cyrilzakka/clinical-trials huggingface dataset:
Pemetrexed and Gemcitabine in Patients With Advanced Head and Neck Cancer

The purpose of this study is to look at how well the combination of two chemotherapy drugs, pemetrexed (Alimta) and gemcitabine (Gemzar) work to treat your cancer.

This research study is being done because we have not yet been able to find the best treatment for recurrent or advanced head and neck cancer (SCCHN). Pemetrexed and gemcitabine have helped fight against SCCHN when each was given by itself. This study is different from others because it tests these two drugs together, which has not been tried before in patients with SCCHN. We will see how well these drugs can work to help to control or shrink your cancer.

We also want to find out what effects (good and bad) gemcitabine and pemetrexed have on you and your head and neck cancer. We do not know if these drugs will help you. Your cancer might get better or it might get worse. It might not have any effect on your condition. We can use what we learn from this research study to help other people with the same cancer.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of squamous cell cancer of the head and neck - unresectable or metastatic. Must have measurable disease by RECIST.
* Karnofsky performance status greater than or equal to 60%
* Up to one prior systemic chemotherapy, immunotherapy allowed in the advanced or metastatic setting. This does not include prior chemotherapy, immunotherapy used with radiotherapy (ie concurrent with radiation therapy or as and induction regimen pror to definitive radiation therapy).
* At least 4 weeks from prior radiation or chemotherapy, must have recovered from all acute effects of treatment.
* Adequate organ and marrow function
* Negative pregnancy test. Agree to use birth control during and for 3 months after last dose of study drug.
* At least 18 years of age.
* Sign an informed consent and HIPAA consent.
* Must be able to take and absorb enteral medication.

Exclusion Criteria:

* Serious concomitant systemic disorder that would compromise safety or ability to complete study.
* Prior treatment with gemcitabine or pemetrexed within the previous year, unless used concurrently with radiation therapy.
* Pregnancy or breastfeeding.
* Symptomatic or uncontrolled brain mets. If treated, must be off steroids for at least 2 weeks.
* Inability or unwilling to take folic acid, vitamin B12, or dexamethasone.
* Treatment within last 30 days with a drug that has not received regulatory approval for any indication.
* Inability to interrupt and NSAID or salicylate with a long half-life (piroxicam or nabumetone) for a 5 day period.
* Presence of clinically relevant third space fluid that cannot be controlled by drainage or other procedure prior to study entry.
* Active, concurrent, invasive malignancy requiring ongoing treatment.
* Corticosteroids impermissible unless for adrenal failure, septic shock or as temporizing measure for symptomatic pain, breathing, or rash.
Cognitive Functions After COVID-19

This study was aimed to evaluate the post-infection cognitive functions of adult individuals with COVID-19. 50 individuals with COVID-19 and 50 healthy control groups were included in the study. Cognitive functions of individuals with COVID19 compared with healthy individuals.

This study was aimed to evaluate the post-infection cognitive functions of adult individuals with COVID-19. Fifty COVID-19 patients, aged between 18-50 years, who had positive RT-PCR test in the last 60 days and later recovered, were included in the study. The study group was compared with the control group consisting of 50 healthy individuals in whom gender, age and education year has not difference significantly. Participants' global cognitive skills were measured by the Montreal Cognitive Assessment Test (MoCA), the Clock Drawing Test and memory functions, the Öktem Verbal Memory Processes Test (Ö-SBST), the attention functions by the Digit Span Forward and Digit Span Backwards Test, the executive functions by Categorical Fluency, Phonemic Fluency, the Stroop Test, Trail Making Test A and B, visuospatial skills were evaluated with the Rey-Osterrieth Complex Figure Test (ROCF), and behavioral symptoms were evaluated with the Neuropsychiatric Inventory (NPI). The study group was evaluated between 21 and 60 days from the onset of the disease.

