cyrilzakka/clinical-trials huggingface dataset:
A Safety and Performance PMCF Investigation of the Avance® Solo NPWT System in Surgically Closed Incisions

The ASOLO-SCI investigation is a Post Market Clinical Follow-up (PMCF) study to investigate the safety and performance of the Avance® Solo NPWT System in treating low to moderate exuding surgically closed incisions for up to 14 days when used in accordance with the Instructions for Use (IfU).

The ASOLO-SCI investigation is designed as a prospective, open, non-comparative, PMCF study to investigate the safety and performance of the Avance® Solo NPWT System in treating low to moderate exuding surgically closed incisions for up to 14 days when used in accordance with the IfU in up to 34 patients (n=34).

The ASOLO-SCI investigation is a multicentre study that is expected to take place in approximately three European centres.

The study treatment shall be stopped earlier (i.e. prior to 14 days), in the event study Subjects withdraw their consent, or shall the Principal Investigator and clinical team deem the Avance® Solo NPWT System to be no longer adequate for the study Subject's wound. Following termination of Subject participation for whichever reason in the study, the patient shall be followed in accordance with the local standard of care in wound management and treatment.

As a primary endpoint, the Principal Investigator and clinical team will evaluate whether the surgical incision remains closed, from baseline to study end at Day 14.

Eligibility Criteria:
Inclusion criteria:

1. Male or female ≥ 18 years of age.
2. Signed written Informed Consent Form.
3. Low to moderate exuding surgically closed incisions suitable for suNPWT, according with the Investigator´s judgement and the Avance® Solo NPWT System Instructions for Use.
4. Study subjects that are deemed capable and willing to comply with the protocol instructions.

Exclusion criteria:

1. Known malignancy in the wound or margins of the wound.
2. Untreated and previously confirmed osteomyelitis.
3. Non-enteric and unexplored fistulas.
4. Necrotic tissue with eschar present.
5. Exposed nerves, arteries, veins or organs.
6. Exposed anastomotic site.
7. Known allergy/hypersensitivity to the dressing or its components.
8. Known pregnancy or planning to become pregnant or breastfeeding at time of study participation.
9. Participation in another investigative drug or device trial currently or within the last 30 days.
10. Subjects not suitable for the investigation according to the Investigator's judgement, Clinical Investigation Plan and Instructions for Use.
Phase I/II Study of Oral S-1 Plus Irinotecan in Patients With Advanced Gastric Cancer

To assess the usefulness of irinotecan plus S-1 therapy based on the antitumor effect and survival period. by performing a phase I/II study of this combination in patients with inoperable or with postoperative gastric cancer

A multicenter Open-label, single-arm, phase I/II clinical trial is conducted on patients with histological stage IV gastric cancer given irinotecan plus S-1. The usefulness of this regimens as 1st line therapy for gastric cancer was evaluated by the disease-free survival rate (DFR), overall survival rate (OS), incidence and severity of adverse event.

Eligibility Criteria:
Inclusion Criteria:

・ Eligibility criteria

1. Histological diagnosis of gastric adenocarcinoma.
2. Measurable or assessable lesions.
3. Age: 18 \~ 75 years.
4. Performance Status (ECOG): 0 \~ 2.
5. No prior chemotherapy or only one regimen of previous chemotherapy (with a washout period \>4 weeks after the final day of the previous therapy). Adjuvant chemotherapy is not defined as previous therapy.
6. No history of treatment with CPT-11 or S-1.
7. No history of radiotherapy to the abdomen.
8. Oral intake of S-1 is possible.
9. Adequate function of major organs (bone marrow, heart, lungs, liver etc.). WBC 3,500/mm3 and 12,000/mm3. Hb 10.0 g/dl. Platelet count 100,000/mm3. GOT and GPT 2.5times the upper limit of normal (excluding liver metastasis). T-Bil 2.0mg/dl. Creatinine \<1.5 mg/dl (but if it is 1.0 \~ 1.5 mg/dl, the dose of S-1 can be decreased according to the dose reduction criteria to allow registration in the trial). Normal ECG (not considering clinically unimportant arrhythmias and ischemic changes).
10. Predicted survival for \>3 months.
11. Able to give written informed consent

Exclusion Criteria:

