cyrilzakka/clinical-trials huggingface dataset:
Investigations of Reproductive Cancers in Women

The goal of this study is to create a non-invasive diagnostic test to rule out gynecological cancer in females aged 45 and older with abnormal uterine or postmenopausal bleeding.


Eligibility Criteria:
Inclusion Criteria:

1. Evidence of a personally signed and dated informed consent form indicating that the subject has been informed of all pertinent aspects of the study.
2. Willing and able to comply with scheduled visits, study plan, and other procedures.
3. Expected to be available for the duration of the study and can be contacted by telephone during study participation.
4. Females aged \>45 (with roughly 80% of enrolled subjects over the age of 50).
5. Presence of uterus.
6. AUB or PMB being evaluated to rule out cancer.

Exclusion Criteria:

1. Investigator site staff members directly involved in the conduct of the study and their family members or subjects who are PinkDx, Inc. employees or their family members.
2. Other medical or psychiatric conditions that would increase the risk of study participation in the judgement of the Investigator.
3. Women who have had a hysterectomy.
4. Women with a known history of endometrial cancer or uterine sarcoma.
5. Women who have received prior treatment for endometrial cancer.
6. Inability or unwillingness to sign informed consent.
7. Clinical suspicion of pregnancy.
8. Women who have used a tampon within 7 days of sample collection.
Effect of Colloid Versus Crystalloid on Coagulation

In order to reduce bloodloss and need for transfusion to investigate the effect of colloid and crystalloid on coagulation assuming no difference between the groups.


Eligibility Criteria:
Inclusion Criteria:

* Patient more than 18 years old
* Indication for elective post-renal operation including cystectomy
* Patient without anticoagulative, acetylsalicylic acid or NSAID treatment for the last 5 days.

Exclusion Criteria:

* Intracerebral bleeding, manifest cardiac insufficient, renal insufficient demanding dialysis, hepatic or coagulation diseases
* Pregnant or nursing
* Allergic
* Disturbance in electrolytes
* Patient under committee
* Patient joining another trial interfering the actual trial.
Cryoablation Versus Radiofrequency Ablation for Small Renal Masses

The purpose of this study is to verify the oncological efficacy and safety of cryoablation and radiofrequency ablation for the treatment of small renal tumors.

By enrolling all patients treated with CA or RFA, this study will document for the first time the safety and the short and long term efficacy of CA compared to RFA as well as provide urologists and decision makers currently unavailable information on CA in Canada.

Eligibility Criteria:
Inclusion Criteria:

* Patients with tumors that progress in size while on a watchful waiting protocol;
* Patients with multiple tumors;
* Patients with a tumor in a solitary kidney;
* Patients with poor renal function and a renal tumor;
* Patients with significant co-morbidities that may benefit from a less invasive approach.

Exclusion Criteria:

* Large tumors \> 4.0cm;
* Unable to have a general anesthetic;
* Unable to comply with follow-up protocol (i.e., routine CT or MRI and a follow-up biopsy);
* Uncorrectable bleeding diathesis;
* Evidence of metastatic disease.
Sternal Fixation With STERN FIX After Medial Sternotomy

The goal of this single arm observational registry is to evaluate the safety and performance of the STERN FIX device in normal conditions of use, in patients treated with medial sternotomy according to the instructions for use.

The main goal of this registry is to evaluate the sternal stability in patients who had their sternum fixed with the STERN FIX system.

Participants will have their sternotomy closed with the STERN FIX device at the end of their cardiothoracic surgery and will be followed up as per standard of care. At discharge and at the 1 month FU visit the sternal stability will be assessed using the sternal instability scale (SIS).


Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years old patient
* Patient undergoing surgery requiring medial sternotomy
* Patient able and willing to provide informed consent to participate in the registry and/or who have provided written consent to have their clinical data added to the registry

Exclusion Criteria:

* Patients that are still growing.
* Patients with Sternal anomalies preventing the use of the STERN FIX Sternal Stabilization System, such as bone tumors located in the implant region.
* Patient with conditions previous to surgery that may impact healing, including bone blood supply limitations, insufficient quantity or quality of bone, or other severe structural bone damage.
* Patients with suspected or known allergies or intolerances to the implant material.
* Patients with severe osteoporosis or other degenerative bone diseases.
* Any patient unwilling to, or incapable of, following postoperative care instructions.
* Patients with any other medical or surgical process that may compromise or limit the adequate functionality of the implant.
* Pregnant patients or planning to become pregnant during the 2 months following surgery.
* Patients with life expectancy lower than 2 months.
* Patients who are or have been participating in an interventionist trial during the last 4 weeks

Intraoperative exclusion criteria

* Latent or active infection, or inflammation in the operating area.
* Signs of infection on the surgical site.
* Parasternal sternotomy.
* When the STERN FIX Sternal Stabilization System cannot ensure sufficient fixation.
* When a STERN FIX Sternal Stabilization System device cannot be placed properly in any intercostal space.
Exploratory Study of the Relevance of a Blood Test in the Management of Patients in the Context of Colorectal Cancer Screening

Colorectal cancer (CRC) is the third most common cancer in men and the second in women with an incidence of 43,350 new cases in 2018. This incidence is increasing every year.

Early detection is crucial in this pathology. In France, free screening is organized by health insurance for people aged 50 to 74 years. This screening is based on an immunological test (FIT: Fecal Immunological test), which aims to detect the presence of blood in the stool. In fact, some polyps or cancers cause bleeding that is often minimal and therefore difficult or even impossible to detect with the naked eye.

If this test is positive, a colonoscopy is done to check whether or not abnormalities are present in the colon or rectum. Performed under anesthesia, this examination can detect the possible presence of polyps or cancer.

Recently, with the covid-19 epidemic, the investigators were faced with an extension of the delays for colonoscopies which led to delays in patient care.

To prevent this, they propose to develop a blood test that would allow rapid identification of patients with colorectal cancer, requiring rapid management.

This blood test will permit to have a parameter for stratifying the therapeutic care in the event of epidemia or situation that constrains the organisation of the health system.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged more than18 years
* Cohort A : patients with suspected colorectal cancer following a positive immunological test during screening (presence of blood detected in the stool) or with gross bleeding OR Cohort B : patients who have already performed colonoscopy (on symptoms, or because of family history, or other ...), for whom the diagnosis of adenocarcinoma was identified by pathology prior to surgery, candidates for surgery on their colorectal tumor
* Signed and dated informed consent
* Patient affiliated to or beneficiary of French social security system.

Exclusion Criteria:

* Vulnerable persons according to the law (minors, adults under protection, persons deprived of liberty ...)
* Not ability to comply with the study protocol, in the Investigator's judgment
* pregnant woman
* Patient in the period of exclusion of another study
Sodium Benzoate and/or N-Acetylcysteine Added to TAU in Patients With Early Schizophrenia Spectrum Disorder.

This study aims to determine if the addition of Sodium Benzoate and / or NAC to TAU will be acceptable and tolerable and result in overall improvement of symptoms, social and cognitive functioning in patients with early schizophrenia spectrum disorder.


Eligibility Criteria:
Inclusion Criteria:

1. Male/Female patients aged between 18-35 years.
2. Diagnosis of schizophrenia confirmed by SCID interview meeting DSM-V criteria for schizophrenia, schizophreniform or schizoaffective psychosis.
3. Stable on medication for the past four weeks
4. In contact with mental health services
5. Within 5 years of diagnosis of psychotic illness
6. Able to demonstrate the capacity to provide informed consent as assessed by their own clinician
7. Able to complete the required evaluations and take oral medication.
8. Effective contraceptive precautions (either the use of barrier methods or the oral contraceptive pill) to be taken by women of child-bearing age. A negative pregnancy test will be required in order to meet inclusion criteria.

