cyrilzakka/clinical-trials huggingface dataset:
Comparison of Efficacy Between Silicone Ahmed Glaucoma Valves and Second Trabeculectomy in Glaucoma Patients

In the management of open angle glaucoma, frequently more then one procedure is necessary to control the intra ocular pressure. There is still no consensus whether this second intervention should be a second trabeculectomy or a shunt device. In the present study we compare a second trabeculectomy versus Ahmed silicone shunt device in open angle glaucoma patients with previous trabeculectomy without proper IOP control.

In the management of open angle glaucoma, frequently more then one procedure is necessary to control the intra ocular pressure. There is still no consensus whether this second intervention should be a second trabeculectomy or a shunt device. In the present study we compare a second trabeculectomy versus Ahmed silicone shunt device in open angle glaucoma patients with previous trabeculectomy without proper IOP control.

40 Patients with clinically uncontrolled open angle glaucoma with previous trabeculectomy surgery were selected from the glaucoma sector of Federal university of Sao Paulo. Patients were randomized to one of two groups:

1. Silicone Ahmed Implant
2. Second trabeculectomy

Surgery description:

Ahmed silicone tube implant: A fornix-based conjunctival flap was created between two adjacent recti muscles. Before placement of the tube implant body to the sclera, tube was irrigated with saline solution to open the valve mechanism. The implant's polypropylene body was sutured to sclera with 6.0 silk suture. The tube then trimmed and the anterior chamber was entered from 1mm posterior to corneoscleral limbus with 23-gauge needle. A human donor scleral flap was placed over the tube and sutured to the sclera with 10.0 nylon suture. The conjunctiva was sutured to the limbus.

Second Trabeculectomy: A fornix-based conjunctival flap was created in the opposite superior quadrant of the previous trabeculectomy. Mitomycin-C was used under the conjunctival flap for up to 4 minutes (0,3mg/mL) and rinsed with 30mL saline solution. Scleral flap with crescent bevel and sclerectomy with a punch. Iridectomy and flap suture with nylon 10-0. Conjunctival suture with nylon 10-0.

Follow up after surgery was in the 1st, 4th, 7th, 15th, 30th days and after that monthly or whenever needed for clinical reasons.

Eligibility Criteria:
Inclusion Criteria:

* Patients with open angle glaucoma and uncontrolled IOP despite the use of maximum tolerated glaucoma medication.
* Patients over 18 years old.
* Patients who can understand and sign the inform consent form.

Exclusion Criteria:

* Other forms of glaucoma other than open angle glaucoma; previous psiquiatric condition ;
* Patients who can understand and sign the inform consent form;
* visual acuity worse than hand motion;
* previous retina surgery with buckle implant
Study to Determine the Efficacy of Bendamustin in Patients With Recurrent Small Cell Lung Cancer (SCLC)

Determination of response rate Assessment of toxicity and determination of "time to progression"

Phase II Study to determine the efficacy of Bendamustin(Ribomustin) in patients with recurrent small cell bronchial carcinoma after cytostatic polychemotherapy

Eligibility Criteria:
Inclusion Criteria:

* Patients with histological proven, curative non treatable small lung cell carcinoma
* Recurrence \>8 weeks, \> 1 year after 1st line treatment with platin- and etoposide polychemotherapy, without brain metastases

Exclusion Criteria:

* Brain metastases
* WHO-PS 3 - 4
Multiple Treatments for Ebola Virus Disease (EVD)

The purpose of this study is to determine whether multiple therapeutic regimens are effective in the treatment of Ebola Virus Disease (EVD)

The ongoing epidemic of EVD has ravaged parts of West Africa, with initial cases reported in December 2013. There is no licensed specific therapy for the disease, which has a case-fatality rate of approximately 50-70%. Although anecdotal clinical data, recent studies in animal models, and in vitro screening suggest that treatment of EVD patients with anti-viral agents, immune modifying agents, and/or convalescent blood products may be effective, they have not been evaluated in clinical trials. This multi-arm clinical trial will evaluate the efficacy and safety of multiple regimens, both as mono-therapy and combination therapy. Provision of these regimens, if found effective and safe, would have a major impact on the current and future epidemics by providing effective treatment options.

