cyrilzakka/clinical-trials huggingface dataset:
Human Amnion Membrane Allograft and Early Return of Erectile Function After Radical Prostatectomy

The purpose of this research study is to evaluate if placing a dehydrated human amnion chorion membrane (dHACM) over the nerves after removal of the prostate during surgery (radical prostatectomy) will allow an earlier recovery of erectile function and urinary control after surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Men aged 40 to 80 years with localized prostate cancer who are undergoing bilateral nerve-sparing RARP at the University of Miami (UM).

Exclusion Criteria:

1. Men requiring any use of pads for urinary leakage.
2. Men requiring the use of any non-oral erectile aids for erectile dysfunction (ED)
3. Men with baseline EPIC26 scores \< 60.
4. Previous treatment for prostate cancer.
5. Previous history of pelvic radiation.
6. Patients with impaired decision-making capacity.
Genotype-drive Study of Irinotecan-Cisplatin Combination for Advanced Gastric Cancer

The purpose of this study is to evaluate the efficacy and safety of first-line chemotherapy with cisplatin and irinotecan in advanced gastric cancer, and try to find out the optimal dosage of combination chemotherapy.

Open label single arm phase II study of cisplatin and irinotecan in patients with advanced gastric carcinoma not previously treated with palliative chemotherapy. 40 Patients will be enrolled in this local trial. The primary objective of this study is to determine the response rate of the treatment.Schedule for this study is as follows: 8 cycles/14 days of irinotecan 125 mg/m2 on Day 1 and cisplatin 50 mg/m2 on Day2. This study will also include genotype investigations of UGT1A1 and ERCC1 expression in order to assess determinants of efficacy and toxicity of the treatment with cisplatin and irinotecan in the study population.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven diagnosis of adenocarcinoma of the stomach (including adenocarcinoma of the gastroesophageal junction)
* Stage III or Stage IV disease, according to American Joint Committee on Cancer criteria
* Patients with UGT1A1\*28 genotype 6/6 or 6/7
* Performance Status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) performance status Scale
* Previous adjuvant or pre-operative chemotherapy without containing irinotecan or platinum at least 6 months before enrollment
* Adequate organ function including the following:

Bone marrow: absolute neutrophil count (ANC) \>or equal to 1.5 \* 109/L, platelets \>or equal to 100 \*109/L, hemoglobin \> or equal to 10 g/dL.

Hepatic: bilirubin \< or equal to 1.5 x ULN; alkaline phosphatase, aspartate transaminase (AST) and alanine transaminase (ALT) \< or equal to 3 x ULN (alkaline phosphatase, AST, ALT minor or equal to 5 x ULN is acceptable if liver has tumor involvement), serum albumin \> or equal to3g/dL.

Renal: Calculated creatinine clearance major or equal to 60 ml/min (using the standard Cockcroft-Gault formula).

Exclusion Criteria:

* No Prior palliative chemotherapy for advanced disease
* Previous radiation therapy is allowed but should have been limited and must not have included whole pelvis radiation. Patients must have recovered from the toxic effects of the treatment prior to study enrollment (except for alopecia). Prior radiotherapy must be completed at least 30 days before study enrollment
* Known or suspected brain metastasis
* Second primary malignancy
Impact of Severe Acute Respiratory Syndrome (SARS-CoV-2/COVID-19) Related Pneumonia on Lung Function and Structure.

Prospective study in a group of patients with COVID-19 pneumonia.

Objective:

Assessment of pulmonary and heart dysfunction, fibrosis-related markers and antibodies as well as the search for risk factors for an unfavorable course and possible complications in patients after pneumonia due to SARS-CoV-2 (COVID-19) infection.

Patients:

A group of approx. 100 patients assessed shortly after pneumonia and followed up, investigated after 3 and 6 months with possible prolongation to 12 months.

Eligibility Criteria:
Inclusion Criteria:

1. Confirmed SARS-CoV-2 infection with pneumonia hospitalized
2. Two negative PCR results of a swab from the respiratory tract in succession, including the last one taken no later than 3 days before the planned lung function tests (1st visit).

Exclusion Criteria:

1. Lack of patient consent,
2. Present contraindications for lung function tests
3. Inability to perform correctly lung function measurements
Epilepsy-Associated Stigma

Few data about epilepsy-associated stigma in France are available. The only study we have found showed that in France 66% of people with epilepsy felt stigmatized by their condition and are often single, compared with the other European patients interviewed (Baker et al., 2000). The purpose of this study is to assess the association between type of epilepsy (drug resistant-epilepsy and stabilized epilepsy) and perceived stigma (using the Stigma Scale) in patients recruited in the Limousin region .

Epilepsy-associated stigma leads important problems in terms of public health because it can provoke significant cognitive repercussions, impairment of quality of life and it causes physical injuries and serious disabilities. These social consequences often cause more suffering for patients than seizures themselves.

