cyrilzakka/clinical-trials huggingface dataset:
Positron Emission Tomography in Extrapulmonary Tuberculosis

Tuberculosis (TB) remains a major public health problem. In extra-pulmonary forms, evidence of bacteriological cure is difficult to be obtained raising the need for other therapeutic assessment tools. 18F-Fluoro-deoxy-glucose (FDG) is a glucose analogue widely used in Positron Emission Tomography (PET). Its uptake is high in cancer cells and in inflammatory cells, especially in active TB foci. The hypothesis is a decrease in the uptake of FDG in the foci of TB during treatment permitting a non-invasive monitoring of therapeutic response. The main objective is to describe the evolution under treatment of the FDG uptake in PET imaging in TB foci in patients cured from lymph node and bone TB. Secondary objectives are to compare the decrease of FDG uptake according to type of location, to define the frequency of localizations revealed by FDG-PET and their impact on therapeutic management at the beginning and the end of treatment, and to describe the evolution of PET in patients not cured.

Longitudinal observational multicenter pilot study. 55 patients to be included Total duration of the study: 51 months. Inclusion period: 27 months Follow up period: 18 to 24 months Number of participating centers: 11 Average number of inclusion per month per center: 1-2

Eligibility Criteria:
Inclusion Criteria:

* Adults
* Affiliated to a social security system or "AME"
* Patient informed of the objectives and constraints of the study and giving informed consent
* Patient can keep lying valid at least 30 minutes
* Patient not HIV infected or, if infected, with CD4 counts\> 200/mm3 for at least 3 months

Exclusion Criteria:

* Suspicion of other concurrent infection
* Severe immunosuppression in case of HIV infection
* Inflammatory disease
* Pregnant or nursing women
* Radiation therapy
* Uncontrolled diabetes
* Prolonged corticosteroid therapy (\> 20mg/day)
* Patient unable to sustain injected CT scan and MRI
Platelet Rich Plasma Injections for Vulvar Lichen Sclerosus

15 patients with biopsy proven active vulvar lichen sclerosus will be recruited by a clinic specializing in vulvar disorders. This study consists of a 2 week screening period and a 12-week treatment period. Participants will receive two separate treatments of autologous platelet rich plasma separated by 6 weeks. A repeat biopsy will be performed 6 weeks after the second autologous platelet rich plasma injection

15 patients with biopsy proven active vulvar lichen sclerosus will be recruited by a clinic specializing in vulvar disorders. This study consists of a 2 week screening period. A 4mm vulvar punch biopsy will be obtained at the initiation of the screening period to confirm that the participant have active lichen sclerosus. 12 weeks after the biopsy, the participants will receive an injection of 5cc of autologous platelet rich plasma into the affected vulvar skin. Six weeks later, participants will receive an additional injection of 5cc of autologous platelet rich plasma. A repeat biopsy will be performed 6 weeks after the second autologous platelet rich plasma injection. The inflammation on both biopsy specimens will be determined by a dermatopathologist.

Eligibility Criteria:
Inclusion Criteria:

* Active lichen sclerosus
* no current treatment
* symptomatic 4/10 on visual analogue scale

Exclusion Criteria:

* history of vulvar carcinoma or VIN
Dysphagia Handicap Index: A Structured Translation From English to German

Establishment of a questionnaire in German to determine in a structured and quantifiable manner the quality of life of patients with dysphagia.


Eligibility Criteria:
Inclusion criteria: All patients with dysphagia

Exclusion criteria: Inability to fill in the questionnaire
Phase I 2-Way Crossover Study to Assess Relative BA of Tablet Versus Liquid Suspension and Food Effect on Tablet Formulation

The purpose of this study is to compare the liquid suspension form of AZD 2624 to a tablet form of the same drug. This study will also study the effect of food on the tablet form of the drug.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female volunteers

Exclusion Criteria:

* Donation of plasma or blood products within one month of of screening
* Clinically relevant abnormalities in physical examination, vital signs,ECG, clinical chemistry, hematology, or urinalysis.
* Previous participation in an AD2624 study.
Mobile Application for Relapse Prevention in Eating Disorders Beliefs in Three Patients in Remission.