Exclusion Criteria:

1. Prior history of intolerance or serious side effects to Sodium Benzoate or N-acetylcystine.
2. Concomitant use of Ascorbic acid
3. Active substance abuse (except nicotine or caffeine) or dependence within the last three months according to DSM-V criteria.
4. Relevant CNS or other medical disorders.
5. Pregnant or breast feeding
6. Diagnosis of Moderate to Severe Learning Disability
7. Relevant current or past haematological, hepatic, renal, neurological or other medical disorder in the opinion of the principal investigator (PI) or the responsible clinician, that may interfere with the trial.
MHealth HIV Prevention for Transgender Women

This study aims to inform the development of an acceptable and usable smartphone app for transgender women (TGW) in Malaysia to deliver an integrated HIV prevention intervention that incorporates screening and guidance for HIV testing and pre-exposure prophylaxis compared to treatment as usual.

This study aims to inform the development of an acceptable and usable smartphone app for transgender women (TGW) in Malaysia to deliver an integrated HIV prevention intervention that incorporates screening and guidance for HIV testing and pre-exposure prophylaxis (PrEP) compared to treatment as usual.

A new clinic-affiliated app (to be called MyLink2Care) will be developed (by adapting an existing app) and tested to deliver an integrated HIV prevention intervention that incorporates tailored HIV prevention and gender affirming care (GAC) services to TGW in Malaysia. The specific aims of the study include:

* Aim 1: Guided by the modified IM Adapt model, an existing mobile app will be adapted, expanded, and refined. Focus groups will be conducted with TGW (n=20) and clinical stakeholders (n=10) to theater test the existing app to develop an interactive prototype of the MyLink2Care app (alpha version), which will undergo usability testing (N=10), followed by full development of the app (beta version).
* Aim 2 Conduct beta testing of the fully developed version of the MyLink2Care app (N=15) to assess its usability and acceptability.
* Aim 3: Assess preliminary feasibility and acceptability of the MyLink2Care app within a pilot, randomized controlled trial, compared with treatment as usual for engagement in the HIV prevention cascade (N=50).

Together, these aims will address multilevel barriers to HIV testing and PrEP uptake in Malaysian TGW. Feasibility is high based on the investigators extensive experience with HIV prevention in TGW, theory-guided behavioral interventions, mHealth expertise, and longstanding work in Malaysia.

Eligibility Criteria:
Inclusion Criteria:

* HIV-negative
* Identify as a transgender woman
* Condomless sex in the last 30 days
* Own a smartphone

Exclusion Criteria:

* Unable to provide informed consent
* Unable to read and understand English or Bahasa Malaysia
Safety and Efficacy of SPD476 (Mesalazine) Given Twice Daily (2.4 g/Day) vs SPD476 Given as a Single Dose (4.8 g/Day) in Subjects With Acute Mild to Moderate Ulcerative Colitis

The aim of this study was to investigate the safety and efficacy of SPD476 2.4 g/day given twice daily (\[BID\] ie 1.2 g/day BID) and SPD476 4.8g/day given QD compared to placebo in subjects with acute, mild to moderate ulcerative colitis.


Eligibility Criteria:
Inclusion Criteria:

* newly diagnosed or diagnosis of relapsing (relapsed \<= 6 weeks to baseline) mild to moderate ulcerative colitis
* women not of childbearing potential or WOCP who agreed to use an effective contraceptive method

Exclusion Criteria:

* severe ulcerative colitis or relapsed for \> 6 weeks prior to baseline
* subjects who had relapsed on maintenance therapy with doses of mesalazine \> 2.0 g/day
* subjects with Crohn's disease, proctitis, bleeding disorders or active peptic ulcer disease
* subjects with asthma if they were known to be mesalazine-sensitive
* subjects who were at immediate or significant risk of toxic megacolon
* subjects who had previous resective colonic surgery
* subjects who had moderate or severe renal impairment
Evaluating the Impact on Quality and Costs of Regional Clinical Data Exchange Programs in New York State

The purpose of this study is to measure the financial effects of health information technology and health information exchange in regional health information organizations in New York State.

