cyrilzakka/clinical-trials huggingface dataset:
Genetic Analysis of Hereditary Non-Syndromic Oral Clefts

In a collaborative effort with the IBN AL-NAFEES Hospital (Damascus, Syrian Arab Republic), individuals from multiplex families determined to have hereditary oral clefts will be studied. The purpose of this study is to identify the gene(s) involved in heritable oral clefts by linkage analysis and gene mapping strategies. Characterization of genes involved in inherited oral clefts could provide important insight into the inheritance and pathogenesis of this disease.

In a collaborative effort with the IBN AL-NAFEES Hospital (Damascus, Syrian Arab Republic), individuals from multiplex families determined to have hereditary oral clefts will be studied. Healthy Syrian individuals with no family history of oral clefts will also be enrolled as a comparison group. The purpose of this study is to identify the gene(s) involved in heritable oral clefts by linkage analysis and gene mapping strategies. Characterization of genes involved in inherited oral clefts could provide important insight into the inheritance and pathogenesis of this disease. All families are enrolled into the study by our Syrian collaborators (under Ethics Board approval from the IBN AL-NAFEES Hospital) and only coded phenotype data and coded biospecimens are ever received at the NIH.

Eligibility Criteria:
* INCLUSION CRITERIA:

Enrollment in this study will be limited to individuals with non-syndromic unilateral or bilateral cleft lip with or without cleft palate and their unaffected relatives, from families which meet the following criteria:

1. A cluster of 2 or more affected first degree relatives, such as a parent and two offspring or 2 siblings, or
2. The occurrence of oral clefts in each of 2 generations in either the proband's paternal or maternal lineages.
3. The occurrence of oral clefts in 2 or more cousins (up to second cousins)

The subject population is comprised of probands and their families previously examined at the IBN-AL NAFEES Hospital or at other hospitals and clinics in the Syrian Arab Republic as well

as healthy controls from the same population. Consent documents are in Arabic language for non-English-speaking subjects

EXCLUSION CRITERIA:

Individuals unable to provide consent, except for cases who are children and mentally impaired persons with consenting parents or guardians.
Hypothermia in Acute Ischemic Stroke - Surface Versus Endovascular Cooling (HAIS-SE)

HAIS-SE is evaluating for the first time ever in a randomized controlled trial efficacy, tolerability, practicability and safety of endovascular versus surface cooling in awake stroke patients.

Mild hypothermia improves outcome in patients with global cerebral ischemia after cardiac arrest. Via animal models hypothermia has been identified as the most promising neuroprotective therapy in focal cerebral ischemia as well. But the prove of clinical benefit in patients with acute ischemic stroke is still missing: Most likely due to the prolonged time window until hypothermia-induction (14 h) in previous studies. In addition, feasibility of the method through which hypothermia is applied is crucial for a broad implementation of hypothermia in stroke therapy. Surface versus endovascular cooling have never been compared in a prospective trial in awake stroke patients.

HAIS-SE is evaluating for the first time ever in a randomized controlled trial efficacy, tolerability, practicability and safety of endovascular versus surface cooling in awake stroke patients.

Eligibility Criteria:
Inclusion Criteria:

* Ischemic stroke
* Intravenous thrombolysis within 4.5h from symptom onset
* Informed consent of the patient
* NIHSS score ≥ 2 and ≤ 20
* Age ≥ 18 and ≤ 90 years
* Placement of cooling catheter / cooling pads within 6h from symptom onset

Exclusion Criteria:

