cyrilzakka/clinical-trials huggingface dataset:
Use of Postop Sling After Biceps Tenodesis

The purpose of this study is to evaluate whether the use of a sling after surgery (biceps tenodesis) is required in recovery and rehabilitation. Biceps tenodesis is one of the most common surgeries for patients who have biceps tendon inflammation and/or instability, rotator cuff tears, and labral tears that do not get better with medications or physical therapy. A biceps tenodesis involves cutting the biceps tendon and reconnecting it to the shoulder with sutures or metal screws. After surgery, most patients are required to wear a shoulder sling and limit certain arm motions to protect the healing tendon. A recent study found using a more flexible rehabilitation protocol for biceps tenodesis did not change outcomes (strength or range-of-motion) and allows patients to return to some regular activities earlier. This data suggests patients may not need to wear a sling after surgery. Therefore, this study aims to evaluate this.

This study will have two groups-one that continues to wear the sling, and one that does not. Patients will be randomly assigned to one of these groups. At each follow-up visit after surgery, shoulder strength and range-of-motion will be measured and several surveys about shoulder function will be completed. These surveys will provide information to compare between both groups. If assigned to the group that wears the sling, patients will record how often they are wearing the sling in a paper diary/log. Additionally, at the 6-month follow-up, an ultrasound will be obtained to make sure the tendon is healing properly regardless of which group patients are assigned to. Finally, medical history will be collected to identify protective and risk factors for any differences that might be found.


Eligibility Criteria:
Inclusion Criteria:

* Patients who undergo open or arthroscopic isolated BT for diagnoses including but not limited to biceps tendinitis or tenosynovitis, biceps tendon tears, partial-thickness rotator cuff tears, subacromial bursitis, superior labrum from anterior to posterior (SLAP) tear, biceps instability
* Patients with minimum 6-month follow-up

Exclusion Criteria:

* Patients who undergo any concomitant procedures necessitating ROM restrictions, including but not limited to rotator cuff repair, labral repair, SLAP lesion repair, or shoulder arthroplasty
* Patients with history of prior ipsilateral proximal biceps procedures
* Patients with history of conditions resulting in severe shoulder strength and ROM limitations (e.g. severe degenerative glenohumeral osteoarthritis, polymyalgia rheumatica, cervical radiculopathy, significant muscle paralysis, etc.)
Pharmaceutical Intervention and Adherence to bDMARDs in Spondyloarthritis.

There is a lack of knowledge among patients concerning their treatment with bDMARDs, which could lead to low adherence.

The objective of this study is to assess the impact of a pharmacist's intervention on the adherence to bDMARDs in patients with Spondyloarthritis.

This is an interventional, controlled, open-label and monocentric study. 80 patients are planned to be included.

After written informed consent will be obtained, the patients will be randomized in two arms:

* Intervention arm: intervention of a pharmacist who will explain bDMARDs management.
* Control arm, without intervention.

Two primary end-points are defined:

1. the changes from baseline to M6 in the patients' knowledge score about subcutaneous bDMARD management
2. the changes from baseline to M6 in Medication Possession Ratio (MPR)

As secondary end-points, the changes in disease activity and patients' satisfaction regarding the pharmacists' intervention are evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Outpatients from Rheumatology Department at Cochin Hospital
* Diagnosis of Spondyloarthritis
* Under treatment with subcutaneous bDMARDs for at least 6 months
* Disease activity stable for at least 6 months
* No treatment modification 3 months before or after inclusion in the study
* Informed consent signed and dated
* Older than 18 years
* Patients who speak french

Exclusion Criteria:

* Patients who have had a change in the treatment of SpA during the 3 months prior or after the inclusion
* History of psychological problems
* Patients who need other persons to manage their treatment.
Establishment of an Anaesthetic Protocol for Examinations for Children With Glaucoma or Suspected Glaucoma

Correct measurement of the intraocular pressure of children with glaucoma or suspected glaucoma is essential for diagnosis and therapy.

Despite new non-invasive measurement methods most of the children are uncooperative during the ophthalmological examination. Therefore examination under anaesthesia is needed.

A lot of perioperative factors influence the measurement of intraocular pressure.