1. Severe pleural effusion or ascites.
2. Metastasis to the central nervous system (CNS).
3. Active gastrointestinal bleeding.
4. Active infection.
5. Diarrhea (watery stools).
6. Uncontrolled ischemic heart disease.
7. Serious complications (such as intestinal paralysis, intestinal obstruction, interstitial pneumonia or pulmonary fibrosis, uncontrolled diabetes mellitus, heart failure, renal failure, or hepatic failure).
8. Active multiple cancer.
9. Severe mental disorder.
10. Pregnancy, possible pregnancy, or breast-feeding.
11. Flucytosine treatment
12. Gilbert's syndrome.
13. Judged to be ineligible for this protocol by the attending physician.
A Clinical Investigation of the Vanguard™ Complete Knee System

The purpose of this prospective clinical data-collection is to document the performance and clinical outcomes of the Vanguard™ Complete Knee System.

This is a 10-year prospective observational data collection on the Vanguard Total Knee system. Patients are asked to come in for a preop, operative, immediate post-operative, 6 Month, 1 Year, 3 Year,5 Year, 7 year, and 10 year visits to check on the function, range of motion, and radiographic assessment of their total knee device.

The Vanguard Knee is an FDA cleared device, and has been on the market since 2004.

Eligibility Criteria:
Inclusion criteria:

* Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
* Correction of varus, valgus, or posttraumatic deformity
* Correction or revision of unsuccessful osteotomy, or arthrodesis

Patient selection factors to be considered include:

* Need to obtain pain relief and improve function
* Ability and willingness of the patient to follow instructions
* Including control of weight and activity level
* Good nutritional state of the patient
* Patient must have reached full skeletal maturity

Exclusion criteria:

Absolute contraindications include:

* Infection
* Sepsis
* Osteomyelitis
* Failure of a previous joint replacement

Relative contraindications include:

* Uncooperative patient or patient with neurologic disorders who are incapable of following directions
* Osteoporosis
* Metabolic disorders which may impair bone formation
* Osteomalacia
* Distant foci of infections which may spread to the implant site
* Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
* Vascular insufficiency, Muscular atrophy, Neuromuscular disease
* Incomplete or deficient soft tissue surrounding the knee

Additional exclusion criteria includes: failure of a previous joint replacement
Induction Chemotherapy Combined With Toripalimab in Locoregionally-Advanced Laryngo-Hypopharyngeal Squamous Cell Cancer

This is a non-randomized phase 1, open-labeled clinical study, 1-arm, single center, to observe efficacy and safety of chemotherapy plus PD-L1 antibody Toripalimab every 21 days for 2 cycles as induction regimen in locoregionally-advanced laryngo-hypopharyngeal squamous cell cancer patients.

Locoregionally advanced laryngo-hypopharyngeal squamous cell cancer patients have the demand of laryngo-preservation. Induction chemotherapy (FP) combined with Toripalimab (a humanized IgG4 monoclonal antibody against PD-1) will be given. This regimen will be given every 21 days for 2 cycles. Radiological examinations and PET(FDG/FAPI) examinations pre/post-treatment will be administrated for response evaluation.

Eligibility Criteria:
Inclusion Criteria:

1. Male/female patients aged≥18 years.
2. Histologically confirmed Laryngo-hypopharyngeal squamous cell cancer, previously untreated (including surgery/radiotherapy/chemotherapy/immunotherapy).
3. Locoregionally-advanced disease stage cT2-4N0-3M0.
4. ECOG performance status 0 to 1.
5. Adequate organ function: Absolute neutrophil count (ANC) ≥1.5x109/L, White blood count ≥3.5x109/L, Platelets ≥75x109/L, Hemoglobin (Hb) ≥70g/L, ALT/AST ≤2.5x ULN (for patient with liver metastasis ALT/AST ≤5x ULN), Serum bilirubin ≤1.5x ULN, Serum creatinine ≤1.5x ULN.
6. HBV infected patients (inactive/asymptomatic carrier, chronic or active) with HBV DNA\<500IU/ml (or 2500 copies/ml).
7. Pregnancy test of female patients with fertile activity should be negative within 7 days before enrollment. Patients should keep contraception during treatment.
8. Willingness and ability to comply with the protocol for the duration of the study including scheduled visits, examinations, investigations and treatment plans with informed consent form.

