cyrilzakka/clinical-trials huggingface dataset:
Prolotherapy Versus Steroids for Thumb Carpo-metacarpal Joint Arthritis

Arthritis of the base of the thumb is a common debilitating problem. It is believed that laxity (loosening) of the joint leads to worsening arthritis in this joint. This can be treated by securing the joint surgically or symptoms can be treated with hand therapy and/or injection of corticosteroids. Recently prolotherapy (sugar water) has been shown to decrease looseness of joints and also be helpful for hand and knee arthritis. We hypothesize that prolotherapy injections for thumb arthritis will be equally or more beneficial to the patients than steroids.

Dextrose prolotherapy has been shown to decrease anterior cruciate ligament (ACL) laxity and decrease knee joint pain. Similar to ACL laxity leading to knee osteoarthritis, laxity of the "beak" ligament can lead to worsening thumb CMC osteoarthritis. We hypothesize that dextrose intra-articular prolotherapy will have similar results in treating the pain and instability related to symptomatic thumb CMC osteoarthritis. This will be a prospective randomized double blind comparison study comparing Celestone to Dextrose intra-articular injections as adjuncts to hand therapy for the treatment of symptomatic thumb CMC osteoarthritis. Twenty patients will be randomized to each treatment arm to provide enough power to show a 20% change in visual analogue scale (VAS) for pain to be significant. We will utilize the ultrasound guided injection protocol described by the co-investigators for both treatment arms to ensure proper placement of the respective solutions. We will measure various grip strengths, and VAS pain scales prior to the first injection, prior to the second injection at 6 weeks and at the final visit at 6 months. A telephone follow-up with pain scale will be administered at 3 months. A Quick Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire measuring upper extremity functional impairment will be obtained at initial and final visits.

Eligibility Criteria:
Inclusion Criteria:

* Age \>45
* Ability to make follow-up visits over the 6 month protocol
* Ability to give informed consent
* Eaton grade 2-3 thumb carpo-metacarpal joint osteoarthritis with pain over 3/10 on visual analogue scale with symptoms present greater then 6 months.

Exclusion Criteria:

* Recent trauma to the hand or wrist or fractures eeen on radiographs
* Eaton grade 1, or 4 joints affected
* Metabolic bone disease
* Recent systemic or localized infection (within last 2 weeks)
* History of rheumatologic disease
* Allergies to injected solutions
* Thumb carpo-metacarpal joint injections in the prior 6 months.
Effect of Local Application of Platelet-rich Fibrin Scaffold Loaded With Simvastatin on Peri-implant Bone Changes

ACKGROUND: Simvastatin (SIM), a pharmacological drug used for hypercholesterolemia, has been found to have pleotropic effects on bones. Simvastatin together with the appropriate carrier may decrease bone loss around implants.

PURPOSE: To compare the long term effects of autologous PRF alone, and PRF loaded with SIM on peri-implant bone changes and implant stability in patients undergoing implant rehabilitation.

MATERIALS AND METHODS: A randomized controlled split-mouth studyincluding 8 males between the ages of 45-60 years. Each patient received two implants, one on each side of the arch. One side was treated with PRF alone and the other side with PRF +Simvastatin, at the time of Osteotomy. A cone-beam CT was used to evaluate bone changes around the insertion of implant sites atthree, six, and twelve months postoperatively. The secondary outcome included measuring implant stability using Ostell device at baseline and 3 months post insertion. To compare groups at different time periods, data was examined using a two-way (ANOVA) analysis.


Eligibility Criteria:
Inclusion Criteria:

* patients with a partially edentulous mandible indicated for rehabilitation with implant prostheses,
* any extractions, or surgeries performed at least six months earlier.