As described for previous adaptive trials, a randomization probability for each of the treatment regimens is created based on 14-day mortality, and is used for weighting randomization of subsequently enrolled participants. Participants will continually be preferentially assigned to regimens with better initial performance. New agents can be added or existing agents removed as the trial evolves.

Eligibility Criteria:
Inclusion Criteria:

* Males and females aged 6 months and \>8kg in weight
* Confirmed case of EVD
* Admission to the hospital \< 48 hours prior to enrollment
* Participant or family member/guardian able and willing to provide signed informed consent

Exclusion Criteria:

* Prior treatment with any other specific experimental anti-EVD product, or expectation to receive another experimental anti-EVD product during the course of the study (this does not include general supportive care or nutritional supplements routinely administered to all hospitalized patients with EVD)
* Unresponsive
* In the treating physicians opinion, an inability to comply with the study treatment regimen
Study in Healthy Volunteers to Assess the Pharmacokinetics (PK) of Digoxin Administered Alone and in Combination With Vandetanib

This is a study in healthy volunteers to assess the pharmacokinetics (PK) of Digoxin administered alone and in combination with Vandetanib.

A Phase I, Open-label, Single-center Study to Assess the Pharmacokinetics of Digoxin in Healthy Subjects When Administered Alone and in Combination with a Single Dose of Vandetanib (CAPRELSA) 300 mg

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated, written informed consent prior to any study
* specific procedures Volunteers must be males or females aged 18 to 45 years and with a weight of at least 50 kg and body mass index (BMI) between 18 and 30 kg/m2,
* inclusive Females must have a negative pregnancy test at screening and on admission to the study center. Females must not be lactating and must be of non-childbearing potential defined as postmenopausal or documentation of irreversible surgical sterilization.

Exclusion Criteria:

* History of any clinically significant disease or disorder such as gastrointestinal, hepatic, renal or skin disease.
* History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity,
* Volunteers who are current smokers and have smoked or used nicotine products within the previous 6 months
* Screening blood pressure of greater than 140/90 mmHg and/or a resting heart rate of less than 45 beats per minute (repeat test allowed at the Investigator's discretion
* Clinically significant abnormal12-lead ECG as assessed by the Investigator, QTcF interval greater than 450 ms
* Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus (HIV), or positive screen for drugs of abuse.
Study To Determine The Pharmacokinetics Of Sulfasalazine In Children With Juvenile Idiopathic Arthritis

This study will characterize the steady state pharmacokinetics of sulfasalazine delayed release tablets in pediatric Juvenile Idiopathic Arthritis patients. Data from this study will fulfill the post approval commitment to the FDA.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of oligoarticular, polyarticular, psoriatic or enthesitis-related JIA as determined by ILAR criteria. Patients who have been continuously treated with generic sulfasalazine delayed release formulation and have tolerated the product for at least 3 months prior to study enrolment and who are switched to Azulfidine-EN at least 8 days prior to Day 0 are eligible.
* Patients must be at least 6 years of age and has not reached his/her 18th birthday prior to the Baseline Visit (Day 0).
* Onset of JIA must have occurred prior to the patient's 16th birthday.
* Patients must weigh at least 20 kg.
* Patients must be on sulfasalazine 500 mg delayed release tablets and the total daily dose must be within the specified range of 30-60 mg/kg/day with a maximum daily dose of 3 g/day

Exclusion Criteria:

* Patient currently with systemic features of systemic JIA.
* Hypersensitivity to sulfasalazine , its metabolites, sulfonamides or salicylates.
* History of sensitivity to heparin or heparin-induced thrombocytopenia.
* Inability to swallow whole (uncrushed) sulfasalazine 500 mg delayed release tablets as required by protocol
Comparative Population Pharmacodynamic Modeling for Sevoflurane Effects Using ADMS and Bispectral Index

The investigators want to compare the performance of anesthetic depth monitoring for sedation (ADMS) to the bispectral index (BIS) as electroencephalographic measures of sevoflurane effect using two combined sigmoidal Emax models via population pharmacodynamic approach.

