cyrilzakka/clinical-trials huggingface dataset:
A Study of Single and Multiple Doses of LP-005 in Healthy Adult Participants

The purpose of this study is to evaluate safety, tolerability, immunogenicity, pharmacokinetics, pharmacodynamics, and efficacy of LP-005 in healthy volunteers. The study will be conducted in 2 parts: Part 1, the single ascending dose (SAD) is the first in human (FIH) study of LP-005 and Part 2, multiple ascending dose (MAD).


Eligibility Criteria:
Inclusion Criteria:

1. Healthy males or females aged 18 through 50 years
2. Male subjects with a weight of ≥50 kg, female subjects with a weight of ≥45 kg, and BMI between 19.0 and 26.0 kg/m² (inclusive).
3. Vaccination: Meningococcal Conjugate Vaccine, Serogroups A, C, W, Y (MPV-ACYW) meningococcal conjugate vaccine and Streptococcus pneumoniae vaccine should be given 14 days or more before randomisation.
4. Male subjects and their partners or female subjects must agree to use one or more non-pharmaceutical contraceptive methods (such as total abstinence, condoms, Iuds, partner ligation, etc.) during the trial period and for 6 months after the trial, and do not plan to donate sperm or eggs.
5. The subjects fully understand the purpose, nature, method and possible adverse reactions of the experiment, and voluntarily participate in the experiment and sign the informed consent.
6. The subjects were able to communicate well with the researchers and complete the study according to the protocol.

Exclusion Criteria:

1. Participants who are immunocompromised or have one of the following underlying diseases: anatomic absence of spleen (including sickle cell disease); congenital complement component deficiencies (complement component 3 and complement component 4).
2. Any history of Neisseria gonorrhea, meningitis infection, and Guillain-Barré syndrome.
3. Contraindications to meningococcal vaccination (previous medical history such as epilepsy or other brain disorders).
4. Presence or suspicion of active viral, bacterial, fungal, or parasitic infection, including herpes, shingles, or cold sores, within 14 days prior to screening.
5. History of unexplained recurrent infections, or use of systemic antibiotics within 90 days prior to dosing.
6. Malignancy or history of malignancy, except non-melanoma skin cancer cured for more than 3 years.
7. Positive HIV test (HIV-Ab), positive hepatitis B virus (HBV) test (HBsAg), positive hepatitis C virus (HCV), positive anti-syphilis helix-specific antibodies.
8. Participation in a clinical trial of any other drug within 3 months prior to screening or within 5 half-lives of other clinical trial drugs (selecting the longer time period).
9. Women who are pregnant, breastfeeding, or at risk of pregnancy.
10. Any condition deemed unsuitable for study participation by the investigator.
A Clinical Study of Increased Dose of TA-650 in Patients With Psoriasis

The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics of TA-650 at increased dose of 10 mg/kg every 8 weeks in patients with psoriasis in whom effect of the treatment was confirmed after the treatment with Remicade® at 5 mg/kg every 8 weeks but decreased thereafter.

* Patients with plaque psoriasis or psoriatic arthritis:

  1. Screening Period:

     TA-650 at 5 mg per kg body weight is administered on the day of TA-650 administration at the start (week 0) and week 8 (if efficacy is not judged as decreased or maintained at week 8 of the screening period) , respectively, by intravenous infusion slowly over at least 2 hours.
  2. Increased Dose Period:

     If efficacy is judged as decreased in the screening period, TA-650 at 10 mg per kg body weight is administered on the day of TA-650 administration at the start (week 0) and at every 8 weeks up to week 32 in the increased dose period , respectively, as one dose by intravenous infusion slowly over at least 2 hours.
* Patients with pustular psoriasis or psoriatic erythroderma:

TA-650 at 10 mg per kg body weight is administered on the day of TA-650 administration at the start (week 0) and at every 8 weeks up to week 32, respectively, as one dose by intravenous infusion slowly over at least 2 hours.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have already been diagnosed as having plaque psoriasis, psoriatic arthritis, pustular psoriasis (excluding a localized), or psoriatic erythroderma.
* Patients in whom effect of the treatment was confirmed for a certain period after the start of administration of Remicade® at 5 mg/kg at every 8 weeks but decreased thereafter.

