cyrilzakka/clinical-trials huggingface dataset:
Effects of Andriol Testocaps in Symptomatic Late-Onset Hypogonadism (43203)

In this study we have evaluated the effects of three different doses of oral testosterone undecanoate in aging men presenting with a combination of symptoms suggestive of hypogonadism and low blood levels of the male hormone testosterone.

Specifically, we have studied the effects on:

* symptoms suggestive of low testosterone levels
* blood testosterone and other hormone levels
* bone mass
* muscle mass and fat mass
* muscle strength
* prostate
* lipids, hematocrit


Eligibility Criteria:
Inclusion Criteria:

* Subjects were at least 50 years of age
* A body mass index (BMI) between 18 and 34 kg/m\^2
* Symptoms of androgen deficiency (as indicated by a positive Androgen Deficiency in Aging Males (ADAM) questionnaire)
* Calculated free testosterone measurement of \<0.26 nmol/L in the morning

Exclusion Criteria:

* History or current diagnosis of breast or prostate cancer
* any clinically significant abnormal finding on physical examination including the prostate
* Clinical symptoms of obstructive benign prostate hyperplasia (International Prostate Symptom Score (IPSS) \>14)
* Prostate specific antigen (PSA) level \> 4 ng/mL at screening
* Cause of androgen deficiency other than aging, e.g. 'classical' diagnosis of primary or secondary hypogonadism
* Hyperprolactinaemia or treatment with prolactin-lowering drugs
* History of known chronic polycythemia and/or hematocrit \>50% at screening
* History or presence of severe sleep apnea
* Unstable or untreated endocrine disorders
* History or presence of clinically significant depression or other psychiatric disorder or any clinically relevant cardiovascular, cerebrovascular, endocrine, hepatic, renal or hematological disease, thromboembolism/thrombosis etc. which, in the opinion of the investigator, might compromise the subject's participation in the trial
* Use of medication that would interfere with the efficacy and safety objectives of the trial
Enabling Sleep Apnea Patient-Centered Care Via an Internet Intervention

The purpose of this study is to examine the effect of different methods of providing education about sleep apnea and continuous positive airway pressure therapy (CPAP) use and how that education might help to improve health outcomes and the amount of time CPAP is used.

Poor treatment adherence with CPAP therapy is well-documented. Set against a backdrop of telemedicine applications that have grown as fast in unsubstantiated claims and assumptions of patient satisfaction, diagnostic accuracy, clinical efficacy, and cost-effectiveness as they have in technological sophistication and capabilities, the evaluative aspect of this proposal is designed as as a randomized, controlled clinical trial-Usual Care patients (control) versus i-PAP patients (intervention). An important empirical-methodological advantage of the project is the objective measurement of CPAP adherence, which is measured by internal microprocessor as the "amount of time CPAP is used at the prescribed pressure." This objective measurement allows feedback of treatment adherence and efficacy to both patient and provider, and the i-PAP intervention was designed around this central feature.

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years
* confirmed diagnosis of OSA
* being newly prescribed CPAP therapy
* having chronic symptoms as noted on screening symptom checklist
* fluency in English

Exclusion Criteria:

* cognitive impairment sufficient to cause inability to complete the protocol (MMSE \< 24/30)
* residence in a geographical area outside of San Diego County
* fatal comorbidity (life expectancy less than 6 months as indicated by treating physician)
* significant documented substance/chemical abuse or other participant circumstances that, in the opinion of a consensus of study team, would interfere with the safety of a prospective participant or their need for treatment
A Study of Atezolizumab in Patients With Unresectable, Locally Advanced or Metastatic NSCLC (J-TAIL)

This prospective, observational study is to assess the long-term effectiveness and safety of Atezolizumab in patients with advanced non-small cell lung cancer in clinical practice.