Eligibility Criteria:
Inclusion Criteria:

* Having positive for the COVID-19 RT-PCR test and turned negative in the last 60 days.
* be 18-50 years old
* 21 days have passed since the onset of the disease

Exclusion Criteria:

* Having any neurological or psychiatric illness
Haplo-PBSC+Cord vs Haplo-PBSC+BM for Hematological Malignancies Undergoing Allo-HSCT

The objective of this study was to explore whether the combination with umbilical cord blood (UCB) is associated with superior disease-free survival (DFS) in the setting of haploidentical donors (HID) transplantation.

The main causes of allogeneic hematopoietic stem cell transplantation (allo-HSCT) failure are primary disease relapse and transplant-related complications, especially relapse. In recent years, with the development of transplantation technology, alternative donors such as HID and UCB have been widely used. But, these alternative donors are associated with high incidences of transplant-related complications and mortalities when compared with human leukocyte antigen (HLA)-matched donors. Some studies suggeted that mixed grafts might overcome the disadvantages of a single alternative graft. UCB transplant (UCBT) supported by third-party HID or HID transplants supported by third-party UCB has been reported to have rapid engraftment and low incidences of graft-versus-host-disease (GVHD), making survival improvement. However, most of these results came from single-arm studies. The comparative studies between haplo-PBSC+Cord and haplo-PBSC+BM are scarce in the setting of HID transplantation. In a retrospective study, the investigators found haplo-PBSC+Cord transplantation has superior DFS than haplo-PBSC+BM in hematological malignancies. To further confirmed this conclusion, the investigators plan to conduct a prospective, multicenter, phase 3 randomized controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* Patients with hematologic malignancies undergoing first HID allo-HSCT
* Age 18 to 65 years old with ECOG performance status 0-2
* Received myeloablative conditioning regimens
* Sign informed consent form, have the ability to comply with study and follow-up procedures

Exclusion Criteria:

* Received PBSCs as only grafts
* Acute leukemia transformed from a myeloproliferative tumor
* Cardiac dysfunction (particularly congestive heart failure, unstable coronary artery disease and serious cardiac ventricular arrhythmias requiring antiarrhythmic therapy)
* Respiratory failure ( PaO2 ≤60mmHg)
* Hepatic abnormalities (total bilirubin ≥3 mg/dL, aminotransferase \>2 times the upper limit of normal)
* Renal dysfunction (creatinine clearance rate \< 30 mL/min)
* ECOG performance status 3, 4 or 5
* With any conditions not suitable for the trial (investigators' decision)
Anti COVID-19 Antibodies in Follicular Fluid and Spermatic Fluid

Patients going through an in vitro fertilization cycle will be asked to participate . Patients will be asked for their COVID-19 exposure : post confirmed disease/post vaccine/not exposed to disease or vaccine . Patients will provide the fluids which are not required , once fertilization process is completed. Patients will also provide 5ml blood sample by the day of procedure. Anti COVID-19 immunoglobulin G type antibodies will be measured in all samples . Data regarding age, date of infection/vaccine will be collected . Progesterone and Estrogen will be measured in female patients' samples and Perlecan level will be measured in follicular fluid.

Patients going through an in vitro fertilization cycle will be asked to participate . Patients will be asked for their COVID-19 exposure : post confirmed disease/post vaccine/not exposed to disease or vaccine . Patients will provide the fluids which are not required in the day of egg retrieval : the follicular fluid remaining after isolation of the egg and spermatic fluid only, if not utilized for fertilization. The fluids will be collected once fertilization process is completed. Patients will also provide 5ml blood sample by the day of procedure. Anti COVID-19 immunoglobulin G type antibodies will be measured in all samples . Data regarding age, date of infection/vaccine will be collected as well as indication for treatment, Estradiol level before the egg retrieval, number of eggs collected and the triggering ovulation modality . Progesterone and Estrogen will be measured in female patients' samples (follicular fluid and serum). Perlecan level will be measured in follicular fluid.