Exclusion Criteria:

* patients with systemic diseases affecting bone quality or resorption
* temporomandibular joint dysfunction,
* severe attrition or parafunctional habits,
* patients undergoing radiotherapy or chemotherapy,
* heavy smokers,
* vulnerable groups such as psychologically unstable patients
Study Evaluating the Safety and Efficacy of JWCAR029 in Adult Subjects With Relapsed and Refractory B-cell Non-Hodgkin Lymphoma

This is a single arm, open-label, dose escalation clinical study to evaluate the safety and efficacy of infusion of autologous CD19-targeted chimeric antigen receptor (CD19 CAR) T cells in adult patients with relapsed and refractory B-cell Non-Hodgkin lymphoma.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must meet all of the following criteria to be enrolled in this study:

  1. Age ≥ 18 years at the time of consent
  2. Signed written informed consent obtained prior to any study procedures
  3. Relapsed or refractory B-cell NHL.
  4. PET-positive disease BY Lugano classification
  5. Archived tumor biopsy tissue available from the last relapse and corresponding pathology report available or, if at least one tumor-involved site is deemed accessible at time of screening, willing to undergo pre-treatment biopsy (excisional when possible) for disease confirmation. If a subject has never had a complete response, a sample from the most recent biopsy is acceptable.
  6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  7. Adequate bone marrow, renal, hepatic, pulmonary and cardiac function
  8. Adequate vascular access for leukapheresis procedure
  9. Subjects who have received previous CD19-targeted therapy must have CD19-positive lymphoma confirmed on a biopsy since completing the prior CD19-targeted therapy
  10. Subjects must agree to use appropriate contraception.

Exclusion Criteria:

* Subjects who meet any of the following criteria will be excluded from participation in this study:

  1. Subjects with central nervous system (CNS)-only involvement by malignancy (note: subjects with secondary CNS involvement are allowed on study)
  2. History of another primary malignancy that has not been in remission for at least 2 years.
  3. Treatment with alemtuzumab within 6 months of leukapheresis, or treatment with fludarabine or cladribine within 3 months of leukapheresis
  4. Active hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection at the time of screening
  5. Subjects with uncontrolled systemic fungal, bacterial, viral or other infection despite appropriate antibiotics or other treatment at the time of leukapheresis or JWCAR029 administration
  6. Presence of acute or chronic graft-versus-host disease (GVHD)
  7. History of cardiovascular disease
  8. History or presence of clinically relevant CNS pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis
  9. Pregnant or nursing women.
  10. Prior CAR T-cell or other genetically-modified T-cell therapy, with the exception of prior JWCAR029 treatment in this protocol for subjects receiving retreatment
Vitamin D and Stroke

Stroke remains one of the most devastating neurological diseases, often causing death, or gross physical impairment. It is the second most common cause of death worldwide and a major cause of acquired disability in adults.Vitamin D deficiency has been reported to contribute to the risk of cardiovascular disease especially stroke.

This case -control observational prospective study will conducted on fifty patients with first -ever acute onset stroke within seven days (25 patients with hemorrhagic stroke and 25 patients with ischemic stroke )

Eligibility Criteria:
Inclusion Criteria:

* Onset is within one week
* Confirmed stroke by brain CAT and / or MRI scan either haemorrhage or infarction

Exclusion Criteria:

* Cognitive and mental changes
* Recurrent stroke
* Hepatic and renal impairment
* Endocrinal diseases
* Steroid therapy
* Vitamin D or Ca supplementation
* Previous fractures
* Bone diseases
* brain neoplasm,
* Autoimmune diseases
* History of acute and chronic inflammatory diseases
* Malignancy,
* Trauma
* Surgery
* Acute vascular diseases that occurred within four weeks prior the onset of stroke
* History myocardial infarction ˂3 months.
A Study of Abemaciclib (LY2835219) in Combination With Fulvestrant Compared to Chemotherapy in Women With HR Positive, HER2 Negative Metastatic Breast Cancer

The reason for this study is to compare the efficacy of abemaciclib, in combination with fulvestrant, to that of physician's choice of chemotherapy in women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer that has spread to internal organs. Your participation in this trial could last up to 31 months, depending on your cancer type and how you and your tumor respond.


