cyrilzakka/clinical-trials huggingface dataset:
Daily-Dose Consensus Interferon and Ribavirin: Efficacy of Combined Therapy

This Phase 3 clinical study is designed to evaluate the safety, tolerability, and efficacy of two dose levels of Infergen (interferon alfacon-1, CIFN) plus Ribavirin administered daily for 48 weeks and no treatment in patients chronically infected with hepatitis C who are nonresponders to previous pegylated interferon alfa plus ribavirin therapy and participated during at least 24 weeks of no treatment in IRHC-001.

At the time of randomization into IRHC-001, the no treatment arm patients will be concurrently randomized in a 1:1 ration to receive Interferon Alfacon-1 (9 or 15 µg) + Ribavirin (both administered daily) or no treatment for up to 48 weeks. Patients will not be eligible for consideration to receive treatment in IRHC-002 until they have completed a minimum of 24 weeks of participation in IRHC-001.

The protocol and informed consent form that will be used must be approved by the Investigator's Institutional Review Board (IRB)/Independent Ethics Committee (IEC) before the study is initiated.


Eligibility Criteria:
(Abbreviated due to space constraints.)

Inclusion Criteria:

1. Signed informed consent form
2. Previously randomized to the No-Treatment Arm in IRHC-001 protocol
3. IRHC-001 no-treatment patients ho have either \< 2 log10 reduction in plasma HCV RNA level by bDNA assay at Week 24 compared to baseline or detectable plasma HCV RNA by bDNA or TMA assays at Week 48
4. All patients and all potentially fertile sexual partners of patients must use 2 reliable forms of effective contraception during the study \& for 6 months after cessation of the study drugs

Exclusion Criteria:

1. Patients who experienced hepatic decompensation during IRHC-001 or show laboratory, clinical, or physiologic evidence of hepatic decompensation at screening for IRHC-002
2. Patients who, in the opinion of the Investigator or the Sponsor, are not suitable candidates for enrollment or who would not comply w/the requirements of the study
3. Pregnant or lactating women
4. Male partners of women who are pregnant
5. Patients who were on any experimental protocols or therapy while participating in IRHC-001
Long-term Observation of PAP-therapy With Telemonitoring: Telemedicine Registry TelePAP

Telemonitoring for Positive Airway Pressure (PAP) therapy might help to establish and maintain long-term therapy adherence and thus support the beneficial effects of PAP therapy on long-term outcomes.

Airway obstructions, airflow resistance by partial occlusion of the airways or central sleep-breathing disorders, where the respiratory effort is reduced or stops, cause a reduction in airflow and lead to arousals from sleep and disturbances in gas exchange during sleep. The negative consequences manifest in increases of blood pressure, higher workload for the heart and daytime sleepiness. PAP (positive airway pressure) treats sleep-related breathing disorders. It applies pressure to nose and mouth to keep the airway from collapsing and provides pressure support to assist the respiratory muscles. The efficacy of the therapy is measured with apnoea- and hypopnoea-indices that count the total number of apnoeic events at night. To ensure an efficacious and efficient therapy, pressures have to be adjusted correctly and the patient needs to use PAP regularly.

Telemonitoring is information and communication technology to exchange sleep data and to provide clinical guidance over distances. There is no defined spectrum of technology. It can comprise phone calls, video support or interaction programs via the internet. Some studies point to advantages of telemonitoring in keeping compliance upright, increase usage hours and some also point to economic advantages. However, we do not have conclusive data from large trials with telemonitoring on the long-term that would show conclusive effects, be it from the side of a patient or from a cost and labour perspective of providers or the healthcare sector. Still, there are uncertainties regarding data safety, reimbursement or connectivity of different systems.

