cyrilzakka/clinical-trials huggingface dataset:
Effects of LY3848575 Versus Placebo in Participants With Painful Distal Sensory Polyneuropathy

The purpose of this study is to evaluate how safe and how well a treatment works compared to placebo for people with nerve pain that begins in their feet and moves up the leg to just below the knee.

Participation may last up to 30 weeks including screening.


Eligibility Criteria:
Inclusion Criteria:

* Have a Visual Analog Scale (VAS) pain value ≥40 and \<95 at screening.
* Presence of painful distal sensory polyneuropathy (DSP) without prominent motor or autonomic features with gradual or insidious onset with a minimum duration of 6 months and a known cause of nerve injury, such as metabolic, toxic exposure, nutritional, immunologic, infectious, hereditary, multifactorial, or no known cause identified (idiopathic), of symmetrical nature and in lower extremities (with or without involvement of the hands).
* Are willing to maintain a consistent regimen of any ongoing nonpharmacologic pain- relieving therapies and/or nutritional supplements and will not start any new nonpharmacologic pain-relieving therapies and/or nutritional supplements during study participation.
* Are willing to discontinue all medications taken for chronic pain conditions, except the allowed pain medications.
* Individuals NOT of childbearing potential may participate in the trial. Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Exclusion Criteria:

* Other etiologies of pain that may not be due to DSP or confound the assessment due to painful DSP.
* Have had a procedure within the past 6 months intended to produce permanent sensory loss in the target area of interest.
* Have not achieved glycemic control on a stable diabetes treatment regimen for at least 90 days prior to screening, have a healthcare provider who manages the participants' diabetes, and have a hemoglobin A1c (HbA1c) \>11% at screening.
* Cancer within 2 years of baseline, except for:

  * cutaneous basal cell or squamous cell carcinoma resolved by excision, or
  * cancer treatment which led to chemotherapy that caused distal sensory polyneuropathy.
* Are, in the judgment of the investigator, actively suicidal and therefore deemed to be at significant risk for suicide.
* Have a surgery planned during the study for any reason.
* History of chronic alcohol, illicit drug, or narcotic use disorder within 2 years prior to screening.
Somofilcon A 1-Day Multifocal Study - Real World Subjective Acceptance Study

The objective of the study is to evaluate the performance of somofilcon A 1 day multifocal when worn on a daily disposable wear modality over a period of up to 3 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Is at least 17 years of age and has full legal capacity to volunteer;
* Has read and signed an information consent letter;
* Is willing and able to follow instructions and maintain the appointment schedule;
* Has had a self-reported oculo-visual examination in the last two years.
* Currently wears multifocal soft contact lenses, and have worn multifocal contact lenses for at least one month;
* Presently wears lenses for minimum wear 4 days/week and 10 hours/day
* Participant has an anticipated ability to wear test lenses for minimum 5 days/week and 10 hours/day.
* Can be fit with the available test contact lens power range to achieve satisfactory vision i.e. 0.18 logMar (20/30) binocular distance acuity with the test lenses.
* Current refraction indicates a reading addition of +1.50 or higher
* Uses a digital device (computer/laptop/tablet etc.) for at least 5hrs/day
* Spends 10 hrs or more indoors at least 5 days/week
* Possesses a smartphone and is willing to download the MetricWire app to receive

Exclusion Criteria:

* Is presently wearing Clariti 1 day multifocal lenses
* Has astigmatism greater than -0.75 DCyl as determined with subjective refraction
* Is participating in any concurrent clinical or research study;
* Has any known active\* ocular disease and/or infection;
* Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
* Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
* Has known sensitivity to fluorescein dye or products to be used in the study;
* Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit);
* Is aphakic;
* Has undergone refractive error surgery;
* Is an employee of the Centre for Contact Lens Research
Efficiency of Manual Therapy on Central Sensitization in Patients With Nonspecific Chronic Back Pain

Central sensitization (CS) is defined as the increased responsiveness of nociceptive neurons in the central nervous system to normal or subthreshold afferent input. CS has been proposed as an underlying mechanism of chronic pain in musculoskeletal disorders including low back pain (LBP).

The aim of this study is to investigate the effect of manual therapy on central sensitization in patients with nonspecific chronic LBP.

A total of 40 LBP patients aged between 24-64 with CSS will be randomized into two groups. The manual therapy group will receive a 4-week manual therapy (two sessions/week) plus the conventional physiotherapy program, while the control group will only receive conventional physiotherapy. Before and after the interventions pain intensity (VAS), and scores of three questionnaires: Oswestry Disability Index (ODI), Central Sensitization Inventory (CSI), and the 36-item Short Form Health Survey Questionnaire (SF-36) will be recorded.The outcomes of the study will be analyzed by appropriate statistical methods.