In 2004, the federal government set an ambitious goal of ensuring that most Americans have electronic health records within 10 years and the presence of a widespread clinical information exchange capability will greatly facilitate this goal. Through HEAL NY, New York State is currently awarding millions of dollars in grants to support health information technology initiatives across the state through regional clinical information exchanges. The financial success of these initiatives is expected to result from improvements in health care quality and efficiency. However, whether these initiatives will be cost saving, as experts assert, and what the return-on-investments of these initiatives will be are unknown. Answering these questions will provide critical information to the nation as we progress towards a national health information network. We will conduct a multi-center financial evaluation of regional clinical information exchanges. The results of the financial evaluations proposed in this study will provide a framework and standardized methodology including metrics for financial evaluations of regional health information organizations and return-on-investment analyses from the perspectives of providers and payers. We will consider the financial effects as driven by changes in quality, safety, and efficiency.

The most advanced community we studied was Rochester, NY, and studying this community allowed us to measure the effects of health information technology and health information exchange on 3 major utilization outcomes (hospital admissions, hospital re-admissions, and repeat medical imaging).

Eligibility Criteria:
Inclusion Criteria:

* Patients and health care providers participating in regional health information organizations or their affiliate institutions.

Exclusion Criteria:

* None
Immunotherapy After Surgery in Treating Patients With Breast Cancer, Colon Cancer, or Melanoma

RATIONALE: Immunotherapy uses different ways to stimulate the immune system and stop cancer cells from growing. Immunotherapy biological extracts may be useful as adjuvant therapy in treating patients who have had surgery for breast cancer, colon cancer, or melanoma.

PURPOSE: Phase III trial to study the effectiveness of Corynebacterium granulosum extract as maintenance immunotherapy following surgery in treating patients with breast cancer, colon cancer, or melanoma.

OBJECTIVES:

* Determine the survival of patients with colon cancer, breast cancer, or melanoma with minimal residual disease after surgical resection treated with maintenance immunotherapy using Corynebacterium granulosum P40.
* Determine leucocyte adherence inhibition, an indication of metastases, over time in patients treated with this regimen.

OUTLINE: This is a multicenter study. Patients are stratified by center and are matched with case-controls by disease type and stage.

Beginning 2 weeks after surgical resection, patients receive Corynebacterium granulosum P40 subcutaneously weekly for 6 weeks, followed by rest for 3 months. Treatment continues for life.

Patients are followed for survival.

PROJECTED ACCRUAL: Not specified

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of colon cancer, breast cancer, or melanoma with minimal residual disease (at least 90% of tumor mass resected) after surgical resection
* Hormone receptor status:

  * Not specified

PATIENT CHARACTERISTICS:

Age:

* 20 to 80

Sex:

* Not specified

Menopausal status:

* Not specified

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* Not specified

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* See Disease Characteristics
Genome Study in Constitutional Thinness

Constitutional thinness (CT) is a recently defined entity as a differential diagnosis of anorexia nervosa (AN), considered to be the most frequent cause of low body mass index (BMI) in young women. CT subjects present no AN psychiatric traits, preserved menses, no biological signs of undernutrition and balanced energy metabolism despite a Body Mass Index (BMI) \<17 kg / m².

CT familial aggregation, low body mass without a hormonal explanation, and specific appetite regulation profile suggest a specific genetic profile in these subjects.

Objective: A family linkage study in order to identify genes involved in the constitutional thinness phenotype by using genome wide scan (GWAS) techniques Studied population: Fifty families including at least one well phenotyped CT index case (grade 2 or 3 of thinness according WHO classification). Blood or saliva is sampled for DNA extraction.

Perspectives: Revealing eventual abnormalities could lead to a more precise diagnosis of constitutional thinness and new hypothesis in understanding extreme bodyweight mechanisms.