Exclusion Criteria:

1. Pregnancy or children bearing potential.
2. Metastasis.
3. Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
4. Have other malignant tumors within 5 years, except for fully treated basal cell/squamous cell skin cancer/cervical cancer
5. Uncontrolled clinical symptoms or diseases of the heart, such as: heart failure above NYHA II, unstable angina, myocardial infarction within 6 months;
6. With uncontrolled auto-immune diseases, interstitial pneumonia, ulcerative colitis, or patients who should receive long-term glucocorticoid treatment (\>10mg/d prednisone).
7. With uncontrollable complications
8. Inadequate organ function
9. known hypersensitivity reaction to any of the study drugs or components.
10. Other unsuitable conditions determined by investigators.
B Vitamin Deficiency and Pregnancy Complications

This case-control study aims to investigate the association between B vitamins and gestational hypertension or preeclampsia.

In clinical practice, women diagnosed with gestational hypertension or preeclampsia will be asked to participate this study to fill a questionnaire reporting their basic information. Meanwhile, women with matched age and gestation week and without any kinds of hypertensive disorders will also be invited for this study. Participants' blood samples will be analyzed for B vitamin levels at the end of the study.

Eligibility Criteria:
Inclusion Criteria:

* pregnant women aged 18-40 years old

Exclusion Criteria:

* women with Hepatitis B, syphilis, HIV/AIDS and other infectious diseases.
* women with severe physical or mental diseases
A Study of Pentamidine in the Prevention of Pneumocystis Carinii Pneumonia (PCP) in HIV-Infected Children Who Cannot Take Trimethoprim-Sulfamethoxazole

Primary: To compare the pharmacokinetics of biweekly and monthly dose regimens of intravenous pentamidine in HIV-infected infants and children who require PCP prophylaxis and who are intolerant to oral trimethoprim - sulfamethoxazole. To determine the safety and tolerance of these regimens in this patient population.

Secondary: To obtain information on the rate of PCP breakthrough in infants and children receiving parenteral pentamidine prophylaxis.

Prophylaxis against Pneumocystis carinii pneumonia is recommended for all HIV-infected children considered to be at high risk. In children younger than 5 years of age with intolerance to trimethoprim - sulfamethoxazole, parenteral pentamidine may be a successful alternative.

Prophylaxis against Pneumocystis carinii pneumonia is recommended for all HIV-infected children considered to be at high risk. In children younger than 5 years of age with intolerance to trimethoprim - sulfamethoxazole, parenteral pentamidine may be a successful alternative.

Thirty-two children are randomized to one of two treatment arms. Patients receive pentamidine on either a biweekly or a monthly treatment schedule. Treatment continues until the last child enrolled has received at least 6 months of pentamidine. Patients are stratified according to age \< 24 months or age \>= 24 months. Steady-state pharmacokinetics will be examined in a subsample of 20 patients.

Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Steroids and intravenous immune globulin (IVIG).

Patients must have:

* Documented HIV infection.
* Need for PCP prophylaxis.
* Known intolerance to trimethoprim - sulfamethoxazole (TMP-SMX).

One of the following required conditions:

* Known intolerance or allergy to dapsone; G6PD deficiency; history of serious or life-threatening reaction to TMP-SMX; exclusion from protocol ACTG 179; election by parent not to enroll child on ACTG 179; or receiving medical care at sites not participating in ACTG 179.

NOTE:

* Co-enrollment in other ACTG pediatric studies is permitted.

Consent of parent or guardian is required.

Prior Medication:

Allowed:

* Prior pentamidine.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

* Active PCP.
* Pancreatitis defined as amylase elevation associated with an elevated lipase that is \> 2 x upper limit of normal.

Prior Medication:

Excluded:

* TMP-SMX or dapsone within 7 days prior to study entry (toxicities to TMP-SMX or dapsone must be clearly resolving).
Study of the Effects of Risperdal Consta on Brain Reward Circuitry Function, Craving and Cocaine Use in Active Cocaine Dependence

The purpose of this study is to examine the effects of the administration of Risperidal-Consta on the brain's reward circuitry using Magnetic resonance Imaging (MRI), behavioral tests and measuring cocaine craving and use among people with active cocaine dependence.


