cyrilzakka/clinical-trials huggingface dataset:
Study Evaluating Efficacy and Safety of Froniglutide (PF1801) in Patients With Idiopathic Inflammatory Myopathy

This is a Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Froniglutide in Patients With Idiopathic Inflammatory Myopathy ("FROniGlutide Study")


Eligibility Criteria:
Key Inclusion Criteria:

* Diagnosis of IIM (DM or polymyositis \[PM\]) as per Bohan and Peter classification criteria
* MMT-8 ≤125 units and two out of the following CSM items, or MMT-8 \>125 units and three out of the following CSM items, together with verifiable muscular weakness A. PGA VAS ≥2 cm B. SGA VAS ≥2 cm C. HAQ-DI ≥0.25 D. Extramuscular activity (MDAAT) ≥2 cm E. Increase in one or more muscle enzyme (CK, LDH, AST, ALT, aldolase) values (must be ≥1.3 × ULN)
* On treatment with standard of care (immunosuppressants and/or corticosteroids) for \>12 weeks and on stable therapy for at least 4 weeks

Key Exclusion Criteria:

* Inclusion body myositis (IBM) or amyopathic DM
* Severe muscle damage (myositis damage index \[MDI\] \>7/10 cm). Permanent deterioration caused by reasons other than PM/DM, or myositis with cardiac involvement
* Clinically significant renal/hepatic impairment
* Severe interstitial lung disease requiring supportive oxygen therapy
Establishment of a Trans-round Window Inner Ear Continuous Drug Delivery System for the Treatment of Severe-to-profound Sudden Sensorineural Hearing Loss

The investigators enrolled patients with total sudden deafness who had failed treatment with systemic combined intra-dural hormone injections. The patients were randomly divided into a pilot group and a control group for a randomized controlled clinical study, with the pilot group receiving a round window niche enlargement via round window inner ear administration and the control group receiving regular intra-drum injection hormone therapy


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years old, ≤ 65 years old
2. The diagnostic criteria for total deafness type of sudden deafness published in 2015 were met, and the patient had sudden, unilateral full-frequency severe or very severe sensorineural deafness with or without deafness, tinnitus, peri-aural numbness, vertigo, and dizziness, and the diagnosis of sudden deafness was supported by physical examination, pure tone audiometry(PTA), acoustic impedance, and auditory brainstem response(ABR). Magnetic resonance(MR) of the internal auditory tract ruled out the occupancy of the internal auditory tract and pontocerebellar region.
3. Those with an onset of ≤ 6 weeks who have received a systemic application of glucocorticoid shock therapy, glucocorticoid intra-drum injections, and medication to improve inner ear circulation, but have not responded to treatment (PTA improvement \< 15 dB).
4. No history of middle or inner ear surgery, no history of radiotherapy or chemotherapy; no general anesthesia - contraindication.
5. Patients voluntarily participate in this study and sign an informed consent form

Exclusion Criteria:

1. Bilateral sudden deafness, drug-based deafness, autoimmune diseases, specific infections, syndromic deafness malignant tumors.
2. Pregnant and lactating women.
3. Cannot tolerate general anesthesia surgery, and severe liver and kidney dysfunction.
4. Any other conditions that the investigator believes should be excluded from this study.
Prevalence Survey of Plasmodium Falciparum Antimalarial Drug Resistance Markers

This study is to measure prevalence of established and candidate molecular markers of drug resistant malaria at Komé, Doba, Republic of Chad.

This is a cross-sectional, observational study using dried blood samples collected from P. falciparum-infected individuals at the time of malaria diagnosis to measure the prevalence of known and candidate molecular markers of resistance to artemisinin and non-artemisinin ACT partner drugs. A maximum of 200 participants will be enrolled at each participating site per year. Study duration is 2 years. Therefore total participant is up to 400.

Prospective participants will have blood collected for dried blood spot (DBS) study sample after providing informed consent. Individuals with confirmed P. falciparum infection will have DBS samples included for molecular analyses for known and candidate molecular markers of antimalarial drug resistance.

Eligibility Criteria:
Inclusion Criteria:

Participants must meet all of the inclusion criteria to participate in the study.

