cyrilzakka/clinical-trials huggingface dataset:
Investigation The Efficacy of Manual Therapy and Exercise in Patients With Glenohumeral Arthritis

The aim of the investigator's study is to compare the efficacy of manual therapy and exercise practices compared to exercise practice in patients with Glenohumeral Arthritis. Thirty volunteer patients will include into the study.

Patients will randomly divide into two groups. A common exercise program was applied to both groups during 15 sessions. Manual therapy techniques will apply to the manual therapy group in addition to exercise practices. Patients will evaluate in terms of functional status, pain, range of motion, muscle strength and health-related quality before and after 5 weeks of treatment. Also, patient's satisfaction from treatment will evaluate at the 5th week of the treatment. DASH and ASES forms for functional status, VAS for pain, digital goniometer for range of motion, manual muscle test for muscle strength, SF-12 for health-related quality of life, and Global Rating of Change (GRC) Scale for patient satisfaction will be used as evaluation criteria.

Eligibility Criteria:
Inclusion Criteria:

* 40 years and older patients
* To be diagnosed with GHOA by specialist physician via MRI, US or radiography and physical examination
* Unilateral shoulder pain lasting more than 2 months seen during daily living activities and at rest

Exclusion Criteria:

Patients with:

* Severe arthrosis
* Tumor
* Cervical radiculopathy
* Emotional or cognitive problems
* A neurological disease that causes muscle weakness on the shoulder
* A skin disease that may affect upper extremity assessment.
* Frozen shoulder
* Thoracic outlet syndrome
Toric Contact Lens Performance Study

This study seeks to quantify digital visual performance and subjective visual acceptance of toric contact lenses as compared to spherical lenses in low to moderate astigmatic patients.

This is a prospective, single site, randomized, masked, crossover study. This study will evaluate the ability of toric contact lenses to decrease signs and symptoms of asthenopia and improve digital reading performance. Symptoms and objective near vision outcomes will be measured at baseline and after 1 week of wear with each correction.

Eligibility Criteria:
Inclusion

+6.00 to -6.00 D vertexed sphere power and -0.75 to -1.50 D vertexed refractive cylinder in the right and left eyes Best corrected acuity of 20/25 or better in each eye Self report of at least 4 hrs/day using digital devices Current/established soft contact lens wearer (has worn contact lenses in the past year)

Exclusion An optometrist or optometry student History of ocular pathology or surgery Binocular vision disorder (i.e., tropia, convergence or accommodative insufficiency) Gas permeable lens wear for at least 3 months Presbyopic (based on refraction)
Open-Label Study for Shoulder Dislocation Using MG-1

To evaluate the efficacy and safety of arthroscopic Bankart repair using MG-1 for dislocation of shoulder


Eligibility Criteria:
Inclusion Criteria:

* Patients with dislocation of the shoulder and indicated for arthroscopic Bankart repair
* Patients of 16 years or older
* Patients who understand the contents of the study and from whom a written consent can be obtained
* Patients who can visit the hospital for follow-ups after surgery

Exclusion Criteria:

* Patients with serious complications
* Patients with comminuted fracture which may prevent fixation of the anchors
* Patients with the following diseases or conditions which may delay healing

  1. Lack of blood, infection, etc.
  2. Psychiatric disorder, alcohol poisoning, drug toxicity, etc.
  3. Tissues around the surgical site are not healthy under steroid therapy or chemotherapy
* Patients with epilepsy or bone disease (cystic change, osteopenia, etc.)
* Patients with dementia
* Patients with a history of allergy to glycolic acid, poly-L-lactic acid, β-tricalcium phosphate, polyethylene or polydioxane
* Patients who cannot undergo general anesthesia
* Patients who cannot undergo plain X-ray examination or MRI examination
* Patients with previous bone grafting in the shoulder joint
* Patients who participated in another clinical trial within past 3 months
* Patients who are pregnant or lactating. Patients who plan to be pregnant within a year
* Patients judged to be inappropriate for the study by the (sub)investigator
Observation of Long-term Effects on Endometrium and Uterine Fibroids in Women With Ulipristal Acetate Therapy

A prospective observational study on italian women undergoing ulipristal acetate (uPa) therapy for symptomatic myomas and its impact on symptomatology and moreover on myomas architecture. We also evaluate changes in the endometrial pattern of selected women.