Established and safe anaesthetic regimes have been modified regarding these factors. Aim of the study is to evaluate, if a standardized anaesthetic protocol generates reliable and reproducible measured values.


Eligibility Criteria:
Inclusion Criteria:

* Indication for a general anesthesia (laryngeal mask) and ophthalmological examination and probably surgery
* Children with glaucoma or suspected glaucoma
* ASA classification I-III
* written informed consent of the legal representatives

Exclusion Criteria:

* Contraindication for a laryngeal mask airway
* Known allergy to propofol or remifentanil
Improving Diagnosis of Tuberculosis in HIV Infected Children in Asia (Cambodia, Vietnam)and Africa (Burkina Faso, Cameroon)

Childhood tuberculosis (TB) accounts for 11% of the total 9 million annual TB cases and the difficulty of its diagnosis is increased in case of HIV infection in children.

The aim of this study is to improve TB diagnosis in HIV-infected children by developing a new diagnostic algorithm incorporating new tools available such as:

* interferon gamma release assays (IGRAs), as alternative to the tuberculin skin test
* alternative specimen collection methods such as string test (or Enterotest (R)), nasopharyngeal aspirates and stools samples, as alternatives to gastric aspirate
* the Xpert MTB/RIF assay


Eligibility Criteria:
Inclusion Criteria:

* children aged from 0 to 13 years
* confirmed HIV infection
* suspicion of tuberculosis
* informed consent signed by at least one parent or guardian
* on ARVs or not

Exclusion Criteria:

* history of anti TB treatment started in the past 2 years
* on going tuberculosis treatment
* Suspicion of exclusive extra-thoracic tuberculosis
Male Partner Involvement in the Prevention of MTCT of HIV

The study aims to invite male sexual partners to attend antenatal clinic with their pregnant partners to either acquire pregnancy information or undergo voluntary counselling and testing for HIV. To see if male sexual partner involvement will decrease sexual risk behaviour.

We will enrol 1000 pregnant women; recruited from antenatal clinic at Khayelitsha Midwive and Obstetric Unit (MOU). Community sensitization activities will be implemented in the catchment community to encourage male partner participation.

At the booking visit all women will be offered antenatal care, HIV group education and VCT as usual. Thereafter women will be recruited to enrol into the study, after signing the consent form half of the cohort members will be randomly assigned to partner VCT (Group A) and half to partner pregnancy information (Group B). Men in group B will be offered VCT at the second interview late in pregnancy. However, VCT will be provided if requested by study participants at any stage of the study or if the female partner is HIV positive. Women in group A will be given a written invitation to hand to their partners to encourage them to invite their partners to come to the antenatal clinic for VCT. In group B, women will be given a written invitation to give to their partners to encourage their partners to attend a pregnancy information session at the antenatal clinic.

VCT will be offered again close to delivery for all women and men who were previously uninfected or of unknown status. For those found to be HIV-infected at a prior visit, CD4 and CD8 T-cell counts, viral load, and full blood count tests will be conducted. Both women and men will be referred to the Antiretroviral clinic where ARV will be offered if appropriate and formula feeding (or exclusive breastfeeding) will be recommended. Reasons for declining VCT and data on sexual behaviour and violence will be sought at each visit.

Eligibility Criteria:
Inclusion Criteria:

* To be eligible for participation, a woman must be less than 30 weeks pregnant at enrolment.

Exclusion Criteria:

* Women who are more than 30 weeks pregnant will be excluded.
Network Dysregulation Among Individuals With Comorbid Tinnitus and PTSD

Evaluation of the overlap between tinnitus-related distress and symptoms of Post Traumatic Stress Disorder (PTSD), to identify functional covariance among resting-state networks among individuals with tinnitus and PTSD

The purpose of this study is to characterize tinnitus and PTSD symptomatically, neurobiologically, and causally, applying causal modeling to psychometric and neurofunctional data. We will enroll 30 individuals with both tinnitus and PTSD. Participants will be asked to complete baseline assessments of subjective tinnitus distress, PTSD, depression, and resting-state fMRI at baseline. Individuals with comorbid tinnitus and PTSD who are eligible for the study will receive 12 sessions of Cognitive Processing Therapy (CPT) over a 6- to 15-week period. CPT is a trauma-focused treatment for PTSD that guides individuals on how to recognize and challenge thoughts that are erroneous and dysfunctional. One-month follow-up assessments of tinnitus-related distress, PTSD, depression, and anxiety will be conducted, along with resting-state functional magnetic resonance imaging (fMRI).