* Patients (6 months - 75 years) with confirmed uncomplicated P. falciparum infection
* Written informed consent obtained

Exclusion Criteria:

* Patients presenting signs of severe malaria will be excluded from the survey to prevent any delay in the management of the patient.
Autologous Platelet Rich Plasma on Low Back Pain

The purpose of this study is to evaluate the effectiveness of autologous platelet-rich plasma (PRP) injection therapy for low back pain patients. Our hypothesis is that PRP will reduce the pain feeling and benefit for restore of the intervertebral disk.


Eligibility Criteria:
Inclusion Criteria:

* Chronic low back pain more than 2months
* Visual analog scale score more than 4
* Positive X-ray, MRI or CT scan findings
* Pfirrmann grading I-III
* Well understanding and communication ability

Exclusion Criteria:

* History of allergy
* Hemorrhagic trend or use of anticoagulant therapy
* Mental diseases
* Active infection or recent infectious diseases within 3 months
* Local skin infection near the puncture location
* Severe lumbar spinal stenosis, lumbar spondylolisthesis, ossification of posterior longitudinal
* Ligament and lumbar disc herniation（more than 5mm）
* Immunologic diseases
* Tumors
* Metastatic disease
* Recent surgery less than 3 months)
* Pregnancy
Ovarian Follicle Function in Patients With Primary Ovarian Failure

No proven therapy to restore ovarian function and fertility is available to patients with karyotypically normal spontaneous premature ovarian failure. We know that one-half of these patients have primordial follicles remaining in the ovary, and these follicles can function intermittently. This is a diagnostic omnibus protocol that permits baseline clinical evaluation of patients with prematurem ovarian failure. The findings will determine patients' suitability for specifically focused therapeutic research protocols.

No proven therapy to restore ovarian function and fertility is available to patients with karyotypically normal spontaneous primary ovarian insufficiency. We know that more than one-half of these patients have primordial follicles remaining in the ovary, and these follicles can function intermittently. This protocol permitted baseline clinical evaluation of patients with primary ovarian insufficiency and ongoing observation of the natural history of the disorder. The protocol is now in the follow up and analysis phase and is not now recruiting new patients. Now a major aim of the protocol is to investigate large scale medical sequencing as a method by which to uncover mechanisms of primary ovarian insufficiency and to assist in the management of women with this condition. This will involve a community-based participatory research approach.

Eligibility Criteria:
* INCLUSION CRITERIA:

Women 18 to 42 years of age with primary ovarian insufficiency who meet the following requirements were candidates for recruitment to the study: 1) at least a four month history of oligo-amenorrhea not due to pregnancy, and 2) clearly elevated gonadotropins in the menopausal range on two separate occasions at least one month apart.

EXCLUSION CRITERIA:

Women with evidence for karyotypic, metabolic, toxic, or iatrogenic cause of the ovarian insufficiency were not candidates.
Enhanced Recovery After Cesarean Section

1. Measure compliance of the care of elective caesarean section with ERAS standards
2. Measure the quality of recovery of women undergoing elective caesarean section

Caesarean section is one of most common surgeries worldwide and in Egypt. The Egyptian Demographic and Health Survey 2014 revealed a rising caesarean section rate .

Many of these procedures are elective allowing time for preparation of the patient for surgery.

Enhanced recovery after surgery (ERAS) is a multimodal, multi disciplinary, evidence based approach to surgical care with an ultimate goal to enhance recovery and improve maternal and neonatal outcome .

This is done through optimizing multiple aspects of patient care to enhance recovery and so accelerate (facilitate) earlier discharge (decrease length of stay, decrease opioids use and encourage breastfeeding) .

A comparative study in Egypt found ERAS to be effective in controlling perioperative gastrointestinal symptoms, pain control and encourages early ambulation with offering earlier resumption of intestinal motility, higher satisfaction and fewer days of admission .

The clinical audit is a tool for assessing the compliance of current practice with the standard of care. In an audit, both process of care compliance and outcome of care can be measured to highlight gaps that need to be addressed by the institution . Enhanced Recovery After Surgery society issued Guidelines for elective Cesarean Section care .

They include elements in preoperative, intraoperative and postoperative care. Compliance with each of these items was associated with improved maternal or neonatal outcome and a better recovery experience .