Eligibility Criteria:
Inclusion Criteria:

* number of myomas from 1 to 4
* heavy menstrual bleeding
* conservative treatment request

Exclusion Criteria:

* concurrent endometrial pathology
* post-menopausal status
* hepatic pathology
* endocrine or metabolic disorders
Evaluation of ACell Hydrated Wound Dressing for Autogenous Skin Donor Sites

The purpose of this study is to see if treating a donor site wound with the ACell dressing is as good as or better than the dressings we currently treat harvested donor sites with. This will be tested on consenting burn patients who require excision and grafting surgery for their burn wounds.

Hypothesis: The mean healing time for wounds treated with the ACell dressing will be less than the mean healing time for wounds treated with the Standard of Care dressing.

This is a single-center, prospective, randomized, and controlled study to evaluate the effectiveness of the ACell Dressing for use as a dressing for autogenous skin donor sites compared to our current standard donor site dressing, which is currently Xeroform.

Eligibility Criteria:
Inclusion Criteria:

* less than 30% total body surface area burn
* burn wounds do not involve the donor site harvesting areas
* requires excision and grafting of sufficient extent to justify two donor site of roughly equal size on non-dependent body surfaces.
* The scheduled excision and grafting procedure is the first such operation for the subject
* subject agrees to participate in follow-up evaluations

Exclusion Criteria:

* Critical illnesses such as those requiring ventilator support, systemic infection, or hemodynamic instability
* Major acute or chronic medical illness that could affect wound healing
* Cellulitis or other infection of the potential donor sites
* Donor site has been previously harvested for grafting
* Subjects who are pregnant
* Religious objections or allergy to porcine products
Near Patient Microbial Testing in Cystic Fibrosis

To identify whether home monitoring of multiple physiological parameters and biomarkers in sputum could provide advanced warning of an infective exacerbation or treatment failure before changes in patient-reported symptoms.

1. To determine if longitudinal profiling of sputum from Cystic Fibrosis patients allow accurate prediction of exacerbations in a study of a larger group and can we confirm the 7+ day early warning system works in this larger group.
2. Is one biomarker sufficient to predict exacerbations - what is the accuracy? Are two or more biomarkers required to achieve an accuracy of greater than 95%?
3. Can we now accurately determine how many hospital bed days a home testing/wellness monitoring device would save? What is the business case for healthcare providers to adopt our future test for home use? We estimate a 50% saving. Can this be confirmed?
4. When used in the clinic, how many hospital days would our test save through faster determination of treatment efficacy? What is the business case for adopting our future test as a point of care test on the ward in Cystic Fibrosis centres? Could this be the new revolutionary tool that we anticipate?
5. We forecast a 50% reduction in costs to treat Cystic Fibrosis patients in disease severity bands 2-A to 5. Can we provide evidence for this to support further investment?

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Cystic Fibrosis based on genetic testing and/or sweat chloride levels.
* Chronic infection with Pseudomonas aeruginosa.
* Patients able to produce daily sputum samples.
* Current history of at least two pulmonary infective exacerbations in the past 12 months.
* Able to give written informed consent

Exclusion Criteria:

* Unable to provide written informed consent
* Patients unable to produce daily sputum samples
* Fewer than two infective pulmonary exacerbations in 12 months
A Study of Intravenously (IV) Infused or Subcutaneously (SC) Injected Risankizumab in Healthy Adult Participants in China

The objective of this study to assess the pharmacokinetics, safety, tolerability and immunogenicity following a single subcutaneous (SC) or intravenous (IV) dose of risankizumab in healthy Chinese participants.


Eligibility Criteria:
Inclusion Criteria:

- Body Mass Index (BMI) is \>= 19.0 to \<= 26.0 kg/m2 after rounding to the nearest tenth. BMI is calculated as weight in kg divided by the square of height measured in meters.

Exclusion Criteria:

- Previous exposure to any anti-IL-12/23 or anti-IL-23 treatment.
Immunotherapy With Bispecific CAR-T Cells for B-Cell Lymphoma, ALL and CLL

This study aims to evaluate the safety, efficacy and duration of response of anti-CD19 anti-CD20 Bispecific Chimeric Antigen Receptor (CAR) redirected autologous T-cells in patients with high risk, relapsed CD19+ and CD20+ haematological malignancies.