Eligibility Criteria:
Inclusion Criteria:

* Participants must be females of post-menopausal status with HR+, HER2- breast cancer that has spread to internal organs
* Participants must have had at least one endocrine therapy
* Participants must be willing to use a device to answer daily questions about how they are doing for the duration of their participation in the study
* If participant has diarrhea from a previous treatment, they should talk to their doctor to ensure they have recovered enough to participate in this study

Exclusion Criteria:

* Participants must not have breast cancer that has spread to the brain if untreated and with symptoms
* Participants must not have had any systemic treatment after their breast cancer has spread unless it is endocrine therapy
* Participants must not have certain active infections including HIV or hepatitis
* Participants must not be pregnant or breastfeeding
* Participants must not have certain types of cancers or certain previous cancer treatments
* Participants must not have certain serious medical conditions, including heart or lung disease, or have had certain types of tissue or organ transplants
Pediatric Pain Rehabilitation Program

The purpose of this study is to describe the demographic, medical, and psychological/behavioral characteristics of children and adolescent patients admitted to the Cleveland Clinic Children's Hospital's Pain Rehabilitation Program. The data will also be used to evaluate the clinical outcomes of patients admitted to the program as well as to examine the impact of various background factors on clinical outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Admitted into the Cleveland Clinic Children's Hospital's Pain Rehabilitation Program

Exclusion Criteria:

-
Effects of Kangaroo Mother Care Among Low Birth Weight (LBW) and Preterm Infants

- Hypothermia, infections ,and ineffective breastfeeding are some of the commonest causes of deaths among premature and low birth weight LBW infants. Even if the infants are born in facilities, incidences of cold stress are possible due to insufficient resources, space and incompetent practices to manage hypothermia in the immediate postnatal period. Kangaroo Mother Care is a well-known intervention to address the issues related to preterm births, such as hypothermia, infection and prolong hospitalization.Besides significant outcome of KMC interventions for preterm infants, no interventional study has been found in literature in Pakistani context. Looking at the potential benefits of KMC in reducing the related complications of prematurity, the study aims to identify the effectiveness of KMC among preterm and LBW infants born in secondary hospital of Aga khan University hospitals.

Hypothesis I Ha: KMC is effective in reducing the incidences of hypothermia among preterm and LBW infants as compared to the usual care.

Hypothesis II Ha: There is a difference in breastfeeding behavior and breastfeeding outcome among experimental and control group.

Secondary Hypothesis Hypothesis I Ha: There is an association between KMC and frequency of suspected infections during hospitalization.

Hypothesis II Ha: There is a difference in length of stay among experimental group and control group.

Hypothesis III Ha: There is a relationship between KMC and weight gain of infants till four weeks.

Hypothesis IV Ha: There is difference in rate of hypothermia among experimental group and control after discharge from hospital.


Eligibility Criteria:
Inclusion Criteria:

* Any preterm neonates (\< 37 weeks of gestation by maternal dates)
* Low birth weight infants less than 2500 gm.

Exclusion Criteria:

* Infants with brain hemorrhage, congenital abnormalities.
* Infants needed double phototherapy.

Exclusion of Mother:

Mothers with severe depression, sickness with intensive care requirements. Mother who refused to participate. Mothers who delivered live multiple babies.
Trifecta-Kidney cfDNA-MMDx Study

Demonstrate the relationship between DD-cfDNA levels and HLA antibodies in blood, and the Molecular Microscope® (MMDx) Diagnostic System results in indication biopsies.