No long-term data of PAP therapy under telemonitoring and its effect on compliance and therapy outcomes is available by now.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years
* New indication for a prescription of a Telemonitoring (AirViewTM)-capable ResMed PAP-device
* Consent to use the telemonitoring System AirViewTM (ResMed GmbH \& Co KG)
* Signed Informed Consent

Exclusion Criteria:

- Pregnant and breastfeeding persons
Effect of Whole Body Vibration Therapy on Pain, Muscle Strength, Balance and Quality of Life in Knee Osteoarthritis

The aim of this study is to examine the effects of whole body vibration therapy on knee osteoarthritis. While the participants did static exercise in one group, whole body vibration therapy was applied during static exercise in another group. As a result of 15 sessions of treatment in both groups, the effects on pain, muscle strength, balance and quality of life were compared.


Eligibility Criteria:
Inclusion Criteria:

* Those who were diagnosed with primary symptomatic knee OA according to ACR criteria,Ages between 35 and 70, Body mass index (BMI) ⩽35, Grade II or III according to Kellgren \&amp; Lawrence scale, Patients with persistent symptoms such as pain and stiffness for at least 3 months were included.

Exclusion Criteria:

* Those who have had knee surgery before, Those with central nervous system disease (especially epilepsy and serious psychotic disorders), those with a history of acute arthritis, Those with a history of DVT in the last 24 weeks, Those with advanced lung or heart disease (COPD and heart failure), Those diagnosed with inflammatory rheumatic diseases (Rheumatoid arthritis, Spondyloarthropathy, etc.), Patients diagnosed with advanced stage cancer were excluded from the study.
How Traditional Chinese Medicine Exercise Improves Parkinson Disease

The goal of this clinical trial is to explore the impact of Simple Gymnastics Training on Limb motor function and mental health in Parkinson's Patients in the Community (≥60 year old) with swallowing disorders. It primarily aims to address two key aspects: 1) the prevalence of Parkinson's Diseases among community-dwelling elderly individuals, and 2) the effects of Simple Gymnastics Training on Limb motor function and mental health in community-dwelling Parkinson's Patients. All patients are required to undergo a continuous three-week (21 days) Simple Gymnastics Training, with weekends off and training conducted only on weekdays. The training will be conducted two sessions per day, lasting 30 minutes each.

In the early stages of Parkinson's disease, many patients do not seek medical attention. The goal of this clinical trial is to explore the impact of Simple Gymnastics Training on Limb motor function and mental health in Parkinson's Patients in the Community (≥60 year old) with swallowing disorders. It primarily aims to address two key aspects: 1) the prevalence of Parkinson's Diseases among community-dwelling elderly individuals, and 2) the effects of Simple Gymnastics Training on Limb motor function and mental health in community-dwelling Parkinson's Patients. All patients are required to undergo a continuous three-week (21 days) Simple Gymnastics Training, with weekends off and training conducted only on weekdays. The training will be conducted two sessions per day, lasting 30 minutes each.

Eligibility Criteria:
Inclusion Criteria:

* Age \>60 years.
* Meeting the diagnostic criteria for Parkinson's disease developed by the Neurology Branch of the Chinese Medical Association in 2006.

Exclusion Criteria:

* Complicated with cognitive impairment or consciousness dysfunction.
* Simultaneously suffering from severe liver, kidney failure, tumors, or hematological diseases.
* Complicated with severe liver and kidney failure, tumors, or hematological disorders.
Clinical Study for the Evaluation of the Efficiency of a Device for the Diagnosis of an Internal Rectal Prolapse, a Pelvic Floor Ptosis and for the Determination of an Internal Hernia Into the Douglas Pouch

The purpose of this study is to determine if the device is supplying sufficient diagnosis results of an internal rectal prolapse, of a pelvic floor ptosis and for the determination of an interal hernia into the Douglas pouch, as well as to determine the technical success of using the device at the patient.

Existing diagnosis methods are inadequate, inaccurate, complicated or can only made intraoperatively. The new device should enable a fast and easy examination procedure well tolerated by the patients. The diagnosis results, received with the device, should assist in the accurate selection of patients for operations as well as to avoid any unnecessary operations.