Exclusion Criteria:

* Patients who have guttate psoriasis.
* Patients who have drug-induced psoriasis
* Patients who have previously used any other biological products than infliximab.
* Patients who have a concomitant diagnosis, or a history within 6 months prior to provisional enrollment, of serious infections that need hospitalization.
* Patients who have a concomitant diagnosis, or a history within 6 months prior to provisional enrollment, of opportunistic infections
* Female patients who are pregnant, breast-feeding, or possibly pregnant.
Lomatuell Pro® Versus UrgoTul® in the Management of Acute Wounds

Comparative evaluation of the propertieS of the contact LAyer dressing LOMatuell Pro® versus UrgoTul® in the management of acute wounds

National, multicenter, prospective, randomized in parallel groups, non-inferiority, open-label investigation study.

Eligibility Criteria:
Inclusion Criteria:

* Acute wound: traumatic wound (dermabrasion, skin tears, other), small burns 1st and 2nd degree requiring the use of dressings
* Acute wound size between 3 cm² and 24 cm² (wound could be covered by 2 investigational products maximum)
* Wound whose duration is ≤ 3 days
* Both gender with an age ≥ 18 years
* Written confirmation from the study nurse that the patient was informed, orally agreed to participate and to comply with study treatment and planned visits
* Subject able to follow the protocol

Exclusion Criteria:

* Chronic and acute surgical wound
* Infected, moderately to strongly exudative and haemorrhagic wound
* Diagnosed underlying disease (e.g. diabetic neuropathy, stroke, etc.) which as judged by the investigator could interfere with the pain assessment
* Known allergy/hypersensitivity to any of the components of the investigational products
* Participation in other clinical investigation within one month prior to start of investigation
* Pregnant or breast-feeding women
* Person protected by a legal regime (tutorship or guardianship)
* Patients unable to manifest an oral consent to participate (e.g. dementia) or to understand the use of the VAS (visual analogue scale) tool
* Patient not covered by health insurance/social security
The Effects of Treatment With Sertraline for Noncardiac Chest Pain

The purpose of this study is to determine whether care as usual or intervention (consisting of sertraline versus placebo), are effective in the treatment of panic disorder and/or depression driven noncardiac chest pain.

Noncardiac chest pain remains an important problem in clinical cardiology. Often, panic disorder and/or depression are the underlying cause. However, this is largely underdiagnosed.

There are no clear existing treatment strategies/methods for this specific patient population.

In our double blind, placebo controlled care as usual versus sertraline study, we want to investigate whether intervention is more effective as care as usual for diminishing chest pain, and also if sertraline is more effective in this specific population compared to placebo.

Eligibility Criteria:
Inclusion Criteria:

* chest pain without a cardiac cause
* diagnosed with panic disorder and or depression according to Diagnostic and statistical Manual (DSM) IV criteria
* Living \< 50 km from the hospital
* informed consent

Exclusion Criteria:

* other primary DSM IV diagnosis
* known sensitivity to sertraline
* using other anti-depressive agents
* not speaking dutch language
* living in a nursery home or having dementia
* other severe, acute or progressive disease, kidney or liver-function disturbances, pregnancy or breastfeeding
Oculogica Portable EyeBOX Study

The objective of this study is to assess the accuracy of a portable version of the EyeBOX device, an eye-tracking based diagnostic, in comparison to a clinical reference standard of concussion. The utility of the portable assessment to aid in the monitoring of symptoms over time after an initial diagnosis of concussion will also be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* 1. Provide documented informed consent or assent along with guardian consent.
* 2. Have presented, at any time post injury, for any complaint related to an injury involving either a direct force to the head or a blow to the body that has the potential to transmit a rapid acceleration/deceleration of the head, with or without loss of consciousness, with or without external signs of head injury.
* 3. Be 5 to 67 years of age, inclusive.
* 4. Have the ability to provide a complete ophthalmologic, medical, and neurologic history as well as report current medications.