Primary endpoint: 18 months OS, Secondary endpoints: Overall Survival(OS), 12 months survival rate(12mo OS), 24 months survival rate(24mo OS), Progression-Free Survival(PFS), Time to treatment failure (TTF), Objective Response Rate(ORR), Disease Control Rate(DCR), Duration of Response(DOR) ,Safety and EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire

Eligibility Criteria:
Inclusion Criteria:

* Patients 20 years of age or older at the time of signed consent.
* Patients with locally advanced or metastatic non-small cell lung cancer.
* Patients who are scheduled to start Atezolizumab monotherapy, based on the Atezolizumab package insert and the Optimal Use Promotion Guideline.
* Patients who signed informed consent form before enrolling the study. The consent from a legally acceptable representative is required for the patients with uncertain capacity of judgments.

Exclusion Criteria:

* Patients who are considered to be unsuitable for enrolment into the study by the investigator's judgment.
Validation of French Version of LCADL and Dyspnea-12

The main objective of this study is to develop and to validate a French version of the London Chest Activity of Daily Living (LCADL) and the Dyspnea 12 and to determine the reliability of this version for the evaluation of the dyspnea in the Activity of Daily Living in COPD patients (stages severe and very severe).


Eligibility Criteria:
Inclusion Criteria:

* COPD with FEV1\< 50% of predictive value

Exclusion Criteria:

* FEV1\> 50% of predictive value
* Patients with an exacerbation of COPD in the previous 30 days the inclusion
Fragmentation of Elastin as a Biological Marker of Frailty and Impact in Tumor Progression in Elderly Patients With Cancer

The aim of the study is to evaluate frailty in patients aged ≥ 65 years with cancer. The elderly population is very heterogeneous, it is necessary to evaluate these elderly patients before treatment to assess the risk-benefit balance. To date, this assessment relies on subjective clinical methods often not optimal, and slow to implement. An innovative method of evaluation could be the determination of elastin peptides. Indeed, the rate of these peptides, which are linked to serious conditions associated with age, rising inexorably with age and dose could help determine more objectively the type of treatment to offer older patients.

Expected results : This study will allow better identification of the group of frail elderly through more relevant biological marker that clinical assessment, often subjective and not available within a period compatible with the treatment of newly diagnosed cancer. This biological assessment will also enable optimal management of elderly patients in particular by allowing the geriatrician better efficiency.


Eligibility Criteria:
Inclusion Criteria:

* 65 years or older
* diagnosis of cancer
* affiliation to a social security scheme
* Signed informed consent for the study and for the collection of biological samples

Exclusion Criteria:

* Patient protected by law (guardianship, trusteeship)
Virtual Therapy in Rehabilitation Spastic Hemiparesis

Evaluate the effectiveness of virtual therapy and conventional physiotherapy in spastic muscles of patients with sequelae of stroke.

Considered the second most frequent cause of death worldwide , the stroke is also responsible for the largest number of functional disability in individuals. The socio - economic hardship that many patients face to perform a program of intensive rehabilitation sensorimotor, has led to functional limitations in many cases , promote irreversible consequences. Spasticity in the upper and lower limb after stroke results in loss of function and mobility being the key therapeutic approaches in order to restore its function. Currently, the Virtual therapy has been used in physical therapy, demonstrating safety, feasibility and potential to facilitate the effective rehabilitation treatment, promoting motor recovery. The objective of this study is to analyze and compare the effectiveness of virtual therapy and conventional physiotherapy in paretic upper and lower limbs of patients with sensory motor deficit after stroke. Virtual therapy will be based on a custom application using virtual reality projection, and conventional treatment will be based on cinesiotherapy for members upper and lower paretic. The evaluation will be performed by biomedical instrumentation using dynamometry, electromyography and analysis from functional movement. Statistical differences are based on t test with significance level of p 0 , 05 . As a result expected - scientifically proven the effectiveness of this new form of treatment aimed at improving quality of life and functional independence of patients with neurological sequel.