This study aims to assess the efficacy of GGED module in preventing relapse in three patients with ED diagnoses in remission. In particular, the objective of the present study is to analyse whether the GGED module diminishes the level of attachment to dysfunctional beliefs related to the maintenance of EDs, which had previously been addressed in CBT therapy. Specifically, an uncontrolled case series design was carried out to assess the changes pre and post use the app. It's expected that after the use of the GGED module for 15 days are, the patients show at the primary level: decrease in the degree of ascription to dysfunctional beliefs associated with ED; and at the secondary level: increase in self-esteem and body satisfaction; decrease in eating symptomatology; and no changes in emotional symptomatology. These results are also expected to be maintained in subsequent follow-ups, at 15 days and a month after to finish the app.

There is a mobile platform, called OCD.app (previously GGtude) which is an evidence-based platform comprising of brief game-like exercises targeting a wide range of psychological symptoms. GGED (GG Eating Disorders) is a module within the app that addresses the core beliefs related to the development and maintenance of eating disorders. In this, a cognitive training exercise is performed: different sentences appear in the form of beliefs, and the person must identify and accept those beliefs that are functional, adaptive and positive, dragging them to the lower part of the screen; and reject those that are dysfunctional, maladaptive and negative dragging them to the upper part of the screen. GGED has shown promising results in reducing maladaptive beliefs in the general adult population and in general adolescent population. In addition, another module that target on obsessive-Compulsive disorder (OCD) has demonstrated its efficacy in preventing relapses in patients diagnosed with OCD in remission. Given that the GGED module has not yet been tested in EDs patients and there is a need for the development of techniques to prevent relapses in these disorders, the objective of the present study is to assess its efficacy in preventing relapse in three patients with ED diagnoses in remission.

Eligibility Criteria:
Inclusion Criteria:

* (1) informed consent signed; (2) a diagnosis of an ED in remission; (3) having received CBT; (4) and access to a mobile device to complete the GGED module.

Exclusion Criteria:

* (1) Not meeting the described inclusion criteria.
Long Term Extension Safety Study in Patients With Dementia of the Alzheimer's Type Who Completed Study CPC-001-07

This is a long-term-safety roll-over extension study for a Phase II Study (Protocol CPC-001-07).

This is a long-term-safety roll-over extension study for a Phase II Study (Protocol CPC-001-07). Patients having safely completed the 12-week maintenance phase of Study CPC-001-07 will be eligible for admission. Subjects will remain on their CPC-201 MTD as determined in Study CPC-001-07. The dose of CPC-201 will be increased from 15 mg/day (administered in Study CPC-001-07) to 20mg/day starting on Day1. For those patients who do not tolerate 20mg/day CPC-201, the dose of CPC-201will be decreased to its previously tolerated level of 15mg/day.

This protocol allows to increase patients' MTD of CPC-201, as previously determined in the Phase II Study (CPC-001-07 protocol) by, 5mg or 10mg increment up to a maximum of 60 mg/day starting on Day7 or Month 3 visits of this extension protocol per Investigator's judgment and patient's tolerability.

This extension study is intended to continue for each enrolled patient for up to 6 months unless medically contraindicated. Patients may withdraw from this study at any time. Upon termination of this study, patients will return to their original daily donepezil dose of 10 mg/day and will continue to receive CPC-201 mg/day for one final week.

Eligibility Criteria:
Inclusion Criteria:

1. Have signed an Institutional Review Board (IRB) approved informed consent document indicating that they understand the purpose of and procedures required by the study and are willing to participate in the study and comply with all study procedures and restrictions. Informed consent must be obtained from the patient and/or a designated representative prior to initiating any procedures of the study.
2. Have safely completed 12 week maintenance phase of CPC-001-07 study.

Exclusion Criteria:

1. Renal and hepatic dysfunction with:

   Total Bilirubin: \>1.5 x UNL AST: \>2.5 x UNL ALT: \>2.5 x UNL Serum Creatinine: \>1.5 x UNL Creatinine Clearance: \<30 mL/min (calculated by Cockcroft and Gault equation)
2. History or presence of myasthenia.
3. ECG findings of:

   Complete Left Bundle Branch Block; Ventricular pacing; 2nd degree or 3rd degree AV block; Atrial fibrillation or atrial flutter; HR \<45 or \>100; PR \>220 msec; or QTcF \>450 msec in male, \>470 msec in female
4. Patients considered unlikely to co-operate in the study, and/or poor compliance anticipated by the investigator.
5. Any other clinically relevant acute or chronic diseases which could interfere with patients' safety during the trial, or expose them to undue risk, or which could interfere with study objectives.
Idronoxil Suppository Combine With Radiotherapy for Metastatic Prostate Cancer

The aim of the study is to determine the toxicity of Idronoxil (NOX66) when used in combination with palliative radiotherapy for metastatic prostate cancer

Who is it for? Patient may be eligible for this study if they have late stage metastatic prostate cancer which is castrate resistant and have metastatic lesions that are suitable for radiotherapy.

Study details There are two groups of patients in this study and no randomisation. The two groups will have two different doses of idronoxil (NOX66), representing a 2-step dose escalation. Both groups receive the same standard radiotherapy dose.

Group 1 will receive the lower dose (400 mg) of idronoxil suppository daily and Group 2 800 mg daily.

Recruitment into Group 2 will only commence once all Group 1 patients have completed the 13-day treatment course of idronoxil suppository without excessive unexpected toxicity. The total treatment duration will be 13-15 days for both groups depends on whether radiotherapy is given on consecutive days or over the weekend.

Day 0: commence idronoxil (NOX66) Days 1-5: 1 or 2 lesions will receive 20 Gy (radiotherapy dose unit) radiotherapy in 5 daily fractionated doses and continue daily NOX66 Day 6-12: Continue NOX66 (the duration of NOX66 will be 13-15 days depends on whether radiotherapy is given on consecutive days or over the weekend).

Both groups will have prostate-specific membrane antigen positron emission tomography (PSMA-PET) scans before starting treatment and three months after the last fraction of radiotherapy to assess treatment response.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed metastatic prostate cancer that is castrate-resistant.
* 2-3 lesions suitable for radiotherapy.
* ECOG Performance status 0-2.

  * Adequate bone marrow, hepatic and renal function
  * At least 4 weeks must have elapsed prior to commencement of idronoxil treatment since prior chemotherapy, investigational drug or biologic therapy

Exclusion Criteria:

* Chemotherapy regimens with delayed toxicity within the last 4 weeks.
* Any situation where the use of suppository therapy is contra-indicated or impractical(eg. chronic diarrhoea, colostomy, ulcerative colitis).
* No concurrent systemic chemotherapy or biologic therapy is allowed.
* Psychiatric disorder or social or geographic situation that would preclude study participation.
* Patient unable to provide consent
CyberKnife Radiosurgery For Low & Intermediate Risk Prostate Cancer: Emulating HDR Brachytherapy Dosimetry

The purpose of this study is to investigate the effects of CyberKnife radiosurgery in patients with early stage organ-confined prostate cancer and to evaluate the effects of this treatment on the quality of life over time.

In this study, CyberKnife radiosurgery will be used to produce dose distributions comparable to those created by High Dose Rate (HDR) brachytherapy treatment, without the use of invasive catheters. The radiosurgery volumes will closely be made to resemble HDR brachytherapy therapeutic volumes with similar dose limitation objectives to adjacent normal tissues.

The CyberKnife Robotic Radiosurgery System is a unique radiosurgical system capable of treating tumors anywhere in the body noninvasively and with sub-millimeter accuracy. The CyberKnife System delivers radiation using a precise targeting methodology allowing a focal treatment margin around the target, thus limiting the volume of adjacent tissue receiving high doses radiation. This in turn allows the delivery of high doses of radiation to the prostate over a short series of treatments.

Eligibility Criteria:
Inclusion Criteria:

* Patient must be at least 18 years of age
* Histologically proven prostate adenocarcinoma
* Biopsy within 1 year of date of registration
* Clinical Stage (CS) T1b-T2b, N0, M0
* Patients belonging to one of the following risk categories:
* Low Risk: CS T1b-T2a, Gleason Score 2-6, Prostate Specific Antigen (PSA) \< or = 10 ng/ml
* Intermediate Risk: CS T2b, Gleason Score 2-6, PSA \< or = 10 ng/ml or CS T1b-T2b, Gleason Score 2-6, PSA \< or = 20 ng/ml or CS T1b-T2b, Gleason Score 7 and PSA \< or = 10 ng/ml
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1