Exclusion Criteria:

* 1. Have penetrating trauma or known skull fracture or intracranial injury.
* 2. Have had a conventional head CT or MRI demonstrating evidence of structural brain injury (subdural, epidural or intraparenchymal hemorrhage, edema/mass effect per attending radiologist read).
* 3. Any of the following conditions, immediately related to the incident injury: loss of consciousness exceeding 30 minutes or best available Glasgow Coma Scale (GCS) score less than 13 within 24 hours or other acute conditions requiring emergency medical management.
* 4. Be blind (no light perception), have missing or non-functional eyes.
* 5. Be unable to open their eyes.
* 6. Have a history of unresolved strabismus, diplopia, amblyopia.
* 7. Have a history of unresolved cranial nerve III, IV, or VI palsy.
* 8. Have a history of unresolved macular edema, retinal degeneration, extensive cataract, or ocular globe disruption.
* 9. Have a history of extensive prior eye surgery or scarring (examples include strabismus surgery, scleral buckle repair of retinal detachment, repair of blow out fractures of the orbit and any procedures that would interfere with extraocular muscle movements; prior cataract surgery or Lasik are not exclusions).
* 10. Have a prior history of unresolved ocular-motor dysfunctions.
* 11. Be intoxicated.
Pain Inhibitory Effects of a Single Painful Mechanical Stimulus Compared to Multiple and Multiple at Different Locations

The objective is to estimate the effects on pain thresholds of a single painful mechanical stimulus compared to multiple and multiple stimuli at different locations.

The mechanical stimulus produced in manual therapy (MT) techniques elicits neurophysiological responses within the peripheral and central nervous system responsible for pain inhibition. Almost all types of MT elicit a neurophysiological response that is associated with the descending pain modulation circuit. But it has not been demonstrated whether this inhibition occurs through a conditioned pain modulation mechanism induced by painful mechanical stimulation that is carried out with manual therapy techniques.

Eligibility Criteria:
Inclusion Criteria:

* healthy male or female between 18 and 65 years
* Free of pain and with no history of chronic pain

Exclusion Criteria:

* Pregnant or having given birth within the last year
SHR-1701 in Combination With Famitinib in Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma

This is an open label, multi-center, phase I/II study to evaluate the efficacy and safety of SHR-1701 in combination with famitinib in subjects with recurrent/metastatic nasopharyngeal carcinoma(R/M NPC).


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed Recurrent/Metastatic Nasopharyngeal Carcinoma
* Subjects failure after platinum-based chemotherapy and anti-PD-1/PD-L1 antibody therapy;
* Able and willing to provide signed informed consent form, and able to comply with all procedures.
* Life expectancy \>= 12 weeks as judged by the Investigator.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at trial entry.
* Disease must be measurable with at least 1 uni dimensional measurable lesion by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
* Adequate hematological, hepatic and renal function as defined in the protocol Other protocol-defined inclusion criteria could apply

Exclusion Criteria:

* Anticancer treatment within 28 days before the first dose of study drug.
* Major surgery within 28 days before start of trial treatment.
* Systemic therapy with immunosuppressive agents within 7 days prior to the first dose of study drug; or use any investigational drug within 28 days before the start of trial treatment.
* With any active autoimmune disease or history of autoimmune disease.
* With active central nervous system (CNS) metastases causing clinical symptoms or requiring therapeutic intervention.
* History of immunodeficiency including seropositive for human immunodeficiency virus (HIV), or other acquired or congenital immunedeficient disease, or any active systemic viral infection requiring therapy.
* Previous malignant disease (other than the target malignancy to be investigated in the trial) within the last 2 years. Subjects with history of cervical carcinoma in situ, superficial or non-invasive bladder cancer or basal cell or squamous cell cancer in situ previously treated with curative intent are NOT excluded.
Anti-inflammatory Effects of Topical Erythromycin and Clindamycin in Acne Patients