This heavy medical and social burden is associated with significant economic cost in terms of care and disability. It is also noted that mortality rate is 2 to 10 times higher than the general population.

It is therefore urgent to consider both medical and social dimension of consequences of epilepsy especially in patients with uncontrolled seizures.

It is also essential to detect a potential psychiatric disorder associated with epilepsy, especially depression and anxiety which are the most prevalent psychiatric comorbidities. These disorders are often under-diagnosed that can frequently leads to an inappropriate care.

The purpose of this study is to assess the association between type of epilepsy (drug resistant-epilepsy and stabilized epilepsy) and perceived stigma (using the Stigma Scale) in patients recruited in the Limousin region .

The primary outcome will be the score of perceived stigma obtained from the Stigma Scale.

This scale estimates a score of perceived stigma for each individual and allows classifying individuals in 3 categories.

Thus, individuals who obtain a total score of 0 will be those who do not feel stigmatized. Those whose scores will be over or equal to 1will be those who feel stigmatized. Finally, respondents whose the score is equal to 3 will be considered as having a strong perception of stigma.

A positive response is characterized by threshold ≥ 1.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and above
* diagnosed by a neurologist as suffering from drug-resistant epilepsy (all types of seizures) outpatient in Neurology service of the investigation centres
* inhabitant in the Limousin region
* having signed the informed consent
* affiliated or profiting of a social security system

Exclusion Criteria:

* patients that are deprived of their freedom
* patients with disabilities
* patients suffering from a chronic or an acute delusional disorder
* patients suffering from others handicaps
68Ga PSMA in Preprostatectomy Patients

This study investigates if a new drug (PSMA) makes prostate cancer easier to identify in positron-emission tomography (PET) imaging. If this works, prostate cancer treatments can be prescribed that match the location of the disease. PSMA is radiolabeled with Gallium-68 (Ga-68). This means a participant receives a small dose of radiation from the drug - less than the annual radiation limit for a medical worker.

To test this new drug, participants will receive an injection of Ga-68 PSMA and then have a PET scan. This PET scan, and the reported results, will be entered into the medical record and shared with the treating oncologists.

This study evaluates PSMA-HBED-CC labelled with Gallium-68, abbreviated 68Ga PSMA. This is a radiotracer that attaches to receptors in the membrane of prostate cancer cells. The 68Ga PSMA is identified using a positron emission tomography (PET) scanner. It is believed that 68Ga PSMA will identify prostate cancer more precisely than normal imaging methods (MRI, CT, or ultrasound). Imaging is key to successful treatment - disease must be identified to be treated.

Men who are scheduled to undergo a prostatectomy are invited to test 68Ga PSMA. Participants undergo the 68Ga PSMA PET scan before the prostatectomy. Information from the prostatectomy, including any MRI, CT, or ultrasound imaging, will be used to determine if the 68Ga PSMA PET imaging was better than the standard imaging.

Depending on the prostatectomy findings, participants may be invited back for a second 68Ga PSMA scan. This is done if the first scan showed positive lymph nodes or soft tissue metastases but the surgery/biopsy results do not.

The results from these scans will be shared with the participant. Results will also be entered into the participant's medical record and shared with the treating oncologists.

Eligibility Criteria:
Inclusion Criteria:

* Biopsy-proven prostate adenocarcinoma
* Intermediate to high-risk disease, defined as one of the following factors: PSA \> 10, T2b or greater, or a Gleason score of 7 or greater
* A PSA level resulted within the past 2 months
* Planned prostatectomy with lymph node dissection
* Karnofsky performance status (KPS) greater than or equal to 50 (ECOG/WHO 0, 1, or 2) within the last 3 months
* Must be treatment naïve (not have received neoadjuvant chemotherapy, radiation therapy, hormonal therapy, androgen deprivation therapy, or focal ablation techniques (e.g., HiFu)
* Not receiving any other investigational agents (i.e., unlabeled drugs or drugs under an IND for initial efficacy investigations
* Ability to understand and the willingness to provide informed consent.

Exclusion Criteria:

* Cannot receive furosemide
* Allergy to sulfa or sulfa-containing medications
* History of Stevens-Johnson syndrome
* Known Paget's disease
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Immunogenicity of HPV Vaccine in Transplant Recipients.

To measure levels of HPV antibodies in post-solid-organ transplant recipients who have gotten the HPV9 vaccine.

This is a prospective open-label nonrandomized single-center cohort study aimed to analyze the immunogenicity of nanovalent human papillomavirus vaccination (GARDASIL 9) in post-solid-organ transplant patients.

The study duration is anticipated to be 36 months. The expected duration of subject participation is 24 months. Immunocompromised populations are at greater risk of HPV infection. Quadrivalent HPV vaccination has been performed and lower titers of antibodies have been compared to published date in non-immunocompromised population (controls). The HPV9 vaccination titers have not been measured in the immunocompromised population to date.