Eligibility Criteria:
Inclusion Criteria:

* Adult military Veterans (age 18-60) who deployed in support of combat operations post-9/11 seeking behavioral health treatment for PTSD and/or tinnitus
* Diagnosis of PTSD determined by the Clinician-Administered PTSD Scale - Interview - Version 5 (CAPS-5)
* Ability to speak and read English
* Meets criteria for tinnitus and considers their tinnitus bothersome, as defined by a score on the Tinnitus Functional Index of 32 or greater

Exclusion Criteria:

* Currently receiving evidence based treatment for PTSD
* Current suicidal ideation severe enough to warrant immediate attention (as determined by the Depressive Symptoms Index- Suicidality Subscale and corroborated by a clinical risk assessment by a credentialed provider
* Psychiatric hospitalization in the last 12 months
* Current and severe alcohol use warranting immediate intervention based on clinical judgment
* Current manic episode or psychotic symptoms requiring immediate stabilization or hospitalization (as determined by the manic and psychosis modules of the MINI)
* Evidence of a moderate or severe traumatic brain injury (as determined by the inability to comprehend the baseline screening questionnaires)
* Neurobiological disorders
* Meniere's disease, temporomandibular joint disorders
* History of seizures
* History of penetrating head trauma or neurosurgery
* Metal objects implanted in the head, ferrous metal filings in the eye
* Inflammation of the brain
* Cardiac pacemaker
* Implanted medical pump or cardiac lines
* Heart disease
* Currently taking certain types of medication for depression or seizures (tricyclic antidepressants or neuroleptics which lower seizure threshold)
Molecular Profiling Project

In this study, the investigators plan to undertake comprehensive molecular profiling of "actionable" alterations in lung cancer specimens in order to determine the prevalence of each genetic subtype in the local population.

ATORG is undertaking a comprehensive molecular profiling of "actionable" alterations in lung cancer specimens in order to determine the prevalence of each genetic subtype. These mutations are screened using the Oncomine Focus Assay, where 52 genetic alterations - including hotspots, single nucleotide variants, indels, CNVs, and gene fusions - may be detected in a single workflow. Oncomine™ Comprehensive Assay v3, an NGS assay which tests for 161 unique genes (Appendix IV), will be used in a later stage of the study, allowing for broader coverage of potentially targetable alterations. Both assays have a rapid turnaround time and addresses one of the main challenges of solid tumor testing - the scarcity of tissue material - requiring minimal sample input and thus enabling the use of a wider range of sample quality and types, including small biopsies and fine needle aspirates. However, as the list of therapeutically relevant biomarkers continues to expand over time, broader NGS panels will be used subsequently to incorporate emerging alterations. In addition, relevant baseline clinical characteristics are collated e.g. patient demographics, smoking history, number of lines of therapy, as well as outcomes including access to targeted therapies, immune checkpoint inhibitors and overall survival. Through comprehensive annotation of clinical-pathological-molecular characteristics, this study will provide a means to rationalize the application of diagnostic tests, as well as identify prognostic and predictive factors in the treatment of Asian lung cancers.

Eligibility Criteria:
Inclusion Criteria:

* The availability of sufficient archival tumor tissue specimen (15 slides of 4 microns per section)
* Age ≥ 21 years
* WHO performance status ≤ 2
* Life expectancy of ≥ 12 weeks
* Patients should have adequate organ function for potential consideration into clinical trials (routine blood tests are valid within 14 days before enrollment):

  * Adequate bone marrow function as shown by: ANC ≥ 1.0 x 10\^9/L, Platelets ≥ 75 x 10\^9/L, Hb ≥ 7.5 g/dL
  * Alanine aminotransferase (ALT) and aspirate aminotransferase (AST) normal range (or ≤3.0 x ULN if liver metastases are present)
* Willing to provide signed informed consent
* Patients whom do not fulfill the above criteria may be discussed on a case-by-case basis with the study team, for potential enrolment

Exclusion Criteria:

- No more than 3 lines of cytotoxic chemotherapy at the time of enrolment
Exercise in All ChemoTherapy

Exercise in all Chemotherapy (EnACT) is a study to assess safety, feasibility, and acceptability of an exercise program within chemotherapy. This will be a single group study to capture the effects of an exercise intervention on the average chemotherapy patient and the patients compliance to the study.