This is a multi-centre, non-randomised, open label Phase I clinical trial of an Advanced Therapy Investigational Medicinal Product named CD19 CD20 Chimeric Antigen Receptor (CAR) T-cells (CD19 CAR T-cells) in patients with high risk, relapsed CD19+ and CD20+haematological malignancies (Leukemia and lymphoma). Following informed consent and registration to the trial, patients will undergo an unstimulated leukapheresis for the generation of the CD19 CD20 CAR T-cells. Patients will receive the CD19 CD20 CAR T-cells following lymphodepleting chemotherapy. The study will evaluate the safety, efficacy and duration of response of the CD19 CD20 CAR T-cells in patients with high risk relapsed CD19+ malignancies.

Eligibility Criteria:
Inclusion Criteria:

1. Relapsed or refractory B cell derived acute lymphoblastic leukemia(ALL), chronic lymphoblastic leukemia(CLL) and non-hodgkin lymphoma.
2. KPS\>60.
3. Life expectancy\>3 months.
4. Gender unlimited, age from 18 years to 70 years.
5. CD19 or CD20 expression must be detected on greater than 15% of the malignant cells by immunohistochemistry or greater than 30% by flow cytometry.
6. Patients who have failed at least one line of a standard treatment.
7. No serious mental disorder.
8. Patients must have adequate cardiac function(no cardiac disease, LVEF≥40% ), adequate pulmonary function as indicated by room air oxygen saturation of \>94%, and adequate renal function(Cr≤133umol/L).
9. No other serious diseases(autoimmune disease, immunodeficiency etc.).
10. No other tumors.
11. Patients volunteer to participate in the research.
12. Patients with history of allogeneic stem cell transplantation are eligible if at least 100 days post-transplant, if there is no evidence of active GVHD and no longer taking immunosuppressive agents for at least 30 days prior to trial.

Exclusion Criteria:

1. KPS\<50.
2. Patients are allergic to cytokines.
3. Central nervous system leukemia within 28 days.
4. Uncontrolled active infection.
5. Acute or chronic GVHD.
6. Treated with T cell inhibitor.
7. Pregnancy and nursing females.
8. HIV/HBV/HCV Infection.
9. Other situations we think improper for the research.
Efficacy and Safety of Probiotic Treatment as a Supportive Therapy in Eradication of H. Pylori

The aim of the study is to establish efficacy and safety of Normia® probiotic, used as an add-on therapy in treatment of H. Pylori infection with the standard triple therapy approach.

The primary objective in the study is determination of efficacy of Normia® probiotic as a supportive therapy in achieving a higher percentage of eradication of H. Pylori.

The secondary objectives are to assess:

* Safety profile of Normia® probiotic in everyday use, e.g. reduction in number of side-effects and better compliance to the eradication therapy
* Safety and efficacy of Normia® probiotic in different demographic subgroups

Gastroenterologists and general practitioners have increasingly more possibilities of prescribing probiotic preparations as the only or (more often) adjuvant therapy in certain indications. A significant step forward was made in the current report of the European Helicobacter Study Group ,which states that "Certain probiotics and prebiotics show promising results as an adjuvant treatment in reducing side effects". At this stage,probiotics are classified as Grade D recommendation. That is precisely why the investigators believe that clinical studies are necessary in order for such effects to be objectively proven in a clinical setting.

The investigators decided to conduct a clinical trial based on a clearly defined and sufficiently frequent indication,with a preparation of known probiotic composition that is easily available on the market, and in a real setting where such approach is bound to show both advantages and disadvantages.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed H. Pylori infection.
* Otherwise healthy subjects taking H. pylori eradication therapy.
* Age above 16 years.
* Male and female subjects.
* Subject who provided written informed consent prior to undergoing any study procedure.