Eligibility Criteria:
Inclusion Criteria:

* Planned egg retrieval procedure (including egg preservation)
* Negative PCR for SARS-Cov-19 in the week before egg retrival
* Informed consent

Exclusion Criteria:

* Positive PCR for SARS-Cov-19 in the week before egg retrival
* expected retrival of 1-3 eggs
Intravenous Immune Globulin (IVIG) Treatment Protocol in Kidney Transplant Patients

The purpose of this study is to test the clinical and laboratory observations of IVIG therapy in the highly sensitized patient. We will study the effects of patients treated with IVIG or Cytogam in combination with plasmaphoresis to modulate the immune response in highly sensitized patients. The goal is to convert a positive crossmatch to a compatible crossmatch that would allow living related transplant to take place or to shorten time on the transplant waiting list.

The purpose of this study is to test the clinical and laboratory observations of IVIG therapy in the highly sensitized patient. We will study the effects of patients treated with IVIG or Cytogam in combination with plasmaphoresis to modulate the immune response in highly sensitized patients. There are two arms in the study, one in which IVIG is administered to patients who have living donors with positive crossmatch results, and another in which intravenous immune globulin is administered to patients with no living donor and have a PRA greater than 30% for 3 consecutive months and a crossmatch with a cadaveric donor while on kidney transplant waiting list. The goal is to convert a positive crossmatch to a compatible crossmatch that would allow living related transplant to take place or to shorten time on the transplant waiting list.

Eligibility Criteria:
Inclusion Criteria:

* 12 years of age or older
* diagnosed with end stage renal disease
* currently receiving either hemodialysis or peritoneal dialysis
* active on the kidney or kidney/pancreas transplant list
* medical clearance of the kidney donor if live related transplant
* elevated panel reactive antibody (PRA) greater that 30% for 3 consecutive monthly tests and one positive crossmatch with a cadaveric donor while on the transplant waiting list

Exclusion Criteria:

* received IVIG within 6 months prior to enrollment
* HIV positive
* Positive Hepatitis Be-antigen and/or hepatitis B viral DNA
* Selective IgA deficiency or known antibodies to IgA
* Allergy to human immune globulin
* Pregnant or breast feeding
Phase 1 Combination Study of MM-151 With MM-121, MM-141, or Trametinib

This is a Phase 1 open-label, dose-escalation trial using "3+3" design, evaluating MM-151 co-administration with MM-121, MM-141, and trametinib at varying dose levels.

This is a two-part Phase 1, non-randomized, open-label study of MM-151 plus MM-121, MM-141, or trametinib in patients with advanced, heregulin-positive lung, head and neck, and colorectal cancers. In part 1 of the study, cohorts of 3 or more patients will be treated at escalating doses of MM-151 in combination with MM-121, MM-141, and trametinib until a maximum tolerated combination dose for each combination is identified. In part 2 of the study, patients will be treated with the combination dose identified in part 1 of the study.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be \>18 years of age
* Patients must be able to provide informed consent
* Willing to abstain from sexual intercourse or to use an effective form of contraception during the study and for 90 days following the last dose of any study therapy). This applies to women of childbearing potential as well as fertile men and their partners
* Patients must be recovered from the effects of any prior surgery, radiotherapy or other antineoplastic therapy, up to CTCAE grade 1
* Patients must have either heregulin-positive cancer, cancer with RAS mutation, IGF-1 positive cancer, or RAS wild type cancer.