Eligibility Criteria:
Inclusion Criteria:

* female patients
* patients with ODS-Symptome-Score according Longo of \>7
* existing results about a perceptible and seeable internal rectal prolapse, pelvic floor ptosis and an internal hernia into the Douglas pouch
* patients who correspond to to the ASA 1 - ASA 2 criteria

Exclusion Criteria:

* male patients
* female patients with inflammable or malign diseases of the urogenital tract as well as of the anorectal area and after rectum operation
* female patients with diarrhea
* pregnant patients because of the x-ray examination
* female patients who get anticoagulants
* serious cardiopulmonary disorders
* disorders of the blood coagulation
* female patients who correspond to the ASA 3 to ASA 4 criteria
Propranolol in Angiosarcoma

This is a window opportunity study of propranolol in patients with angiosarcoma. The aim of this study is to prospectively evaluate the activity of propranolol in the clinical setting as monotherapy, where the neoadjuvant setting provides a good opportunity to rapidly evaluate both the clinical response and histological response, without a significant delay in anti-cancer treatment.

A pilot neoadjuvant window of opportunity study will be performed to explore the activity of propranolol monotherapy in angiosarcoma. The study consists of a single arm. Propranolol will be administred as monotherapy in a dose of 40-80 mg 2-3 times a day, if tolerated. When patients are diagnosed, standard anti-cancer treatment will be scheduled in 6 weeks while propranolol treatment can start immediately after diagnosis and will be continued until the day the standard anti-cancer treatment is started. The duration of treatment will therefore be 3-6 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Histological proof of angiosarcoma
2. Patients with primary, recurrent and metastasised disease are eligible;
3. Patients with a window of at least 3 weeks before surgery or systemic therapy;
4. Age ≥ 18 years;
5. Able and willing to give written informed consent;
6. WHO performance status of 0, 1 or 2;
7. Evaluable disease according to RECIST 1.1 criteria; radiologic visible disease is not obligated in patients with cutaneous angiosarcoma
8. Minimal acceptable safety laboratory values
9. ANC of ≥ 1.5 x 109 /L
10. Platelet count of ≥ 100 x 109 /L
11. Hepatic function as defined by serum bilirubin ≤ 1.5 x ULN, ASAT and ALAT ≤ 2.5 x ULN
12. Renal function as defined by serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 50 mL/min (by Cockcroft-Gault formula);
13. At least one tumor lesion accessible to safely biopsy per clinical judgement of the treating physician

Exclusion Criteria:

1. Contraindication for propranolol therapy, like severe hypotension or bradycardia, sicksinus syndrome, second or third grade heart block, cardiogenic shock, untreated heart failure, severe peripheral vascular disease asthma or other obstructive lung diseases, untreated pheochromocytoma, metabolic acidosis, prolonged fasting.
2. Current treatment with β-blockade therapy.
3. Any anticancer treatment within 30 days prior to receiving the first dose of investigational treatment; with the exception of hormonal therapy for breast cancer.
4. Concurrent treatment with an anticancer therapy: with the exception of hormonal therapy for breast cancer.
5. Patients with known alcoholism, drug addiction and/or psychiatric of physiological condition which in the opinion of the investigator would impair study compliance;
6. Evidence of any other disease, neurological or metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment-related complications;
7. Pregnancy;
8. Legal incapacity
Efficacy of Titanium Granules in the Treatment of Periodontal Intrabony Defects

The ideal goal of the periodontal treatment is not only to prevent the progression of the disease, but also the regeneration and reconstruction of lost tissues. Many surgical techniques have been used to regenerate intrabony defects (IBD).

Titanium stimulates activation of the complement system, surface binding of platelets, and platelet activation as reflected by increased levels of platelet-derived growth factor, which is a substantial promoter of bone growth. Hence we may speculate that using a bone substitute made of titanium may be positive from the perspective of bone formation in osseous defects.

Titanium granules consist of irregular porous granules of commercially pure titanium. The porous properties may lead to ingrowth of newly formed bone.The osseointegrating response to titanium may be the result of the potent activation of the intrinsic coagulation system and the subsequent release of growth factors from platelets.Therefore, the aim of this study is to compare the effect of titanium particles and hydroxyapatite on osseous regeneration in intrabony defects.

