cyrilzakka/clinical-trials huggingface dataset:
Combining Pelvic Floor Rehabilitation With Postural Re-education in Women With Stress Urinary Incontinence and Chronic Low Back Pain: a Preliminary Study.

Stress Urinary incontinence (SUI) is a common health condition in female population. Although its prevalence increases with the age, women of all ages could be affected. Several epidemiological studies have shown an association of SUI with Low Back Pain (LBP) demonstrating, moreover, that the presence of one condition may predispose the patient to the onset of the other. Concerning the LBP, the clinical practice guidelines provided recommendations for physical rehabilitative treatment. Different techniques and physical exercises have been developed and it is difficult at the date to affirm the superiority of one approach as compared to another. Moreover, the crucial role plays by the pelvic floor muscles (PFM) both as an integral part of trunk and lumbo-pelvic stability and in maintenance of urinary continence, lead the pelvic floor muscles disfunction to be associated both with SUI and LBP, making the PFM rehabilitation a useful approach in both the conditions. In this rehabilitative context the present study aims to verify the effectiveness of a global physical approach based on postural re-education combined to the pelvic floor rehabilitation in women with diagnosis of stress urinary incontinence associated with non-specific chronic low back pain.


Eligibility Criteria:
Inclusion Criteria:

* woman aged from 18 to 75 years;
* diagnosis of Stress Urinary Incontinence associated with non-specific chronic Low Back Pain

Exclusion Criteria:

* severe pelvic organs prolapse (\>second stage following the International Continence Society (ICS) classification);
* pregnancy;
* perineal denervation;
* inverted perineal command;
* presence of pelvic pain;
* fecal incontinence;
* vaginal infections;
* associated pathologies involving the Central Nervous System (CNS);
* psychotic disorders
A Cohort Study to Determine the Incidence of Dengue Fever and to Build Capacity for Dengue Vaccine Trials in Dengue-endemic Regions of South Asia

The purpose of this study is to determine the incidence of dengue fever and to build capacity for dengue vaccine trials in dengue-endemic regions of South Asia.

This study aims to estimate the burden of dengue illness in selected sites South Asia and to prepare sites for the conduct of future vaccine efficacy trials.

Operational goals include:

* Build long-term collaboration with sites in dengue-endemic regions of South Asia where the incidence of clinical dengue illness can be studied.
* Establish dengue surveillance cohorts that can be followed long-term.
* Establish operational feasibility of future Phase III studies with regard to recruitment, case capture and sampling procedures.
* Prepare sites for participation in Phase III clinical endpoint studies.

Eligibility Criteria:
Inclusion Criteria:

* Subject and/or subject's parent(s)/legally acceptable representative(s) (LAR\[s\]) who, in the opinion of the investigator, can and will comply with the requirements of the protocol. (e.g., willingness to go to the hospital/clinic for visit\[s\] in case of AFI, able to observe the signs of dengue and to understand how to take and report body temperature, etc.).
* Signed/thumb-printed (and video recorded if required by law) informed consent (and assent if applicable) must be obtained from the subject/subject's parent(s)/LAR(s) at the hospital/clinic or during a home visit. If the subject/subject's parent(s)/LAR(s) are illiterate, the informed consent form (ICF) (or informed assent form \[IAF\] when applicable) will be countersigned by an impartial witness.
* Subject is part of a household with at least one child (aged less than 18 years) and in which informed consent (and assent if applicable) to study participation was obtained from at least one adult and one child.
* Male or female aged between and including 6 months and 50 years at the time of enrolment.
* Subject who plans, at the time of enrolment, to remain at same residence/study area during the two-year study period.

Exclusion Criteria:

* Child in care.
* Participation (current or planned) in another epidemiological study or in a clinical trial that would conflict with the current study, based on investigator's judgement.
* Terminal illness based on investigator's judgement.
* Mental incapacity based on investigator's judgement.
Measurement of Alanine Aminotransaminase (ALT) Following Initiation of Antidiabetic Agents in Patients With Type 2 Diabetes in a Real-world Clinical Setting: a Retrospective Cohort Study

The primary objective of this study is to investigate the change in Alanine Aminotransaminase (ALT) in patients with Type 2 Diabetes Mellitus (T2DM) initiating Sodium Glucose Cotransporter 2 (SGLT2) inhibitors, liraglutide, or sitagliptin, compared to a control group of patients who did not initiate a new antihyperglycemic therapy. The hypothesis is that patients using Sodium Glucose Cotransporter 2 inhibitors (SGLT2i) will achieve a greater reduction in ALT compared to the control group.