Eligibility Criteria:
Inclusion Criteria:

* current cocaine dependence who use cocaine at least every 2 weeks
* Non-treatment seekers who intend to continue using cocaine
* Male 18-60 years of age
* Potential participants must be literate in the English language, and be able to understand and complete rating scales and questionnaires accurately
* Able to provide informed consent
* Potential participants must be able to identify at least one "locator" person to assist in tracking the participant for follow-up assessments

Exclusion Criteria:

* Other current substance dependence requiring immediate detoxification
* Diagnosis of schizophrenia, bipolar disorder, current major depressive disorder
* Currently suicidal or at high risk for suicide in the judgment of the investigator
* Carrying a medical device incompatible with MRI (e.g., metal implants such as surgical clips or pacemakers and extensive dental work such as bridges) or suffering from significant claustrophobia that would make MRI unfeasible.
* Size incompatible with MRI procedures
* Serious medical illness including HIV-1 infection
* Hepatitis C + titer with liver enzymes more than 2x normal or a Mini-Mental Status Exam Score of \<25/30
* Insulin dependent diabetes mellitus (IDDM) or non- insulin dependent diabetes mellitus (NIDDM) and abnormal Hemoglobin A1C
* Severe hepatic or renal impairment
* History of seizure disorder, delirium, dementia, or mental disorders due to general medical conditions
* History of head trauma or stroke with lasting neurological sequelae
* Tardive dyskinesia, extrapyramidal movement disorder, Parkinson's Disease or history of Neuroleptic Malignant Syndrome
* Clinical or laboratory evidence of uncontrolled hypothyroidism/hyperthyroidism
* Orthostatic hypotension, defined as a decrease of at \> 10 mm Hg in systolic blood pressure and/or an increase in heart rate of \> 20 beats per minute, measured one minute following transition from a supine to a standing position.
* History of allergy or hypersensitivity to Risperidone
* Treatment with: Neuroleptics, Antidepressants, Antiarrhythmics, Carbamazepine, Phenytoin, Valproate, Rifampin, Phenobarbital, Levodopa and other dopamine agonists, Fluoxetine, Interferon, Propylthiouracil, Methimazole, Opiates.
* Treatment within 30 days prior to screening with an investigational drug or medication with the potential to influence cocaine use outcomes
Efficacy and Safety Study of Naproxcinod in Subjects With Osteoarthritis of the Knee

To study of efficacy and safety of Naproxcinod vs. Naproxen and Placebo in the indication of signs and symptoms of osteoarthritis

This is a 53 week study consisting in a 26 week randomized, double-blind, parallel group, multicenter study comparing efficacy and safety of Naproxcinod, Placebo and Naproxen. The first 26 weeks will be followed by a naproxen-controlled treatment period up to 52 weeks and a 1-week post-treatment safety follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Men and Woman (40 or older) with a diagnosis of primary OA of the knee.
* Must be a current chronic user of NSAIDS or acetaminophen
* Must discontinue all analgesic therapy at Screening

Exclusion Criteria:

* Uncontrolled Hypertension or Diabetes
* Hepatic or Renal Impairment
* Current or expected use of anti-coagulant
* Clinical relevant abnormal ECG
* A history of alcohol or drug abuse
* Candidates for imminent joint replacement
* Participation within 30 days prior to screening in another investigational study
Assessing and Addressing Community Exposures to Environmental Contaminants

The purpose of this study is to build on our equitable, eight-year Tribal-academic partnership with the Ramapough Nation of northern NJ to advance tradition-centered farming practices and management strategies supporting sustainable food systems to relieve local food insecurity and nutritional deficiency, prevent disease and promote health. Furthermore, assessing the extent of environmental contamination, individual toxicant burdens and micronutrient levels and health disorders in Ramapough Tribal members of both sexes as outlined in the following:

* Collect in-person/online survey information on demographics, health and food intake, nutrition, food security, and psychosocial stressors, and perform core anthropometric measurements (i.e., height, weight, body mass index, body circumference and blood pressure) at enrollment on Tribal members to inform health promotion strategies and community actions.
* Determine individual-level contaminant burdens and micronutrient concentrations (e.g., iron, calcium, folate, vitamins) in urine and blood from surveyed (sub-aim 1a) Ramapough Turtle Clan volunteers.
* Test soil, plants and surface water where Turtle Clan residents live, recreate and attend church in Ringwood, NJ using a community-based, citizen scientist approach.