Exclusion Criteria:

* Patients who are pregnant or lactating
* Patients who have an active infection or with an unexplained fever \> 38.5°C during screening visits or on the first scheduled day of dosing (at the discretion of the investigator, patients with tumor fever may be enrolled.)
* Patients with untreated (primary) or symptomatic CNS (primary or metastatic) malignancies; patients with CNS metastases who have undergone surgery or radiotherapy or who have been on a stable dose of corticosteroids for at least 2 weeks and whose disease is stable prior to the first scheduled day of dosing will be eligible for the trial.
* Patients who have received other recent antitumor therapy including any standard chemotherapy or radiation within 14 days (and having passed the time of any actual or anticipated toxicities) prior to the first scheduled dose of the study treatment.
ONO-4538 Phase I Study in Patients With Advanced Malignant Solid Tumors in Japan

Evaluation of the safety, tolerability and pharmacokinetics (PK) of a single dose and multiple doses of ONO-4538 in Japanese patients with advanced malignant solid tumors, and exploratory evaluation of the pharmacological effect and efficacy of ONO-4538.


Eligibility Criteria:
Inclusion Criteria:

* Histological or cytological diagnosis of solid tumor with at least one measurable lesion of ≥ 10mm.
* Tumor must be advanced or recurrent which is refractory to standard therapies or for which no alternative, appropriate therapy exists.
* ECOG Performance Status of 0-1
* Life expectancy ≥ 3 months
* Other inclusion criteria as specified in the study protocol

Exclusion Criteria:

* History of severe hypersensitivity reactions to other antibodies.
* Residual adverse reactions or effect of prior therapy, which deemed to affect the safety evaluation of the study drug by the investigator or subinvestigator.
* Two or more synchronous tumors, except for adequately treated basal cell cancer or cancer in situ, or superficial bladder cancer, or any other cancers from which the patient has been disease-free for at least 5 years.
* Patients with any active autoimmune disease or a documented history of chronic or recurrent autoimmune disease, or current medical condition that requires systemic immunosuppressive doses of steroids or other immunosuppressive medications.
* Other exclusion criteria as specified in the study protocol
Effect of the Pelvic Floor Training in Postmenopausal Women With or Without Hormonal Therapy

The purpose of this study is to evaluate the effect of pelvic floor muscle training (PFMT) on muscle function of postmenopausal women using or not using hormonal therapy replacement (HTR). The study will evaluate also the prevalence of urinary incontinence reports, its severity and impact on quality of life.

The climacteric period is marked by the decline of estrogens and androgens which represents negative effect on the urogenital system and may present, as a consequence, pelvic floor muscles (PFM) dysfunction and urinary incontinence (UI). The pelvic floor muscles training (PFMT) and hormone therapy (HT) could result in a significant increase in muscle mass with functional improvement and consequent decrease in complaints of urine loss. The aim of this study is to evaluate the effect of PFMT on muscle function, in the presence of UI, severity and impact on quality of life in postmenopausal women with or without HT.

The variable sexual function was abandoned due to the fact that the majority of the women do not presented active sexual life, which is a criteria to answer the questionnaire Index of Female Sexual Function (IFSF), or did not agree to answer the questionnaire. The anxiety scale was also abandoned because it was a tool to assess sexual function in a broader way.

This is a randomized controlled trial. Postmenopausal women will be divided into 4 groups:

* Group 1- without exercise and without HT
* Group 2 - with exercise and without HT
* Group 3 - without exercise and with HT
* Group 4 - with exercise and HT

Women will be evaluated at baseline and up to 12 weeks. The evaluations of the PFM function will be accomplished through the use of vaginal palpation using the Modified Oxford Scale (MOS) and perineometry. The International Consultation on Incontinence Questionnaire- Short Form (ICIQ - SF) will be used to assess reports of UI, quality of life will be evaluated by the SF36 (Medical Outcomes Study 36 - Item Short - Form Health Survey).

The electromyography was not performed because during the collection of data from the pilot sample there was an excess of outcome measures which made the patients' adhesion unfeasible.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women with a maximum of ten years of menopause.
* It is considered menopausal cessation of menstrual cycles for more than twelve months (WHO).
* To be included women must have the ability to contract the pelvic floor muscle (PFM) and have never done PFM training.