Exclusion Criteria:

* Pregnancy or lactation.
* Severe diseases such as malignant diseases, severe renal/liver impairment, HIV infection etc.
* Chronic diseases such as diabetes mellitus, hypertension, epilepsy or atherosclerosis which are under treatment and well regulated are not an exclusion criterion.
* Subject who is not mentally capable of adhering to the protocol.
* Drug addiction or alcoholism.
* Any other clinical condition which, in the opinion of the attending physician, would not allow safe administration of the study medications.
* Subjects participating in any other clinical trial.
Study to Assess the Clinical Efficacy and Safety of a Novel Method of Specific Allergen Immunotherapy in Grass Pollen Allergic Subjects by Epicutanous Allergen Administration

Primary Objective Comparison of the inhibition of the allergic response assessed by nasal provocation test after epicutanous pollen allergen administration and placebo epicutaneous administration.

Secondary Objectives Comparison of the efficacy of the placebo with that of the epicutanous pollen allergen administration evaluated by visual analog symptom scales (nasal itching, sneezing, rhinorrhea, conjunctival redness, and lacrimation, lung symptoms ), Comparison of the inhibition of the allergic response assessed by skin prick test after epicutanous pollen allergen administration and placebo epicutaneous administration.

* Trial with medicinal product


Eligibility Criteria:
Inclusion criteria:

* Written informed consent
* History of grass pollen allergic rhinitis
* Male and female between 18 years to 65 years
* Positive skin prick test to grass pollen
* Positive nasal provocation test

Exclusion criteria:

* Atopic eczema in history or permanent
* Perennial allergic rhinitis
* Symptoms of infectious disease with rhinitis in between the last 2 weeks
* Surgical intervention in between the last 30 days
* Pregnancy or nursing
* History of HIV or AIDS
* Mastocytosis (cutaneous or systemic)
* Significant cardiovascular disease
* Hypertension (blood pressure \> 160 / 95)
* Significant pulmonary, renal and/or hepatic disease
* Significant hematological disorder
* Moderate or severe asthma
* History of malignancy
* History of neurological or psychatric disease
* Autoimmune disease
* Antihistamines with longed half-lives in the last week
* Systemic or topical steroids for 5 days
* Active infectious disease
* Contraindicated medications: - immunosuppressive agents

  * Betablockers
  * ACE-inhibitors
  * Tricyclic antidepressants
  * Daily use of Beta-agonists or steroid inhalers
* Participation in another clinical trial /study in between the last 60 days
* Participation in another clinical trial / study at the moment
Celecoxib in Treating Postmenopausal Women Who Are Undergoing Surgery for Invasive Breast Cancer

This randomized phase I trial is studying the side effects of celecoxib in treating postmenopausal women with invasive breast cancer who are scheduled to undergo surgery at Memorial Sloan-Kettering Cancer Center. Celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth.

PRIMARY OBJECTIVES:

I. Determine whether celecoxib suppresses aromatase activity in postmenopausal women with invasive breast cancer planning to undergo surgery.

SECONDARY OBJECTIVES:

I. Correlate celecoxib-mediated inhibition of aromatase activity with levels of cyclooxygenase (COX)-2 and HER-2/neu and estrogen receptor status in these patients.

II. Determine the effect of this drug on histology, Ki67, RNA expression profile by microarray analysis, PI3-K, AKT and ERK1/2 MAP kinase activities, and PGE_2 levels in these patients.

III. Determine whether any observed biological effect of this drug is dose-dependent in these patients.

IV. Identify collateral targets (COX-2-independent) of this drug in these patients.

OUTLINE: This is a randomized study. Patients are randomized to 1 of 3 treatment arms.

Arm I: Patients receive oral celecoxib twice daily for 1-3 weeks (according to the duration between biopsy and surgery) in the absence of unacceptable toxicity.

Arm II: Patients receive a higher dose of oral celecoxib as in arm I.

Arm III: Patients do not receive treatment.

All patients undergo definitive surgery.

