cyrilzakka/clinical-trials huggingface dataset:
Azithromycin Reduction to Reach Elimination of Trachoma

The investigators propose a randomized controlled trial of discontinuation versus continuation of annual mass azithromycin distribution in hypoendemic communities of Maradi, Niger. The investigators will randomize communities with up to 20% Trachomatous Inflammation - Follicular (TF) prevalence following at least 5 years of mass azithromycin distribution to discontinuation or continuation of 3 additional years of annual mass azithromycin distribution.


Eligibility Criteria:
Inclusion Criteria:

* Provision of appropriate informed consent
* Stated willingness to comply with all study procedures
* Live in one of the 80 communities with up to 20% prevalence of TF selected for the trial

Exclusion Criteria:

* Does not consent to participation
* Unwilling to comply with all study procedures
* Does not live in one of the 80 communities with up to 20% prevalence of TF selected for the trial
Comparing the Effect of Video-cases and Text-cases on Medical Students' Learning in Tutorial

This study is designed to examine how the type of learning case affects the thinking of medical students in tutorial

Tutorials at Harvard Medical School use problem-based learning with written cases. Students work in groups under the supervision of a tutor who guides their exploration of the material. As students progress through the curriculum there is an opportunity to advance the complexity of the material they are presented with. Video-based patient case studies have been shown to improve critical thinking ratios in paediatric medical student problem-based learning exercises, and time spent on data exploration, theory building and theory evaluation in postgraduate residency programs. We hypothesize that video provides a stimulus that improves cognitive processing and critical thinking among medical students, as compared to working from the text-based transcript of the same case.

Eligibility Criteria:
Inclusion Criteria:

* medical student participating in the endocrine and reproductive pathophysiology course at Harvard Medical School

Exclusion Criteria:

* None
Clinical Trial of Desmopressin on Nocturia in Obstructive Sleep Apnoea Patients

The purpose of the study is to evaluate the efficacy of desmopressin on symptoms of nocturia in patients with Obstructive Sleep Apnoea (OSA). The improvement of sleep quality and the quality of life will be measured.

Nocturia is one of the commonest urinary symptoms in elderly and in patients with obstructive sleep apnoea (OSA). According to the International Continence Society (ICS) definition, nocturia is defined as "the complaint that the individual has to wake at night one or more times to void" . It implies a continuum beginning from what might be considered normal, to a bothersome state. Bothersome nocturia is a common and age-dependent condition. A prevalence ranging from 48.6% to 77% were reported in the literature. Pathogenesis of nocturia is multi-factorial, and has closely related to OSA. OSA patients generate negative intrathoracic pressure during sleep, this leads to increased venous return and distension of the right atrium. This leads to an increase of hormone secretion, namely Atrial Natriuretic Peptide (ANP). ANP causes increased sodium and water excretion, and inhibits the secretion of antidiuretic hormone. All of the above factors results in an increased nocturnal urine production and nocturia.

Middle-aged men with OSA always present to urology clinic with lower urinary tract symptoms with predominant nocturia. Many a time they were treated as benign prostatic hyperplasia with multiple medications with suboptimal response. The underlying genuine pathology of OSA-related nocturia is overlooked.

Desmopressin is an analogue of antidiuretic hormone, it is the pharmacological therapy of choice for patients with nocturia where night-time polyuria is present.

In this study, the investigators would like to evaluate the efficacy of desmopressin on symptoms of nocturia in patients with Obstructive Sleep Apnoea (OSA). The improvement of sleep quality and the quality of life will be measured.

Eligibility Criteria:
Inclusion Criteria:

* Adult male or female patient (aged\</=65 years old)
* Obstructive sleep apnoea diagnosed by sleep study
* Stable treatment on obstructive sleep apnoea and / or LUTS
* Nocturia on average more than once per night
* Having the ability to communicate and comply with the requirements of the study

Exclusion Criteria:

* Presence of urethral strictures and neurogenic bladder dysfunction
* Clinical evidence of bladder stones, bladder tumor or an active urinary tract infection
* History of prostate cancer or prostate specific antigen (PSA) level \> 10ng/ml or suspicious of prostate cancer on digital rectal examination (DRE), unless a transrectal biopsy of prostate has been performed and the presence of prostate cancer has been excluded.
* Patient on intermittent self-catheterisation
* Recent start or change of treatment on obstructive sleep apnoea and / or nocturia
* Uncontrolled medical problems: e.g. Diabetes Mellitus or Diabetes insipidus
* Hyponatraemia
* Pregnancy
Branch Retinal Vein Occlusion (BRVO) Treatment With Bevacizumab and Dexamethasone or Bevacizumab Only.

The aim of this study is to evaluate the visual outcome and prognostic factors after intraocular injections of Bevacizumab or combination of Bevacizumab And Dexamethasone under pro re nata treatment regimen for Branch Retinal Vein Occlusion (BRVO) patients.

The aim of this study is to evaluate the clinical outcome after intraocular injections of Bevacizumab or combination of Bevacizumab and Dexamethasone under pro re nata treatment regimen for the patients with Branch Retinal Vein Occlusion (BRVO) patients. Mean change of logarithm of the minimal angle of resolution (logMAR) visual acuity (VA), central foveal thickness (CFT), contrast sensitivity (CS) as well as predictive factors including best-corrected visual acuity (BCVA), vision related questionnaires and various other ocular parameters will be assessed.

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent must be obtained before any study assessment is performed
2. Diagnosis of visual impairment exclusively due to ME secondary to BRVO
3. BCVA score at Screening and Baseline between 10/40 (0.5) to 20/400 (0.05) on the Snellen chart.
4. Central foveal thickness (CFT) ≥ 300 µm
5. Naive Eyes

Exclusion Criteria:

1. Pregnant or nursing (lactating) women
2. Stroke or myocardial infarction less than 3 months before Screening
3. Uncontrolled blood pressure defined as systolic value of \>160 mm Hg or diastolic value of \>100 mm Hg at Screening or Baseline.
4. Any active periocular or ocular infection or inflammation at Screening or Baseline in either eye
5. Uncontrolled glaucoma at Screening or Baseline or diagnosed within 6 months before Baseline in either eye
6. Neovascularization of the iris or neovascular glaucoma in the study eye
7. Use of any systemic or ocular antivascular endothelial growth factor (anti-VEGF) drugs within 6 months before Baseline
8. Panretinal laser photocoagulation performed, anticipated or scheduled in the study eye
9. Focal or grid laser photocoagulation in the study eye
10. Use of intra- or periocular corticosteroids (including sub-Tenon) or ocular anti-VEGF treatment within 3 months before Screening in the study eye
11. Any use of intraocular corticosteroid implants (eg, dexamethasone \[Ozurdex®\], fluocinolone acetonide \[Iluvien®\]) in the study eye
HIPEC Combined With Sintilimab for Gastric Cancer With Peritoneal Metastasis

To evaluate the Safety and Efficacy of HIPEC Combined With Sintilimab for Gastric Cancer Patients with Peritoneal Metastasis.

Peritoneal metastasis is the most common pattern of disease relapse and is attributed to the dismal prognosis of the gastric cancer. The National Comprehensive Cancer Network (NCCN) guidelines suggest that systemic chemotherapy is the first-line standard strategy, and chemotherapy combined with trastuzumab for patients with positive HER-2. HIPEC can significantly improve survival in peritoneal metastasis from gastric cancer. PD-1/PD-L1 antibody has shown promising outcomes for unresectable or metastatic solid tumors. The present study aimed to evaluate the safety and efficacy of HIPEC combined with Sintilimab (Tyvyt®) in gastric cancer patients with peritoneal metastasis.

Eligibility Criteria:
Inclusion Criteria:

1. Advanced gastric (gastroesophageal junction) adenocarcinoma confirmed by histology;
2. Age 18-75 years, Male or Non pregnant female
3. ECOG (Eastern Cooperative Oncology Group) : 0\~1；
4. Negative for HER-2 by IHC/FISH；
5. Peritoneal metastasis is confirmed by laparoscopic exploration, and the PCI≤20；
6. Untreated (e.g. radiotherapy, chemotherapy, target therapy and immunotherapy);
7. Normal Bone marrow, liver and kidney function indices before the recruitment:
8. Expected survival≥ 12 week
9. Signed the Informed Consent Form, and blood and tissue samples can be obtained;

Exclusion Criteria:

1. Other distal metastases besides peritoneal metastases (e.g., liver, lung, pleural, brain, bone metastases, etc.);
2. Previous systemic therapy for gastric cancer;
3. Recurrent gastric cancer after surgery;
4. Cardiopulmonary dysfunction;
5. Immunosuppressive drugs(eg.Corticosteroids) were used within 14 days before treatment, eg.corticosteroids,
6. There is any active autoimmune disease or a history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; subjects with vitiligo or asthma in childhood have been completely relieved, and those who do not need any intervention after adulthood can be included Asthma requiring medical intervention with bronchodilator was not included.)
7. Allergy to the drugs in this protocol；
8. Patients with other diseases not suitable for inclusion, such as immune deficiency, active tuberculosis, hepatitis B (non-active hepatitis B surface antigen (HBsAg) carriers, hepatitis B virus titer \<500IU/ml after treatment and with normal liver function can be included), hepatitis C virus positive;
9. A history of idiopathic pulmonary fibrosis, tissue pneumonia, drug pneumonia, idiopathic pneumonia, or r active pneumonia;
10. Other patients who were considered unsuitable for inclusion by the researchers;
Sacral Massage with a Tennis Ball on Labor Pain and Comfort During the Intrapartum Period

Although pregnancy and labor are physiological events, the pain caused by uterine contractions during labor is among the most severe pains. This causes many women to fear labor. For this reason, control of labor pain should be one of the main goals of the care given to women in labor. Therefore, this study was designed to determine the effect of sacral massage with a tennis ball on labor pain and labor comfort in the intrapartum period.

Pregnant women hospitalized in the maternity unit will be evaluated for compliance with the inclusion criteria. Women who meet the inclusion criteria and are willing to participate in the study will be randomized according to the simple random numbers table and the study group will be determined by the researcher by drawing lots. The purpose and stages of the study will be explained verbally to the women whose group is determined and the women will be asked to read and sign the Informed Voluntary Consent Form. Then, the Pregnancy Identification Form will be filled in by the researchers using the face-to-face interview method. Then the massage will be explained to the pregnant women in the experimental group and they will be asked to evaluate the Visual Analog Scale (VAS) before the procedure. While performing this application, the researcher will apply pressure to the sacral region with a tennis ball in a circular motion in a way that the patient can feel but not feel pain. The application will be applied to the pregnant woman for a total of 3 contractions. 30 minutes after each procedure, the woman will be asked to mark the intensity of the pain she feels on the VAS scale and to mark the Birth Comfort Scale.

Eligibility Criteria:
Inclusion Criteria:

* To be able to read and write Turkish,
* Being over 18 years old
* Being primiparous
* Singular foetus and head presentation
* Pregnancy at term (37-42 weeks)
* Those without risk factors during pregnancy
* Being in the active phase of labour in stage 1
* Women without any chronic diseases
* Those without a diagnosed psychiatric illness
* To agree to participate in the research

Exclusion Criteria:

* If the participant wishes to leave the study voluntarily
* Administration of any analgesic medication to reduce pain during labour
* Development of any of the unexpected maternal-fetal risk conditions during labour
* Having a caesarean section for any reason
* The pregnant woman has spine and bone structure problems.
Antineoplaston Therapy in Treating Patients With Advanced Mesothelioma

Current therapies for advanced Mesothelioma provide limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of advanced Mesothelioma.

PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with advanced Mesothelioma.

Advanced Mesothelioma patients receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues up to 12 months in the absence of disease progression or unacceptable toxicity.

OBJECTIVES:

* To determine the efficacy of Antineoplaston therapy in patients with advanced Mesothelioma, as measured by an objective response to therapy (complete response, partial response or stable disease).
* To determine the safety and tolerance of Antineoplaston therapy in patients with advanced Mesothelioma.
* To determine objective response, tumor size is measured utilizing physical examination and radiologic studies, performed every 8 weeks for the first two years, every 3 months for the third and fourth years, every 6 months for the 5th and sixth years, and annually thereafter.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed stage IV mesothelioma that is unlikely to respond to existing therapy and for which no curative therapy exists

  * Evidence of disease by CT scan or MRI

PATIENT CHARACTERISTICS:

Age:

* 1 and over

Performance status:

* Karnofsky 60-100%

Life expectancy:

* At least 2 months

Hematopoietic:

* WBC at least 2,000/mm\^3
* Platelet count at least 50,000/mm\^3

Hepatic:

* Bilirubin no greater than 2.5 mg/dL
* SGOT and SGPT no greater than 5 times upper limit of normal
* Hepatic function adequate

Renal:

* Creatinine no greater than 2.5 mg/dL
* No renal insufficiency
* No history of renal conditions that contraindicate high dosages of sodium

Cardiovascular:

* No uncontrolled hypertension
* No history of congestive heart failure
* No cardiovascular conditions that contraindicate high dosages of sodium

Pulmonary:

* No serious lung disease (e.g., chronic obstructive pulmonary disease)

Other:

* Not pregnant or nursing
* Fertile patients must use effective contraception during and for 4 weeks after study participation
* Not at high medical or psychiatric risk
* No nonmalignant systemic disease
* No active infection

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* At least 4 weeks since prior immunotherapy and recovered
* No concurrent immunomodulatory agents

Chemotherapy:

* At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered

Endocrine therapy:

* Concurrent corticosteroids allowed

Radiotherapy:

* At least 8 weeks since prior radiotherapy (or less if multiple tumors) and recovered

Surgery:

* Recovered from prior surgery

Other:

* Prior cytodifferentiating agents allowed
* No prior antineoplastons
* No other concurrent antineoplastic agents
Study Assessing Metabolism, Excretion and Pharmacokinetics of a Poly (ADP-Ribose) Polymerase (PARP) Inhibitor in Patients With Solid Metastatic Tumours

Open, non-randomized, radiolabelled, single centre study designed to characterize the metabolism, excretion and pharmacokinetics of a single oral dose of 100 mg \[14C\]-radiolabelled AZD2281 (KU-0059436) in patients with advanced or metastatic solid tumours.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed advanced or metastatic tumour, refractory to standard therapies

Exclusion Criteria:

* Anti-cancer therapy including chemotherapy, radiotherapy (excluding palliative radiotherapy), endocrine therapy, immunotherapy or use of other investigational agents within 4 weeks prior to study entry.
* Patients may continue the use of LHRH agonists for cancer, bisphosphonates for bone disease and corticosteroids provided the dose is stable before and during the study.
* Females will be able to continue to take hormone replacement therapy
Effects of Clopidogrel on Blood Pressure

Context: Soluble CD40 ligand (sCD40L) released from activated platelets induces inflammatory transformation of the vascular endothelium and is an independent predictor of cardiovascular events. Arterial hypertension is associated with platelet activation, increased sCD40L levels and endothelial dysfunction suggesting that inhibition of platelet-derived sCD40L release may improve endothelial function and lower blood pressure (BP).

Objective: To determine the effects of clopidogrel on sCD40L, endothelial function and BP.

Design: Randomized, controlled, investigator-blinded, parallel-group, 2-phase trial in patients with coronary artery disease and essential arterial hypertension and those without hypertension.

Intervention: Participants receive a single 600-mg clopidogrel loading dose (phase I) followed by a daily 75-mg clopidogrel maintenance dose over 28 days (phase II).

Outcome Measures: Primary outcome measure is the change in BP from baseline. Secondary outcome measures are changes in biomarkers of platelet and endothelial function and their correlation with BP.


Eligibility Criteria:
Inclusion Criteria:

* Patients with coronary artery disease (CAD) and a clinical presentation of stable angina pectoris or acute coronary syndrome who had undergone percutaneous coronary intervention (PCI) with stent implantation
* 5-year history of essential arterial hypertension with a systolic BP between 140 and 170 mmHg or no hypertension (systolic BP \<140mg Hg and diastolic BP \<90 mmHg)
* treatment with clopidogrel (75 mg per day) for 6 to 12 months after PCI
* continuous use of aspirin (100 mg per day)
* no change in drug therapy within 3 months prestudy

Exclusion Criteria:

* stent thrombosis or another ischemic cardiovascular event following PCI
* use of other antiplatelet drugs or anticoagulants within 3 months prestudy
* surgery within 3 months prestudy
* arrhythmia
* valvular heart disease
* hematologic disorder
* severe renal disorder
* severe hepatic disorder
* chronic inflammatory disorder
* autoimmune disorder
* acute or chronic infection
* active malignancy
* a body-mass index below 18.5 or above 40 kg/m2
* nonadherence to therapy
* nonattendance to control visits
Effects of Sex Steroid Hormones on Human Brain Function, Structure and Connectivity

This ultrahigh-field MRI study gives us the unique opportunity to measure changes in brain function and structure induced by long-term opposite-sex steroid hormone administration in transsexual subjects. Our aim is 1. to prove the influence of high-dose, long-term opposite-sex steroid hormone treatment on functional brain response in transsexuals. 2. to investigate the influence of hormone treatment on resting state functional connectivity and brain morphology. 3. to investigate differences between transsexuals and healthy control subjects in brain function and functional connectivity, brain morphology and structural connectivity. In this longitudinal study, transsexuals and healthy control subjects will undergo three 7 Tesla ultrahigh-field MRI scan sessions: 1. baseline (before hormone treatment), 2. after 4 weeks of treatment and 3. after 4 months of treatment.


Eligibility Criteria:
Inclusion criteria for transsexuals are:

* DSM-IV diagnosis of Gender Identity Disorder (DSM-IV: 302.85, 302.6; ICD-10: F64.9, F64.8) by a structured clinical interview (SCID)
* general health based on history, physical examination, ECG, laboratory screening, SCID
* willingness and competence to sign the informed consent form

Exclusion criteria for transsexuals are:

* severe neurological or internal diseases
* steroid hormone treatment within 2 months prior to inclusion (including birth control pill, phytohormones)
* treatment with psychotropic agents such as SSRIs
* any implant or stainless steel graft
* abnormal values in routine laboratory screening or general physical examination
* current substance abuse (determined using drug screening at the screening visit)
* pregnancy (determined at screening visit and first MRI scan)
* failure to comply with the study protocol or to follow the instructions of the investigating team.

Inclusion criteria for healthy controls are:

* general health based on history, physical examination, ECG, laboratory screening, SCID
* willingness and competence to sign the informed consent form

Exclusion criteria for healthy controls are:

* severe diseases
* any implant or stainless steel graft
* steroid hormone treatment within 2 months prior to inclusion (including birth control pill, phytohormones)
* abnormal values in routine laboratory screening or general physical examination
* current substance abuse (determined using drug screening at the screening visit)
* pregnancy (determined at screening visit and first MRI scan)
* failure to comply with the study protocol or to follow the instructions of the investigating team
A Phase 3, Open-label, Crossover Study to Evaluate Self-administration of Rozanolixizumab by Study Participants With Generalized Myasthenia Gravis (gMG)

The purpose of this study is to evaluate the ability of study participants with generalized Myasthenia Gravis (gMG) to successfully self-administer rozanolixizumab after training in the self-administration technique using the syringe driver and manual push methods.


Eligibility Criteria:
Inclusion Criteria:

* Study participant must have a documented diagnosis of generalized Myasthenia Gravis (gMG)
* Study participant is willing to perform and capable of performing home self-administration
* Study participant is considered by the investigator for additional rozanolixizumab treatment with the posology proposed in this study.
* Body weight ≥35 kg
* Study participants may be male or female

Exclusion Criteria:

* Study participant has a known hypersensitivity to other anti-Fc receptor (FcRn) medications, to any components of the study medication, to any of the excipients (including polysorbate 80), or has a known history of hyperprolinemia, since both polysorbate 80 and L-proline are constituents of the rozanolixizumab formulation
* Study participant with a known tuberculosis (TB) infection, at high risk of acquiring TB infection, or latent tuberculosis infection (LTBI), or current or history of nontuberculous mycobacterial infection (NTMBI)
* Study participant has a clinically relevant active infection or a history of serious infection (resulting in hospitalization or requiring IV antibiotic treatment) within 6 weeks before the Baseline Visit
* The study participant previously participated in any rozanolixizumab MG study and met any mandatory withdrawal criteria (unless the reason is directly related to MG0020 participation) or mandatory study drug discontinuation criteria.
* Study participant has received a live vaccination within 4 weeks before starting treatment, or a Bacillus Calmette-Guérin (BCG) vaccine within 1 year before starting treatment; or intends to have a live vaccination during the course of the study or within 8 weeks following the last dose of rozanolixizumab
* Study participant with severe (defined as Grade 3 on the Myasthenia Gravis Activities of Daily Living (MG-ADL) scale) weakness affecting oropharyngeal or respiratory muscles, or who has myasthenic crisis or impending crisis