The combined bacteriostatic and immunomodulatory effects of erythromycin and clindamycin will be explored. Treatment effects will be extensively characterized by conventional methods including lesion counts, global assessment scales and visual grading as well as state-of-the-art methodology, including multi-modal photo analysis, perfusion by laser speckle contrast imaging, analysis of local skin surface, biopsy biomarkers and skin microbiota. This extensive response profiling, combined with the mechanistic insights from concurrent in vitro and in vivo studies in healthy volunteer challenges, will increase the understanding of erythromycin's and clindamycin's effects in acne vulgaris.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy male and female subjects, 18 to 45 years of age. The health status is verified by absence of evidence of any clinical significant active or uncontrolled chronic disease other than AV following a detailed medical history, a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, virology and urinalysis;
2. Mild to moderate inflammatory acne vulgaris on the face, ≥5 inflammatory lesions (papules and/or pustules), present at screening and baseline visit
3. A maximum of 5 nodules present at screening and baseline visit
4. Inflammatory acne present for at least 6 months
5. Fitzpatrick skin type I-II (Caucasian)
6. Able and willing to give written informed consent and to comply with the study restrictions.
7. Willing to comply with 2x2mm facial skin punch biopsies

Exclusion Criteria:

1. Severe acne where systemic treatment is needed
2. Use of any topical (anti-acne) medication (prescription or OTC) within 2 weeks prior to baseline
3. Use of any oral/systemic treatment for acne, including oral antibiotics, excluding OAC, within 4 weeks prior to baseline
4. Use of systemic isotretinoin within 6 months prior to baseline
5. History of pathological scar formation (keloid, hypertrophic scar)
6. Known hypersensitivity to erythromycin or clindamycin, drugs of the same class, or any of their excipients.
7. Known contact dermatitis reaction to any product
8. Tanning due to sunbathing, excessive sun exposure or a tanning booth within 3 weeks of enrollment.
9. Participation in an investigational drug or device study within 3 months prior to screening or more than 4 times a year.
10. Loss or donation of blood over 500 mL within three months (males) or four months (females) prior to screening
11. Pregnant, a positive pregnancy test, intending to become pregnant, or breastfeeding
PRIMADOS Study:A Study of Avastin (Bevacizumab) Plus Docetaxel for First Line Treatment of Patients With Metastatic Breast Cancer

This single arm study will assess the efficacy and safety of first line combination treatment with Avastin + docetaxel in patients with HER2 negative metastatic breast cancer.Patients will receive Avastin (15mg/kg iv every 3 weeks) plus docetaxel (75mg/m2 every 3 weeks for 6 cycles). The anticipated time on study treatment is until disease progression, and the target sample size is 100 individuals.


Eligibility Criteria:
Inclusion Criteria:

* male and female patients, \>=18 years of age;
* stage IV, HER2 negative metastatic breast cancer;
* candidate for taxane-based therapy;
* ECOG performance status 0-2.

Exclusion Criteria:

* prior chemotherapy for metastatic breast cancer;
* concomitant primary malignant disease, except for adequately treated cervical cancer in situ, or basal or squamous cell skin cancer within last 5 years;
* suspicion of CNS metastasis;
* clinically significant cardiovascular disease.
Dynamics of the Anti-factor VIII Antibody Signature During Treatment With Emicizumab

The goal of this observational study is to learn about the changes of antibodies and inhibitors against the coagulation factor VIII in patients with severe hemophilia A receiving emicizumab therapy. No additional visits or procedures are planned. Patients in this study will continue to receive their routine care and analysis will be done from left over samples from routine visits.


Eligibility Criteria:
Inclusion Criteria:

* Severe congenital hemophilia A (CHA)
* Treatment with emicizumab irrespective of any other treatment
* Informed consent

Exclusion Criteria:

* No therapy with emicizumab
* Immunosuppressive therapy
* HIV-infection with CD4 (cluster of differentiation 4) cells \<200/µl
Oral Berotralstat Expanded Access Program

This expanded access program will provide access to berotralstat for eligible participants with hereditary angioedema in the U.S.