Eligibility Criteria:
Inclusion Criteria:

* Male or female between the age of 18 - 80 years old at the time of enrollment
* Living on the streets of Halifax Road, Orange Turnpike, Ramapo Ave, 1st-7th Streets, Mountain Avenue and Fox Hollow Road in Hillburn, NY; Peter's Mine Road, Canon Mine Road, Pipeline Road, Milligan Drive, Cable House Road and Van Dunk Lane in Ringwood, NJ; Stag Hill Road, and Ramapo Brae Lane in Mahwah, NJ
* Willing and able to provide consent

Exclusion Criteria:

* Pregnant women and individuals under 18 or over 80 years old
* Do not live in the identified streets above and/or have lived there for less than 2 years will be excluded from the study
Evaluation of the Efficacy and Safety of Laxymig® as Prophylactic Treatment in Patients With Migraine

The purpose of this study is to evaluate the efficacy and safety of Laxymig® ER compared with placebo in prophylactic monotherapy treatment of migraine headache.

The purpose of this study is to evaluate the efficacy and safety of Laxymig® ER compared with placebo in prophylactic monotherapy treatment of migraine headache.

Four weeks baseline, following with 12 weeks treatment phase. Subjects migraine are recorded by diary cards and re-evaluated by the investigator.

Subject will have visit every 4-week (+/- 7 days).

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of migraine with or without aura (typical aura with migraine headache)
* Subjects who had an average of two or more migraine frequencies per month during the 3 months before screening

Exclusion Criteria:

* Female subjects who are pregnant, lactating
* Chronic daily headache
* Previous treatment with three or more migraine prophylaxis medications failed
* Subjects with hepatic disease whose liver enzymes are over 2 times of upper limit of reference or significant dysfunction
* Coexisting medical, neurological, or psychiatric disorder that may hinder the study according to the investigator's judgment
Prevalence of Fabry's Disease in a Population of Patients With Chronic Pains

Fabry disease (FD) is a rare X-linked multisytemic lysosomal disorder caused by alpha-galactosidase deficiency. Globotriaosylcéramide (Gb3) deposits are observed in almost all tissues examined. Signs of the disease appear earlier and are more severe in affected males than in females. Myocardiopathy, renal failure and neurological signs including chronic pain and peripheral neuropathies are the most frequent signs. The availability of two enzymatic replacement therapies now provides a specific and effective treatment for patients. The prevalence of FD is estimated between 1/40,000 and 1/117,000. The frequency of Fabry disease has previously been estimated in several series of patients presenting one single sign, ie renal failure, hypertrophic myocardiopathy and early onset stroke. However, no data are available about the prevalence of FD in populations of patients suffering from chronic pains of unknown origin.

The diagnosis of FD will be performed by standard procedures following international recommendations. These require the search for a deficiency of alphagalactosidase A activity on leucocytes in males and genetic analysis of the GLA gene in females (Lidove et al. 2007).

The patients in whom the diagnosis of FD is established during this study, will be call in for an additional visit in the Investigating Centre in order to confirm the diagnosis and propose suitable assessment and care.


Eligibility Criteria:
Inclusion Criteria:

* patients of both sex
* aged from 6 to 65
* with chronic pains of unknown aetiology including:
* acroparesthesias
* and/or pain crises evolving more than 3 months
* continued neuropathic evolving more than 3 months
* and/or multiple pains evolving more than 3 months
* and/or recurrent abdominal crises of pain who come for a clinical visit in the Centre Douleurs Chroniques in the CHU of Bordeaux.

Exclusion Criteria:

* chronic pain of known cause
Fatty Acids Omega -3 Diet Supplementation Efficiency and Safety Evaluation in Anorexia Nervosa

The purpose of this study is to determine whether omega -3 fatty acids are effective and safe in treating anorexia nervosa.

10-week, randomized, placebo-controlled, parallel-group study to compare the efficacy and safety of omega-3 fatty acids with placebo in the treatment of anorexia nervosa. Patients will be randomly assigned to blinded study treatment. Double-blind treatment will be preceded by a medication washout period of 1-28 days if necessary. Some patients may be taking anti-depressants or anti-psychotics, e.g. fluoxetine, prior to admission to the study. In such case the wash out period will depend on the medical treatment (dependent on the drug given) given prior to qualification to the study. Patient will be treated as inpatients during 10 weeks of the study. The study will recruit female inpatients with anorexia nervosa (aged 12 to 19 years), with DSM-IV and ICD-10 diagnosis of anorexia nervosa.BMI below 5 percentile and EAT-26 score \> 30 is required at both screening and randomization.

Eligibility Criteria:
Inclusion Criteria:

* Anorexia nervosa (DSM IV,ICD-10)
* Female
* Age 12-19
* Written informed consent given by patient and his parents

Exclusion Criteria:

* Lack of informed consent