Non-alcoholic fatty liver disease (NAFLD) is very commonly associated with type 2 diabetes mellitus (T2DM) 1. Alanine aminotransferase (ALT) is a common biomarker used to predict levels of NAFLD. The only class of antidiabetic agents thought to be protective of NAFLD are thiazolidinedione's. Few studies have investigated the effect of other antidiabetic agents on bio markers of fatty liver disease 2. A recent pooled analysis of randomized controlled trials that compared canagliflozin to either placebo or sitagliptin showed significant reductions in ALT in the canagliflozin cohorts, which were fully explained by HbA1c and body weight reductions 3. As well, a study that compared ALT change in patients initiating liraglutide found significant reductions in ALT, which was strongly correlated to reduction in body weight 4. However, the effect of different antidiabetic agents on bio markers of fatty liver disease is not well characterized.

The primary objective of this study is to investigate the change in ALT in patients with T2DM initiating SGLT2 inhibitors, liraglutide, or sitagliptin, compared to a control group of patients who did not initiate a new antihyperglycemic therapy. The hypothesis is that patients using SGLT2i will achieve a greater reduction in ALT compared to the control group.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of T2DM based upon historical clinical diagnosis
* Patients who initiated canagliflozin, dapagliflozin, liraglutide or sitagliptin by an LMC physician between January 2011 and December 2015, or patients who did not initiate a new diabetes therapy between June 2014 and June 2015.

Exclusion Criteria:

* Diagnosis of type 1 diabetes
* Patients who switched to one of the study treatments from another medication of the same medication class
A Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children With Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement Who Have Poor Response to Methotrexate (GO KIDS)

The purpose of this study is to evaluate the efficacy and safety of golimumab (CNTO 148) in patients who have active juvenile idiopathic arthritis (JIA) and at least 5 joints with active arthritis that have poor response to methotrexate.

Approximately 170 juvenile patients will take part in the study worldwide. All patients will receive 30mg/m2 (milligrams per meter squared, up to 50 mg per dose) of golimumab subcutaneously (injection under the skin) every 4 weeks from Week 0 through Week 12. At Week 16, patients who have shown at least a 30 percent improvement in their signs and symptoms from when they started the study will be randomized to receive either placebo (sham medicine injection) or 30 mg/m2 of golimumab injections every 4 weeks from week 16 through week 48. If a patient gets markedly worse and is receiving placebo injections, they will be restarted on golimumab at the next scheduled visit and will continue on golimumab. Patients can leave the study at any time without question. Between the Week 48 analyses timepoint to Week 144, which is subsequently amended to Week 248, all patients will receive golimumab 30mg/meter squared, unless, by measurements, they have been nearly cured (clinical remission) by being on placebo, whereby they will be discontinued from the study. Patients may have a change in background treatment after Week 48 based on therapeutic effect. Patients will continue active treatment after Week 48 in a long-term extension until Week 144, which is subsequently amended to Week 248. All patients will receive their fixed dose of commercial methotrexate throughout the study duration. Safety will be monitored up to 152 week, which is subsequently amended to 256 weeks including drawing blood and looking at laboratory tests, vital signs (eg, blood pressure), and the frequency and type of adverse events (side effects).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis must have been before the patient's 16th birthday
* Disease duration of at least 6 months before study entry
* Must have 5 or more joints with active arthritis
* Must be taking a stable dose of methotrexate 10-30 mg/meter squared (patients with body surface area \[BSA\] 1.67 square meter or more must be taking a minimum of 15 mg/week of methotrexate)
* May take a stable dose of prednisone less than 10 mg/day 4 weeks prior to entry or may take a stable dose of NSAIDS (non-steroidal anti-inflammatory drugs) 2 weeks prior to entry
* Must have qualifying laboratory values at the first visit.