* (Expected) intubation (e.g. for interventional treatment)
* Pregnancy
* Body weight \> 120kg
* Body height \< 150cm
* Life-expectancy \< 3 months
* Fever \> 38.5°C at screening
* Known hematologic disease with increased risk of thrombosis (e.g. cryoglobulinemia, cold agglutinins, sickle cell anemia)
* Known vasospastic vascular disorder (e.g. Raynaud's phenomenon or thromboangiitis obliterans)
* Possible compression of the inferior vena cava (e.g. due to tumor) or vena cava filter
* Acute pulmonary embolism
* Acute myocardial infarction
* Severe cardiac insufficiency (NYHA ≥ III)
* Threatening ventricular dysrhythmia
* QTc-interval \> 450ms
* Bradycardia \< 50/min
* Sick-Sinus-Syndrom
* AV-block \> I°
* Severe infection with bacteremia or sepsis ≤ 72h
* Severe renal (GFR \< 30ml/min) or liver insufficiency (Child-Pugh C)
* Myopathy
* Known intolerance or allergy against acetaminophen, buspirone, clonidine, magnesium sulphate or pethidine.
* Treatment with MAO-inhibitors ≤ 14 days
* Acute closed-angle glaucoma
Early Active Rehabilitation After Arthroscopic Rotator Cuff Repair

The purpose of the study is to compare two different rehabilitation protocols after arthroscopic rotator cuff surgery.


Eligibility Criteria:
Inclusion Criteria:

* surgery of the rotator cuff after full thickness tear
* informed consent
* understanding german language

Exclusion Criteria:

* previous surgery of the shoulder
* neurological or systemic diseases with impairment of shoulder function
A Text-based Reduction Intervention for Smokeless Tobacco Cessation- Pilot Study

All participants will receive the EnufSnuff.TXT scheduled gradual reduction (SGR) intervention for 6 weeks and, for those who do not reach the point of quit, includes getting randomized (like the flip of a coin) into either an additional 8-10 weeks of the EnufSnuff.TXT intervention or into receiving an additional 8-10 weeks of the EnufSnuff.TXT intervention along with a dedicated text quit coach to send and receive live support.

All participants will receive the EnufSnuff.TXT intervention (a text-based personalized reduction plan and daily text-based cessation support messages) for 6 weeks and, for those who report that they have not achieved complete cessation, includes getting randomized into either an additional 8-10 weeks of the EnufSnuff.TXT intervention or into receiving an additional 8-10 weeks of the EnufSnuff.TXT intervention along with a dedicated quit coach to send and receive live text support. The investigators will conduct phone-based or smart phone-based assessments with participants at baseline, end of program, and 7-month follow-up after intervention completion. The investigators will also conduct a brief midpoint check (after the first 6 weeks of intervention) with participants to ask if they have quit using smokeless tobacco. Research staff will email participants redcap surveys at baseline, end of program, and 7-months. Participants will be able to opt for a recorded telephone interview at the 7-month check-in. Each opted-in participant will be interviewed only once.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age and older
2. Have used smokeless tobacco for the last year, currently dip 3 or more times a day
3. Have an address in a rural census tract defined by a RUCC code of 4-10 and/or an IMU of 62 or lower
4. Interested in participating in a cessation program; and
5. Have access to a cell phone with unlimited texting ability.

Exclusion Criteria:

1. Non-English speaking;
2. Have smoked cigarettes or used any other tobacco product in the past 30 days (i.e., dual user) and are not willing to abstain during the intervention period
3. Currently participating in a smokeless tobacco cessation study.
Endocrine and Exocrine Secretory Function Alterations After Moderately Severe and Severe Acute Pancreatitis

The goal of this observational study is to learn about post-acute pancreatitis diabetes mellitus (PPDM-A). The main questions it aims to answer are:

1. Are the incident rates of glucose metabolic disorders (pre-diabetes and diabetes mellitus) after acute pancreatitis of different etiologies the same?
2. Are alterations in endocrine and exocrine secretory function in patients with acute pancreatitis associated with all-round outcomes?

All patients with acute pancreatitis have been given the standardized treatment for the condition.

Investigators will compare the incident rates of glucose metabolic disorders (pre-diabetes and diabetes mellitus) after acute pancreatitis of different etiologies in patients with moderately severe (MSAP) and severe acute pancreatitis (SAP) to explore the association between alterations in endocrine and exocrine secretory function and all-round outcomes.