There is a need for better screening of kidney transplant patients for rejection. Patients with kidney transplants are routinely tested (creatinine, urine protein, histology and donor specific antibody (DSA) as standard of care to detect rejection, but these tests are not adequate. Rejection is often missed by these tests (false negatives) and other processes such as acute kidney injury can produce false-positive results. Moreover, histology has a high interobserver disagreement diagnosing rejection, and cannot accurately assess acute injury. A definitive molecular assessment of rejection and injury in kidney biopsies has emerged - the Molecular Microscope® Diagnostic System (MMDx) - developed by the Alberta Transplant Applied Genomics Centre, University of Alberta. Now a new screening test is being introduced: the monitoring of donor-derived cell-free DNA (DD-cfDNA) released in the blood by the kidney during rejection. The Natera Inc DD-cfDNA Prospera® test is based on the massively multiplex PCR that targets 13,392 single nucleotide polymorphisms and targeted sequences are quantified by Next Generation Sequencing. The Prospera® test done on kidney transplant recipients detected "active rejection" and differentiated it from borderline rejection and no rejection. It is likely, however, that DD-cfDNA test may miss some T cell-mediated rejection (TCMR) cases and the distinction between early and fully developed antibody-mediated rejection (ABMR) was not tested. No study has actually examined the DD-cfDNA results in kidney transplants with acute or chronic kidney disease (AKI and CKD). DD-cfDNA measurements have only been correlated with histology, a flawed standard. DD-cf-DNA test must now be calibrated against MMDx that is based on global gene expression, the new standard for biopsy interpretation. The present study will calibrate centrally measured (Natera Inc) DD-cfDNA levels obtained at the time of an indication biopsy against the MMDx measurements of TCMR, and ABMR (early-stage, fully-developed, and late-stage), AK, and atrophy-fibrosis. We will compare blood DD-cfDNA measurements in 600 samples at the time of 300 indication biopsies to the MMDx results, as well as central assessment of HLA antibody (One Lambda) in 300 blood samples, interpreted centrally as DSA based on the tissue typing results. This study is an extension of the INTERCOMEX ClinicalTrials.gov Identifier: NCT01299168. We have collected 1203 kidney biopsies and 2422 corresponding blood samples. We extend this study to the total of 1400 biopsies and 2800 blood samples.

Eligibility Criteria:
Inclusion Criteria:

* All kidney transplant recipients undergoing a kidney biopsy for clinical indications, as determined by their physician or surgeon, will be eligible to enroll in the study.

Exclusion Criteria:

* Patients will be excluded from the study if they decline participation or are unable to give informed consent or multiple organ recipients.
Evaluation of Clinical, Morphologic and Biochemical Markers in Multiple Sclerosis

By combining clinical, morphological and biochemical markers a better understanding of the formation and progression of multiple sclerosis (MS) should be obtained

The current study aims to comprehensively investigate the individual clinical, morphological and biochemical aspects of MS in order to elucidate underlying mechanisms leading to disease progression. This shall ultimately serve to identify imaging and biochemical markers, which may support clinical management of persons with MS (pwMS). The following markers will be assessed: demographics (age, sex), clinical (EDSS at baseline, disease duration); neuropsychological (SDMT (Symbol Digit Modalities Test) score); MRI (Magnetic Resonance Imaging) (lesion load, atrophy); Biochemical markers analyzed in cerebrospinal fluid (CSF), blood, DNA, RNA, peripheral blood mononuclear cells (PBMCs)

Eligibility Criteria:
Inclusion Criteria:

* Patients with suspected or proven multiple sclerosis
* The participants are patients who are in inpatient or outpatient care of the Department of Neurology at the Medical University of Graz, Austria

Exclusion Criteria:

* Excluded from the examinations are all patients for whom an MRI examination is impossible or problematic
Adherence to Exercises for Neck Pain.

This project continuing to study on the effectiveness of a Chatbot in promoting adherence to home physiotherapy treatment for patients, in this case, with cervical musculoskeletal injuries and pain. The use of digital technologies and media is an important option to complement in-person treatment and promote adherence to treatment at home. The research aims to verify whether the use of a Chatbot as a means of communication can produce improvements in patient adherence and clinical results.


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years.
* Diagnosis of cervical pain.
* Indication of treatment through home exercises.
* With a personal smartphone
* Verbally confirms to have installed an instant messaging service or app, and accesses it at least 3 times a week

Exclusion Criteria:

* No to sign the informed consent.
* Not able to understand, read and write in the Spanish language
Randomized Study to Compare the Bioavailability of Two Fluticasone Propionate 0.005% Topical Ointments

The purpose of this study was to compare the relative vasoconstrictive effects of test and reference topical Fluticasone Propionate 0.005% Ointments in healthy, female subjects.