Eligibility Criteria:
Inclusion Criteria:

* Medical referral for physiotherapy;
* Maximum grade 2 spasticity in the upper and lower limbs according to the Modified Ashworth Scale;
* Total passive range of elbow joint and knee to the movement of flexion and extension;
* Independent ambulation, with or without support;
* Cognitive preserved, being able to respond to the command of the examiner;
* Least 6 months of injury;

Exclusion Criteria:

* Active infection, and rash at the site of application of NMES;
* Visual and hearing impairment;
* Joint stiffness and musculoskeletal injuries of the elbow and knee,
* Inability to interpret the therapeutic resources to be displayed;
* Presenting lesions in areas of Wernick and drill;
* Uncontrolled hypertension.
Safety and Efficacy of Prochymal® for the Salvage of Treatment-Refractory Acute GVHD Patients

This study is designed to evaluate the safety and efficacy of Prochymal® (Ex-vivo Cultured Adult Human Mesenchymal Stem Cells) in participants experiencing treatment-refractory acute GVHD, Grades III-IV, that is refractory to standard first-line therapies and at least one second-line therapy.

Allogeneic hematopoetic stem cell transplantation (HCT) is used in the treatment of a variety of hematological, myeloproliferative and lymphoproliferative disorders, and malignancies involving solid tumors. Patients receiving HCT can develop a life-threatening condition called graft versus host disease (GVHD). GVHD occurs when donor T cells from the donor bone marrow recognize host cells as "foreign" and initiate an inflammatory immunological response. The standard of care for treatment of acute GVHD consists of intravenous delivery of methylprednisolone starting on day 1 and continuation of either cyclosporine or tacrolimus. This regimen of steroids and immunosuppressive drugs may relieve symptoms of GVHD, but some patients are refractory to current standard of care treatment. For treatment-refractory patients with grades III-IV GVHD mortality is approximately 80%. A therapy that could effectively suppress the immunological response from GVHD and help repair the damaged tissue could significantly decrease the mortality rate from this disease.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be 6 months to 70 years of age inclusive.
* If female and of childbearing age, participants must be non-pregnant, not breast-feeding, and use adequate contraception. Male participants must use adequate contraception.
* Participants must have Grade III-IV acute GVHD that has failed to respond to standard first and at least one second-line therapy. Biopsy for confirmation of both skin and gastrointestinal GVHD is not mandatory, but is recommended when feasible. Enrollment should not be delayed awaiting biopsy results.
* Participants must have minimal renal function as defined by: Calculated creatinine clearance (CrCl) of \> 30 milliliters/minute (mL/min) using the Cockcroft-Gault equation.
* Participants must provide written informed consent and authorization for use and disclosure of protected health information (PHI).

Exclusion Criteria:

* Participant has uncontrolled alcohol or substance abuse within 6 months of treatment.
* Participant has any underlying or current medical or psychiatric condition that, in the opinion of the Investigator, would interfere with the evaluation of the participant (e.g., uncontrolled infection, right heart failure, pulmonary hypertension, etc.).
* Participant has a clinically significant, unstable arrhythmia.
* Participant has a known allergy to bovine or porcine products.
* Participant is unwilling to sign consent form for the long-term follow-up study, Protocol 271.
Prevalence of Upper Limb Musculoskeletal Abnormalities in Type 2 Diabetic Patients and Its Relation to Hypoglycemic Control.

to investigate prevalence of upper limb musculoskeletal disorders and correlations to glycemic control.

). DM is associated with a number of complications including renal disease, peripheral neuropathy, retinopathy, vascular events and musculoskeletal complications. DM is complicated by musculoskeletal problems of upper extremity and particularly the hand, collectively referred as "the diabetic hand." (3) The most common upper limb musculoskeletal disorders associated with DM are adhesive capsulitis, rotator's cuff tendinitis, limited joint mobility (LJM), Dupuytren's disease (DD), trigger finger (TF), and carpal tunnel syndrome (CTS). Upper limb musculoskeletal disorders affect hand functions and activities of daily living (ADL). Aim of the study: to investigate prevalence of upper limb musculoskeletal disorders and correlations to glycemic control.

Inclusion criteria: patients will be included to this study(cases) if they are:

1) Diabetic patients. 2) Age \> 18 years. 3) Diagnosed as type 2.

Exclusion criteria:

Patients will be excluded if they have rheumatoid arthritis, other rheumatological diseases or previous upper limb surgeries.