Investigators will prospectively collect data from patients with moderately severe (MSAP) and severe acute pancreatitis (SAP) in participant centers.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female Chinese subjects;
2. Age ≥18 years at the time of signing the informed consent;
3. Patients with a complete diagnosis of MSAP and SAP (according to the Chinese guidelines for the diagnosis and treatment of acute pancreatitis 2019);
4. Voluntary signatories of informed consent

Exclusion Criteria:

1. Patients with a history of diabetes mellitus or pre-diabetes mellitus, or glycosylated hemoglobin ≥ 6.0% or venous FPG ≥ 6.1 mmol/L at admission;
2. Patients have any evidence of type 1 diabetes-related autoimmunity;
3. Patients have any risk for secondary diabetes due to exposure to medications or other endocrine diseases;
4. Combined with pancreas-related trauma or a history of pancreatic surgery;
5. Patients undergo pancreatic surgery during treatment;
6. Pregnancy or breastfeeding;
7. Patients suffer from severe cardiac, hepatic or renal insufficiency or malignant diseases;
8. Failure to sign informed consent due to cognitive impairment or other conditions
Levo-Dexa vs. Tobra+Dexa for Prevention and Treatment of Inflammation and Prevention of Infection in Cataract Surgery

The purpose of this study is to demonstrate the non-inferiority of the study treatment (combined levofloxacin + dexamethasone eye drops) followed by dexamethasone eye drops alone vs. standard treatment in the prevention and treatment of postoperative ocular inflammation and prevention of infection.

In clinical practice, topical treatment following cataract surgery is frequently administered using a combination between an antibiotic and a corticosteroid to promote patient adherence to therapy and to obtain both prevention of infection and treatment of post-surgical inflammation.

The combination of tobramycin and dexamethasone is among the most widely used combinations, however, treatment duration and the need for tapering posology over several weeks may favour the development of bacterial resistance. The study treatment associating a broad-spectrum antibiotic with a highly effective corticosteroid that can be used for a short period of time (one week) is therefore of considerable interest.

The aim of this study is to evaluate the non-inferiority of the study treatment, used for a limited period of time and followed by dexamethasone alone, compared to standard treatment in preventing and treating ocular inflammation and in preventing post-operative infection while limiting the emergence of antibiotic resistance.

Eligibility Criteria:
Inclusion Criteria prior to surgery:

1. Signed written informed consent
2. Male or female, age ≥40 years
3. Scheduled senile or presenile cataract surgery
4. Willing to interrupt the use of contact lenses for the entire duration of the study
5. Able and willing to follow study procedures
6. Female patients must be postmenopausal, surgically sterile or must agree to use an effective method of contraception

   Inclusion criteria following surgery:
7. Surgery completed without complications

Exclusion Criteria:

1. Ocular conditions that at the discretion of the Investigator may interfere with the efficacy and/or safety evaluations
2. Patients undergoing bilateral cataract surgery
3. Patients under treatment with prostaglandin analogues or intravitreal injections of anti-vascular endothelial growth factor (VEGF) drugs
4. Systemic diseases that may interfere with the results of the study
5. Any condition that could interfere with correct instillation of eye drops
6. Ocular surgery in the study eye (including laser surgery) in the 3 months before screening
7. Monocular patients
8. Visual Acuity \< 20/80 of the contralateral eye measured as ETDRS or Snellen
9. Contraindications to ocular treatment with Tobradex®, Maxidex® or levofloxacin/dexamethasone
10. Hypersensitivity to the study product or its excipients
11. Participation in other clinical studies within at least 5 half-lives of the Investigational Medicinal Product (IMP) used in the previous studies
12. Pregnancy or breastfeeding
Nosocomial COVID-19 Infections in Patients Hospitalized at the Metz-Thionville Regional Hospital in 2021

The rate of nosocomial SARS-CoV2 infections found in the different studies since the beginning of the pandemic is very variable (\<1% in hospitals in the USA to about 20% in a British hospital). Mortality related to these nosocomial SARS-CoV2 infections is higher than in the general population. The risk factors identified for this nosocomial acquisition are multiple. We were confronted with nosocomial acquisitions and cluster situations in the services, without exhaustive data to measure these phenomena, and we lacked data to consider areas for improvement.