Eligibility Criteria:
Inclusion Criteria:

* non-spesific low back pain patients with pain longer than 12 weeks
* aged between 20-64 years male and female participants

Exclusion Criteria:

* concomitant disease that would interfere with treatment
* pregnancy
* have had any spinal surgery or fracture
Safety and Immunogenicity Following Meningococcal and Pneumococcal Immunization Among Adult People Living With HIV

MENPI is an investigator-initiated single-centre randomized controlled trial which aims to assess the efficacy and safety of meningococcal and pneumococcal vaccination in adults living with HIV receiving antiretroviral treatment.

Participants are randomized 1:1 to either a two-dose Menveo® and Bexsero® regimen or a Prevenar13®/Pneumovax23® prime-boost regimen at day 0 and day 60 and cross over on day 90. All participants will follow an identical follow up program including plasma collection, pharyngeal swab, and adverse event registration.

Immunogenicity will be determined on venous blood sampled at 30 days post-vaccination and yearly for five years.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Seropositive for HIV-1
* Recipient of ART
* Plasma HIV-RNA \< 500 copies/ml
* Patients written consent obtained

Exclusion Criteria:

* Pregnancy or breastfeeding
* History of meningococcal or pneumococcal vaccination
* Allergies towards any of the vaccine components
* Temperature \> 38 ᵒC
* Sign of bacterial infection
* Previous known or suspected disease caused by N. meningitidis
* Active AIDS associated illness
* Active malignancy
* End-stage renal or liver disease
* Bleeding disorder
* Recipient of any blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation within the last month
* Use of immunosuppressive agents (corticosteroids, cancer chemotherapeutic agents etc.)
Obalon US Commercial Registry

Retrospective study of the data reported in the Obalon US Commercial Registry

Retrospective analyses of the safety and effectiveness data in the Obalon US Commercial Registry reported by participating clinics through August 28, 2018 from patients who started the Obalon therapy from January to December 2017 to represent the first year of commercialization. All patients included in the safety and efficacy analyses must have data through balloon removal and a starting BMI greater than or equal to 25, the definition of overweight and obese patients.

Eligibility Criteria:
Inclusion Criteria:

* Started Obalon Balloon Therapy between Jan.-Dec. 2017
* Weight loss data through balloon removal
* BMI \>25kg/m2
Intestinal Microbiota and Chronic Fatigue Syndrome

Gut microbiota of 1) patients with chronic fatigue syndrome and 2) their healthy family members are analyzed.

Up to 40 patients with chronic fatigue syndrome are randomized to receive either 1) a faecal transplant from a healthty donor or 2) their own feces via colonoscopy. Patient's health related quality and ability to work are assessed (baseline, 1 and 6 months after the procedure)

Patients with chronic fatigue syndrome (CFS) and their healthy family members (living together in the same house) are recruited in the study. CFS has been diagnosed in Tampere University Hospital and the diagnosis is based on thorough clinical assessment fulfilling the Institute of Medicine 2015 criteria. Patients microbiota is analyzed (microbiological analysis, mediators of inflammation) and results are compared with their family members.

Via colonoscopy, up to 40 patients with CFS are randomized to receive either a faecal transplant from a healthy donor (treatment group) or his/her own feces (placebo group). Products are blinded, investigators and patients are blinded. Patients' health related quality of life and ability to work or study are assessed (baseline, 1 and 6 months after the procedure).

Eligibility Criteria:
Inclusion Criteria:

-Chronic Fatigue Syndrome

Exclusion Criteria:

* Other conditions causing chronic fatigue
* Diseases affecting the intestinal system
A Comparison of the Pharmacokinetics, Safety and Tolerance of Two Formulations of a Liquid IVIg in Healthy Volunteers

The main object of the study is to compare the AUC0-84, of a single intravenous infusion of Vigam® Liquid (infused at the licensed rate of up to 3mL/min) with Gammaplex® (infused at up to 3mL/min and up to 6mL/min).


Eligibility Criteria:
Inclusion Criteria:

* Healthy, normotensive, non-smoking male and female volunteers aged 18 to 60 who gave written informed consent and fulfilled all of the inclusion criteria and none of the exclusion criteria.
* Female volunteers of childbearing potential had a negative pregnancy test before entering the study and had to use either a double barrier method of contraception or use the oral contraceptive pill.
* Postmenopausal or surgically sterile female volunteers could be enrolled.