Exclusion Criteria:

* Have known allergies, hypersensitivity, or intolerance to golimumab or similar therapeutics
* Are pregnant or breast-feeding, or planning a pregnancy or fathering a child within 6 months after the last study agent administration
* Have initiated DMARDS and/or immunosuppressive therapy within 4 weeks prior to study initiation
The CircumVent Project: A CPAP/O2 Helmet Solution for Non-Invasive Ventilation Among Patients With COVID-19

The purpose of the CircumVent Project is to evaluate the feasibility, adaptability and acceptability of a CPAP/O2 helmet solution for non-invasive ventilation among patients with COVID-19 and health workers in eight COVID-19 treatment and isolation centers in Nigeria.

Acute respiratory failure, a major cause of death in COVID-19, is managed with high-flow oxygen therapy via invasive mechanical ventilation. In resource-limited settings like Nigeria the shortage of ventilators and oxygen supply make this option challenging. Evidence-based non-invasive alternatives to mechanical ventilation such as the use of continuous positive airway pressure (CPAP) devices exist, but there have been concerns that non-invasive ventilation may expose healthcare workers to infection from aerosolized dispersion of SARS-CoV-2. The investigators propose to evaluate the feasibility, adaptability and acceptability of a CPAP/O2 helmet solution for non-invasive ventilation among patients with COVID-19 and health workers in eight COVID-19 treatment and isolation centers in Nigeria.

The study will occur in 4 stages: 1) Convene a Steering Committee of key stakeholders and recruit implementation sites; 2) Use the integrated Promoting Action on Research Implementation in Health Services (i-PARiHS) framework to guide a needs assessment of treatment centers' capacity to use high-flow oxygen therapy to treat COVID-19 patients, and utilize the findings to develop an implementation strategy for use of CPAP/ O2 helmet solution; 3) Build infrastructure to support training and data monitoring processes and to develop implementation protocols to evaluate the adaptability of the strategy for the use of the CPAP/O2 helmet; and 4) Train health workers, distribute a CPAP/O2 helmet solution for non-invasive ventilation, pilot test the implementation strategy, and assess feasibility of its use and acceptability that includes monitoring altered risk of SARS-CoV-2 infection among healthcare workers.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients admitted to a study site with respiratory distress and suspected or confirmed COVID-19 infection

Exclusion Criteria:

* Patients who do not meet eligibility criteria
Aortic-Stent-Register

The aims of the aorta-stent-Registry are:

• participating hospitals (with audit) document all consecutive patients diagnosed with a disease of the distal thoracal aorta that receive one of the following therapies:

1. Endovascular Aorta-Stent-Graft
2. Surgical operation of the distal thoracal aorta

   * Documentation of the indications, the procedural results and the clinical short- and long-term results of the endovascular and chirurgical treatment in day to day hospital routine.
   * Documentation of the operational risk (Euroscore)
   * Documentation of the technical enforcement of the procedure as well as the result of the intervention
   * Documentation of the hospital lethality and the non-fatal serious complications (Spinal Cord Ischemia, SCI, Stroke, TIA, high blood loss etc.)
   * Documentation of medication at hospital discharge
   * Documentation of long-term lethality and non-fatal serious complications (SCI, Stroke, TIA, major bleeding etc.) as well as hospitalization, re-intervention rates and medicinal drug therapy after 30 days, 1, 3 \& 5 years.

Eligibility Criteria:
Inclusion Criteria:

* Patients with significant illness of the distal thoracal aorta (distal Aortic-dissection; TAA; penetrated ulcer; covered perforation; traumatically transection of the distal thoracal aorta) including those that receive an endovascular stent or an open surgical operation.

Exclusion Criteria:

* Missing signed informed consent
A Study to Evaluate Pharmacokinetics of C3G and to Estimate Antioxidative Markers After Repeated Administration of Mulberry Fruit Extract

This study is to evaluate pharmacokinetic-pharmacodynamic property of C3G after administration of Mulberry fruit extract to 12 healthy Korean volunteers. Plasma concentration of C3G and the antioxidative markers such as total antioxidative capacity and attack of free oxygen radical will be measured.

Additional objective is to investigate the multiple dose (2 weeks) safety of daily 1000mg Mulberry fruit extract.

This study, as an exploratory trial, does not required statistical hypothesis.