The objectives of this study are to determine the proportion of nosocomial SARS COV 2 infections in the total number of patients hospitalized with a Covid-19 infection at the CHR Metz-Thionville in 2021, and to describe the characteristics of this population.


Eligibility Criteria:
Inclusion Criteria:

* Patients hospitalised at the CHR Metz-Thionville in medicine, surgery and obstetrics (MCO) or geriatric follow-up and rehabilitation care (SSR) units, in 2021 for a Covid-19 infection defined by the existence of a positive PCR result for SARS-CoV2 during the stay, or by the existence of an ICD10 code for COVID in the PMSI data of the health care establishment

Exclusion Criteria:

* Opposition to participate in the study after reading the patient information note.
Transoral Endoscopic Liver Biopsy During Laparoscopic Gastric Bypass

This research is being done to evaluate the ability to obtain a liver sample using upper endoscopy rather than through a laparoscopic procedure. The investigators hypothesize that the endoscopic transoral route is as effective as the laparoscopic route.


Eligibility Criteria:
Inclusion Criteria:

1. Any patient who meets criteria to undergo laparoscopic Roux-en Y Gastric Bypass (BMI\>40 or BMI\>35 with multiple medical co morbidities).
2. Age greater than 18 years.
3. Ability to complete all necessary components of study (gastric bypass surgery standard qualifications).

Exclusion Criteria:

1. Inability to give informed consent
2. Women who are pregnant or in whom pregnancy status cannot be confirmed.
Study to Analyze Mutations in V600 BRAF Oncogen in Participants With Metastatic Melanoma

This is a national, multicenter, cross-sectional epidemiological study in adult Spanish participants diagnosed with advanced or metastatic melanoma.


Eligibility Criteria:
Inclusion Criteria:

* Valid tumor samples from participants diagnosed with Stage IIIc or IV melanoma
* Written informed consent granted

Exclusion Criteria:

- Do not fulfill one or more inclusion criteria
Clinical Study on 5-aminolevulinic Acid Hydrochloride (5-ALA) for Fluorescence-guided Resection of Malignant Gliomas

This study is planned to detect a dose-efficacy relationship between the chosen dose levels of MC506/1 and the extent and quality of fluorescence in the tumour core in patients with newly diagnosed malignant glioma.


Eligibility Criteria:
Inclusion Criteria:

* Radiological suspicion of a malignant glioma with distinct ring- or garland shaped, contrast agent-enhancing tumour structures and a core area of reduced intensity in the MRI (tumour necrosis)
* Indication for surgical tumour resection
* First operation of the tumour, no other tumour-specific pre-treatment
* Karnofsky Performance Scale 70%
* Patient's written informed consent
* Age 18-75 years

Exclusion Criteria:

* Porphyria, hypersensitivity to porphyrins
* Renal insufficiency:

  * Creatinine \> 2.0 mg/dl
* Hepatic insufficiency:

  * Bilirubin \> 3 mg/dl
  * Quick test \< 60 %
  * GT \> 100 U/I
* Other known malignancy (except basaliomas)

Women:

* Existing/planned pregnancy (to be checked by a pregnancy test if of child-bearing age)/lactation or inadequate contraception (hormone cycle regulation pill or condom)

Men:

* Inadequate contraception (condom)
* Dementia or mental condition making it impossible to understand the therapy and therefore prohibiting written consent
* Simultaneous participation or participation in another clinical trial in the preceding 30 days
MK0767 Glipizide Comparator Cardiac Safety Study (0767-018)

A study to evaluate the cardiac and metabolic effects of MK0767 in patients with Type 2 Diabetes.

This is an early phase trial and some specific protocol information is in progress and not publicly available at this time. (Full information is available to trial participants).


Eligibility Criteria:
Inclusion Criteria:

* You are taking at least one medication for high blood sugar
* Age 21 to 80

Exclusion Criteria:

* History of Type 1 Diabetes Mellitus
* Currently on estrogen replacement therapy regimen
* Currently on a weight loss program with ongoing weight loss or taking medications for weight loss
* Having surgery 30 days before starting the study
* Have taken any other investigational drug in the past 90 days
* Have Hepatitis B or C
* Active liver or gallbladder disease
Detection of Human Beta Cell Death in Type 1 Diabetes Mellitus (T1DM) by Methylation Specific Polymerase Chain Reaction (PCR)

To investigate the use of methylation-specific PCR (MSP) assays to detect human beta cell-specific gene methylation patterns in serial blood samples drawn from newly diagnosed Type 1 diabetics.