Intraoperative awareness under general anesthesia is rare, but it may cause serious psychological sequelae. Anesthetic depth monitoring system based on electroencephalography(EEG) or evoked potential are broadly used methods. Bispectral index (BIS) monitor is most popular anesthetic depth monitoring system. Anesthetic depth monitoring for sedation (ADMS) is developed in Korea as an electroencephalographic monitor for measuring the depth of anesthesia. The investigators want to compare the performance of ADMS to the bispectral index (BIS) as electroencephalographic measures of sevoflurane effect using two combined sigmoidal Emax models via population pharmacodynamic approach.

Eligibility Criteria:
Inclusion Criteria:

* adult patients scheduled for an elective operation and postoperative epidural PCA with ASA physical status 1,2,3 who have signed the wrtten informed consent.

Exclusion Criteria:

* preventive anticoagulation treatment
* Significant liver, kidney, coagulation dysfunction
* Clinically significant ECG abnormalities
* administration of psychologic durgs or opioid within 14 days before surgery
Effectiveness of Pilates Exercises in the Treatment of Dysmenorrhea: A Randomized Controlled Trial

The aim of this study is to investigate the effectiveness of Pilates exercises in the treatment of dysmenorrhea and to contribute to the literature and information on this subject.

The study was planned as a randomized controlled study. The study will be conducted at the Fizyorapt physiotherapy and exercise consultancy center. It will be divided into 2 main groups as those between the ages of 18-50, those with a menstrual period of 3-9 days, those with menstrual pain complaints, and those who cooperate in completing the assessment scales. Participants will be asked to continue the given exercises for 6 weeks, 2 days a week and 45 minutes. People with psychological and physical disabilities will not be included in regular exercise. A personal information form will be prepared by the researcher in order to collect data on the sociodemographic characteristics of the participants. Visual analog scale (VAS) will be used to measure pain intensity and pain relief, Beck depression scale to determine depression symptoms, and menstruation symptom scale to evaluate menstrual pain and symptoms. These surveys will be repeated before and at the end of the study. The data to be obtained will be evaluated using the SPSS24 package program.

Eligibility Criteria:
Inclusion Criteria:

* Female individuals between the ages of 18-50
* Those with a menstrual period of 3-9 days
* Having menstrual pain complaints in most of their menstrual cycles
* Cooperating in completing the assessment scales

Exclusion Criteria:

* Having a history of abdominal surgery
* Having an active infection
* Having knee pain

  -. Using medication
* Participants with any pathology that prevents exercise will not be included in the study
In Vivo Assessment of Glutamine Utilization by Bone Marrow Plasma Cells

This pilot study will first establish the feasibility of an in vivo methodology of assessing the utilization of glutamine into the TCA cycle of normal bone marrow plasma cells from healthy subjects while comparing it to an ex vivo approach

Twenty healthy adult study participants between the ages of 18 and 60 years will be recruited to participate in this pilot study that will include two groups: a) Ex Vivo group (10 volunteers) and b) In Vivo group (10 volunteers). Volunteers will be recruited to either group in a sequential alternating fashion.

In vivo 13C SIRM studies evaluating the utilization of glutamine into the TCA cycle of normal bone marrow plasma cells.

Eligibility Criteria:
Inclusion Criteria:

* Ages 18-60
* Able to provide written consent

Exclusion Criteria:

* Renal Failure
* Pregnancy
* Active steroid use
* Active liver Disease
* Anemia (Hemoglobin \< 12.5 g/dL in men and \< 11.5 g/dL in women)
* H/O alcohol use (average \> 2 drinks per day)
* BMI \> 30
Xylitol for the Prevention of Acute Otitis Media Episodes in Children

This is a randomized controlled trial of regular daily use of xylitol (or "birch sugar"), a natural sweetener that has antimicrobial properties, for the prevention of acute otitis media (AOM, primary outcome) as well as upper respiratory tract infections and dental caries (the two secondary outcomes) in preschool aged children. This trial will be conducted through the TARGet Kids! research network.