Exclusion Criteria:

-
Study of the Impact of a School Program Combining - Promotion of HPV Vaccination and HPV Vaccine Offer in Middle School - on Adherence to HPV Vaccination in Middle School Students

Cervical cancer (CCU) is the fourth most common cancer in women worldwide. In Reunion island, CCU is the third leading cause of cancer in women (standardized incidence rate on the world population (TIS) in 2013 of 10.3 / 100,000) and is the eighth deadliest cancer with a rate standardized mortality of 4.8 / 100,000, almost three times higher than in mainland France where it was 1.7 / 100,000 in 2018.

CCU results from infection with the human papillomavirus (HPV), which is the most common sexually transmitted viral infection.

CCU prevention is mainly based on cervical smear screening and anti HPV vaccination (VHPV) which has demonstrated its effectiveness on the prevalence of HPV carriage, but also on incidence of condyloma or intermediate grade dysplasia. Since HPV is mainly transmitted sexually, it is important to vaccinate before the start of sex.

In Reunion island, the HPV vaccination coverage rate is the lowest in France, estimated by Public Health France at 8.1% among girls aged 16 years in 2018, while the already low national average was established 23.7%.

Thus, in view of the epidemiological situation in Reunion island (high incidence and mortality for the CCU, very low VHPV coverage rate), we thought it would be interesting to study the impact of a health promotion program sex and prevention of sexually transmitted infections (STIs) including papillomavirus-related pathologies, with a program to promote HPV vaccination among young students in middle school.


Eligibility Criteria:
Inclusion Criteria:

* schooled in one of the classes drawn at random in the 2 colleges selected for the study,
* members or beneficiaries of a social security scheme,
* having agreed to participate in the study and whose parents or holder (s) of parental authority have signed a free, informed and written consent.

Exclusion Criteria:

* under the age of 9, or over the age of 17 at inclusion,
* with hypersensitivity to the active substances or to any of the excipients of the vaccine (Gardasil 9®),
* with a permanent contraindication to vaccination.
* having already initiated the HPV vaccination (complete or incomplete scheme). Students with an incomplete vaccination schedule will be referred to their attending physician to complete the missing dose (s).
* pregnancy or breastfeeding (based on the declaration)
Results of Emotional Support Activities During Hospital Admission With a Diagnosis of COVID19

The aim of the study is to find out what care patients affected by anxiety, fear or loneliness have perceived and the perceived impact of this care. This knowledge will allow us to design measures aimed at improving nursing care of these aspects in the future.

This is a cross-sectional descriptive study to be carried out at the Consorci Corporació Sanitària Parc Taulí (CCSPT). The results of this study will provide information on the care received by patients admitted to COVID 19 affected by anxiety, fear or loneliness, the perceived impact of this care and will enable measures to be implemented to improve nursing care in the future. 450 patients, randomly selected from the Hospital de Sabadell database, will be included. In the sample, we will ensure that the proportion of women and men is in line with the distribution of the population to enable the incorporation of the gender perspective in the analyses. The quantitative variables will be described by means of their mean and standard deviation. Qualitative variables will be described in absolute and relative frequencies. In order to evaluate the suitability of the intervention to the needs of the patient, a table of concordance will be constructed between the actions proposed by the panel of experts and the actions carried out as referred by the patient. The kappa concordance index will be calculated and the degree of concordance will be classified according to the Landis and Koch scale. As regards the effectiveness of the intervention, the patients who were treated correctly and those who were not will be identified, and the percentage of positive impacts according to Csq-8 between the two groups will be compared by means of the Chi-square test.

Eligibility Criteria:
Inclusion Criteria:

* Patients over the age of 18 who were admitted with a diagnosis of COVID-19 to any CCSPT unit between March 13, 2020 and April 30, 2020 and were discharged with a recovery result

Exclusion Criteria:

* Communication problems or inability to read and speak Spanish
XmAb5871 Bioavailability Study

An open label comparison of concentration of the study medication administered intravenously (IV) versus subcutaneously (SC) in healthy volunteers.

The study will enroll approximately 50 eligible healthy male and female subjects between the ages of 18 to 55 inclusive. There will be 5 parallel dose cohorts (Cohorts 1-5) consisting of 10 subjects in each cohort. No subject will be a member of more than 1 cohort. Subjects will receive 3 administrations of study medication.