Eligibility Criteria:
Inclusion Criteria:

* Non-tobacco using female subjects, 18 to 50 years of age
* Demonstrated blanching response to Reference Drug
* Weight within +/- 20% from normal for height and weight for body frame
* Good health as determined by lack of clinically significant abnormalities in medical history and clinical assessment, as judged by the Investigator
* Signed and dated informed consent form which meets all criteria of current FDA regulations

Exclusion Criteria:

* History of allergy to systemic or topical corticosteroids
* Presence of any skin condition or coloration that would interfere with the placement of test sites or the response or assessment of skin blanching
* Presence of medical condition requiring regular treatment with prescription drugs
* Drug or alcohol addiction requiring treatment in the past 12 months prior to dosing
* Use of any tobacco products in the 30 days prior to study dosing
* Use of any dermatological drug therapy on the flexor surface of the forearms within 30 days of dosing
* Receipt of any drugs as part of a research study within 30 days prior to study dosing
* Pregnant or lactating
Randomized Study of Osseotite Certain Tapered Prevails vs. Osseotite Certain Tapered

This study will demonstrate the benefits of platform switching design of the Osseotite dental implant.

The Osseotite Certain Prevail implant with its platform switch feature will demonstrate higher success rate than the non-platform Osseotite Certain implant

Eligibility Criteria:
Inclusion Criteria:

* patients of either sex and older than 18 years of age
* patients needing at least one dental implant to treat partial edentulism
* patients physically able to tolerate surgical and restorative dental procedures
* patients agreeing to all protocol visits

Exclusion Criteria:

* patients with infection or severe inflammation at the intended treatment sites
* patients smoking greater than 10 cigarettes per day
* patients with uncontrolled diabetes mellitus
* patients with uncontrolled metabolic diseases
* patients who received radiation treatment to the head in the past 12 months
* patients needing bone grafting at the intended treatment sites
* patients known to be pregnant at screening visit
* patients with para-functional habits like bruxing and clenching
Impact of Serum Progesterone Levels on the Day of Fresh and Frozen Embryo Transfer on the Ongoing Pregnancy Rates.

Serum progesterone levels prepare the endometrium for implantation and play an important role during embryo transfer (ET). In clinical practice, luteal phase support progesterone supplementation is systematically offered to all women undergoing medically assisted procreation (AMP), independently of ET conditions (fresh and frozen).

The investigators propose to perform a prospective cross-sectional single-center cohort study to measure progesterone levels on the day of the ET on all AMP cycles and to compare these levels between active pregnancies and ET unsuccessful cycles. They will determine progesterone threshold levels corresponding to successful attempts in all ET strategies (fresh and frozen) as well as clinical and biological risk factors leading to luteal phase deficiency during ET. They could therefore individualize progesterone supplementation according to patient's needs.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* planned embryo transfer
* signed informed consent

Exclusion Criteria:

* patients falsely included, major inclusion criteria not respected
* lack of social insurance
* refusal to participate in the research
Effects of Myofascial Induction Pressure Pain Threshold in Trigger Points of the Proximal Muscles of Gastrocnemius

In the present study we will test the effects of myofascial induction technique in the muscles close to the application in the gastrocnemius muscle.

In the present study we will test the effects of myofascial induction technique on nearby muscles. The calf maneuver proposed by Pilat for myofascial induction will be applied and the effects on the pain pressure threshold of the trigger points of the flexor digitorum brevis biceps femoris extensor digitorum longus muscles will be observed.

Eligibility Criteria:
Inclusion criteria:

* Subjects aged 18-39 years.
* Healthy subjects with trigger point 1 of the gastrocnemius muscle in both lower limbs.

Exclusion criteria;

* Diagnosis of lower limb injury, including any tendinopathy, bursitis, ligamentous involvement and/or fasciitis.
* History of lower limb surgery or history of lower limb injury with residual symptoms (pain or sensation of sensation) within the last year.
* Participants could not have undergone ankle stretching or any other treatment.
* Diabetes due to possible impaired distal arterial circulation.
* Foot deformity, cavus and flat feet.
* Foot deformities such as hammertoes and hallux valgus,
* plantar calluses.
* Dysfunction of the lower extremities or chronic injuries.