Several national and international agencies recommend exercise participation for all persons following a cancer diagnosis. The current evidence suggests that exercise training is safe during primary adjuvant therapy and improves physical function and quality of life outcomes. Moderate exercise has been shown to improve fatigue (extreme tiredness), anxiety, and self-esteem. It also helps heart and blood vessel fitness, muscle strength, and body composition. However, despite guidance on implementing exercise recommendations for cancer patients, exercise counseling is still not standard of care in cancer centers across the U.S. Our goal is to collect data that will assist with translation of the evidence from randomized clinical trials into standard of care.

Eligibility Criteria:
Inclusion Criteria:

* Males and females ≥18 years of age
* Fluent in written and spoken English
* Must be able to provide and understand informed consent
* Must have an ECOG PS of ≤ 2
* Diagnosed with a solid tumor malignancy
* Cancer patients (stage 1-4)
* Scheduled to receive chemotherapy at Penn State Cancer Institute
* Absence of absolute contraindications for exercise according to the American Heart Association
* Primary attending oncologist approval

Exclusion Criteria:

* Receiving chemotherapy at a location other than Penn State Cancer Institute
* Not fluent in written and spoken English
* Hematological malignancy
* Evidence in the medical record of an absolute contraindication for exercise
* Cardiac exclusion criteria:

  * Class II, III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system
  * History of acute coronary syndromes (including myocardial infarction and unstable angina), coronary angioplasty or stenting within the past 6 months prior to the start of chemotherapy
  * Uncontrolled arrhythmias; patients with rate controlled atrial fibrillation for \>1 month prior to start of chemotherapy may be eligible
  * syncope
  * acute myocarditis, pericarditis, or endocarditis
  * acute pulmonary embolus or pulmonary infarction
  * thrombosis of lower extremities
  * suspected dissecting aneurysm
  * pulmonary edema
  * respiratory failure
  * acute non-cardiopulmonary disorder that may affect exercise performance or be aggravated by exercise
  * mental impairment leading to inability to cooperate
* Non-English speaking
* Pregnant women
* Children (the protocol will only include individuals 18 and older)
Outcomes of a Trifocal IOL in Post-refractive Patients

To compare the prediction error of ORA vs formula for post-LASIK cataract patients when PanOptix IOL was implanted. Using post-operative outcomes to determine if preoperative IOL calculations, including Barrett TK, Barrett Universal II, Hill RBF, ASCRS post-refractive calculator, or intraoperative aberrometry is more accurate when the two methods disagree in patients who have had previous refractive surgery undergo cataract surgery.

The study will be non-interventional with data being collected prospectively and retrospectively between at least two surgical sites. All subjects will have previous LASIK and be at least 3 months post op PanOptix implantation. The study will enroll up to 200 patients and a statistical database will be created.

Eligibility Criteria:
Inclusion Criteria:

* Previous myopic refractive surgery
* At least 3 months post op cataract surgery with a trifocal IOL

Exclusion Criteria:

* Pre-existing or subsequent eye condition that interferes with accurate data collection (retinal detachment, etc.)
Chlorobutanol, Potassium Carbonate, and Irrigation in Cerumen Removal

Accumulation of cerumen in the external ear canal is a common problem. The presence of cerumen not only interferes with the clinician's view of the tympanic membrane, but may also result in hearing loss and vertigo, and may predispose to ear infections.

Removal of cerumen is facilitated by the use of a variety of ceruminolytics, or wax solvents. The current study was designed to evaluate the ceruminolytic effects of a single, brief application of the two most frequently used products in the investigators area, containing chlorobutanol or potassium carbonate with or without irrigation in the primary care setting in a randomized, single-blind trial. To our knowledge, this is the first randomized study comparing ceruminolytics with chlorobutanol versus potassium carbonate.