This is an RCT of regular daily use of xylitol (or "birch sugar"), a natural sweetener that has antimicrobial properties, for the prevention of acute otitis media (AOM, primary outcome) as well as upper respiratory tract infections and dental caries (the two secondary outcomes) in preschool aged children. Clinical equipoise over the efficacy of xylitol in preventing AOM - a common and costly condition in early childhood - persists even after the completion of three RCTs by a single research group in Finland and one in the United States. Several clinical trials of xylitol for the prevention of dental caries and other studies have demonstrated that the intervention in this trial (3-5 doses of xylitol per day) is safe, well tolerated and feasible for the study period. This trial will be conducted through the TARGet Kids! research network which is undertaking several CIHR funded RCTs and will leverage existing CIHR funded infrastructure and important collaborations. The nominated principal applicant's salary is supported by a CIHR RCT training grant to develop this RCT under the mentorship of a co-principal applicant who is an experienced trialist. This trial has the potential to transform the management of three common conditions during early childhood from treatment to prevention using a currently underutilized antimicrobial substance.

Eligibility Criteria:
Inclusion Criteria:

* Children already enrolled in the TARGet Kids! Network, age 2 - 4 years at start of intervention, parents or care provider able to give consent, able to understand the information in English.

Exclusion Criteria:

* craniofacial malformations, structural middle ear abnormalities, sibling or any other child living at the same address already enrolled in the trial, insertion of ventilation tubes prior to study period, current use of a xylitol product or reported xylitol sensitivity.
Complex Problem Solving Training in Schizophrenic Patients

The primary purpose of the study is to assess whether a planning and problem-solving training is more effective in improving work therapy performance in patients with schizophrenia than traditional training programs addressing basic cognitive functions.

In patients with schizophrenia, cognitive deficits often lead to an impairment in daily life. This observation has led to the development of cognitive training packages aiming a improving these deficits. However, it is far from clear which level of cognitive functioning provides the best target for cognitive interventions. Traditionally, training has aimed a basic cognitive functions like attention and memory. In the present study we aim at a higher-level of function, namely planning and problem-solving skills, which are trained using the software package Plan-A-Day. The primary hypothesis is that complex problem solving training improved functional capacity more than traditional training programs addressing basic cognitive function.

Eligibility Criteria:
Inclusion Criteria:

* Patients with schizophrenic or schizoaffective Disorder (DSM IV)
* Remitted positive symptoms (PANSS positive all ≤ 4), clinical stability
* Native German speaker
* Verbal IQ \> 80
* Visual acuity normal or corrected to normal

Exclusion Criteria:

* Concurrent Axis-I disorder
* Drug abuse during last 2 months
* Neurological or medical conditions potentially affecting cognition
Study to Evaluate the Safety and Preliminary Efficacy of IDCT, a Treatment for Symptomatic Lumbar Intervertebral Disc Degeneration

The purpose of this study is to compare the safety and preliminary efficacy of intradiscal injections of two doses of IDCT (Discogenic Cells + Sodium Hyaluronate vehicle) and two controls (saline, Sodium Hyaluronate vehicle) in subjects with chronic low back pain due to Degenerative Disc Disease (DDD) at one lumbar level from L3 to S1.

This is a Phase I, first-in-human, randomized, double-blind, vehicle and placebo-controlled, parallel-group, multi-center study in subjects with single-level, symptomatic lumbar intervertebral disc degeneration (\>6 months) and unresponsive to conservative therapy for at least 3 months. The study will compare single intradiscal injections of high and low dose IDCT with two control groups (saline, Sodium Hyaluronate).

8 study visits will be completed by all subjects; screening, day 1 (injection day), week 4, week 12, week 26, week 52, week 72 and week 104. The subject will be assessed for safety and efficacy utilizing VAS and ODI questionnaires alongside radiographic evaluations. The study will have a 1 year follow-up and a 1 year extension period (total 2 years).

Eligibility Criteria:
Inclusion Criteria: The subject must have:

1. Diagnosis of early to moderate degenerative disc disease (DDD), Modified Pfirrmann Grade 3-7.
2. Chronic low-back pain for at least 6 months prior to screening; unresponsive to at least 3 months of conservative care.
3. Low-back pain of 40 to 90 mm on the VAS and ODI score of 30 to 90.