Eligibility Criteria:
Inclusion Criteria:

* Women undergoing elective caesarean section in the study period

Exclusion Criteria:

* Women who cannot apply ERAS protocol

  1. emergency caesarean section
  2. anticipated surgical difficulty e.g. placenta previa/accrete, tumors obstructing lower uterine segment
  3. Severe maternal disease
  4. severe intraoperative bleeding or visceral injuries necessitating modification of postoperative care
Dosing Study of Remifentanil for Smooth Removal of the Laryngeal Mask Airway (LMA)

The investigators attempted to determine the optimal effect-site concentration of remifentanil for smooth removal of the LMA from propofol anesthesia.

At the end of the surgery, propofol infusion was stopped and remifentanil was titrated to predetermined (initial concentration 1.0 ng/ml for the first patient). LMA removal was performed when the patients opened their eyes and spontaneous respiration and adequate tidal volume and ventilatory frequency were confirmed.

Eligibility Criteria:
Inclusion Criteria:

* ASA I-II patients undergoing general anesthesia for short elective surgery (\<1 hr)

Exclusion Criteria:

* G-E reflux
* obesity (BMI\>30)
* anticipated difficult airway
The Effect of Dietary Intervation on Endothelial Glycocalyx in COVID-19 Patients.

The food supplement Endocalyx is considered to support the endothelial glycocalyx integrity by supplying sulfated polysaccharides, anti-oxidant enzymes and additional substrates for glycocalyx synthesis. The investigators will study the effect of Endocalyx on endothelial, vascular and left ventricular myocardial function in patients with COVID-19 infection.

Sixty patients who have been hospitalized due to COVID-19 infection will be randomized to receive food supplement Endocalyx (4 capsules per day) (n=30) or placebo (n=30) for 4 consecutive months.

Eligibility Criteria:
Inclusion Criteria:

* caucasian patients
* hospitalization for COVID-19 infection
* diagnosis of COVID-19 proven by PCR

Exclusion Criteria:

* Pregnancy and breastfeeding
* Foreseen inability to attend scheduled visits
* History of acute coronary syndrome. Coronary artery disease will be excluded by a clinical history, examination and electrocardiogram.
* Moderate or severe valve disease
* Primary cardiomyopathies
* Chronic obstructive pulmonary disease
* Asthma
* Chronic kidney disease (estimated glomerular filtration rate \[eGFR\] ≤60 ml/min/1.73 m2)
* Liver failure
* Malignancies
Study of the Electrocardiographic Effects of TA-8995

A study in healthy males and females to see if a high single dose of TA-8995 has an effect on the ECG QTcF interval.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or females of non-child bearing potential

Exclusion Criteria:

* Receiving any other drug therapy
* Clinically significant medical history
* Abnormal ECGs or vital signs
Molar Intrusion Using High Pull Headgear

This prospective clinical study will evaluate the effect of high pull headgear for molar intrusion, compared with the control group, in adolescent patients with open bite malocclusion.

The study sample will consist of 24 patients with anterior open bite divided equally in two groups. The sample will be collected consecutively from patients attending the Orthodontic Department at Damascus university.

A modified version of the OBA (Open Bite Appliance),introduced by Erverdi and Usumez, will be applied for all patients. High pull headgears will be used in the first group, while, in the second (control) group, Open Bite Appliances will be used only.

The skeletal and dentoalveolar changes occurring after intrusion of posterior teeth will be assessed by using posteroanterior and lateral cephalometric radiographs; pre- and post- treatment changes for each group will be evaluated.

Open bite malocclusion is considered one of the most difficult malocclusion to correct in orthodontic treatment because it appears as a result of different etiological factors such as genetic, dental, skeletal, functional, soft tissue, and habits that play roles in its development. Different treatment modalities used for the treatment of an anterior open bite. Multiloop edgewise archwires, miniscrews, high-pull headgear, and bite blocks have been used for anterior open bite patients, most open bite patients characterized by increased facial height, class II skeletal pattern, and vertical excess in maxillary posterior teeth.

Functional appliances, magnets, posterior bite blocks, and high pull headgear are used for posterior teeth intrusion. It is possible to generate intrusive force by using high pull headgear. Furthermore, direction of force can be changed according to the center of resistance of the dental units to achieve a better tooth movement control. The intrusion of posterior teeth will lead to decreased lower facial height by a counterclockwise rotation of the mandible; and improve class II skeletal relationship.