The study will follow 25 newly diagnosed type 1 diabetic patients from the onset of symptoms to one year post-diagnosis. A total of 11 fasting blood draws will be taken, the first near the time of diabetes diagnosis, then 2 weeks later, monthly for the next 6 months, and every other month until 12 months. Each blood sample will be evaluated by the MSP assay, as well as for measurement of fasting plasma glucose, HbA1c, c-peptide, and autoantibodies. The study will also need 25 healthy volunteers to help us match some DNA markers needed for this data. Healthy volunteers will be se=matched healthy individuals who have one blood sample drawn.

Eligibility Criteria:
Inclusion Criteria:

Healthy volunteers:

* Age \> 18 years of age,
* Otherwise healthy individuals with no cancer and not pregnant.

Type 1DM:

* Newly diagnosed type I diabetes,
* Age \> 18 years of age,
* Otherwise healthy individuals with no severe complications, no cancer, not pregnant,
* Willing and able to comply with the scheduled visits to the clinic for blood sampling,
* Remain under the continuing care of an Endocrinologist.
Marijuana's Impact on Alcohol Motivation and Consumption

This laboratory study will employ a repeated measures experimental design to examine the effect of high (7.2% THC) and moderate (3% THC) dose of marijuana, relative to placebo, on alcohol craving and on behavioral economic measure of alcohol demand after exposure to alcohol cues, and on subsequent drinking in an alcohol choice task in which participants choose either to drink or receive monetary reinforcement for drinks not consume. The study will recruit 173 non-treatment seeking heavy episodic alcohol drinkers who smoke marijuana at least twice weekly.

This laboratory study will employ a repeated measures experimental design to examine the effect of high (7.2% THC) and moderate (3.0% THC) dose of marijuana, relative to placebo, on alcohol craving and on behavioral economic measure of alcohol demand after exposure to alcohol cues, and on subsequent drinking in an alcohol choice task in which participants choose either to drink or receive monetary reinforcement for drinks not consumed. Moderators of the marijuana's effects on alcohol-related dependent variables will be tested: DSM5 alcohol use disorder severity, affective vulnerability, trait impulsivity, and working memory functioning. Several empirically-determined mechanisms that may explain why marijuana may increase risk of alcohol relapse and help maintain heavy drinking will be tested as mediators of marijuana's effects on alcohol. The study will recruit 173 non-treatment seeking heavy episodic alcohol drinkers who smoke marijuana at least twice weekly to obtain the final sample of 150 with complete data (15% of attrition). Participants will be tested at a baseline session and during three experimental sessions. Investigators will collect blood samples for analysis of cannabinoid plasma levels and to examine marijuana-induced changes in hormones and other biomarkers potentially related to appetite, inflammation and stress. Collection of these biomarkers would allow for a greater understanding about the mechanisms whereby marijuana may acutely increase alcohol motivation and use. The findings will inform researchers and clinicians about how marijuana acutely increases alcohol craving and consumption. The strategy of this proposal is to use the most comprehensive controlled test characterizing marijuana's putative effects on alcohol.

Eligibility Criteria:
Inclusion Criteria:

* Age 21 to 44
* English-speaking
* marijuana smoking in past month
* report of current heavy episodic (binge) drinking
* in good physical health and weighing \< 250 lbs
* zero breath alcohol at each visit

Exclusion Criteria:

* history of seizures
* smoking \>20 tobacco cigarettes per day
* positive pregnancy test
* nursing
* positive urine toxicology screen for drugs other than cannabis
* interest to quit or receive treatment for marijuana or alcohol use
* meeting criteria for a current affective disorder (depression, or mania, panic disorder, and having psychotic symptoms as assessed by the SCID)