Sample size calculation: By reviewing literature, it is found that the most relevant study (3) to our work found that the prevalence of upper limb musculoskeletal abnormalities in type 2 diabetic patients is .22 and for control group is .05 so, by using piface calculator (version 1.76) to calculate sample size (power = 0.8, alpha error = 0.05 and beta= 0.2) it is found that we need 71 participants for every group. To increase power of the study will enroll 100 participants for every group.

Eligibility Criteria:
Inclusion Criteria:

* patients will be included to this study(cases) if they are: 1) Diabetic patients. 2) Age \> 18 years. 3) Diagnosed as type 2.

Exclusion Criteria:

- Patients will be excluded if they have rheumatoid arthritis, other rheumatological diseases or previous upper limb surgeries.
Immune Response and Risk of Serious Infection to SARS-Cov2

To date, nearly 2 million people, including at least 100,000 in France, have been infected with SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2). This infection is very heterogeneous in nature, ranging from asymptomatic forms to acute respiratory distress syndrome patterns in 6.1% of cases, leading to an estimated overall mortality of 5.2%.

Apart from age, few risk factors for a pejorative evolution have been identified: arterial hypertension, diabetes, cardiovascular history, obesity and chronic respiratory pathology in particular. The median incubation period is 5 days and the median time between the appearance of the first symptoms and the onset of hypoxia requiring admission to intensive care is 7 to 12 days. The mechanisms involved in the occurrence of these secondary worsening patterns are unclear. One hypothesis is that it is related to an inappropriate inflammatory response rather than a direct cytopathic effect of the virus. The objective of this study is to measure the intensity of the T lymphocyte response in patients hospitalized for Cov2 SARS infection in order to determine whether the intensity of the response is associated with worsening of symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Person having given his or her non-opposition
* Patient hospitalized with an SARS-Cov2 infection proven by virological sampling (nasopharyngeal or sputum PCR) less than 8 days old.

Exclusion Criteria:

* Person subject to a legal protection measure (curatorship, guardianship)
* Person subject to a safeguard measure of justice
* Pregnant, parturient or breastfeeding woman
* Major incapable or incapable of giving consent
* Minor
Long-term Safety Study of Alogliptin in Participants With Type 2 Diabetes in Japan

The purpose of this study was to evaluate the long-term safety and efficacy of SYR-322, once daily (QD), to an α-glucosidase inhibitor, three times daily (TID), administered for 40 consecutive weeks in participants who completed a phase 2 dose-ranging study.

Both insulin hyposecretion and insulin-resistance are considered to be involved in the development of type 2 diabetes mellitus.

Takeda is developing SYR-322 (alogliptin) for the improvement of glycemic control in patients with type 2 diabetes mellitus. Alogliptin is an inhibitor of the dipeptidyl peptidase IV (DPP-IV) enzyme. DPP-IV is thought to be primarily responsible for the degradation of 2 peptide hormones released in response to nutrient ingestion. It is expected that inhibition of DPP-IV will improve glycemic control in patients with type 2 diabetes.

To evaluate the long-term safety and efficacy of alogliptin, this extension study was administered for 40 consecutive weeks (52 weeks from the start of treatment in the phase 2 dose-ranging study) to participants who had completed the phase 2 dose-ranging study SYR-322/CCT-001 (NCT01263470).

Eligibility Criteria:
Inclusion Criteria:

* Had completed the phase 2 dose-ranging study (i.e., the subject had completed the study visit at Week 12).

Exclusion Criteria:

* Had clinical manifestations of hepatic impairment (e.g., an aspartate aminotransferase or alanine aminotransferase value 2.5 times or more of the upper reference limit at Week 8 of treatment in the phase 2 dose-ranging study).
* Had clinical manifestations of renal impairment (e.g., a creatinine value of 2 mg/dL or more at Week 8 of treatment in the phase 2 dose-ranging study).
The Comparison of Supraperiosteal Nerve Block With Opiate Analgesia in Alleviating the Pain of Toothache

This study will compare the degree of pain control provided by two techniques for persons with toothache in an emergency department. The two techniques include;

* standard oral narcotic pain medication
* numbing the tooth with local anesthetic by needle injection

Background: Toothache is a common complaint among patients presenting to the emergency department. There are two commonly employed methods of alleviating this severe form of pain. Oral opioid analgesia is the most commonly utilized strategy for treating this pain. However, many emergency physicians and dentists employ a local anesthetic technique known as supraperiosteal nerve block. This study will compare the relative efficacy of these techniques.