After reflection of flap and degranulation, bone graft i.e., titanium particles (test group) or hydroxyapatite(control group) will be placed in the void created by the defect and sutures will be placed.

Eligibility Criteria:
Inclusion Criteria:

Systemically healthy male and female patients of age \>18 years with two-walled or three-walled intrabony defects and probing pocket depths (PPD) of \>3mm.

Exclusion Criteria:

Medically compromised patients, patients \<18 years of age, pregnant women, heavy smokers, and patients who underwent radiotherapy or chemotherapy are excluded.
Oxytocin Effect on Attentional Bias Towards Emotional Expression Faces in Individuals With High and Low Autistic Traits: A Functional Magnetic Resonance Imaging (fMRI) Study

to investigate whether oxytocin alter attentional bias towards emotional expression faces in individuals with high and low autistic traits, and the brain mechanism of this effect

In the present study, investigator plan to use a double-blind, between-subject placebo controlled design.Firstly, all healthy male subjects' autistic trait levels will be assessed by the Autism Spectrum Quotient (ASQ) and only subjects with higher or lower ASQ score will be recruited in the next experiment and divided into high and low subgroup. Then, subjects are randomly assigned to receive either intranasal administration of oxytocin (24 IU) or placebo. 45 min later, subject need to complete an attentional bias task named rapid serial visual presentation (RSVP) task in fMRI scanner.

Eligibility Criteria:
Inclusion Criteria:

* healthy subjects without past or current psychiatric or neurological disorders

Exclusion Criteria:

* history of head injury;
* claustrophobia;
* medical or psychiatric illness.
Association Between Subtypes of Anti Citrullinated Peptide Antibodies and Lung Damage in Rheumatoid Arthritis

Rheumatoid arthritis is a genuine systemic disease associated with diffuse interstitial pneumopathy and bronchial disorders. According to the literature review, the prevalence of PID on thoracic CT scan is one-third of patients. Diffuse interstitial pneumopathy is responsible for a significant morbidity and mortality, is currently under-diagnosed and its treatment is poorly codified. The lung seems to have a central role in the genesis of rheumatoid arthritis. It also appears that some subtypes of anti citrullinated peptide antibodies are preferentially present in the lungs.

The hypothesis behind our project is that one or more subtypes of anti citrullinated peptide antibodies with a preferential tropism for the lung would attack the parenchyma and pulmonary airways.

Currently, there are no data on interstitial pneumopathy in black and Afro-Caribbean subjects with rheumatoid arthritis.


Eligibility Criteria:
Inclusion Criteria:

* Patient with rheumatoid arthritis ACR/EULAR 2010
* Patient with a higher age or equal to 18
* Patient receiving social security
* Patient giving his free and informed written consent

Exclusion Criteria:

* Patient with overlap syndrome with another autoimmune disease
* Patients with known severe cardiopulmonary pathology
* Woman who is pregnant and breast feeding
* Patient with language difficulties or understanding
Evaluation of Blood Loss During Knee Arthroplasty

Primary arthroplasties are frequent interventions that can present hemorrhagic complications: postoperative hematoma, deglobulization justifying monitoring blood tests and blood transfusion if necessary.

The attitude regarding the drainage of the surgical site supposed to limit these events differs from one surgeon to another, even in the same team. Its use is common practice; for some, systematic. For others, depending on intraoperative findings or the patient's condition. For others, the drain is never laid.

Faced with the divergence of data from the literature on the benefit of the placement of a drain for intra and postoperative bleeding in knee arthroplasty, the lack of randomized prospective studies on large series of patients, and in a desire to homogenization and standardization of the operating procedure of our surgeons, investigators decided to conduct this prospective interventional, comparative and randomized study.

After obtaining the patient's consent and randomisation, the operating surgeon will have the information of placing or not a drain, lately at the end of the intervention so that the course of the intervention is not influenced by the prior knowledge of the patient randomization arm.