Eligibility Criteria:
Inclusion Criteria:

* Are adult males and females aged 18 to 55 years inclusive as of dosing (Day 1) with total body weight between 45.0 and 100.0 kg inclusive and body mass index (BMI) between 19.0 and 32.0 kg/m2 inclusive;
* Healthy as assessed by the Investigator with no clinically significant abnormality identified on medical or laboratory evaluation and no history of any clinically significant disorder, condition, or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion;

Exclusion Criteria:

* Subjects who have a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, connective tissue diseases or disorders that would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.
* Subjects who are positive for drugs of abuse or alcohol on screening or admission;
* Subject is pregnant or breast feeding, or planning to become pregnant within 3 months of administration of XmAb5871.
* Subjects who have used prescription drugs (with the exception of hormonal birth control for women of child-bearing potential) within 14 days or 5 half-lives, whichever is longer, prior to dosing (Day 1), unless agreed as not clinically relevant by the Principal Investigator and Sponsor.
* Subjects who have received live vaccines ≤3 months from Day 1.
* Malignancy within 5 years (except successfully treated in situ cervical cancer, resected squamous cell or basal cell carcinoma of the skin).
* Unable or unwilling to partake in follow-up assessments or required protocol procedures.
Post-Marketing Surveillance (Special Use-results Surveillance on Long-term Use) With Sogroya®

Participants are invited to take part in this study because they have AGHD (only severe case). The purpose of this study is to assess long term safety and effectiveness of Sogroya® in patients with AGHD (only severe case) under normal clinical practice condition in Japan. Participants will get Sogroya® as prescribed by the study doctor. Participants will be in the study for about 2 to 5 years depending on when they take part in the study. Participants will be asked to fill in the quality of life questionnaires.


Eligibility Criteria:
Inclusion Criteria:

1. Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol)
2. The decision to initiate treatment with commercially available Sogroya® has been made by the patient/LAR and the treating physician before and independently from the decision to include the patient in this study.
3. Male or female, no age limitation
4. Diagnosis of AGHD (only severe case)
5. GH treatment naïve ("naïve patients") or "switched patients". "Naïve patients" are patients who are not exposed to any GH product to date or patients who were exposed to other GH product more than 180 days prior to registration. "Switched patients" are patients who is now treated by other GH product or patients who were exposed to other GH product within 180 days prior to registration.

Exclusion Criteria:

1. Previous participation in this study. Participation is defined as having given informed consent in this study
2. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
3. Patients with hypersensitivity to the active substance or to any of the excipients
4. Patients with malignant tumor
5. Female patients who are either pregnant or likely to be pregnant
Implementation of Bright Light Therapy ID

Many adults with intellectual disabilities (ID) have depressive symptoms, which negatively impact their quality of life. A lot of of the non-medicinal forms of treatment are not or hardly suitable for people with ID. Bright light therapy (BLT) seems to be a good option. Earlier research has shown that BLT is applicable in this group and seems promising in terms of reducing depressive symptoms, without serious side effects.

In part 1 of this project we investigate the implementation of BLT at Amarant. We will take the lessons learned into part 2 of this project: the implementation of BLT at Abrona. We will evaluate this process and the outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Involved in the implementation of BLT (staff) OR
* Involved in the prescription or application of BLT (staff/relatives) OR
* receiving BLT for their depressive symptoms (patients with ID)
* 18 years or older
* informed consent

Exclusion Criteria:

* n/a
Phase II Study of Intensity Modulated Radiotherapy in Dose Painting for Sinus Carcinomas After Endoscopic Surgery

The patient is randomized to one of the following groups:

* Experimental group: Radiotherapy in painting dose on histoscannographic mapping
* Control group: standard pan-sinus radiotherapy


Eligibility Criteria:
Inclusion Criteria:

* Patients \>18 years of age
* Patient with histologically confirmed nasosinus carcinoma
* Patient treated by endoscopic sinonasal surgery with histosurgical mapping within 2 months prior to radiotherapy
* Indication for radiotherapy treatment (photontherapy or protontherapy), without neoadjuvant chemotherapy (concomitant chemotherapy is permitted)
* Signature of informed consent prior to any specific study procedure
* Subject affiliated to a social security system

Exclusion Criteria:

* Patient with not operated in place tumor
* Patient with distant metastases
* Patient treated with neoadjuvant chemotherapy
* Delay between surgery and radiotherapy greater than 8 weeks
* Other histologies (melanoma, sarcoma, lymphoma, etc.)
* Pregnant or breast-feeding woman or absence of contraception during genital activity
* History of any other malignant disease in the last 3 years, except basal cell skin cancer, carcinoma in situ or superficial bladder tumor. Any other solid tumor or lymphoma (without bone marrow involvement) must have been treated and show no sign of recurrence for at least 3 years.
* Simultaneous participation in another therapeutic clinical trial
* Patients deprived of their liberty, under guardianship, under curatorship, or subject to a legal protection measure, or unable to express their consent.
* Patients unable to undergo trial monitoring for geographical, social or psychopathological reasons