Eligibility Criteria:
Inclusion Criteria:

* Body weight \>55 kg for male, \>45 kg for female (within 80-120% of Ideal body weight)
* Give written informed consent and voluntarily decide participation

Exclusion Criteria:

* Acute or chronic disease symptom on screening
* Existing active and clinically significant disease involving more than one organ system
* Known allergy to Mulberry or other berries
* Positive drug or alcohol screening
* Smokers of 10 or more cigarettes per day
* Participation in a clinical trial during last 2 month prior to the start of the study
* Pregnancy
Phase 2 Safety and Efficacy Study of AT-101 in Combination With Rituximab in Patients With Chronic Lymphocytic Leukemia

This is an open-label Phase 2 study to evaluate the safety and efficay of AT-101 in combination with rituximab in patients with relapsed or refractory chronic lymphocytic leukemia.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of CLL as defined by the NCI-working group
* Previous treatment with standard systemic chemotherapy or immunotherapy.
* Disease progression or relapse after treatment.
* Indication for treatment as defined by the NCI Working Group Guidelines (Cheson, 1996)
* ECOG performance status ≤ 2
* Adequate liver and renal and bone marrow function

Exclusion Criteria:

* Treatment of CLL with chemotherapy, monoclonal antibody or radiotherapy within 60 days prior to entering the study. Acute toxicities from prior therapy must have resolved to Grade ≤ 1.
* Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification
* Severe or debilitating pulmonary disease (dyspnea at rest, significant shortness of breath, COPD)
* Active secondary malignancy or history of other malignancy within the last five years
* Active symptomatic fungal, bacterial and/or viral infection including active HIV or viral hepatitis (A, B or C).
* Patients who are contraindicated for treatment with rituximab
* Diagnosis of prolymphocytic leukemia, hairy cell leukemia, leukemic phase of non-Hodgkin's lymphoma, or other non-B-CLL B-cell malignancy;
* T-CLL or other T-cell malignancy
RCT: Can a Single Counseling Phone Call Improve Contraception After an Abortion?

Hypothesis: Use of an effective contraceptive six weeks after abortion will be higher in the treatment group than in the control group.

Primary Aim ·To determine use of an effective contraceptive method six weeks after abortion in women who choose combined hormonal contraception (CHC) and who receive a three-week educational phone call as compared to women who do not receive the intervention.

Secondary Aims

* To describe the most common concerns and logistical problems women experience with initiating and adhering to CHC after abortion.
* To describe the concerns that lead to discontinuation or method change. \*To assess feasibility of conducting a follow-up telephone call in this population This is a randomized, controlled trial to assess the effect of a three-week follow-up phone call in women who choose combined hormonal contraception on the day of their abortion at the San Francisco General Hospital Women's Options Center. Subjects randomized to the treatment group will receive an interventional phone call three weeks after their abortion; participants randomized to the control group will not receive the call. All subjects will receive a follow-up call six weeks after their abortion to assess and compare method use between the two groups. Calls will be made at three- and six-weeks post abortion in order to give subjects enough time to initiate CHC and to assess continuation into the second month of the method. Data will be collected at baseline, during the intervention for the treatment group and during the final follow-up call for both groups. The primary outcome is use of an effective contraceptive six weeks after abortion.


Eligibility Criteria:
Inclusion Criteria:

* Women over the age of 15 who choose pill, patch or ring to begin after their abortion
* Women able and willing to be contacted by phone for up to 2 months after enrollment

Exclusion Criteria:

* Women who do not speak and read English or Spanish
The Altered Immune Response to Exercise in Patients With Fibromyalgia Before and After a Mind-body Intervention

The purpose of this study is to compare two different exercise programs to see if there are differences after exercise in fibromyalgia (FM) symptoms and responses from the immune system.


Eligibility Criteria:
Inclusion Criteria for FM Patients:

* Patients with a diagnosis of FM
* Clearance from patient's physician to participate in a clinical trial
* Not participating or willing to discontinue FM treatment with trans-cutaneous electrical nerve stimulation, biofeedback, tender-point injections, acupuncture, Yoga, and Tai Chi.