Investigators will carry out especially within the framework of this research 3 samples of a total of 10.7 ml of whole blood (appendix. 12.5) distributed as follows:

Sample no. 1 : 2.7 ml of blood in a hemostasis tube (sodium citrate tube) one day before the procedure (D-1) for the determination of the prothrombin level (PT), activated partial thromboplastin time ( TCA) and the INR or International Normalized Ratio.

Sample no. 2 : 4 ml of blood in a purple EDTA tube for NFS, one day before the operation (D-1) for the determination of hemoglobin ( Hb ) and hematocrit ( Hct ) Sample no. 3 : 4 ml of blood in a violet EDTA tube for NFS for the determination of hemoglobin ( Hb ) and hematocrit ( Hct ) on the fifth postoperative day (D5). This last assessment will be prescribed to the patient to be carried out in the rehabilitation center..

The knee prosthesis implantation surgical technique is performed according to the standard operating procedure of the orthopedic surgery team.

According to the operating standard procedure of our orthopedic department, the drain is non-aspirated for 6 hours and then put back under vacuum until the morning after the knee prosthesis operation.

Three months after the intervention the patient will be seen again in consultation and examined.

Eligibility Criteria:
Inclusion Criteria:

* Patient consent
* Patient aged over 18 years
* Patient scheduled for primary knee arthroplasty

Exclusion Criteria:

* Patient expresses his/her opposition to participating in the study
* Patient scheduled for revision, revision or totalization arthroplasty
* Primary arthroplasty after septic arthritis
* Patient requiring an additional planned or unplanned surgical procedure such as TTTA, osteosynthesis for an intraoperative fracture and/or removal of material
Can Thyroidectomy be Considered Safe in Obese Patients?

Obesity is a growing public health concern in most western countries. More and more patients with high body mass index (BMI) are undergoing surgical procedures of all kinds and, in this context, obese patients are undergoing thyroid surgery more than ever before. This study showed that obesity, in the field of thyroid surgery, is not associated with any increase of postoperative complications. Thus, it is possible to conclude that thyroidectomy can be performed safely in obese patients.

Background: Obesity is a growing public health concern in most western countries. More and more patients with high body mass index (BMI) are undergoing surgical procedures of all kinds and, in this context, obese patients are undergoing thyroid surgery more than ever before. The aim of the present study was to evaluate whether thyroidectomy can be considered safe in obese patients.

Methods: Patients undergoing thyroidectomy in our Unit between January 2014 and December 2018 were retrospectively analysed. Patients were divided into 2 groups: those with BMI \< 30 kg/m2 were included in Group A, while those with BMI ≥ 30 kg/m2 in Group B.

Eligibility Criteria:
Inclusion Criteria:

* Patients submitted to thyroidectomy in our Unit

Exclusion Criteria:

-
Safety, Efficacy, and Pharmacokinetic Study of Intravenous Ibuprofen in Pediatric Patients

The primary objective of the study is to determine the superiority of a single dose of intravenous ibuprofen compared to acetaminophen for the treatment of fever during the first two hours of treatment.

The primary objective of the study is to determine the superiority of a single dose of intravenous ibuprofen compared to acetaminophen for the treatment of fever as measured by the area under the change in temperature versus time curve during the first 2 hours of treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Have written informed consent provided by legal parent, guardian, or authorized agent prior to participation in the study or study-only related procedures.
2. Be between birth (28 weeks to \< 40 weeks gestational age) to ≤ 16 years of age.
3. Have new (less than 7 days) onset of fever, documented by temperature greater than or equal to 101.0 ºF (38.3 ºC).

Exclusion Criteria:

1. Have inadequate intravenous access.
2. Have received antipyretic drug therapy within 2 hours before dosing.
3. Have any history of allergy or hypersensitivity to NSAIDs or aspirin.
4. Have received another investigational drug within the past 30 days.
5. Be otherwise unsuitable for the study, in the opinion of the Investigator.
6. Have a fever due to hyperthermia.
7. Pregnant or nursing.