INTERVENTIONS: Subjects were randomly assigned to one of three different treatments: Otocerum®; Taponoto ®, and a control group with sterile saline solution (NaCl 0.9%, Braun Medical SA, Barcelona, Spain). The test medication was instilled into an occluded ear for 15 minutes. Following this treatment, the subject's ear was irrigated with 50 mL of water. The main outcome was the proportion of tympanic membranes that were completely visualized after cerumenolytic agents or saline, alone or with irrigation if needed.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of ear cerumen

Exclusion Criteria:

* Infection
Multiple Dose Escalation Study (14 Days) to Investigate Safety, Tolerability, PK and PD of Vardenafil and BAY60-4552

Safety, tolerability, pharmacokinetics and pharmacodynamics will be investigated in this multiple dose escalation study. In three treatments groups different dosages of BAY 60-4552 and vardenafil will be given with patients with erectile dysfunction.


Eligibility Criteria:
Inclusion Criteria:

* The informed consent must be signed before any study specific tests or procedures are done
* Male patients with a history of erectile dysfunction (ED) for at least 6 months, defined as "the inability to achieve and maintain an erection of the penis sufficient to complete satisfactory sexual intercourse" by the NIH consensus report 1993. The diagnosis of 'Erectile dysfunction' has to be confirmed by a physician
* Age: 18 to 70 years (inclusive) at the first screening examination
* Ethnicity: White
* Body mass index (BMI): equal to or above 18 and below 32 kg / m²
* Confirmation of the patient's health insurance coverage prior to the first screening examination / visit
* Ability to understand and follow study-related instructions

Exclusion Criteria:

* Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal
* Known hypersensitivity to the study drugs (active substances or excipients of the preparations)
* Known severe allergies, non-allergic drug reactions, or multiple drug allergies
* Any underlying cardiovascular condition, including unstable angina pectoris that would preclude sexual activity according to the NIH consensus report 1993
* History of myocardial infarction, stroke or life-threatening arrhythmia within 6 months prior to screening
* Bleeding disorder
* History of prostatectomy because of prostate cancer, including nerve-sparing techniques. Clarification: Any surgical procedures for the treatment of Benign Prostate Hypertrophy (BPH) are permitted, with the exception of cryosurgery, cryotherapy or cryoablation
* Hereditary degenerative retinal disorders such as retinitis pigmentosa
* History of loss of vision because of NAION (Bayer Study 12912), temporary or permanent loss of vision, including unilateral loss of vision
* History of uni- or bilateral hearing loss
Study to Evaluate Efficacy and Safety of Histrelin Subdermal Implant in Men With Advanced Prostate Cancer

Objective was to evaluate the efficacy and safety of the histrelin acetate subdermal implant (originally versus Lupron Depot-3 Month) in male patients with advanced prostate cancer during 52 weeks of treatment with the implant. After consultation w/ FDA, design was modified to eliminate the Lupron arm and continued the study as an open-label non-randomized study.

Primary endpoint was testosterone suppression, as assessed by the percent of patients whose testosterone indicated chemical castration levels (\<=50 ng/dL) through 52 weeks of treatment with an implant.

Other outcome measures included serum levels of LH, PSA, as well as non-clinical assessments, eg, WHO Performance Status, pain level assessment, and quality of life questionnaires. Safety was evaluated via adverse events, vital signs, clinical laboratory outcomes, physical examinations, and ECGs. Local tolerability outcomes were also evaluated.

An extension period for the study included annual replacement of the implant until the implant was approved by the FDA (October 12, 2004). Efficacy and safety were followed during the extension period.

Eligibility Criteria:
Key Inclusion Criteria:

* Male Age 45 or older
* Histologically confirmed adenocarcinoma of the prostate
* Disease Staging III or IV
* Clinical indication for androgen suppression therapy
* Serum testosterone at least 150 ng/dL at screening
* WHO Performance Scale 0 to 3
* Life expectancy of at least one year

Key Exclusion Criteria:

* Bilateral orchiectomy
* Prior androgen-ablative therapy within past year
* Second malignancy with 5 years (except adequately treated non-melanomatous skin cancer or superficial bladder cancer)
* Spinal cord compression