Patients meeting enrollment criteria will be randomized to either receive a supraperiosteal nerve block or oral hydrocodone 10 mg/acetaminophen 650 mg. They will otherwise be managed identically. Reduction of pain scores between entry and 30 minutes post intervention will be compared as well as numeric pain scores obtained by phone contact 24 hours later. Secondary outcomes will include the proportion of individuals from each group filling prescriptions for pain medication and the number of pain pills taken.

Eligibility Criteria:
Inclusion Criteria:

* Involvement of a single tooth
* Percussive tenderness of the crown of the suspect tooth

Exclusion Criteria:

* Age younger than 18 years
* Women who are breast feeding
* Allergy or intolerance to hydrocodone, bupivacaine or acetaminophen
* Pregnancy
* Involvement of multiple teeth
* Pain resulting from pericoronitis.
* Pain resulting from dental trauma occurring less than 90 days prior
* Pain of more than 96 hours duration
* Facial or neck swelling or tenderness
* Alteration in phonation
* Cognitive impairment
* Concurrent use of opiate analgesics
* Impairment of liver function
* Consumption of more than 4 grams of acetaminophen in the past 24 hours.
* Patients who are visually impaired.
Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) During Soft Tissue Open Surgeries

This study is designed to assess the safety and efficacy of fibrin sealant (FS) Grifols in patients undergoing elective (non-emergency) soft tissue open surgery where bleeding may be present. The purpose of this study is to demonstrate that FS Grifols is not inferior to commercially-available oxidized cellulose pads (Surgicel®) in providing benefit in the time to hemostasis (i.e, the stoppage of bleeding). This study has a Preliminary Part (I) for study teams to become familiar with the application of FS Grifols and a Primary Part (II) to assess the safety and efficacy of FS Grifols. In both parts of the study, patients will be randomized in a 1:1 ratio to either FS Grifols or Surgicel.


Eligibility Criteria:
Inclusion Criteria:

* Hemoglobin (Hgb) ≥ 8.0 g/dL at Baseline (within 24 hours prior to surgical procedure).
* Require elective (non-emergency), open (non-laparoscopic) surgical procedure involving soft (non-parenchymous) tissue.
* Target bleeding site is identified on soft tissue during urologic, gynecologic or general surgery procedures: 1) Simple or radical nephrectomies, 2) Total adrenalectomies, 3) Radical prostatectomies, 4) Pyeloplasties, 5) Radical cystectomies, 6) Simple or radical hysterectomies, 7) Lymphadenectomies (in the retroperitoneal or pelvic region only), 8) Retroperitoneal tumor resections, 9) Mastopexies, and 10) Abdominoplasties.
* A target bleeding site can be identified.
* Target bleeding site has moderate bleeding according to the Investigator's judgment.

Exclusion Criteria:

* Require thoracic, abdominal, retroperitoneal or pelvic surgery due to trauma.
* Infection in the anatomic surgical area.
* History of severe (e.g. anaphylactic) reactions to blood or to any blood-derived product.
* Previous known sensitivity to any FS Grifols component or any Surgicel® component.
* Females who are pregnant or nursing a child at Baseline (within 24 hours prior to surgical procedure).
* Receiving an organ transplant during the same surgical procedure.
* Undergone a therapeutic surgical procedure within 30 days from the screening visit.
* A target bleeding site cannot be identified.
* The target bleeding site has a mild or severe bleeding.
* Occurrence of major intraoperative complications that require resuscitation or deviation from the planned surgical procedure.
* Application of any topical haemostatic material on the cut soft tissue surface identified as the target bleeding site prior to application of the study treatment.