Exclusion Criteria: The subject is excluded if he/she has:

1. Symptomatic involvement of more than one lumbar disc.
2. Other persistent pain/nerve issues including, for example, radiculopathy, leg pain, cauda equine syndrome, etc.
3. Fracture of the spine, previous lumbar spine surgery or previous treatment of the target disc.
4. Evidence of dynamic instability on lumbar flexion-extension radiographs.
5. Grade 2 or higher spondylolisthesis at the target disc, lumbar spondylitis or other undifferentiated spondyloarthropathy, or Type III Modic changes around the target disc.
6. Clinical suspicion of a full thickness annular tear at the target disc or other abnormal disc morphology.
7. Clinical suspicion of facet pain as primary pain generator.
8. Subjects who test positive for communicable disease, have significant systemic disease, or are prone to infection.
9. Patients who are deemed unsuitable for clinical study participation by the investigator.
Management of Excess Gingival Display Using Tunnel Technique With 3D Designed PEEK Shell: A Case Series

The aim of the current study is to evaluate the use of a PEEK shell placed in the anterior maxilla placed by tunnel technique in decreasing the gingival display

While lip repositioning has been established as a treatment modality to address excess gum display (EGD) , an often overlooked contributing factor is the lack of lip support. This is often caused by the architecture of the maxilla at the subnasal area. Maxillary overgrowth may give rise to a subnasal skeletal depression producing decreased lip support and marked upper lip retraction during a smile.

Restricting muscle pull by lip repositioning surgery as a treatment option limits muscle movement, however it does not address lip support. In 2018 an alternative intervention was later proposed in a case report study . The technique involves raising a full thickness flap and applying PMMA (polymethyl methacrylate) cement to fill the subnasal depression and limit the upper lip movement. Since its introduction, a limited number of studies have attempted to investigate the technique, however there are not enough studies to support the outcome or the stability of the technique. The aim of the current study is to evaluate the use of a tunnel technique with a 3D printed PEEK (Polyetherether ketone) shell to fill the skeletal subnasal depression

Eligibility Criteria:
Inclusion Criteria:

* Patients with excess gingival display 2.5mm or more
* Patients with an exaggerated subnasal concavity
* Decreased/normal value of SNA ( angle between sella, nation, A point) in cephalometric measurement
* Decreased/normal cephalometric measurement of A to N-perpendicular (perpendicular from N on FHP)
* Decreased/normal value in cephalometric measurement of the convexity at point A (linear measurement from point A to facial plane)
* Decreased/normal value of Ricketts Esthetic plane in cephalometric measurement
* Decreased/normal value of Holdaway H-angle in cephalometric measurement
* Nasolabial angle range from 100° to 120°
* Patients 20-60 years old
* Medically free
* Compliant patient that agrees to the follow up period

Exclusion Criteria:

* Pregnant and lactating females
* Smokers
* Diabetics
* Patients with parafunctional habits that may affect the outcome of the procedure
* Medically compromised patients
Comparison of Live Birth Rate in Natural Cycle Single Euploid FET Versus Without Luteal Phase Support

To evaluate whether single euploid embryo transfer in NC without routinely administered LPS is non-inferior to NC with routinely administered LPS.

In case the study will show that the live birth rate in single euploid NC frozen embryo transfer cycles without LPS is not inferior to NC cycles with LPS, treatment can be simplified, and participants comfort can be increased.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18 to 40 years
* Regular ovulatory cycles
* Availability of at least one euploid embryo after Trophectoderm biopsy for PGT-A on day 5 or day 6
* Detection of ovulation by P4 rise \> 1.0 ng/ml after LH surge
* P4 value of at least 5 ng/ml on day 4 after ovulation

Exclusion Criteria:

* History of repeated pre-menstrual spotting
* Factors affecting the implantation through anatomical changes of the uterus / ovaries or the tubes (adenomyosis, Asherman syndrome, endometriosis, uterine fibroids / polyps, isthmocele with intracavitary fluid presence, hydrosalpinx....)