We plan to enroll 30 adult solid-organ transplant recipients ages 18-45 years \>6 months from transplant receiving treatment at clinics at F\&MCW Main Campus.

Patients will be scheduled to receive 3-dose 9vHPV vaccination (vaccination at enrollment \[time 0\], 2 months \[+ 6 weeks\], and 6 months \[+ 6 weeks\] per standard guidelines).

Serial serum samples will be obtained for geometric mean titers (GMT) prior to vaccination, at 7 months (+ 6 weeks), 12 months (+ 6 weeks), and 24 months (+ 6 weeks) after completion of the vaccination series. If a patient is subsequently scheduled to undergo a transplant, we will obtain the GMT prior to the transplant.

Subjects will be asked to consent to optional banking of whole-blood for future research and translational studies. Blood will be stored in the Obstetrics \& Gynecology Specimen and Data Bank (PRO 11631) at Medical College of Wisconsin.

If subjects chose to participate in the optional banking of their blood, approximately 5 mls of additional blood will be drawn prior to vaccination and at the time of the 7, 12, and 24- month GMT blood draws.

Anti-HPV antibody responses will be measured using a proprietary MERCK Competitive Luminex Immunoassay (cLIA) which will be performed by Merck and expressed as geometric mean titers (GMT).

Eligibility Criteria:
Inclusion Criteria:

1. Patient between the age of 18 and 45 years
2. Patient is at least 6 months post-solid-organ transplant and has not received GARDASIL 9.
3. Patient who can participate in their health care and sign informed consent.
4. Patient may have had bivalent or quadrivalent HPV vaccination previously.
5. Living or deceased donor transplant patient is eligible.

   Exclusion Criteria:
6. Contraindication: Hypersensitivity, including severe allergic reactions to yeast (a vaccine component), or after a previous dose of GARDASIL 9 or GARDASIL.
7. Patient had completed vaccination series with a nonavalent HPV vaccine (e.g., GARDASIL 9) in the past
8. Patient with a diagnosis of HIV.
9. Patient that endorses being currently pregnant.
Assessment of Root Parallelism Following Orthodontic Treatment in Adolescent vs Adult Patients Treated With Maxillary First Premolar Extraction

Panoramic radiographs of finished orthodontic cases will be collected after fulfilling the inclusion and exclusion criteria. Then the collected data will be divided into two groups according to age either adolescent (12-18 years old) or adult group (after 18 years old).

in the panoramic views the long axes of canines and second premolar will be traced digitally using Digital softwares (microDicom vierwer Simeo Antonov Stoykov 0.7.7) \& (IC Measure 2.0.0.161).

The objective of this study is to assess the root parallelism between maxillary canines and second premolars in adolescents versus adults group of patients requiring maxillary first premolar extraction during the orthodontic treatment.


Eligibility Criteria:
Inclusion Criteria:

* Adults group of Patients (above 18 years old). .
* Adolescent group of patients (from 12 to 18 years old).
* Extraction of permanent maxillary first premolar in at least one quadrant.
* Same head position at scanning time.
* Same machine: Orthopantomograph Planmeca Promax 2P (Planmeca USA) with a kilovoltage of 55 to 85 and an exposure time of 15 seconds at a focal distance of 46 cm.
* Same type of bracket (Roth prescription, slot size #22).
* Full set of teeth (not necessarily including third molars)

Exclusion Criteria:

* Systematic diseases.
* non extraction cases.
* severe divergence or convergence between roots of maxillary canine and second premolar.
Intervention for Persons Leaving Residential Substance Abuse Treatment

This research uses a multi-phase approach to adapt and implement an established intervention, Critical Time Intervention, for a new population and setting among individuals with substance use who are at risk of relapse following residential substance abuse treatment. The goals of the study are to: (PHASE 1) identify challenges and strategies of community reentry among individuals in residential substance abuse treatment and their providers and social support networks (e.g., family, friends, community members); (PHASE 2) adapt CTI for individuals in residential substance abuse treatment to prepare them for discharge and transition back into the community; and (PHASE 3) conduct a pilot study to examine the feasibility, acceptability, and preliminary outcomes of the adapted CTI compared to enhanced usual discharge planning services.

This randomized pilot study will examine the feasibility, acceptability, and preliminary outcomes of the adapted CTI compared to enhanced usual discharge planning services. More specifically, 60 participants will be randomized to either CTI (n=30) or enhanced usual discharge planning services (n=30) at the time of discharge. Participants will complete a baseline interview (prior to randomization) and 3-, 6-, 9- and 12-month follow-up assessments post-discharge.

Eligibility Criteria:
Inclusion Criteria:

* Eligible participants will be enrolled in residential substance abuse treatment and who are at least 18 years of age, speak English, and expect to be discharged within 3 months.