Physicians may request access to berotralstat for eligible participants with unmet medical need

Physicians can send email inquiries to access.us@inceptua.com or call 1-888-225-8677

Patients who may be interested should contact their physician about participation

Berotralstat (BCX7353) will be available through this expanded access program until it is commercially available

Eligibility Criteria:
Inclusion Criteria

Patients must meet all of the following inclusion criteria to be eligible for participation in this program:

1. At least 12 years of age
2. Able to provide written, informed consent or assent
3. Patients with a clinical diagnosis of HAE Type I or II who, in the opinion of their treating physician, are expected to benefit from an oral treatment for the prevention of angioedema attacks, and who are not eligible or able to access a berotralstat clinical trial
4. Females must use acceptable effective contraception

Exclusion Criteria

Patients must meet none of the below exclusion criteria to be eligible for participation in this program:

1. Pregnancy or breast-feeding
2. Any clinically significant medical condition or medical history that, in the opinion of the treating physician, would interfere with the patient's safety
3. Current infection with hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)
Safety and Efficacy Study of Healos as a Bone Replacement to Treat Degenerative Disc Disease

The purpose of this study is to determine the safety and effectiveness of HEALOS compared with autograft using the transforaminal lumbar interbody fusion (TLIF) method.


Eligibility Criteria:
Inclusion Criteria:

* Persistent back and/or leg pain refractory to 6 months of non-surgical therapy
* Male or female 18 to 70 years of age (inclusive)
* Objective evidence of significant disc degeneration at one or two adjacent lumbar level(s) from L2/L3 to L5/S1

Exclusion Criteria:

* Significant disc degeneration at more than two adjacent levels
* Greater than Grade II spondylolisthesis
* Prior fusion surgery of the lumbar spine (prior discectomies and intradiscal electrothermal therapy \[IDET\] are allowed)
* Insulin-dependent diabetes mellitus
* Pregnant or lactating, or wishes to become pregnant within the 24 month duration of the study
Performance of Novosyn® in Patients Undergoing Uterus Closure in Cesarean Section

The aim of this study is to collect clinical data on the use of Novosyn® applied for the uterus closure in cesarean section. Diverse parameters have been selected to assess that the safety and effectiveness of Novosyn® is comparable to published results, where the rate of SSIs in patients undergoing uterus closure in cesarean section was 10.6%.


Eligibility Criteria:
Inclusion Criteria:

* Female patients.
* Age ≥ 18 years
* Patients undergoing one of the following gynaecologic surgeries:
* scheduled (elective) cesarean section
* cesarean section in labour
* urgent cesarean section
* Use of Novosyn® following routine clinical practice.
* Patients with available electronic health records (EHR).

Exclusion Criteria:

* Any medical or psychological disorder that, in the investigator's opinion, may interfere with the patient's ability to comply with the study procedures.
* Participation in any clinical trial
Immunopathogenesis of Chlamydia

Sexually transmitted Chlamydia trachomatis infections are a widespread public health concern due to their prevalence and potentially devastating reproductive consequences, including pelvic inflammatory disease, infertility, and ectopic pregnancy. The goal of this study is to evaluate the risk factors for adverse outcomes following genital tract infection with Chlamydia trachomatis and to evaluate whether or not the presence of C. trachomatis in the rectum act as a reservoir for infection.

Sexually transmitted Chlamydia trachomatis infections are a widespread public health concern due to their prevalence and potentially devastating reproductive consequences, including pelvic inflammatory disease, infertility, and ectopic pregnancy. The goal of this study is to evaluate the risk factors for adverse outcomes following genital tract infection with Chlamydia trachomatis and to evaluate whether or not the presence of C. trachomatis in the rectum act as a reservoir for infection. Our target population will be adolescent females age 11-21 evaluated at the ACH Adolescent Center who are undergoing pelvic examinations or urine screening for sexually transmitted infections (STIs). Laboratory specimens obtained will include cervical and rectal swabs, urine and blood specimens, as well as, chart review and comprehensive subject interviews in the initial data collection with follow-up evaluations at 3, 6, 12, 24 and 36 months for qualifying subjects

Eligibility Criteria:
Inclusion Criteria:

* Female
* 11 to 21 years of age at the time of enrollment
* Positive for Chlamydia infections by urine or cervical PCR
* 5th Chlamydia-negative subject who fits all other inclusion criteria
* Negative pregnancy test
* Written informed consent provided
* Signed a HIPAA authorization form
* Willingness to comply with all the requirements of the protocol

Exclusion Criteria:

* Positive pregnancy test
* Negative for Chlamydia, unless 5th negative subject to be in the control group
* Any condition that in the opinion of the investigator would interfere with the ability of the potential subject to complete the study or would result in significant risk to the subject