This study was the first clinical trial, that compare the effect of high pull headgear for molar intrusion with the control group in adolescent patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients with skeletal open bite determined by an increased B angle (angle between maxillary plane and mandibular plane), sum of Bjork and the mandibular plane angle (angle between SN plane and mandibular plane).
* patients between 12 and 18 years old with permanent dentition stage.
* Negative over bite of more than a mm
* Class I and Class II skeletal anteroposterior relationship.

Exclusion Criteria:

* Previous orthodontic treatment.
* Patients with syndromes, clefts, or craniofacial abnormalities.
* Class III skeletal anteroposterior relationship.
Brief Behavioral Activation Treatment for Depression With Inpatients

The purpose of the current study was to examine Brief Behavioral Activation Treatment for Depressions (BATD) effectiveness, credibility, and acceptability with moderate to severly depressed inpatients. The study is a systematic replication of a randomized controlled trail from 2003, that provided initial support for BATD With inpatients. The current study compared BATD to Treatment as Usual in a randomized controlled trial.


Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe depression (BDI-II \> 28 Points).
* Admission length of at least 3 days
* Evaluated to benefit from depression treatment by unit psychiatrist.

Exclusion Criteria:

* Current psychotic disorder
* Previously diagnosis with psychotic disorder (including Bipolar disorder)
Long-term Safety Extension to Study TRCA-301

This study is a 40-week, blinded, placebo-controlled extension of Study TRCA-301 (NCT03317444). Eligible subjects who complete the 12-week treatment period in Study TRCA-301 have the option to participate in this extension study evaluating the long-term safety and durability of effect of TRC101 in subjects with non-dialysis dependent chronic kidney disease and metabolic acidosis. Eligible subjects will be treated with TRC101 or placebo once daily (QD) on an out-patient basis for the subsequent 40 weeks. Subjects will continue to receive the same blinded treatment (TRC101 or placebo) that they received in Study TRCA-301.


Eligibility Criteria:
Key Inclusion Criteria:

* Completed the 12-week treatment period and attended the Week 12 Visit in the parent study TRCA-301.
* Blood bicarbonate level of \>= 12 mEq/L at the Week 12 Visit in the parent study TRCA-301.

Key Exclusion Criteria:

* Any level of low blood bicarbonate at the Week 12 Visit that, in the opinion of the Investigator, requires emergency intervention or evaluation for an acute acidotic process.
* Required dialysis for acute kidney injury or worsening CKD during the parent study TRCA-301.
* Planned initiation of renal replacement therapy within 6 months following study entry.
* History or current diagnosis of diabetic gastroparesis, bowel obstruction, swallowing disorders, severe gastrointestinal disorders, inflammatory bowel disease, major gastrointestinal surgery, or active gastric/duodenal ulcers.
* Serum calcium \<= 8.0 mg/dL at the Week 10 in the parent study TRCA-301.
Cone Beam and CT Scan for the Diagnosis of Otosclerosis (TACOS)

Computed tomography scan (CT) is routinely used for the diagnosis and the pre-operative assessment of otosclerosis.

The cone-beam computed tomography (CBCT) is a imaging technique with reduced irradiating and, therefore, could replace the CT.

In this study, a CBCT will be proposed to all patients undergoing a CT exam for the diagnosis and/or the pre-operative assessment of an otosclerosis.

The results of the CBCT will be compared to those of the CT scan.


Eligibility Criteria:
Inclusion Criteria:

* CT scan indicated for the diagnosis and pre-operatice assessment of an otosclerosis

Exclusion Criteria:

* Pregnancy
* Breast feeding
* Patient under a legal protection procedure
* Patient denying to participate to the study
* Lack of affiliation to a social security system
A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of 200 Mcg of gp120 (CHO) BIOCINE in MF59 Emulsion Versus the Emulsion Control: Three Injections at 0, 1, and 6 Months

To evaluate in healthy volunteers the safety and immune response to 200 mcg gp120 candidate vaccine in MF59 emulsion without MTP-PE at 0, 1 and 6 months.

Preliminary evaluations of two dose levels of gp120 administered to volunteers in protocol VEU 007A indicate that a gp120 dose of potentially greater immunogenicity may be of interest.

Preliminary evaluations of two dose levels of gp120 administered to volunteers in protocol VEU 007A indicate that a gp120 dose of potentially greater immunogenicity may be of interest.