Eligibility Criteria:
Inclusion Criteria:

* For all subjects:

  * age \> 18 yrs
  * affiliation to health insurance
  * member of a family including at least 2 CT members and overall 3 evaluable members over 2 generations
  * written and signed consent
* For CT subjects :

  * grade 2 or 3 of thinness according WHO classification
  * women, BMI \< 17 kg/m² at 20-30 yrs or \< 19 for older subjects
  * men, BMI \< 18 kg/m² at 20-30 yrs or \< 20 for older subjects
  * absence of DSM criteria for anorexia nervosa
  * young women : normal menses and fat mass percentage 15 % ; absence of DSM criteria for anorexia nervosa
  * men : normal testosterone level
* For subjects without CT :

  * women, BMI \> 19 kg/m²
  * men, BMI \> 20 kg/m²

Exclusion Criteria:

* CT subjects:

  * smoking \> 5 cigarettes / day
  * history of emaciating pathologies
  * intense physical activity \> 7 hours / week
* For all subjects :

  * refuse of written consent
A Three-year Behavioral Treatment of Obese Children

The prevalence of overweight and obesity among children and adolescents has reached epidemic proportions worldwide. Among Swedish 10-year old children 15-20% are overweight and 3-5% are obese. The probability that an obese child becomes an obese adult is very high. This chronic disease requires lifetime treatment. The standard treatment of childhood obesity involves behavioural interventions focused on eating habits and physical activity. Studies often include small study samples, the absence of control groups and short treatments times. Several long-term follow-up studies of shorter interventions are available. The results from these studies are disappointing since the number of children who are "cured" i.e., have become non-obese is low. Thus, effective treatments are currently lacking.The National Childhood Obesity Center treats children in a University hospital setting. The children are enrolled from the catchment areas of the hospital as well as the rest of Sweden. Treatment alternatives include behavioural treatment (individual and group), low and very low calorie diet, pharmacological and surgical treatment. Patients treated with surgical and pharmacological methods safety is ensured using these treatments exclusively in controlled studies. The clinic was the first in Sweden with this wide range of treatment options.

BORIS is a national health care quality register for childhood obesity, supervised by the Swedish Association of Local Authority and Regions.

The primary aim of this study was to compare treatment effects (changes in BMI SDS) during the first three years of behavioral treatment in relation to age at start of treatment. The secondary aim was to evaluate specific factors of importance (gender, heredity, parental weight status, socioeconomic factors and age at obesity onset) for treatment effects. The third aim was to investigate factors correlated to drop out.

This is a longitudinal study of all patients referred to National Childhood Obesity Center between January 1997 and December 2004. Only patients with behavioral treatment were included. Patients with other treatments (VLCD/LCD, drugs and surgery) and other diagnoses (syndromes, craniopharyngioma, Mb Down, myelomeningocele, various types of mental and psychological disorders) and children \<6 and \>17 year at inclusion were excluded. The remaining children were divided into three age groups of obese children depending of age at onset of obesity treatment (6-9, 10-13 and 14-16year). All patient data were registered in the BORIS nationwide childhood obesity database.

Eligibility Criteria:
Inclusion Criteria:

* All children treated with behavioral treatment at the National childhood obesity center Stockholm between january 1998 - december 2004.
* Classified as obese by using the Tim Cole standard.

Exclusion Criteria:

* Children with obesity together with other diagnosis
* Children with other treatment like pharmacological, low calorie diets and surgery
Evaluation Of Clinical Results And Imaging Of Anterior Cruciate Ligament Reconstruction With Orthopure Xt

The purpose of this study is to evaluate subjective and objective clinical outcomes and imaging data of subjects undergoing reconstruction or revision of LCA reconstruction using OrthoPure XT


Eligibility Criteria:
Inclusion Criteria:

* Patients between the ages of 18 and 65 at the time of ACL reconstruction surgery;
* Patients aged 35 to 65 at the time of primary ACL reconstruction surgery;
* Male and female sex;
* First injury of the ACL with impossibility of use of autograft (patellar tendinopathy, quadriceps tendinopathy, goose leg tendinopathy) or refusal to use allograft (Bank tendon);
* Recurrence of ACL injury with impossibility of use of autograft (prior use/tendinopathy of the patellar, previous use/tendinopathy of the quadriceps, previous use/tendinopathy of the goose leg) or refusal to use allograft (tendon of Bank);

Exclusion Criteria:

* Patients who do not consent to be included in the study
* Presence of haematological, rheumatic or haemorrhagic disease time of assessment
* ACL primary reconstruction in subjects under 35
* Allergies and/or reactions from hypersensitivity or religious objection to the use of porcine derivation
* Pregnant and/or breastfeeding women