PROJECTED ACCRUAL: A total of 75 patients (25 per treatment arm) will be accrued for this study within 2-3 years.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed invasive breast carcinoma

  * Tumor at least 1 cm by radiologic estimate or physical exam
  * No disease limited to ductal carcinoma in situ only
* Planning to undergo surgery at Memorial Sloan-Kettering Cancer Center
* Hormone receptor status:

  * Not specified
* Female
* Postmenopausal as defined by at least 1 of the following:

  * No menstrual period within the past 12 months
  * Prior bilateral oophorectomy
* No known liver disease
* No renal insufficiency
* No congestive heart failure
* No coronary artery disease
* No history of documented peptic ulcer disease
* No gastritis
* No medical condition that would preclude definitive surgery
* No allergy to NSAIDs or sulfa-containing drugs
* No connective tissue diseases, including any of the following:

  * Systemic lupus erythematosus
  * Reynaud's disease
  * Scleroderma
* More than 3 months since prior chemotherapy
* More than 2 weeks since prior hormone replacement therapy
* More than 2 weeks since prior tamoxifen
* More than 2 weeks since prior aromatase inhibitors
* More than 2 weeks since prior raloxifene
* More than 2 weeks since prior steroids
* More than 1 week since prior nonsteroidal anti-inflammatory drugs (NSAIDs)
* More than 1 week since prior cyclooxygenase (COX)-2 inhibitors
* No concurrent warfarin
* No concurrent thiazide or loop diuretics
* No concurrent COX-2 inhibitors
* No concurrent NSAIDs
Safety, Tolerability and Immunogenicity of Three Doses of Novartis Meningococcal B Vaccine When Administered to Healthy At-risk Adults

This study is aimed to evaluate safety, tolerability and immunogenicity of three doses of Novartis 4CMenB and of one dose of Novartis Meningococcal ACWY vaccine when administered to healthy at-risk adults.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults,18 through 50 years of age, who were or might be routinely exposed to N. meningitidis cultures

Exclusion Criteria:

* Previous ascertained or suspected disease caused by N. meningitidis;
* Pregnancy or breastfeeding;
* History of any anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or known hypersensitivity to any vaccine component;
* Any present or suspected serious acute or chronic disease
* Known or suspected autoimmune disease or impairment /alteration of immune function
Midfacial Gingival Margin Changes Following Immediate Implants.

Dimensional changes, including the loss of labial soft tissues and midfacial gingival recession, seem to be inevitable following immediate placement. The clinical relevance of this study is proposing a treatment modality namely customized healing abutment with immediate implant placement that is proposed to minimize and control midfacial gingival recession and support buccal soft tissue contour, and maintain long term stability of these tissue, which might enhance the esthetics

Tooth extraction is followed by ridge alteration and soft tissue collapse and recession. Different strategies were proposed to limit this collapse however, the ability of these techniques to mimic the original soft tissue level and to maintain long term stability is unclear (Slagter et al., 2014). Using customized contoured healing abutments at the time of immediate implant placement is a treatment modality to improve esthetics by maintaining the soft tissue level and contour (Ruales-Carrera et al, 2019, Perez et al, 2020). Using connective tissue grafts has been suggested to enhance and maintain soft tissue stability, however, the effect of the combined procedures for maintenance of the soft tissue morphology compared to customized healing abutments alone remains unclear (Atieh et al, 2019).

Eligibility Criteria:
Inclusion Criteria:

* Patient-related criteria:

  * Adults at or above the age of 18.
  * Non-restorable maxillary anterior or premolar tooth requiring extraction and needed an implant placing therapy.
  * The failing tooth will have adjacent and opposing natural teeth.
  * Sufficient mesial-distal and interocclusal space for placement of the implant and definitive restoration.
  * Able to tolerate surgical periodontal procedures.
  * Good oral hygiene.
  * Compliance with the maintenance program.
  * Provide informed consent.
  * Accepts the one-year follow-up period.

Teeth related criteria:

* Intact thick biotype gingival tissue with at least 2mm band of keratinized tissue.
* Intact socket wall before the extraction, buccal bone thickness ≤1mm assessed by CBCT.
* Sufficient apical bone to place an immediate implant with minimum primary stability of 30Ncm

Exclusion Criteria:

* Patients diagnosed with periodontal diseases.
* Current or previous smokers.
* Pregnant and lactating females.
* Patients with medical conditions that would compromise the surgical procedures; uncontrolled diabetes mellitus, taking IV Bis-phosphonates for treatment of osteoporosis.
* Patients with active infection related at the site of implant/bone graft placement.
* Patients with parafunctional habits