Ten healthy volunteers receive 200 mcg gp120 in MF59 emulsion, and four volunteers receive placebo consisting of MF59 emulsion in PBS vehicle. Injections are given at months 0, 1, and 6. Patients are followed for 12 months following the third injection.

Eligibility Criteria:
Inclusion Criteria

Subjects must have:

* Normal history and physical exam.
* Negative ELISA for HIV.
* Normal cell-mediated immune responses using Merieux skin test.
* Normal urinalysis.

Exclusion Criteria

Co-existing Condition:

Subjects with the following conditions are excluded:

* Evidence of psychological or psychiatric problems that may lead to noncompliance with study requirements.
* Positive syphilis serology. If serology is documented as a false positive or is due to a remote (\> 6 months) treated infection, subject is eligible.
* Circulating hepatitis B surface antigen.

Subjects with the following prior conditions are excluded:

* History of immunodeficiency, chronic illness, autoimmune disease, or use of immunosuppressive medications.
* History of anaphylaxis or other adverse reactions to vaccines.

Prior Medication:

Excluded:

* Prior HIV vaccines.
* Immunoglobulins or vaccines within the past 3 months.
* Experimental agents within the past 30 days.

Prior Treatment:

Excluded:

* Blood transfusions or cryoprecipitates within the past 3 months.

Identifiable high-risk behavior for HIV infection, including:

* Any history of intravenous (IV) drug use within the past year.
* Syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease) in the past 6 months.
* More than two sexual partners, or sexual contact with a high-risk partner, in the past 6 months.
Combination of Alverine-simeticone and i3.1 Probiotic in IBS-D and IBS-M in Mexico

This randomized study evaluates the usefulness of the I31 probiotic formula, alone or in combination with alverine/simethicone, against placebo, in the treatment of diarrhea-predominant or mixed irritable bowel syndrome

Irritable Bowel Syndrome (IBS) is a functional gastrointestinal disease in which recurrent abdominal pain is associated with defecation or a change in bowel habits. Disordered bowel habits are typically present (ie, constipation, diarrhea, or a mix of constipation and diarrhea), as are symptoms of abdominal bloating/distention.

I31 is a probiotic formula composed of strains Pediococcus acidilactici CECT7483 and Lactobacillus plantarum CECT7484 and CECT7485, previously shown to improve quality of life in patients with IBS of Caucasian descent.

Alverine/simethicone is a combination of two drugs: Alverine citrate relaxes muscle cramps that occur in the intestine in conditions such as irritable bowel syndrome and diverticulosis. Simethicone is an antifoam administered orally. Reduces gas formation and facilitates its elimination from the digestive tract

Eligibility Criteria:
Inclusion Criteria:

* Subjects attending Hospital Juarez de Mexico with a diagnosis of diarrhea-predominant or mixed irritable bowel syndrome (IBS-D and IBS-M), according to Rome-IV criteria (Lacy et al. Gastroenterology 2016), providing Informed Consent.

Exclusion Criteria:

* Unexplained weight loss, blood in feces, anemia.
* Use of systemic antibiotics, NSAIDs, antipsychotic or prokinetic medication in the 3 weeks before study initiation.
* Pregnant or lactating women.
* History of gastrointestinal cancer.
* Suspicion of coeliac disease, inflammatory bowel disease (IBD), endometriosis or pelvic inflammatory disease.
* History of abdominal surgery within 2 years (3 months if appendectomy or herniorraphy)
* BMI below 18
* Known allergy to any of the components in the treatments
A Powered Ankle Foot Rehabilitation Orthosis

Ankle rehabilitation training becomes a tough question for the patients with ankle joint injuries especially with the hemiplegia after stroke. Here a novel powered ankle foot orthoses which can provide ankle dorsiflexion and plantar flexion assistant using electric motor is proposed in this paper. The mechanical structure of the orthoses includes wearing parts, ankle joint hinged part, driving unit, transmission mechanism and sensing units. This study provides a new method for ankle foot orthoses design and has great significance for ankle rehabilitation.


Eligibility Criteria:
Inclusion Criteria:

* ankle joint injuries about dorsiflexion and plantar flexion
* Ability to keep balance independently

Exclusion Criteria:

* ankle joint injuries about varus and valgus rehabilitation
* two assistants needed while walking