Exclusion Criteria:

* Clinical Stage T2c or greater
* Prior prostatectomy or cryotherapy of the prostate
* Prior radiotherapy of the prostate or lower pelvis
* Implanted hardware or other material that would prohibit appropriate treatment planning or delivery
* History of an invasive malignancy other than basal or squamous skin cancers in the last 5 years
* Hormone ablation for two months prior to enrollment or during treatment
Assessment of Efficacy of Calprotectin and Cross-linked N-telopeptides

The study aims to assess the efficacy of Calprotectin and cross-linked N-telopeptides of type I collagen levels in crevicular fluid as a biomarker in patients with peri-implantitis.

Ethical approval will be obtained from the ethical committee of the Riyadh Elm University and written consent will be obtained from all the patients after explaining in detail the entire research protocol.

Inclusion criteria for the present study:

* 10 patients who underwent dental implant procedure five to ten years ago; among these- 5 patients will be with healthy peri-implant status and 5 patients with presence of peri-implant diseases
* Patients of comparable age and gender distribution- Patients within the age group of 25 to 45 years; and 3 males and 2 females in peri-implant diseases group and 3 males and 2 females in healthy peri-implant status group
* Patients with negative history of any systemic illness, metabolic disease.
* Patients with negative history of antibiotic therapy in past ninety days.

After collecting the PICF and GCF, examination of probing depth (PD), bleeding on probing (BOP) and gingival index (GI) will be done.Modified Löe and Silness criteria will be used for evaluating the GI score.Using modification of criteria described by Schei et al, bone loss rate of alveolar bone will be analyzed on radiographic assessment. Periodontal sites with PD of equal to or more than 3mm with GI score of equal to or more than 1mm and presence or absence of BOP, will be categorized as peri-implant disease sites. Periodontal sites with PD of less than 3mm with GI score of 0 and absence of BOP will be categorized as healthy implant sites. Sterile paper strips will be used for collecting PICF samples, followed by PICF sample preparation using modified criteria described previously in the literature. Isolation of the PICF sampling sites will be done using cotton roles. This will be followed by removal of supra-gingival plaques and gentle air drying. Insertion of the periopaper will be done into the peri-implant crevice and will be kept there for thirty seconds. Periotron will be used for measuring the volume of PICF. Further, all the samples will be sent to laboratory where ELISA technique will be used for measuring the calprotectin

Eligibility Criteria:
Inclusion Criteria:

Exclusion Criteria:

* Patients with history of any systemic illness, metabolic disease.
* Patients with history of antibiotic therapy in past ninety days.
Evaluation of Quality of Life and Utilities Following Surgical Treatment of Stage I-IV Rectal Cancer

This study evaluates quality of life and utilities following surgical treatment of stage I-IV rectal cancer. This study may help researches learn more about quality of life in patients who have or have had rectal cancer.

PRIMARY OBJECTIVE:

I. To assess post-treatment related health state utilities among patients with rectal cancer after treatment at 2 years.

SECONDARY OBJECTIVES:

I. To longitudinally compare the effects of treatment on quality of life and utilities among patients treated with or without (neo)adjuvant radiation therapy.

II. To characterize the impact of treatment on quality of life and utilities among patients with rectal cancer.

III. To assess changes in quality of life and utilities among patients treated for rectal cancer over time.

OUTLINE:

Patients complete quality of life questionnaires over 20-30 minutes at baseline, 6 and 12 months after surgery, and 2, 3, 4, and 5 years after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patient has histologically proven adenocarcinoma of the rectum (stage I - IV) that is planned to be treated by surgical resection performed with curative intent, or who has already received surgical treatment
* Patient must sign an approved informed consent document and have the literary and physical ability to complete the questionnaire in English

Exclusion Criteria:

* Patient has been treated with pelvic radiation therapy for a diagnosis other than rectal cancer
* Patient has a concurrent cancer diagnosis at the time of consent
* Patient has recurrent disease
Kindness Interventions in Enhancing Well-Being in Breast Cancer Survivors

Emerging evidence suggests that both extending kindness towards others and self-kindness practices may have beneficial effects on well-being. This randomized pilot clinical trial will investigate the efficacy of two kindness interventions -acts of kindness (to self or to other) and loving-kindness meditation- for use with early-stage breast cancer survivors.

PRIMARY OBJECTIVES:

I. To refine two interventions - loving kindness and acts of kindness- for use with breast cancer survivors using an online platform.

II. To determine the feasibility and preliminary efficacy of these interventions on positive affect, depressive symptoms, and other aspects of well-being among women with breast cancer.

OUTLINE: Participants are randomized to 1 of 4 groups.

GROUP I (ACTS OF KINDNESS TO OTHERS): Participants perform small acts of kindness or generosity for others 3 times per week for 4 weeks and complete weekly online questionnaires.

GROUP II (ACTS OF KINDNESS TO SELF): Participants perform small acts of kindness for themselves 3 times per week for 4 weeks and complete weekly online questionnaires.

GROUP III (SELF-KINDNESS MEDITATION): Participants direct kind, loving thoughts to themselves, via guided meditation, 3 times per week for 4 weeks and complete weekly online questionnaires.

GROUP IV (CONTROL): Participants keep track of their daily activities, focusing on factual information rather than thoughts and feelings, on 3 separate days each week. At the end of the week, participants report on their activities and complete several online questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Women previously diagnosed with stage 0-IIIA breast cancer
* Have completed treatment with surgery, radiation, and/or chemotherapy
* Have not had a cancer recurrence
* Have access to the internet and an active email account
Circumcision With Use of Thermocautery and Histopathological Changes

Histo pathological changes that occurs in thermo cautery circumcision and the range of damage prepuce from thermal effect in comparison with scalpel circumcision

Circumcision is one of the most commonly performed surgical procedures worldwide. It is known that more than one million children are circumcised annually in the USA alone . Moreover, the WHO has begun to recommend circumcision on the basis of studies indicating its positive effects on human health and especially its role in protection from AIDS . Because of this, thousands of people have been circumcised by many migratory circumcision teams, especially in Africa.

Considering that 1 200 000 children are born annually in Turkey and 51% of them are male, on the basis of data from the Turkish Institute of Statistics, it may be speculated that about 60 000 circumcisions are performed annually in Turkey.

However, the circumcision procedure cannot be performed in health institutions as a routine procedure because of health regulations. When the Social Security Institute incorporated circumcision into the social insurance coverage in 2007, it led to circumcision being performed in the health institutions. Health institutions that were already burdened cannot meet the demands for circumcision. Thus, the search has begun for faster and reliable circumcision techniques with fewer complications. The present study aimed to compare bipolar thermal cautery-assisted circumcision technique, considered to be capable of meeting such demands, with the classical circumcision technique.

Aim of Work This study is aiming to assess the outcome of using thermo cautery in circumcision

Surgical Steps:

small skin incision over prepuce by thermo cautery

stitching if there is bleeding

Insertion of a urinary catheter if suspect uretheral injury

Eligibility Criteria:
Inclusion Criteria:

* all male gender

Exclusion Criteria:

* females
* micro penis
* hypospedias
* epispedias
* ambigilious genitalia
Bleb Vascularity and the Outcomes After Trabeculectomy

1. Study objective: To evaluate the relationship between filtering bleb vascularity and the surgical outcomes after trabeculectomy
2. Study design: A prospective study of 51 eyes of 44 patients after primary MMC-augmented trabeculectomy. The follow-up was 12 months.

Total vessel area of a filtering bleb was measured with ImageJ software on colour photographs of a filtering bleb on day 1, 14, 1, 3 and 6 months and 1 year after trabeculectomy. Blebs were classified clinically as successful (IOP below 18 mmHg and a \>30% reduction in IOP without antiglaucoma medications or additional surgical interventions) or failed. Linear regression analysis was performed to determine the correlation of the bleb vascularity with IOP.

Eligibility Criteria:
Inclusion Criteria:

* primary open angle glaucoma (POAG) with medically uncontrolled intraocular pressure (IOP)
* pseudoexfoliation glaucoma (PEXG) with medically uncontrolled intraocular pressure (IOP)

Exclusion Criteria:

* primary angle closure glaucoma (PACG)
* secondary glaucoma except PEXG
* previous eye surgery
* subjects with decreased vision due to other reasons than glaucoma (e.g., exudative age-related macular degeneration (AMD), proliferative diabetic retinopathy, inflammatory eye diseases)