Exclusion Criteria:

* Individuals that do not meet the aforementioned inclusion criteria will be excluded from the study.More specifically, the following categories will be excluded:

  1. Anyone under the age of 18
  2. Non-English speaking individuals due to limited resources
  3. Individuals who are considered vulnerable/protected populations, including children, pregnant women, and prisoners.
  4. Individuals judged by clinical treatment staff to be in immediate crisis, i.e., suicide watch or inadequate decisional capacity to participate in the study.
Relationships Between Ultrasound Data and the Impact of Lateral Epicondylar Pain

Our primary objective is to study the relationship between ultra sound data and the pain associated with tennis elbow.


Eligibility Criteria:
Inclusion Criteria for Tennis Elbow patients:

* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* The patient is available for 90 days of follow up
* Pain when pressure applied to the epicondyl
* Pain upon forced movement of both epicondylien muscles
* Absence of pain upon forced movement of an epitrochlear muscle
* Absence of one or more skeletal-muscle problem on the homolateral arm felt by the patient to be just as problematic as his/her tennis elbow
* at least one consult for pain treatment associated with tennis elbow (on the same elbow)

Inclusion Criteria for healthy volunteers:

* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* No pain when pressure applied to the epicondyl
* No pain upon forced movement of both epicondylien muscles
* No neck pain
* No skeletal-muscle problems in the arms during the 3 months preceding the study

Exclusion Criteria for Tennis Elbow patients:

* The patient is included in another study
* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection, under tutorship or curatorship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* The patient is pregnant
* The patient is breastfeeding
* Absence of one or more skeletal-muscle problem on the homolateral arm felt by the patient to be just as problematic as his/her tennis elbow

Exclusion Criteria for Health Volunteers:

* The subject is included in another study
* The subject is in an exclusion period determined by a previous study
* The subject is under judicial protection, under tutorship or curatorship
* The subject refuses to sign the consent
* It is impossible to correctly inform the subject
* Presence of one or more skeletal-muscle problems in the arms within the 3 months preceding the study
* Pain when pressure applied to the epicondyl
* Pain upon forced movement of both epicondylien muscles
* Consultation for any kind of treatment for elbow pain
Sonographic Evaluation of the Effect of Shoulder Orthosis on the Subluxation in Stroke Patients

Shoulder pain is frequently reported as a complication among stroke patients. Muscular imbalance disrupts stability of the glenohumeral joint creating a subluxation. Stretching the soft tissue can cause shoulder pain which impedes quality of life, length of stay and rehabilitation outcome. To align the humeral head in the cavitas glenoïdalis a shoulder orthosis is often provided to the patient. Since the use of these orthoses is not always considered positive by the patient nor the therapist the question rises if the investigators can objectify if the subacromial space is reduced when wearing a sling.

Sonography is a valid way to asses subluxation of the shoulder joint by measuring the subacromial space. To objectify if an orthosis can reduce the enlarged subacromial space the investigators will use sonography to measure the distance between acromion and greater tuberosity are between acromion and the humeral head. This distance will be measured with and without the orthosis and also after a period of at least 4 hours of wearing the orthosis. This last measurement might inform us about how long the orthosis can correct the glenohumeral position. To validate the sonographic measurement X-rays will be taken by a sample of the investigators study population to compare with the ultrasound data.

Two different orthoses will be compared. First of all the actimove sling, which is standardly used in the rehabilitation centre where patients will be recruited. This sling can be adapted by the patient itself and is very easy to wear. The disadvantage is that the elbow is continuously flexed, which enlarges the risk on contractures of m. biceps and m. brachioradialis. Also the negative influence on the interpretation of the body scheme and on the quantitative use of the arm can be reasons not to wear this kind of orthosis. The shoulderlift on the other hand is a newly developed orthosis which supports the shoulder joint with the arm extended. This is a more normal position during the daily living and stimulates the use of the paretic arm. An extra adaptation can be adjusted to make it possible to position the arm flexed in order to reduce oedema of the hand if necessary. The control group does not wear any orthosis at all.

Additional the investigators will evaluate passive range of motion of the shoulder, spasticity of the upper limb (modified ashworth scale), active motion of the upper limb (fugl meyer assessment) and trunk stability (Trunk Impairment Scale) at starting point and after a period of 6 weeks wearing the orthosis minimal 6 hours a day.

If possible the investigators will do an evaluation of balance on a moving platform and an evaluation of gait with and without the orthosis after 6 weeks to assess the impact of on balance and gait.


Eligibility Criteria:
Inclusion Criteria:

* First stroke
* Patients must be able to sit independently on a chair with arm support during 30 minutes

Exclusion Criteria:

* No shoulder problems prior to stroke
* No severe cognitive problems that make it impossible to understand brief commands;