Exclusion Criteria:

* Women with diabetes mellitus, thyroid disease, hyperprolactinemia, genital prolapse (above grade 1), neuropathy and vasculopathy.
* Those who are intolerant (pain, allergy gel or latex condom or other discomfort) to PFM function evaluation and those that deny answer the questionnaires during the protocol.
Lateral Closing Wedge Osteotomy for Cubitus Varus Deformity in Children

Humeral osteotomy is the most effective method for evident cubitus varus correction in children. Several osteotomy methods and fixation materials have been developed in the past. By applying the principles of deformity correction described by Paley, the investigators describe a novel corrective technique for cubitus varus involving lateral osteotomy using Kirschner wires.

Supracondylar humerus fractures (SHFs) account for approximately 10% of all pediatric fractures in children. Poorly treated SHFs can lead to the most common cubitus varus deformity especially in patients treated conservatively. The cosmetic aspect of this deformity is the main concern of patients, together with reduced remodeling ability. Inevitably, surgery is the first choice for such patients. Several osteotomy techniques and fixation materials have been developed in the last several decades. With the advent of three-dimensional printing techniques and computed tomography reconstruction methods, more accurate computing designs have been applied in the correction of cubitus varus. These techniques make the surgery more complex and require the performance of computed tomography (CT), resulting in high radiation exposure in children. Paley described the principles of deformity correction that are widely used for the lower limbs. These principles represent an alternative with easy application without the need of CT, with less occurrence of prominence and good cosmetic outcome. According to the Paley principles, all the vertex of the triangular osteotomy should site on the center of rotation of angulation (CORA) line, by doing this, the gun-butt deformity was corrected perfectly. More importantly, they help to accurately correct the anatomic axis of the upper limb. According to our knowledge, this is the first study describes the lateral closing wedge osteotomy for correction cubitus varus deformity in children by applying Paley's principles and fixation with K-wires.

Taken together, the investigators aimed at verifying the feasibility of Paley's principles for deformity correction to treat cubitus varus in children.

Eligibility Criteria:
Inclusion Criteria:

* surgery performed over 6 months after the occurrence of SHFs
* difference in flexion angles of the affected and unaffected limbs of \>15 degrees
* recovery of elbow function pre-ostomy

Exclusion Criteria:

* any other surgical approach used
* consent not obtained from the patient's guardians
* incomplete follow-up
Physical Therapy Intervention in Dental Students

The main purpose of our study is to assess whether guided strength training and stretching intervention with a written home exercise program is more effective than a home exercise program alone for pre-clinical dental students in improving and preventing pain associated with dental laboratory practice. Secondary aims will be to assess relationships between strength and quality of life measures of an individual and pain levels.

Musculoskeletal (MSK) pain has been identified as a major concern among dental professionals. This can lead to decreased productivity, efficiency and quality of work along with higher costs for the medical system. The body region that is affected the most is the neck, followed by the back and shoulders.

Ergonomic assessments and interventions can identify the areas of concern with workplace set up, however, training the muscles to adapt to abnormal postures may be an effective way of increasing the resilience of the MSK system while decreasing MSK pain as well. Specifically, strength training and stretching has been well researched as a way to prevent and improve pain for neck pain, low back pain and shoulder pain. Physical therapists are well trained in prevention and treatment of injuries, including a wealth of knowledge regarding strength training and stretching for specific regions. The main purpose of our study is to assess whether guided strength

Thus, the main purpose of our study is to assess whether guided strength training and stretching intervention with a written home exercise program is more effective than a home exercise program alone for pre-clinical dental students in improving and preventing pain associated with dental laboratory practice. The secondary aim will be to assess the relationships between strength and quality of life measures of an individual and pain levels.

Eligibility Criteria:
Inclusion Criteria:

* Adults ages 18+
* Current 2nd year university dental students

Exclusion Criteria:

* Any type of musculoskeletal surgery in the past 6 months