks after surgery.

The aims of this research project are the following:

1. Determine to what extent a nutritional prehabilitation regimen, which includes whey protein, initiated before surgery and continued after surgery, optimizes the recovery of functional walking capacity following colorectal resection for cancer.
2. To understand further which measures of immediate surgical recovery are sensitive to prehabilitation interventions, and predict change in later outcome measures.

Eligibility Criteria:
Inclusion Criteria:

* +18 years of age
* referred electively for resection of malignant, non metastasized, colorectal lesions
* French or English speaking

Exclusion Criteria:

* ASA class 4-5
* co-morbid medical, physical and mental conditions (e.g.dementia, disabling orthopedic and neuromuscular disease, psychosis)
* cardiac abnormalities
* severe end-organ disease such as cardiac failure (New York Heart Association classes I-IV), COPD, renal failure (creatinine \> 1.5 mg/dl, and hepatic failure ALT and AST \>50% over the normal range)
* sepsis
* morbid obesity (BMI \>40)
* anemia (hematocrit \< 30 %, haemoglobin \<10g/dl, albumin \< 25mg/dl).
Genomic DNA in Human Blastocoele Fluid

The objective will focus on the characterization of DNA fragments present in Blastocoele fluid, and the evaluation of these fragments as potential target for Preimplantation Genetic Diagnosis. To reach this goal, real-time PCR, Whole Genome Amplification techniques and -subsequently- Next Generation Sequencing and aCGH approaches will be used.


Eligibility Criteria:
Inclusion Criteria:

* IVF patient with supernumerary embryos to vitrify at blastocyst stage

Exclusion Criteria:

* IVF patient without blastocyst formation
Examining Executive Functions in Medical Students Across Different Types of Study Breaks

This study aims to expand on previous findings and compare the effects of an active break (ten minutes of walking or upper body movement), a digital break (ten minutes of phone use), and no break on memory and attention in medical students after a prolonged period of studying. The List Learning Task, Stroop Test, and Sustained Attention to Response Task will be administered to measure memory, executive function, and attention, respectively. Information on how different types of breaks affect memory and attention may prompt medical students to be more mindful and intentional of the way they spend their time in between studying.

120 people will be recruited. Following consent procedures, those who choose to participate will be randomized to physical intervention, digital intervention or control. 40 will be randomly selected to be in the active physical break group, another 40 participants will selected to be in the passive digital break group, and another 40 will be selected to be in the group without any break.

All participants will complete a demographic form and a baseline Stroop and Sustained Attention to Response Task tests prior to starting the experiment. Next, participants in all three groups will self-study any form of class material for 45 minutes without any breaks or phone usage. At the 45 min mark, the first part of the List Learning Task will be administered to all participants. Following completion, participants in the active physical break and passive digital break groups will begin their 15 min breaks. Those in the former group will engage in 10 min of walking or upper body movement. Those in the latter group will engage in 10 min of social media usage. An additional 5 min will be allotted to allow participants to get settled after their break and use the bathroom if needed before continuing with the study. Participants in the control group will continue studying for 15 min. All participants will not be permitted to converse or interact with each other throughout the break. Once the 15 min break has concluded, all participants will be administered the second part of the List Learning Task. When that is completed, participants will be given the Stroop Test and Sustained Attention to Response Task. A survey will be given to the passive digital break group to determine which social media app(s) were used. All groups will be surveyed about their thoughts regarding their respective type of break or lack thereof and its effect on their studying.

Eligibility Criteria:
Inclusion Criteria:

* have and regularly use some form of social media
* able to perform light physical activity such as walking or upper body movement

Exclusion Criteria:

* no social media usage
* color blindness (cognitive tests require color perception)
* ADHD or other known conditions that affect attention and/or concentration,
* current concussion
* any condition that prevents upper or lower body physical activity.
Effectiveness of DN With or Without Mulligan Two Leg Rotation Technique on Pain ROM and Joint Dysfunction in KO

The objective of study is to determine the effectiveness of dry needling with or without mulligan two leg rotation technique on pain, range of motion and joint dysfunction in knee osteoarthritis. The study will be a single blinded randomized controlled trial conducted at the Physical Therapy Department of Hussain Memorial Hospital, focusing on the treatment of knee osteoarthritis in adults aged 40 to 80 years.

The selection criteria will include patients with a confirmed diagnosis of knee osteoarthritis according to the Kellgren and Lawrence classification system, persistent symptoms for at least 6 months, and willingness to participate in the study. Exclusion criteria will include patients with other joint pathologies, severe psychiatric disorders, unstable medical conditions, or currently enrolled in another clinical trial. The sample size will be 40 patients, and divided into two groups, with Group A receiving dry needling combined with Mulligan two-leg rotation technique and Group B receiving only dry needling.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with age 18-65 diagnosed with chronic coccydynia for at least 3 months were recruited.
* Participants who will be willing \& able to adhere to the study protocol.
* Including participants who will be attending follow-up appointments \& completing outcome measures.
* Participants who will be able to understand \& provide written informed consent.
* Participants with a complete screening of other medical conditions and previous medical records.

Exclusion Criteria:

* Participants with previous surgery on the coccyx or lumbosacral spine, pregnancy or breastfeeding, history of bleeding disorders or anticoagulant use, active infection, or significant medical condition that could pose a safety risk during the procedures (GIB or CESI) was omitted.
* Patients above the age of 65 were eliminated to reduce confounding by age-related health concerns and to provide a more homogenous study population for more accurate treatment outcomes.
* Participants with neurological conditions affecting pain perception or sensation were excluded.
* Participants with known allergies to medications used in the study (local anesthetic, steroid for injections) were not part of the study.
* Participation in another interventional clinical trial within the past 3 months was not included.
* Participants who were unable to safely undergo fluoroscopy were also excluded.
Evaluation of a Psychoeducation Program for Families Caregivers of Schizophrenic Patients : Randomized Study in Two Arms

The involvement of family members is crucial and improves the prognosis of psychiatric patients and reinforces therapeutic adherence and reduces the frequency of relapses. For schizophrenia, the scientific literature clearly shows that it's in the interest of the patient to offer to his family a psychoeducational program.

Therapeutic education programs are now part of the recommendations of good clinical practice and in the French health through the law n ° 2009-879 of July 21, 2009 on the reform of the hospital and relating to patients, health and territories.

Objectives We conducted a randomized study in two groups to evaluate the impact of a psychoeducational program for caregivers.

Methods 60 patients with a DSM-V diagnosis of schizophrenia and their families' caregivers are recruited. Families' caregivers are randomly assigned to receive either a 6 session psychoeducation program, or no psychoeducation.

Baseline evaluations:

Patients: symptomatology (PANSS), medication adherence (MARS); Families' Caregivers: Quality of Life (S-CGQoL), Burden (Zarit), knowledge of disease (KAST), therapeutic alliance (4PAS caregivers), depression (CES-D), medication adherence (CRS).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of schizophrenia, based on ICD-10 (F20 to F29)
* Receive in-patient treatment at hospital (or medical center linked to Charles Perrens Hospital)
* Be the caregiver or parent of the patient
* Patient informed of the diagnosis of his disease

Exclusion Criteria:

* Mental retardation or other diagnoses that could affect the ability to answer questionnaires, after the acute schizophrenia psychosis is controlled
* Suicidal ideation
* Non-comprehension of the French language