Exclusion Criteria for all Participants:

* Diagnosis of severe psychiatric illness
* Abuse of alcohol, benzodiazepines, or other drugs
* Active cardiovascular, pulmonary, hepatic, renal, gastrointestinal, or autoimmune disease (except Hashimoto's or Graves' disease that has been stable for 3 months before screening)
* Current systemic infection
* Active cancer (except basal cell carcinoma);
* Unstable endocrine disease
* Severe sleep apnea
* Prostate enlargement or other genitourinary disorder (male patients)
* Pregnancy or breastfeeding

Inclusion Criteria for Healthy Controls:

* Female
* No apparent medical condition that will interfere with participation in the study
* Not on any medication that will interfere with participation in this study

Exclusion Criteria for Healthy Controls:

* Medical or surgical conditions including medication that preclude participation in the study
* Presence of motor or neuromuscular deficits that may preclude participating in fatigue exercise
Clinical Features and Risk Factors Associated With Worse Outcome in Patients Hospitalized for Covid-19 Pneumonia

The aim of the research is to improve patient management by rapidly identifying, based on the terrain and clinical and biological characteristics, those patients likely to present a severe form of ARDS at risk of leading to intensive care


Eligibility Criteria:
Inclusion Criteria:

* Major patient (≥18 years of age)
* Admitted in March 2020 for confirmed Covid-19 lung disease (nasopharyngeal smear or sputum with SARS-CoV-2 positive PCR).

Exclusion Criteria:

* Patient who has expressed opposition to participation in the study.
* Mild forms of infection that do not require hospitalization,
* Subject under safeguard of justice
* Subject under guardianship or trusteeship
Sequential Targeting of Cluster of Differentiation 52 (CD52) and Tumor Necrosis Factor (TNF) Allows Early Minimization Therapy in Kidney Transplantation

The aim of the study is to evaluate the efficacy of new immunosuppressive protocol based on two applications of anti-CD52 MabCampath (Alemtuzumab) a single dose of anti-TNF-α Remicade (infliximab) monoclonal antibodies in the early posttransplant period followed by either monotherapy based on tacrolimus or sirolimus.


Eligibility Criteria:
Inclusion criteria:

* First deceased-donor kidney transplantation
* Age \>18 years
* Donor \<65 years
* Cytomegalovirus (CMV)/ Epstein-Barr virus (EBV) seropositivity
* panel reactive antibodies (PRA) \<10%
* Written consent

Exclusion criteria:

* Retransplantation, combined transplantation
* Prior immunosuppression less than 6 months prior transplantation
* Induction therapy with antibodies
* Leukopenia \< 4000, thrombocytopenia \< 100 000, Haemoglobin \< 80 g/l
* History of antithymoglobulin (ATG) or anti-cluster of differentiation 3 (CD3) monoclonals or anti-TNF-α
* Tuberculosis history
* Anti-hepatitis C virus (HCV) positivity, HBsAg
* HIV positivity
* Malignancy history
* Allergy to study medication
* Fertile women without contraception
* Pregnancy, breastfeeding mothers
Efficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Gel in Psoriasis Vulgaris

The objective of the study is to compare the use of calcipotriol plus betamethasone dipropionate gel with betamethasone dipropionate in the gel vehicle, calcipotriol in the gel vehicle and the gel vehicle alone when used in patients with psoriasis vulgaris on the trunk and/or limbs. Patients will be treated once daily for up to 8 weeks.

The primary response criterion is the number of patients with controlled disease at week 8.


Eligibility Criteria:
Inclusion Criteria:

* Psoriasis vulgaris involving trunk and/or arms and/or legs amenable to treatment with a maximum of 100 g of topical medication per week
* An investigators' global assessment of disease severity of at least mild

Exclusion Criteria:

* PUVA or Grenz ray therapy within 4 weeks prior to randomisation
* UVB therapy within 2 weeks prior to randomisation
* Systemic treatment with biological therapies, with a possible effect on psoriasis vulgaris within 6 months prior to randomisation
* Systemic treatment with all other therapies than biologicals, with a possible effect on psoriasis vulgaris (e.g., corticosteroids, vitamin D analogues, retinoids, immunosuppressants) within 4 weeks prior to randomisation
* Any topical treatment of the trunk/limbs (except for emollients) within 2 weeks prior to randomisation
* Topical treatment for other relevant skin disorders (except WHO group I-II corticosteroids, tar, retinoid and dithranol on face, scalp, or flexures) within 2 weeks prior to randomisation
* Planned initiation of, or changes to concomitant medication that could affect psoriasis vulgaris (e.g., beta blockers, anti-malaria drugs, lithium) during the study
* Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis