cyrilzakka/clinical-trials huggingface dataset:
Effect of Pumpkin Seeds on the Dietary Fatty Acid Intake and Blood Pressure in Women

The purpose of this study is to determine if the inclusion of 1.5 ounces of pumpkin seeds per day in the diet of women will alter dietary fatty acid intake or blood pressure.

Cardiovascular disease is the number one cause of morbidity and mortality in United States. Diets high in polyunsaturated and monounsaturated fatty acids have been shown to decrease the risk of cardiovascular disease. Pumpkin seeds are a good source of monounsaturated and polyunsaturated fatty acids. Oil extracted from pumpkin seeds has been shown to lower blood pressure. One purpose of this study is to determine whether eating 1.5 ounces of pumpkin seeds per day will improve polyunsaturated and monounsaturated fatty acid intake in the diet in healthy adult women. Another purpose of this study is to determine whether eating 1.5 ounces of pumpkin seeds a day will lower blood pressure.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Over the age of 18
* Able to read, write, and speak English
* Able to keep a three-day diet diary
* Willing and able to consume pumpkin seeds

Exclusion Criteria:

* Pregnant or planning to become pregnant
* Allergic to pumpkin seeds
* High blood pressure
* Regularly consuming pumpkin seeds (more than 4 times per month)
* Taking blood pressure medication
* Liver disease
* Kidney disease
* Gastrointestinal disease
* History of bariatric surgery
* History of a major cardiovascular event
* Heart disease
* Currently undergoing cancer treatment (except nonmelanoma cancer)
* Following a weight control diet
* Following a disease specific diet
* Following a vegan diet
* Have a diagnosed eating disorder
Evaluation of Efficacy of Photodynamic Therapy in Basal Cell Carcinoma

The purpose of this study is to evaluate the efficacy of pdt in treatment of bcc and factors that affect response rate.

Background and Aim: Basal cell carcinoma (BCC) is the most common skin cancer .Photodynamic therapy _as a novel , non-invasive therapeutic approach _may be considered a valuable strategy. This study was designed with the aim of the evaluation of efficacy of PDT in treatment of BCC and factors that may affect response rate.

Materials and Methods: This was a clinical trial which was done on 28 BCCs. Patients were treated with ALA-PDT monthly for 1-6 sessions and evaluated for clinical response,cosmetic results and probable side effects.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven BCCs

Exclusion Criteria:

* rodent ulcer
* morphea type
* ANA +
* history of photosensitivity or photodermatosis or ingestion of phototoxic drugs during last month
* pregnancy
* breast feeding
* age\< 18
* history of another therapeutic intervention for bcc during last 6 months
A Clinical Study to Assess the Safety of a Disposable Intra-vaginal Device for Stress Urinary Incontinence

This study will evaluate the safety of the pessary device by objective evaluation of vaginal wall integrity and subjective assessment of comfort during in-use conditions.


Eligibility Criteria:
Inclusion Criteria:

* be female 18 years or older;
* provide written informed consent prior to study participation and been given a signed copy;
* be in generally good health as determined by the Investigator;
* have a ≥ 3 month history of experiencing Stress Urinary Incontinence (SUI) per week (self reported);
* be willing to use the pessary investigational device to control stress urinary incontinence;
* be willing to comply with study requirements and instructions;

Exclusion Criteria:

* are pregnant, lactating, or planning to become pregnant during the study;
* within 3 months post partum;
* intrauterine device (IUD) placement of less than 6 months;
* has self-reported difficulty emptying her bladder;
* a history of Toxic Shock Syndrome (TSS) or symptoms consistent with TSS;
* experience difficulty inserting or wearing an intra-vaginal device, including a tampon;
* vaginal surgery, perineal surgery, uterine surgery, or abortion (spontaneous or induced) within the past 3 months;
* has any Screening laboratory value outside the laboratory reference range considered clinically significant by the Investigator and could impact the safety of the subject or the outcome of the study; or
* for any reason, the Investigator decides that the subject should not participate in the study.
Evaluation of the Effect of Telmisartan on Blood Pressure Control of High Risk Patients

The study is designed to evaluate the effect of treatment with Micardis/MicardisPlus on blood pressure and its ability to reduce different indicated cardiovascular risk scores. The study will also evaluate the current antihypertensive treatment pattern in the daily practice among the patient population at increased cardiovascular risk.


Eligibility Criteria:
Inclusion criteria:

* diagnosis of essential arterial hypertension (BP\>140/90 mm HG or BP\>130/80 mm Hg for diabetic patients)
* at least one additional cardiovascular risk factor and/or known single or multiple end organ damage and/or previous cardiovascular disease

Exclusion criteria:

* hypersensitivity to the active substance or to any of the excipients in any ACE inhibitor or angiotensin receptor blocker (ARB) available on the local market, as prescribed in the SPC
* pregnancy and lactation
* diseases involving biliary obstruction
* severe liver impairment
* severe hypertension
* malignant hypertension
* secondary hypertension
* patients age under 18 years
Scientific Substantiation and Assessment of the Effectiveness of Pathogenetic Methods of Therapy for Congenital Ichthyosis in Children

This is an experimental non-randomized clinical study aimed at expanding the indications for the use of biological drugs with the aim of using them for the pathogenetic therapy of children with congenital ichthyosis.

This is an experimental non-randomized clinical study aimed at expanding the indications for the use of biological drugs with the aim of using them for the pathogenetic therapy of children with congenital ichthyosis.

The study will include 50 children aged 6 months to 18 years with a clinically and genetically confirmed diagnosis of congenital ichthyosis. Patients will be divided into 4 groups who will receive symptomatic therapy (using active external agents, emollients and / or systemic retinoids) or biologics targeting the cytokines IL-12 / IL-23, IL-4 / IL-13 and IL -17A. Immunophenotyping of all patients will be performed, the cytokine profile and spectrum of sensitization and the degree of NF-kB activation in lymphocytes will be determined. In experimental group №3, 10 patients with Netherton syndrome will receive dupilumab, in experimental group №2, 10 patients will receive ustekinumab, and in experimental group №1 10 patients will receive secukinumab. Efficiency will be assessed using the Ichthyosis Area Severity Index (IASI), determination of the level of TEWL, and the change in quality of life will also be assessed using the Children's Dermatological Life Quality Index (CDLQI) in comparison from baseline, than at 16 and 52 weeks. Throughout the study, the safety profile (registration of the development of infectious diseases) will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* The subject has signed an informed consent; parental or legal representative consent for patients under 18 years of age, as well as additional consent for patients aged ≥ 15 and \<18.

  * At the time of participation in the study, the age of the subject is not less than 6 months and not more than 18 years.
  * At the time of participation in the study, a clinical diagnosis was established: Congenital ichthyosis with various clinical forms, with the exception of vulgar and X - linked congenital ichthyosis (genetic research is not a prerequisite for participation in the study).
* Subjects should have at least moderate IASI erythema associated with his / her ichthyosis, and a decrease in the quality of life according to CDLQI ≥ 10
* Absence of signs of severe infectious diseases (pneumonia, tuberculosis, etc.)
* No previous history of the use of the following genetically engineered biological drugs: ustekinumab, secukinumab, dupilumab

Exclusion Criteria:

* Subjects who have an allergic reaction to ustekinumab, secukinumab or other components of the drugs.
* Subjects who have bacterial and/or fungal diseases.
* Subjects who have problems in dynamic observation.
* Subjects who will have a worsening of clinical symptoms
Clozapine-associated Infection

perform a study in VigiBase® to assess if clozapine was associated with an over-reporting of infections and to characterize those infections. The investigators also decided to assess the dose dependency associated with those infections.


Eligibility Criteria:
Inclusion Criteria:

* Case reported in the World Health Organization (WHO) database of individual safety case reports to 11/04/2023
* Adverse events reported were including the MedDRA terms: infections (SOC)

Exclusion Criteria:

Chronology not compatible between the drug and the toxicity
Domestic Surgical Robot Clinical Study

Central South University in collaboration with Tianjin University developed the first domestically produced Chinese minimally invasive surgical (MIS) robot system which named "Micro Hand S" in 2013. Recently, as the domestic surgical robot research project's main section, this new MIS robot had been authorized to enter the clinical trial stage by the Ethics Committee of the Third Xiangya Hospital at Central South University.

One surgeon perform these surgical trials using the robot "Micro Hand S". All of the patients were followed for 12 months, and pre- and postoperative changes in blood route test and hepatorenal function examination, surgery duration, hospital stay, total robotic setup time, total robotic operation time, intraoperative blood loss, total postoperative drainage amount, duration of bearing drainage tubes were recorded. In addition, the pre- and postoperative changes in the pathological and functional outcomes were measured.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of gastric tumor, colorectal tumor, acute cholecystitis and ileocecal tumor respectively
* 18years\<age\<65years
* male or female

Exclusion Criteria:

* patients with a history of open abdominal surgery
* unstable psychiatric illness
* an inability or reluctance to cooperate during long-term follow-up
* alcohol or drug addiction
* or relatively high surgical risks, such as abnormal coagulation function or bad heart, lung, liver and kidney function, were excluded from this study
Efficacy and Tolerability of an Antiretroviral Bi-Therapy in HIV Infected Patients With Multidrug Resistance

This study investigated whether a calibrated reduction in antiretroviral drug pressures could stabilize the evolution and the pathogenic potential of resistant HIV viruses.

In patients with HIV multidrug resistance, maintaining a failing full-dose HAART regimen usually results in significant drug toxicity and in continued accumulation of resistance mutations that can preclude future therapeutic options. In contrast, treatment interruption provokes the reemergence of wild-type virus with full replicative and pathogenic capacity. The researchers investigated whether a calibrated reduction in drug pressure could stabilize the evolution and the pathogenic potential of resistant virus.

A prospective pilot study was conducted in patients receiving protease inhibitor-based HAART with a resistance genotype predicting less than two active drugs according to the 2002 ANRS algorithm, CD4 counts over or equal to 100/mm3 and plasma HIV RNA below or equal to 5 log/ml. The treatment was low-dose IDV/RTV (200/100 BID) and 3TC 150mg BID. IDV doses were adjusted at week 4 to ensure a Cmin of 250+/-100ng/ml, which, based on a panel of multi-PI resistant viruses, was calculated to yield an inhibitory quotient (Cmin/IC50) of 0.50. Primary end-points were over 25% decrease in CD4 counts (immunological failure-IF), or over 0.7 log increase in plasma HIV RNA (virological failure-VF) at two consecutive monthly visits during the 24-week study. Inclusions were to stop when the total number of failures (VF+IF) reached 7

Eligibility Criteria:
Inclusion Criteria:

* HIV-1 infection confirmed by Western Blot
* Karnofsky score over or equal to 70
* CD4 over or equal to 200/mm3
* Plasma viral RNA over or equal to 10 000 copies/ml and below 100 000 copies/ml.
* Stability of plasma viral load and CD4-during the last 3 months
* failure of two antiretroviral regimens with 2 PI and one NNRTI
* New efficacy drug on genotype not available
* Treatment on hand with 3 antiretroviral drugs with one PI since 3 months.
* Written inform consent
* Pregnancy

Exclusion Criteria:

* Hemoglobin below 8g/dL
* Neutrophils below 750/mm3
* ASAT, ALAT over 5N
* Hepatic insufficiency (prothrombin below 50%)
* Acute opportunistic infection
* Immunotherapy
* Treatment with active antiretroviral regimen
* Treatment with enzyme inductor
An Open-Label Follow-on Trial to Assess the Long-Term Safety and Efficacy of Oral SPM 927 in Subjects With Postherpetic Neuralgia (PHN)

This trial was the follow-on trial to a preceeding double-blind, placebo controlled trial which included patients with at least moderate pain due to postherpetic neuralgia. It was conducted at six sites in Germany and has been clinically finalized. The patients had successfully completed the above mentioned trial in postherpetic neuralgia and, in the investigator's opinion, would benefit from long-term administration of Lacosamide. After a 1-week run-in phase the patients were uptitrated to their optimal dose and then continued into the maintenance phase. Dose adjustments were allowed throughout the trial.The change in pain was measured daily as well as interference of pain with sleep and general activity. As per protocol this trial was terminated after two years of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Postherpetic Neuralgia

Exclusion Criteria:

* Does not benefit from long term treatment
Chronic Hepatitis C and Insulin Resistance

Chronic hepatitis C (CHC) is among the commonest chronic infectious disease in Australia with \>200,000 exposed persons. Amongst non-infectious chronic conditions- Type 2 diabetes, obesity and heart disease are extremely common. This study will examine the relationship between insulin resistance, fat deposition in the liver, muscle and abdomen, and liver injury due to CHC


Eligibility Criteria:
Inclusion Criteria:

* Caucasian male
* Age: 25-55 years
* Chronic Hepatitis C (PCR positive) and fibrosis ≤ F2 (if liver biopsy done)
* Genotypes 1 or 3
* Due to commence antiviral therapy
* BMI \< 30

Exclusion Criteria:

* Cirrhosis or F3 fibrosis on liver biopsy (if done)
* \> 20 g ETOH per day
* Type 2 Diabetes (need an OGTT if fasting BGL\> 5.7)
* Concurrent HIV
* Other cause of liver disease
Descemet Membrane Endothelial Keratoplasty Combined With Intraocular Lens Exchange: Sequential Versus Combined Surgery

Surgical treatment of corneal endothelial decompensation in the presence of an anterior chamber intraocular lens (AC IOL) is technically challenging. The ultimate management is to perform Descemet membrane endothelial keratoplasty (DMEK). However , unfolding the DMEK graft in the presence of an AC IOL can be difficult and injurious to the graft so the investigators recommend exchanging the AC IOL with a posterior chamber IOL first. In this study , the investigators aim to compare the outcome and complications of performing DMEK and IOL exchange as combined one stage surgery versus .sequential 2 stage procedure

Pseudophakic Bullous keratopathy is the second leading indication for endothelial keratoplasty. One of the main controversies in the management of PBK in the presence of an AC IOl is whether to retain the IOL or perform an IOL exchange with a PC IOL. The investigators believe that retention of an AC IOL can be hazardous to the DMEK graft due to reduced depth of the anterior chamber and traumatic touch between the graft and the IOL during graft unfolding and even postoperatively. On the other hand , performing an IOL exchange is relatively time consuming and requires excess manipulation of the iris tissue with the risk of intraoperative hyphema and postoperative inflammation which can affect the endothelial graft survival and cell count.

Aim of the study : to compare the outcome and complications between performing intraocular lens (IOL) exchange and Descemet membrane endothelial keratoplasty (DMEK) as single stage versus two stage procedure in the management of pseudophakic bullous keratopathy associated with anterior chamber IOL.

Methods :

The study will be a prospective randomized controlled trial. Eligible subjects with pseudophakic bullous keratopathy and AC IOL will be assigned into two groups each comprising 10 eyes. One group will undergo AC IOL exchange with posterior chamber (PC) IOL ( Poly methyl methacrylate (PMMA) lens or iris claw lens if there is no adequate capsular support) combined with DMEK in the same setting. The other group will undergo 2 stage procedure ; first one is IOL exchange , iridoplasty (if required) and inferior peripheral iridectomy and the second stage is DMEK one month later.

Eligibility Criteria:
Inclusion Criteria:

1. Patients having pseudophakic bullous keratopathy associated with an anterior chamber intraocular lens.
2. Age above 18 years old.

Exclusion Criteria:

1. Patients with corneal stromal scarring .
2. Patients who had prior glaucoma drainage devices implantation. 3 Patient with non-repairable loss in the iris tissue.
To Evaluate the Efficacy and Safety of DW1903 in Acute and Chronic Gastritis Patient

A Multi-center, Double-blind, Randomized, Parallel, Active-controlled, Non-inferiority, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DW1903 in Patients with Gastritis


Eligibility Criteria:
Inclusion Criteria:

* Patients who were diagnosed with acute or chronic gastritis in a gastroscopy performed within 7 days prior to administration of this trial.
* At least one or more erosions have been identified on gastroscopy.
* Patients who decided to voluntarily participate in this trial and agreed in writing.

Exclusion Criteria:

* Patients who can not undergo gastroscopy
* Peptic ulcer (except scarring) and reflux esophagitis
* Patients who have had gastric acid suppression surgery or stomach/esophagus surgery (except for simple perforation surgery and appendectomy)
* Patients with a history of gastrointestinal malignancies
* Zollinger-Ellison syndrome patients
* Patient with spontaneous coagulation disorder
* Patients with an allergic or hypersensitive response to a study drug
* Patients with a potential pregnancy.
* Patients who had clinically significant abnormalities in the screening test.
* Pregnant and lactating women
* Those currently taking other study drugs
* patients who were judged to be ineligible for the trial by the principle investigator and the person in charge.
A Study to Evaluate MK0476 and Fluticasone to Control Asthma in Patients With Mild Persistent Asthma (0476-910)

A study to evaluate MK0476 and Fluticasone to control asthma in patients with mild persistent asthma.


Eligibility Criteria:
Inclusion Criteria:

* Patient is male or female, 6-14 years of age with mild persistent asthma
* Patient has a history of the following symptoms: wheezing, chest tightness, cough, etc.
* Patient has asthma diagnosed by a doctor

Exclusion Criteria:

* Patient is hospitalized
* Patient has had major surgery or participated in another clinical trial in the last 4 weeks
* Patient has been on a breathing tube for asthma
Troriluzole in Adult Participants With Spinocerebellar Ataxia

The purpose of this study is to compare the efficacy of Troriluzole (200 mg once daily) versus placebo after 48 weeks of treatment in subjects with spinocerebellar ataxia (SCA).


Eligibility Criteria:
Inclusion Criteria:

1. Participants with a known or suspected diagnosis of the following specific hereditary ataxias: SCA1, SCA2, SCA3, SCA6, SCA7, SCA8 and SCA10.

   1. A participant should have a confirmed genotypic diagnosis from a Clinical Laboratory Improvement Amendments (CLIA) certified lab (can produce test results); or,
   2. A participant has a family member that has a confirmed genotypic diagnosis from a CLIA certified lab (can produce test results) and must be willing to undergo genetic testing to confirm underlying SCA diagnosis; or,
   3. A participant has a confirmed genotypic diagnosis from a lab that is not CLIA certified and must be willing to undergo genetic testing to confirm underlying SCA diagnosis; or,
   4. A participant has clinical evidence that supports diagnosis of one of the aforementioned SCA genotypes but does not have producible test results from a CLIA certified lab from either a family member or for his or herself and the participant must be willing to undergo such testing to confirm the SCA diagnosis (in this case, site must wait for results of genotypic testing prior to randomization)
2. Ability to ambulate 8 meters without human assistance (canes and other devices allowed)
3. Screening Modified Functional Scale for the Assessment and Rating of Ataxia (f-SARA) total score ≥3.
4. Score of ≥1 on gait subsection of the f-SARA
5. Determined by the investigator to be medically stable at Baseline/randomization as assessed by medical history, physical examination, laboratory test results, and electrocardiogram testing.

Exclusion Criteria:

1. A ≥ 2-point difference on the Modified Functional SARA score between screening and baseline
2. Mini Mental State Exam (MMSE) score \<24
3. Any medical condition other than one of the hereditary ataxias specified in the inclusion criteria that could predominantly explain or contribute significantly to the participants' symptoms of ataxia.
4. A prominent spasticity or dystonia that, in the opinion of the investigator, will compromise the ability of the SARA instrument to assess underlying ataxia severity.
5. A score of 4 on any individual item (Items 1-4) of the f-SARA
6. Participants should be excluded at screening or baseline if medical conditions have arisen or there is a change in disease status that could confound the ability of the SARA to accurately reflect changes in ataxia severity.
7. Active liver disease or a history of hepatic intolerance to medications that in the investigator's judgment, is medically significant.
Could Pre-operative Rectal Misoprostol Reduce Intra-operative Blood Loss During Ceserean Section?

* Misoprostol reduces the uterine bleeding after cesarean delivery without harmful effects on either mother or baby.
* The aim of the this study is to address if there is any benefits 'regarding the intra-operative blood loss' from preoperative rectal administration of 400 mic of Misoprostol in addition to the routinely administrated 10 units of oxytocin

Research question:

In women undergoing elective ceserean section, is preoperative 400 mic Misoprostol reduce intra-operative blood loss?

Research hypothesis:

pre-operative Misoprostol doesn't reduce intraoperative blood loss in women undergoing ceserean section

Eligibility Criteria:
Inclusion Criteria:

* 38-41 weeks of amenorrhea
* scheduled for elective lower segment cesarean section

Exclusion Criteria:

* confirmed intrauterine fetal death
* more than previous 2 ceserean sections
* multiple pregnancy
* antepartum haemorrhage
* self-reported maternal heart disease
* current diagnosis of severe malaria or acute bacterial infection